[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stress\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stress":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,236,0,25,[9,48,76,104,129,161,191,216,262,285,314,350,377,409,429,455,483,512,542,567,589,606,631,654,686],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053370","impact-of-serial-bedside-video-calls-on-stress-level-in-parents-of-infants-admitted-to-nicu-100053370",false,"NCT06252883","Impact of Serial Bedside Video Calls on Stress Level in Parents of Infants Admitted to NICU","Impact of Serial Bedside Video Call Communication on Stress Level in Parents of Infants Admitted to NICU.","Inclusion Criteria:\n\n\\- Newborns with 7 days or more of NICU stay\n\nExclusion Criteria: Infant with\n\n* intrauterine drug exposure\n* major critical congenital cardiac anomaly\n* major neurologic anomaly\n* chromosomal disorder.","ALL","7 Days","60 Days",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this randomized prospective interventional study is to determine if serial bedside video calls w\u002Faudio feature to NICU parents in addition to the routine phone and\u002For bedside updates can reduce parental stress level. The main question it aims to answer is if the impact of audio-visual calls to nicu parents can improve parent-infant relationship in the form of reduced parental anxiety\u002Fstress level.\n\nParticipants will be parents of infants admitted to NICU for more than seven (7) days.\n\nParents in Group A will receive serial video call communication, 2-3 days a week in addition to the daily phone and\u002For bedside updates.\n\nParents in Group B will receive daily phone and\u002For bedside updates per our NICU routine.\n\nParents will complete a series of questionnaires (PSS-NICU, STAI Y-1 \\& 2 and MSPSS) at 3 designated periods during an 8-week time frame.\n\nResearchers will compare Group A (intervention group) and Group B (control group) to see if there is any difference in the stress levels in relation to the intervention (serial video calls) at the end of the study time frame.",[28],"Stress",[30,31,32,33,34],"Parental stress","Anxiety","NICU","PSS-NICU","STAI-Y","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2024-06-01",{"date":43,"type":22},"2027-04",{"name":45,"class":46},"Cook County Health","OTHER_GOV",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":47},"100053580","diaphragmatic-and-box-breathing-on-heart-rate-variability-and-perceived-stress-100053580","NCT07698652","Diaphragmatic and Box Breathing on Heart Rate Variability and Perceived Stress","Enhancing Physiological and Psychological Resilience: A Comparative Study of Diaphragmatic and Box Breathing in Physical Therapy Students.","HRV DB BB PSS","Inclusion Criteria:\n\n* Academic Status: Currently enrolled, full-time undergraduate Physical Therapy students\n* Age Range: 18-25 years\n* Health Status: Generally healthy individuals with no known chronic respiratory or cardiovascular diseases.\n* Informed Consent: Ability and willingness to provide written informed consent and commit to the 4-week protocol (6 sessions\u002Fweek).\n* Stress Level: A baseline score on the Perceived Stress Scale (PSS) indicating at least moderate stress.\n\nExclusion Criteria:\n\n* Pre-existing Breathing Expertise: Individuals with professional training in yoga (Pranayama), formal meditation, or advanced breath work that might bias the baseline results.\n* Medical Conditions: Diagnosed respiratory conditions (e.g., Asthma, COPD).\n* Cardiovascular issues (e.g., Arrhythmias, Hypertension).\n* Clinical psychological disorders (e.g., Generalized Anxiety Disorder or Panic Disorder) that may require medication.\n* Pharmacological Factors: Use of medications that influence the Autonomic Nervous System (e.g., Beta-blockers, antidepressants, or heavy use of stimulants\u002Fsedatives).\n* Substance Use: Smokers\u002FVapers\n* Excessive Caffeine \"Participants consuming more than 400 mg of caffeine per day (equivalent to approximately 4 standard cups of brewed coffee) will be excluded.\n* Recent Acute Illness: Any respiratory tract infection or fever within two weeks prior to the start of the study",true,"18 Years","25 Years",{"count":60,"type":22},60,[25],"The goal of this clinical trial is to learn if diaphragmatic breathing and box breathing work to enhance resilience and manage stress in physical therapy students. It will also learn about their effects on overall physiological and psychological parameters. The main questions it aims to answer are:\n\nDo these breathing techniques improve heart rate variability (HRV)?\n\nHow do these interventions affect participants' perceived stress levels, cognitive performance, and academic achievement?\n\nResearchers will compare diaphragmatic breathing and box breathing to a control group to see if these non-invasive methods work to improve physiological adaptation and manage stress.\n\nParticipants will:\n\nBe randomly assigned to practice diaphragmatic breathing, practice box breathing, or join a control group Have their heart rate variability (HRV) measured as a primary sign of physiological adaptation Complete assessments to evaluate their perceived stress, cognitive performance, and academic achievement",[28,64,65],"Psychological Resilience","Healthy Students","NOT_YET_RECRUITING","2026-07-07",{"date":38,"type":39},{"date":70,"type":22},"2026-07-01",{"date":72,"type":22},"2027-03-01",{"name":74,"class":75},"Cairo University","OTHER",{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":47},"100053787","prevention-of-burnout-in-spanish-healthcare-professionals-through-attachment-based-compassion-therapy-abct-100053787","NCT07698379","Prevention of Burnout in Spanish Healthcare Professionals Through Attachment-Based Compassion Therapy (ABCT)","Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services: A Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Active healthcare professionals (physicians and nurses) of both sexes.\n2. Understanding of spoken and written Spanish.\n3. Availability of a computer and internet connection.\n4. Written informed consent.\n\nExclusion Criteria:\n\n* Previous psychological treatment within the last year, or current psychological treatment.\n\nPresence of a severe uncontrolled medical, infectious, or degenerative disease that may interfere with affective symptoms.\n\nPresence of a mental disorder related to substance dependence\u002Fabuse, or any other disease affecting the central nervous system.\n\nSuicide risk, defined as a score of ≥2 on item 9 of the PHQ-9. Scheduled surgical intervention during the course of the study.","75 Years",{"count":85,"type":22},180,[25],"Burnout is a common problem among healthcare professionals and may affect their psychological well-being, quality of life, and professional functioning. This study will examine whether an intensive compassion-based intervention can help reduce burnout and improve well-being in healthcare professionals. Participants will be randomly assigned to either an Attachment-Based Compassion Therapy intervention or a relaxation intervention. Outcomes will be measured before the intervention, immediately after the intervention, and three months later.\n\nAttachment-Based Compassion groups will be composed of 80 participants each, and TAU group will be composed of 80 participants (total sample n = 160).\n\nBurnout Inventory-Human Services Survey - MBI-HSS. Burnout will be assessed using the Maslach Burnout Inventory-Human Services Survey. This questionnaire evaluates the three main dimensions of burnout: emotional exhaustion, depersonalization, and personal accomplishment.\n\nItems are rated on a Likert-type scale according to the frequency with which the participant experiences each symptom. Scores are calculated separately for each burnout dimension.\n\nIn this study, emotional exhaustion and depersonalization will be considered the primary outcome variables, while reduced personal accomplishment will be considered a secondary outcome variable",[89,90,28],"Burnout Syndrome","Anxiety Depression",[92,93,94,95,96,97],"burnout","anxiety","Mindfulness","Compassion","ABCT","healthcare personnel",{"date":38,"type":39},{"date":36,"type":22},{"date":101,"type":22},"2028-04-30",{"name":103,"class":75},"Hospital Miguel Servet",{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":47},"100644924","the-effect-of-a-stress-ball-during-oral-care-procedures-100644924","NCT07676422","The Effect of a Stress Ball During Oral Care Procedures","The Effect of a Stress Ball on Pain, Anxiety, and Stress During Oral Care Procedures: A Randomized Controlled Experimental Study","Inclusion Criteria:\n\n* Being 18 years of age or older,\n* Being conscious and able to communicate,\n* Having an indication for oral care application,\n* Agreeing to participate in the study voluntarily.\n\nExclusion Criteria:\n\n* Being under heavy sedation,\n* Those with limited upper extremity movement,\n* Those with severe neurological disorders,\n* Having any problem with squeezing a ball in their hand (wound, fracture, weakness)\n\nTermination Criteria:\n\n* Those who wish to withdraw from the study,\n* Those who change institutions\u002Fcity,\n* The study will be terminated in the event of the patient's death.",{"count":112,"type":22},52,[25],"This study aims to evaluate the effect of using stress balls during oral care procedures performed on conscious patients in the intensive care unit on patients' pain, anxiety, and stress levels.",[116,28],"Pain",[118,119],"Stress ball","Oral Care Procedures","2026-06-29",{"date":122,"type":39},"2026-06-30",{"date":124,"type":39},"2026-05-25",{"date":126,"type":22},"2026-08-25",{"name":128,"class":75},"Yuzuncu Yil University",{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":56,"sex":17,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":47},"100596464","body-awareness-therapy-in-high-stressed-young-adults-effects-on-function-balance-sleep-and-mood-100596464","NCT07045792","Body Awareness Therapy in High Stressed Young Adults: Effects on Function, Balance, Sleep and Mood","Investigating the Effects of Body Awareness Therapy on Functional Capacity, Balance, Sleep Quality and Psychological State in Young Adults With High Stress Levels: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Be between 20 and 30 years old\n* Be literate\n* Score 10 or above on the stress subscale of the Depression Anxiety Stress Scale -21\n* Be willing to participate in the study voluntarily\n\nExclusion Criteria:\n\n* Individuals with orthopedic, neurological, rheumatological, psychiatric, mental, or any systemic chronic diseases\n* Those with cardiac problems that may prevent exercise\n* Those suspected of being pregnant\n* Individuals with malignancy\n* Individuals with active infection\n* Those who do not regularly attend the treatment program","20 Years","30 Years",{"count":139,"type":22},30,[25],"Body Awareness Therapy (BAT) is a holistic approach to human movement that considers the physical, physiological, psychological, and existential aspects of human existence. This planned randomized controlled study will be conducted on young adults with high stress levels. One group will be subjected to BAT and the other group will be the control group. The BAT exercises will be performed in supine, sitting and standing positions. In the BAT group, the exercises will be performed as a group exercise, not individually. After the initial evaluations in both the BAT and control groups, a re-evaluation will be performed at the end of 8 weeks. Functional capacity will be assessed with the 6-minute walk test, static balance with the single-leg balance test (eyes open-eyes closed), dynamic balance with the Y-balance test, psychological status with the Depression-Anxiety-Stress Scale-21 (DASS-21), and sleep quality with the Pittsburgh Sleep Quality Scale. BAT will be performed 2 days per week for 8 weeks and will be continued progressively. This study will examine the effects of BaT on functional capacity, balance, sleep quality, and psychological state in young adults with high stress levels.",[28,143,144,145],"Psychological Factors","Sleep","Postural Balance",[147,148,149,150,151,152,153,145],"Body Awareness Therapy","Stress Levels","Psychological Stress","Balance","Sleep Quality","Functional Capacity","Physical Therapy",{"date":70,"type":39},{"date":156,"type":39},"2025-05-30",{"date":158,"type":22},"2026-06-28",{"name":160,"class":75},"Mustafa Kemal University",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":56,"sex":17,"minAge":57,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":47},"100490484","state-dependent-interoception-value-based-decision-making-and-introspection-100490484","NCT05666726","State-dependent Interoception, Value-based Decision-making, and Introspection","State-Dependent Interoception, Value-Based Decision Making, and Introspection","* INCLUSION CRITERIA:\n\nSubject selections will be equitable among those individuals who meet the inclusion criteria. Every effort will be made to balance sex and race. In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* All sexes; Age 18 to 55.\n* Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nFor all experiments:\n\n* Unable to comply with study procedures or follow-up visits\n* Has any serious or unstable medical condition or history that in a clinician s assessment implies a cardiovascular, neurological, or physical risk from the study procedures performed to induce negative valence states. This may include chronic systemic disorders that could worsen due to stress (e.g. uncontrolled hypertension, coronary artery disease for example a history of myocardial infarction or stable or unstable angina, or diabetes)\n* Has any current psychiatric diagnosis (based on SCID or the MINI Mini International Neuropsychiatric Interview) or no diagnosis but scores \\>=29 on Beck Depression Inventory II or \\>=26 on Beck Anxiety Inventory\n* Meets criteria for diagnosis of any substance-related or addictive disorder, or endorses any kind of problematic gambling behavior or problematic media-based addictive behavior (such as videogames, social-networking, online shopping, etc.)\n* Regular use of psychoactive medications or psychoactive substances\n* Regular use of corticosteroids\n* Is pregnant\n\nFor stress and pain induction:\n\n* Has a major medical condition or medical history that in a clinician s assessment could affect temperature sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, neurological, psychiatric, or chronic systemic disorders (including but not limited to stroke, blindness, deafness, history of brain damage, neurodegenerative, neurotoxic or demyelinating disorder, or diabetes)\n* Has a medical condition that in a clinician s assessment might affect somatosensation (e.g., Raynaud s disease, peripheral neuropathy, or circulatory disorder)\n\nFor pain induction:\n\n* Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months)\n* Has a dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous 4 weeks that might influence cutaneous sensibility\n* Regular and recent use of prescription or over-the-counter medication that has a significant effect on pain or heat perception. These include medications such as centralacting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbiturates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an as needed basis is acceptable as long as the last dose taken was within 5 half-lives of testing.\n\nFor craving induction:\n\n* Has a condition that in a clinician s assessment could preclude the ability to hold 4-6 hours of fasting or that is associated with a risk of hypoglycemia (such as diabetes, kidney disease, insulinoma, adrenal or pituitary tumors or disorders, or anorexia nervosa)\n* Is currently engaged in any kind of diet medically- or self-prescribed or endorses a very strong desire to start a diet that involves eliminating or decreasing carbohydrate consumption\n* Has a history of food allergies such as tree-nut or peanut allergy.\n\nFor fMRI experiments:\n\n* Individuals with conditions that could pose a risk relating to the safety of the fMRI procedure but do not meet specific exclusion criteria for all experiments or for specific inductions will be excluded from the MRI portion of the protocol but may participate in the non-MRI sessions. Such conditions include:\n* Those with ferromagnetic metal in the cranial cavity or eye (e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body)\n* Those with an abnormality on a structural MRI\n* Those with an implanted cardiac pacemaker or auto-defibrillator\n* Those with an insulin pump\n* Those with an irremovable body piercing\n* Pregnancy (based on urine test completed within 24 hours prior to scan)\n* Left-handed (only for fMRI experiments involving thermal pain stimulation)","55 Years",{"count":170,"type":22},900,[25],"Background:\n\nNegative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then make riskier choices. Other negative emotional states that can change behavior include stress, pain, and sadness. By learning more about how emotions affect thinking and behavior in healthy people, researchers hope to better understand how to identify and treat people with mental disorders.\n\nObjective:\n\nTo learn how negative emotions affect the brain and decision-making behavior.\n\nEligibility:\n\nHealthy people aged 18 to 55 years.\n\nDesign:\n\nParticipants will have 3 clinic visits in 3 weeks.\n\nParticipants will fill out questionnaires. They will be asked about their personal history, their personality, and state of mind.\n\nFor 2 visits, participants will be assigned to different groups. Each group will experience 1 type of emotional stressor:\n\nSome participants will watch a video.\n\nSome will have to do arithmetic problems.\n\nSome will have heat applied to an arm or leg.\n\nSome will experience cold by immersing their hand in ice water.\n\nFor a snack craving test, some will be tempted by food after a 4-hour fast.\n\nDuring these tests, participants will have sensors attached to their bodies. They will be videotaped. Saliva samples will be collected.\n\nAfter the stressors, participants will do tasks on a computer. They will need to make choices.\n\nSome participants will perform these decision-making tasks while lying in a brain scanner for functional magnetic resonance imaging. The brain scan involves lying on a table that slides into a cylinder that takes images of the brain.\n\n...",[28,116,174,175,176],"Emotions","Craving","Frustration",[178,179,180,28,116,181],"Decision-Making","Interoception","Metacognition","Negative Emotion","2026-06-27",{"date":122,"type":39},{"date":185,"type":39},"2023-07-25",{"date":187,"type":22},"2029-12-31",{"name":189,"class":190},"National Institute of Mental Health (NIMH)","NIH",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":137,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":47},"100644565","effects-of-an-osteopathic-manual-therapy-protocol-on-heart-rate-variability-stress-and-anxiety-in-young-adults-100644565","NCT07670806","Effects of an Osteopathic Manual Therapy Protocol on Heart Rate Variability, Stress, and Anxiety in Young Adults","Effect of an Osteopathic Intervention Protocol on the Parasympathetic System on Stress and Anxiety in Young Adults: a Randomized Clinical Trial","Inclusion Criteria:\n\n* age between 18 and 35 years old;\n* presence of symptoms\u002Fdiagnosis of stress and\u002For anxiety in the last week.\n\nExclusion Criteria:\n\n* individuals with cognitive impairments that prevent participation;\n* individuals with cardiovascular problems;\n* pregnant women;\n* those taking medications that affect cardiac function, anxiolytics, and antidepressants;\n* caffeine consumption in the last 4 hours;\n* alcohol consumption in the previous 24 hours;\n* tobacco use in the last 48 hours;\n* recent cervical trauma;\n* students of osteopathy.",{"count":139,"type":22},[25],"Anxiety is characterized by excessive worry and anticipation of future threats, often accompanied by physiological and behavioral manifestations. Anxiety disorders are among the most prevalent mental health conditions worldwide and represent a significant public health concern, particularly among young adults and university students, who frequently experience academic, social, and financial stressors. The aim of this randomized clinical trial is to evaluate the effect of a protocol, consisting of 4 manual techniques, compared to a placebo group, in heart rate variability immediately after the intervention and in anxiety after one week in young adults. The main questions it aims to answer are:\n\nDoes the osteopathic intervention protocol influence the parasympathetic nervous system? Does the osteopathic intervention protocol influence anxiety and stress?\n\nThe researchers will compare the osteopathic protocol to a placebo (simulation technique), in order to see if the protocol influences anxiety and stress. Participants will:\n\nPrior to the intervention, complete the EADS questionnaire and undergo measurement of heart rate variability; Undergo the protocol or placebo; Immediately after the intervention, they will undergo the measurement of heart rate variability; After one week in the intervention, complete the questionnaire EADS.",[28,31],[31,203,204,205,206,207],"Autonomic System Nervous","Parasympathetic Autonomic System Nervous","heart rate variability","Manual Therapy Techniques","Young Adults","2026-06-25",{"date":120,"type":39},{"date":211,"type":22},"2026-06",{"date":213,"type":22},"2026-09",{"name":215,"class":75},"Escola Superior de Tecnologia da Saúde do Porto",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":224,"minAge":57,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":228,"conditions":229,"keywords":251,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":47},"100586442","personalized-care-for-prenatal-stress-reduction--prevention-of-preterm-birth-ptb-disparities-100586442","NCT06915428","Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities","Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) A Randomized Controlled Trial (RCT) of Personalized Care for Prenatal Stress Reduction and Preterm Birth Disparities Prevention","PTBCARE+","Inclusion Criteria:\n\n1. Viable, singleton pregnancy, 8+0 to 19+6 weeks, dated by last menstrual period ± ultrasound using standard obstetric criteria per American College of Obstetricians and Gynecologists.\n\n   Gestational age at first ultrasound by last menstrual period (LMP) \u002F Ultrasound method \u002F Measurement agreement with LMP required • Up to 8 weeks 6 days \u002F crown rump length \u002F ± 5 days\n   * 9 weeks 0 days to 13 weeks 6 days \u002F crown rump length \u002F ± 7 days\n   * 14 weeks 0 days to 15 weeks 6 days \u002F standard fetal biometry \u002F ± 7 days\n   * 16 weeks 0 days to 19 weeks 6 days \u002F standard fetal biometry \u002F ± 10 days\n   * Gestational dating \u002F fetal viability must be confirmed by ultrasound prior to enrollment \u002F randomization.\n   * Ultrasound report must include documentation of normal fetal heart rate of ≥ 120 beats per minute, or subsequent medical record documentation of auscultation of fetal heart rate ≥ 120 beats per minute.\n   * Viability must be confirmed \u002F re-confirmed within 7 days of randomization.\n\n   If initial consent occurs early in pregnancy and V1\u002Frandomization occur later, viability must be reconfirmed to ensure ongoing eligibility prior to initiating V1 activities (including surveys) and proceeding with randomization.\n2. No signs or symptoms of, or clinical diagnosis of, evolving miscarriage, active preterm labor, preterm prelabor rupture of membranes at the time of enrollment.\n\n   * Cervical dilation at the time of enrollment is an exclusion criterion. However, cervical evaluation and digital cervical exam is not required prior to enrollment.\n\n     (3a) High a priori risk for medically indicated preterm birth - must meet at least one of the following 3 criteria (maternal medical history, prior pregnancy history, or moderate risk factor history)\n   * miPTB criteria #1: Maternal Medical History - any one of the following:\n\n     o Known chronic hypertension requiring medications in the 3 months prior to conception or prior to 22 weeks gestation.\n\n     o At least 2 blood pressure readings 6 hours apart, \\\u003C20 weeks gestation, with systolic ≥ 130 mmHg or diastolic ≥ 80 mmHg \\*regardless of need for medication or formal diagnosis of hypertension in chart\\*\n\n     o Pre-gestational diabetes mellitus.\n     * Diabetes diagnosed \\\u003C20 weeks gestation.\n     * Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:\n\n       \\*biopsy proven chronic renal disease history; and\u002For\n\n       \\*serum creatinine ≥ 1.1 mg\u002FdL at any time during pregnancy prior to enrollment, in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis); and\u002For\n\n       \\*chronic proteinuria, defined as baseline urine protein:creatinine ratio ≥ 0.30 mg\u002FdL or 24 hour total urine protein ≥ 300 mg in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis)\n\n       \\*Systemic Lupus Erythematosus\n       * Antiphospholipid Antibody Syndrome\n   * miPTB criteria #2: Prior pregnancy history - any ONE of the following: o Previous pregnancy complicated by preeclampsia or hypertensive disorders of pregnancy at any gestational age, in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Previous history of stillbirth ≥ 16+0 weeks in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy. The stillbirth etiology must not have been attributed to physical trauma (e.g., domestic violence, motor vehicle accident) or illicit drug use (e.g., cocaine use leading to abruption and stillbirth).\n   * miPTB criteria #3: Any two or more of the following moderate risk factors: o Nulliparity, defined as no prior pregnancy to reach at least 20 weeks gestation note that this is the traditional \u002F classic definition of 'nulliparous' and that there is overlap between nulliparity as defined this way and 'preterm birth' due to cervical insufficiency, which allows for deliveries in the 16-19 week gestational age range to be considered as 'preterm births'\n\n     o Obesity: current or pre-pregnancy body mass index ≥30 kg\u002Fm\\^2\n\n     o Family history: first degree relative with a history of preeclampsia\n\n     o Advanced maternal age: maternal age ≥ 35 years at estimated date of confinement\n\n     o Prior adverse obstetric history - one or more of the following:\n\n     \\- history of low birth weight or small for gestational age baby in a singleton gestation, defined as weight \\\u003C10% for gestational age and fetal sex; the fetus must not have had major structural anomalies or aneuploidy.\n\n     \\- history of adverse pregnancy outcome in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Long interpregnancy interval: ≥ 10 year (3650 day) pregnancy interval, defined as the time (in days) between the date of delivery of the last pregnancy to reach ≥ 20 weeks gestation and the first day of the last menstrual period for the current pregnancy.\n\n     o Black or African-American race (as a proxy for underlying racism) - self-reported. Participants who self-identify as being of more than one racial group will be considered to be of Black race for the purposes of this criterion if one of the racial groups is Black or African-American.\n     * Low socioeconomic status, defined as one or more of the following: housing or food insecurity noted in chart within the last year, self-pay or Medicaid insurance, less than high school education\n\nand\u002For\n\n(3b) High a priori risk for spontaneous preterm birth - must meet at least one of the following 2 criteria (prior pregnancy history or current pregnancy course)\n\n* sPTB criteria #1: Prior pregnancy history\n\n  * EITHER a history of a delivery of a singleton, non-anomalous baby between 16+0 and 34+6 weeks gestation or delivery of a twin, non-anomalous pregnancy between 160 \u002F7and 276 \u002F7 weeks gestation due to spontaneous preterm labor, preterm premature rupture of membranes, cervical insufficiency, or placental abruption - Chart documentation of prior preterm birth, the gestational age of the prior preterm birth (referred to as the 'qualifying delivery') should be determined. If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the greater of the two will be used assuming that neither is the 'source document' (i.e. an ultrasound report with a due date, a c-section report, a delivery note, etc).\n\nUse the following table as a validation of the previous delivery. For example, if the infant was male and weighed more than 2763 grams (6 pounds, 1.5 ounces) then the patient would be ineligible based on history of a preterm birth criteria. This table should only be used to determine whether the qualifying delivery is most likely to be preterm less than 35 weeks gestation when the gestational age CANNOT be verified\u002Fcalculated by review of the medical records or is not available in the medical records.\n\nGestational age 90th percentile - boys 90th percentile - girls 33 weeks \\> 2488g 5 lbs 7.8 oz \\> 2116g 4 lbs 10.6 oz 34 weeks \\> 2763g 6 lbs 1.5 oz \\> 2379g 5 lbs 3.9 oz 35 weeks \\> 3084g 6 lbs 12.8 oz \\> 2661g 5 lbs 13.9 oz\n\n* Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \\\u003C25mm between 16+0 and 23+6 weeks gestation or cervical dilation ≥ 0.5cm requiring cervical cerclage placement prior to 24+0 weeks gestation, even if delivery ultimately occurred ≥ 35 weeks gestation or at term.\n\n  • sPTB criteria #2: Current pregnancy course\n* Asymptomatic cervical shortening \\\u003C25mm in the current pregnancy, diagnosed by transvaginal ultrasound that is performed ≥14+0 weeks gestation, per Registered Diagnostic Medical Sonographer(RDMS) certified Sonographer or physician with transvaginal ultrasound training program (or similar) qualifications\n* Cervical cerclage in situ in the current pregnancy due to concern for risk of preterm birth, at the discretion of the primary obstetric provider\n\n  (4) Ability to provide written, informed consent in English or Spanish\n\n  (5) Planned prenatal care at the University of North Carolina at Chapel Hill obstetrics clinics and planned delivery at the University of North Carolina Women's Hospital (Chapel Hill, NC).\n\nExclusion Criteria:\n\n1. Participation in another intervention based clinical trial during pregnancy that is deemed, at the discretion of the investigative team for the current study or the other concurrent study, to conflict with this research and\u002For confound the study results.\n\n   o There are some concurrent studies, even those designed to test an intervention, which may be compatible with the current study; this will be reviewed by the investigative leadership team on a case-by-case basis.\n2. Previous participation in the PTBCARE+ program in another pregnancy, with randomization to the PTBCARE+ (active intervention) group.\n3. Current, ongoing, illicit drug use ≥ 12 weeks gestation.\n\n   * Use of tobacco and\u002For marijuana products is not an exclusion.\n   * Receiving treatment for opioid use disorder with methadone, suboxone, or similar in an approved treatment program is not an exclusion.\n4. History of radical trachelectomy\n5. Planned voluntary termination of pregnancy.\n6. Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:\n\n   * Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment\n   * Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment\n   * Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment\n7. Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system\n\n   1. Mild renal abnormalities, clubfoot, isolated cleft lip\u002Fpalate, etc. in the fetus are not a reason for exclusion.\n   2. Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion.\n   3. If a major congenital anomaly is diagnosed \\*after\\* enrollment, the patient will continue to participate in the study, however, the investigators will plan to analyze the study results with and without these individuals included.\n8. Positive aneuploidy screening test (traditional biochemical assay, e.g., quad screen - risk of aneuploidy of 1:25 or higher or cell free deoxynucleic acid (DNA) test result that is screen positive for trisomy 13, trisomy 18, trisomy 21, or sex chromosome abnormality) in the absence of definitive fetal karyotype evaluation.\n\n   * Definitive fetal karyotype evaluation can only be obtained through direct testing of the tissue from the conceptus - by chorionic villus sampling or amniocentesis during pregnancy.\n   * The term \"suspected aneuploidy\" is commonly used in the medical record but this is not a diagnosis and by itself is not informative and not an exclusion criteria.\n9. Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.\n\n   * Note that a cystic hygroma remains an exclusion criterion regardless of subsequent diagnostic testing results because fetuses with this history carry an elevated risk of major congenital heart disease.\n   * Fetal echocardiogram is most accurately performed at 22-24 weeks gestation, which is later than the enrollment gestational age window.\n10. Polyhydramnios at or prior to enrollment.\n\n    o Polyhydramnios is defined as a maximum vertical pocket ≥ 8.0 cm, given that polyhydramnios \\\u003C22 weeks has a high likelihood of being associated with congenital anomalies\u002Faneuploidy and\u002For preterm birth due to preterm prelabor rupture of membranes.\n11. For potential participants who meet eligibility criteria ONLY due to prior spontaneous or medically indicated preterm birth: if the prior preterm birth was in a pregnancy complicated by twins, confirmed fetal aneuploidy, or major congenital fetal anomalies in the absence of another pregnancy meeting inclusion criteria they are not eligible.\n12. Known HIV positive with viral load greater than 1,000 copies\u002FmL or cluster of differentiation 4 (CD4) count less than 350\u002Fmm\\^3\n13. Unwillingness to undergo randomization.","FEMALE",{"count":226,"type":22},1228,[25],"The goal of this clinical trial is to learn if a personalized prenatal support program \\[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \\& Beyond, (PTBCARE+)\\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\\[s\\] it aims to answer are:\n\n* Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?\n* Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?\n* Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term?\n\nResearchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term.\n\nParticipants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care.\n\nAll participants will be asked to:\n\n* complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device.\n* complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit.\n\nPeople who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as:\n\n* a stress reduction toolkit;\n* access to an online website that can also be downloaded as a smart phone app;\n* the option to receive an electronic massage while in clinic, and more.\n* additional support gifts provided at routine clinical appointments\n\nPeople who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.",[230,231,232,233,234,235,236,28,237,238,239,240,241,242,243,244,245,246,247,248,249,250],"Preterm Birth Complication","Preterm Birth","Preterm Birth Recurrence","Preeclampsia","Preeclampsia (PE)","Hypertensive Disorders of Pregnancy","Support Program","Resilience, Psychological","Empowerment, Patient","Emotional Stress","Pregnancy","Pregnancy Complications","Pregnancy Induced Hypertension","Neonates and Preterm Infants","Cervical Insufficiency","Social Determinants of Health (SDOH)","Cervical Shortening","Disparities in Pregnancy Complications","Disparities","Prenatal Care","Care Coordination",[222,252,253,254],"pregnancy-related disparities","patient support program","enhanced prenatal care",{"date":120,"type":39},{"date":257,"type":22},"2026-08-01",{"date":259,"type":22},"2029-01",{"name":261,"class":75},"University of North Carolina, Chapel Hill",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":269,"maxAge":57,"enrollmentInfo":270,"targetDuration":4,"studyType":272,"phases":4,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":47},"100271830","improving-renal-complications-in-adolescents-with-type-2-diabetes-through-research-cohort-study-national-icare-study-100271830","NCT02818192","Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)","iCARE","Inclusion Criteria:\n\n* All youth with T2D that do not meet exclusion criteria are eligible for the study.\n\nCriteria for Diagnosis of T2D:\n\n1. Diagnosis of diabetes will be made according to the Canadian Diabetes Association criteria. There must be 2 abnormal blood glucose tests on different days OR 1 abnormal blood glucose test + symptoms of diabetes:\n\n   * Fasting plasma glucose of \\> 7.0 mmol\u002FL or\n   * Random glucose \\> 11.1mmol\u002FL or\n   * 2 hour glucose \\> 11.1 mmol\u002FL after a standard oral glucose tolerance test (75g) or\n   * Hemoglobin A1c value ≥ 6.5%\n2. Distinguishing T2D from type 1 diabetes (T1D) will be based on clinical risk factors including:\n\n   * Presence of overweight\u002Fobesity,\n   * Other evidence of insulin resistance (acanthosis nigricans)\n   * Family history of type 2 diabetes (1st degree relative)\n   * Intrauterine exposure to hyperglycemia,\n   * Family heritage from a high-risk ethnic group (Indigenous, Hispanic, South Asian, Asian or African descent)\n   * Absence of diabetes associated auto-antibodies\n   * HNF-1 alpha heterozygote or homozygote\n\nExclusion Criteria:\n\n1. Diabetes secondary to medication use or surgery\n2. Antibodies suggestive of type 1 diabetes\n3. Current treatment with oral steroids or immunosuppressive agents as they may interfere with cortisol assessment and inflammatory markers\n4. Ever cancer\n5. Other chronic illness associated with systemic inflammation (ex. Juvenile rheumatoid arthritis, Crohns disease)\n6. Patient and or caregiver unable or unwilling to provide voluntary informed assent\u002Fconsent","10 Years",{"count":271,"type":22},500,"OBSERVATIONAL","The overall aim of the project is to elucidate the primary bio-psycho-social (BPS) risk factors for albuminuria in youth with type 2 diabetes (T2D) and the mechanisms by which they cause renal injury. The Study aims include:\n\n1. Characterize the primary BPS risk factors associated with prevalent and progressive albuminuria in youth with T2D.\n2. Determine individual, family and community level factors that influence biological and psychological risk factors and behaviors (adherence) that could be modified to protect against prevalent and progressive albuminuria.\n3. Determine if systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.\n\nStudy Hypotheses include:\n\n1. Biological factors (poor glycemic control and systolic ambulatory hypertension), and psychological and social adversity (stress, mental distress and poverty) are significant predictors of prevalent and progressive albuminuria in youth with T2D.\n2. Community and family support will be negatively associated with stress, and a lower risk of both prevalent and progressive albuminuria.\n3. Systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.",[275,276,28,277],"Type 2 Diabetes","Proteinuria","Nephropathy",{"date":120,"type":39},{"date":280,"type":39},"2017-01",{"date":282,"type":22},"2027-03",{"name":284,"class":75},"University of Manitoba",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":302,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":310,"leadSponsor":312,"locationsCount":4},"100644755","a-two-part-intervention-to-target-cardiovascular-health-100644755","NCT07673172","A Two-Part Intervention to Target Cardiovascular Health","Autism Research Consortium on Physical Health: A Two-Part Intervention to Target Cardiovascular Health","Inclusion Criteria:\n\n* • Have a diagnosis of autism or be told by a healthcare provider that you have autism\n\n  * Be between the ages of 9 and 26\n  * Have a BMI greater than the 84th percentile\n  * English speaking\n\nExclusion Criteria:\n\n* • Children younger than 9 years of age\n\n  * Adults older than 26 years of age\n  * Individuals without a diagnosis of autism\n  * Individuals with a BMI less than the 84th percentile","9 Years","26 Years",{"count":295,"type":22},130,[25],"Obesity is one of the most common health conditions among autistic young people and its prevalence rises at faster rates for autistic-relative to non-autistic-individuals. This places them at heightened risk for cardiovascular disease (CVD) and mortality before they enter adulthood. Studies have identified three key contributing factors to CVD outcomes in autistic individuals: unhealthy lifestyle behaviors, Adverse Childhood Experiences (ACEs), and chronic stress.\n\nThis study will explore the effectiveness of two CVD-focused primary care interventions for autistic individuals (ages 9-26): (1) lifestyle medicine consultations tailored towards supporting health-promoting behaviors; and (2) a Cognitive Behavioral Therapy (CBT) intervention tailored towards addressing chronic stress that contributes to excess weight and maladaptive eating behaviors and results in obesity and CVD. Participants and their caregivers will be randomly placed into either the Lifestyle Medicine Group, CBT Group, or combined Lifestyle Medicine with CBT Group. Participants will respond to questionnaires and surveys measuring lifestyle habits, stress, and psychological risk factors at their first visit, 6-month visit, and 3 months post-intervention visit. Over the course of 6 months, participants will attend virtual sessions (up to three times a month) in accordance with their intervention group.",[299,300,28,301],"Autism","Adverse Childhood Experience","Cardiovascular (CV) Risk",[303,304,305,306],"autism","adverse childhood experiences","stress","cardiovascular risk","2026-06-22",{"date":120,"type":39},{"date":70,"type":22},{"date":311,"type":22},"2028-08-31",{"name":313,"class":75},"University of California, Los Angeles",{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":23,"phases":321,"briefSummary":322,"conditions":323,"keywords":327,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":47},"100620667","act-together-implementing-a-web-based-program-with-brief-coaching-for-parents-of-children-with-disabilities-in-pediatric-outpatient-clinics-100620667","NCT07360600","ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics","Inclusion Criteria (Parents of children with disabilities):\n\n1. Community-dwelling adults (aged ≥18 years) with primary caregiving responsibility for a child with disabilities (aged \\\u003C18 years) who is enrolled in a participating clinic;\n2. Expected to use services at the participating clinic at least once per week over the next three months;\n3. Willing to learn strategies to cope with emotions and thoughts; and\n4. Have access to a web-enabled device (e.g., smartphone, tablet, laptop, or desktop) with reliable internet access at home or in a public space (e.g., library).\n\nExclusion Criteria (Parents of children with disabilities):\n\n1. Cognitive, physical, sensory impairments, or language barriers (non-English speaking) that would impede participation;\n2. Suicidal intent or suicide attempt(s) within the past six months;\n3. Participation in another parent support research study at the time of recruitment; or\n4. More than three hospitalizations of either the parent or child within the past year, or other serious health concerns that would interfere with program engagement.\n\nInclusion Criteria (Occupational therapists):\n\n1. Be willing to participate in training, program implementation, and study evaluations; and\n2. Currently work in a pediatric clinic that serves at least 15 children who attend the clinic at least once per week.\n\nExclusion Criteria (Occupational therapists): N\u002FA",{"count":60,"type":22},[25],"The goal of this clinical trial is to evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. ACT Together includes six self-paced, web-based modules and brief weekly one-on-one coaching sessions led by a trained occupational therapist. The program is based on acceptance and commitment therapy (ACT), which teaches practical skills to help people handle stress and difficult thoughts or feelings while taking steps toward what matters to them.\n\nThe main questions this study aims to answer are:\n\n* Can parents and occupational therapists complete the study activities as planned (e.g., module completion, coaching sessions, and surveys)?\n* Is the program usable and acceptable\u002Fappropriate\u002Ffeasible to implement in this setting?\n* Do parents show improvements in mental health and coping-related outcomes after participating in the program?\n* What are the experiences and perspectives of parents and therapists regarding the program?\n\nParents as participants will:\n\n* Complete six self-paced web-based modules and brief weekly individual phone coaching sessions with a trained occupational therapist working in pediatric outpatient clinics.\n* Complete online questionnaires before starting and after completing the program.\n* Take part in one online interview about their experiences and perspectives on the program.\n\nOccupational therapists as participants will:\n\n* Complete therapist training materials and deliver brief individual phone coaching sessions to parent participants, including completing a post-session checklist.\n* Complete brief online questionnaires before starting and after delivering the program.\n* Take part in one online interview about their experiences and perspectives on the program.",[324,325,28,326],"Parents","Children With Disabilities","Depression",[328,329,330,331,332,333,334,305,335,336,337,338,339,340,341],"Acceptance and Commitment Therapy","web-based intervention","internet-based intervention","occupational therapist","parents","children with disabilities","depressive symptoms","feasibility","acceptability","usability","implementation","mixed methods","Pilot Study","phone coaching",{"date":343,"type":39},"2026-06-23",{"date":345,"type":39},"2026-03-18",{"date":347,"type":22},"2026-12",{"name":349,"class":75},"University of South Florida",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":362,"conditions":363,"keywords":366,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":47},"100503580","phase-2-efficacy-and-safety-of-magnesium-vitamin-b6-in-first-episode-bipolar-disorder-100503580","NCT05837104","Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder","A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder","Inclusion Criteria:\n\n* Persons between the ages of 18 and 50\n* DSM V diagnosis of bipolar I disorder, onset of illness in the last 10 years\n* Minimum of two of the following symptoms on the Hamilton Rating Scale of Depression HAM-D (HAM-D, 17 item): depressed mood, feelings of guilt, anxiety-psychic, anxiety-somatic, somatic symptoms-general, somatic symptoms-gastrointestinal.\n* Young Mania Rating Scale (YMRS) scores of less than 15\n* Ability to sign informed consent.\n* Stable disorder and no change in psychiatric medications within 2 weeks of screening and expected to not require addition of any new psychiatric medications during the duration of the 4 weeks of the study.\n\nExclusion Criteria:\n\n* Unable to sign informed consent.\n* Persons weighing over 350lbs.\n* Declines to participate.\n* Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.\n* 2 or more manic symptoms that meet DSM-V criteria.\n* Persons of childbearing potential who are not using a medically accepted means of contraception.\n* Persons who are deemed a serious suicide or homicide risk.\n* Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.\n* The following DSM-V diagnoses: 1) substance use disorders, including alcohol, active within 2 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not otherwise specified; 5) schizoaffective disorder; 6) acute bereavement; 7) severe borderline or antisocial personality disorder.\n* Persons meeting criteria for bipolar mixed episode.\n* Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening.\n* Severe hypomagnesemia (serum magnesium of 0.45 mmol\u002FL).\n* Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose.\n* Seizure disorder.\n* Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba.\n* Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation.\n* Have a history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months.\n* Have any medical condition that would prevent blood draws.\n* Have a history of significant head injury.\n* Individuals with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)\n* Individuals with allergies to magnesium citrate anhydrous, pyridoxine hydrochloride or any of the other components of Magne B6\n* Patients taking psychostimulant medication","50 Years",{"count":359,"type":22},40,[361],"PHASE2","This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress, and anxiety in patients with first episode bipolar I disorder.",[364,365,28],"Bipolar I Disorder","Depression, Anxiety",[367,368,369,326,31,28],"First episode Bipolar Disorder","Magnesium vitamin B6","Brain energy metabolism",{"date":208,"type":39},{"date":372,"type":39},"2023-12-13",{"date":374,"type":22},"2026-10",{"name":376,"class":75},"Mclean Hospital",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":47},"100556552","stress-management-program-100556552","NCT06526585","Stress Management Program","Examining the Immediate and Training Effects of Regular Stress Reduction Practices on Psychophysiological Markers of Anxiety","Inclusion Criteria:\n\n* Age 18 or older\n* No contraindications to MRI imaging (like ferromagnetic metal in their body)\n\nExclusion Criteria:\n\n* Pregnant or planning to get pregnant during study participation.\n* Not able or willing to come to research location twice for MRI assessments",{"count":385,"type":22},80,[25],"This study will test the immediate and long term (post 4 weeks of daily practice) effectiveness of two breathwork practices, cyclic sighing and box breathing, in comparison to hypnosis and an audiobook about stress, on psychological and physiological variables.",[28,31],[28,390,391,392,393,394,31,395,396,397,398,399,144],"Breathwork","Cyclic Sighing","Box Breathing","Hypnosis","Mood","Physiology","Heart Rate Variability","Respiratory Rate","fMRI","Brain Activity","2026-06-19",{"date":402,"type":39},"2026-06-24",{"date":404,"type":39},"2025-03-12",{"date":406,"type":22},"2026-08-30",{"name":408,"class":75},"Stanford University",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":272,"phases":4,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":426,"locationsCount":428},"100641700","preoperative-stress-assessment-in-patients-undergoing-surgery-for-rotator-cuff-tendinopathy-100641700","NCT07658326","Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy","Tendistress","Inclusion Criteria:\n\n* Patient, male or female, over 18 years of age\n* First-line surgery for rotator cuff tendinopathy (torn and untorn)\n* Subject affiliated with or covered by a social security scheme\n* Collection of the patient's non-opposition to participate in the study\n\nExclusion Criteria:\n\n* Patients with medical history of adhesive capsulitis or complex regional pain syndrome (CRPS)\n* Patients with a history of diabetes or thyroid dysfunction\n* Patients with a history of fibromyalgia\n* Patients with a history of mental illness (PMD, schizophrenia)\n* Patients taking antidepressants or similar medications\n* Patients participating in another clinical trial\n* Protected patients: adults under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision;\n* Pregnant, breastfeeding, or parturient women;\n* Patients hospitalized without their consent.",{"count":417,"type":22},100,"Orthopedic surgery of the limbs presents a unpredictable postoperative course, which can be more or less lengthy in terms of functional recovery and resumption of personal or professional activities. Not uncommon, convalescence can require many months with dramatic personal and\u002For socio-professional consequences (disability, unemployment, etc.), particularly in the postoperative development of complex regional pain syndrome (CRPS) and\u002For adhesive capsulitis.\n\nAmong the suspected contributing factors, the existence of an unfavorable preoperative psychological context in patients is often mentioned.\n\nThis research is based on the hypothesis that a high level of preoperative stress in patients could contribute to the occurrence of more significant postoperative complications in patients who have undergone shoulder surgery.\n\nThe main objective is to measure the level of preoperative stress in patients undergoing surgery for rotator cuff tendinopathy.",[28,420],"Tendinopathy Rotator Cuff","2026-06-16",{"date":307,"type":39},{"date":424,"type":39},"2023-09-28",{"date":213,"type":22},{"name":427,"class":75},"Ramsay Générale de Santé",3,{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":56,"sex":224,"minAge":57,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":438,"conditions":439,"keywords":443,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":47},"100641063","the-effect-of-pre-breastfeeding-breathing-exercises-on-maternal-anxiety-well-being-and-infant-stress-in-mothers-whose-infants-are-in-the-neonatal-intensive-care-unit-100641063","NCT07634445","The Effect of Pre-Breastfeeding Breathing Exercises on Maternal Anxiety, Well-being, and Infant Stress in Mothers Whose Infants Are in the Neonatal Intensive Care Unit","The Effect of Pre-Breastfeeding Breathing Exercises on Maternal Anxiety, Well-being, and Infant Stress in Mothers Whose Infants Are in the Neonatal Intensive Care Unit: A Radicalized Controlled Study","Inclusion Criteria:\n\n* Ability to communicate verbally,\n* Being 18 years of age or older,\n* Having a baby in the neonatal intensive care unit,\n* Breastfeeding.\n\nExclusion Criteria:\n\n* Having a psychiatric diagnosis according to medical records,\n* The mother having a definite health problem in the postpartum period that prevents breastfeeding (heart disease, etc.),\n* The study being terminated due to the newborn being discharged from the hospital,\n* Incomplete data collection.",{"count":21,"type":22},[25],"Aim: This study was conducted to examine the effects of breathing exercises on maternal anxiety, well-being, and infant stress.\n\nMaterials and Methods: The research was initiated in a hospital in eastern Turkey between November 2024 and November 2026, after obtaining ethical committee and institutional approvals. The study population consisted of mothers whose babies were hospitalized in the neonatal intensive care unit (NICU) of that hospital.The generally available G\\*Power 3.1.9.7 for Windows software was used to calculate the sample size. Similar literature studies were referenced when determining the sample size of the research (Shamsdanesh et al., 2023). Furthermore, after the research is completed, a post-hoc power analysis will be performed on the main dependent variable, maternal anxiety level (MAL), to determine the power of the study (approximately 35 experimental, 35 control). The aim of the research is to ensure that the resulting sample size has sufficient statistical power to reveal the effect being examined. The research data is collected using a Demographic Information Form, prepared by the researcher through a literature review, the State and Trait Anxiety Inventory, the Psychological Well-being Scale, and the Neonatal Stress Scale. Mothers perform this exercise three times a day for two days (days 1 and 2), under the supervision of a researcher. The four-square breathing exercise is a non-pharmacological pain reliever that has been shown to be beneficial in conditions other than pain. Each breathing exercise lasts 5-10 minutes. Mothers in the experimental group are given a questionnaire before the start of the study and after the exercise on days 1 and 2. Mothers in the control group are given only a questionnaire before the start of the study, at the end of day 1, and at the end of day 2. Mothers in the control group do not perform the four-square breathing exercise and receive routine hospital care. At the end of both days, mothers in the control group who wish to practice the breathing exercise are given the opportunity to do so.",[31,440,28,441,442],"Psychological Well-being","Breath Exercise","Newborn",[444,93,305,445,446],"newborn","breathing exercise","psychological well-being",{"date":448,"type":39},"2026-06-18",{"date":450,"type":39},"2024-12-10",{"date":452,"type":22},"2026-11",{"name":454,"class":75},"Inonu University",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":463,"enrollmentInfo":464,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":468,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":47},"100436177","job-stress-in-ophthalmology-physicians-and-residents-100436177","NCT04959838","JOB STRESS in OPHthalmology Physicians and Residents","Monitoring of JOB STRESS Related to Night Shifts in OPHthalmology Physicians and Residents","JOBSTRESS-OPH","Inclusion Criteria:\n\n* Ophthalmologists defined as physicians who completed the ophthalmology DES (Specialized studies diploma), as well as ophthalmology residents defined as a resident registered in the ophthalmology DES working during the inclusion period in the ophthalmology department of the university hospital center of Clermont-Ferrand.\n* Ability to give a written informed consent to participate in research.\n* Affiliation to a social security system.\n* Age between 18 and 65 years old\n\nExclusion Criteria:\n\n* Participant refusal to participate\n* Children under the age of 18, pregnant and breastfeeding women, protected adults (individuals under guardianship by court order), adults deprived of their liberty.","65 Years",{"count":139,"type":22},[25],"Ophthalmology physicians and residents work under stress conditions during night emergency ophthalmology shifts. Under time pressure, that is a characteristic of the urgency of care, they must use all their cognitive resources to make an accurate diagnosis and to provide accurate decisions, with sometimes surgical emergency acts. In addition, in France, they work at night following by an usual day work, and they can also work 48 consecutive hours during weekends, followed by a work day … i.e. 60 consecutive hours of work … Long working hours with a short recovery time has been demonstrated to be a major factor of stress and fatigue. Even if not demonstrated on ophthalmologists, those working conditions may contribute to symptoms of mental exhaustion and physical fatigue (sleep deprivation), often accompanied by a loss of motivation at work. This may leads to a feeling of loss of time control; stress can also distort the perception of time and leads to hasty actions or delayed decision-making. The combined effects of stress, feelings of loss of time control, and fatigue necessarily have an impact on work performance and work quality, with a high risk of medical error. Moreover, prolonged stress may expose ophthalmologists to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease.\n\nThe main hypothesis is that prolonged work (up to 60 consecutive working hours) may impact on HRV, comparatively to a typical working day.",[28,396],[469,470,305,471,205,472,473,474],"ophthalmologists","on-call duty","surgical simulator","sleep","questionnaires","actimetry","2026-06-15",{"date":421,"type":39},{"date":478,"type":39},"2021-07-06",{"date":480,"type":22},"2027-07",{"name":482,"class":75},"University Hospital, Clermont-Ferrand",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":510,"locationsCount":47},"100641488","the-effect-of-using-weighted-blanket-on-anxiety-stress-depression-and-comfort-level-among-patients-with-cancer-undergoing-intravenous-anticancer-therapy-and-its-feasibility-of-use-by-nurses-compared-to-routine-care-100641488","NCT07653035","The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care","The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care; a Randomized Controlled Study (CALM-WB)","CALM-WB","Inclusion Criteria: for patients\n\n* Newly diagnosed cancer patients aged 18 years and older.\n* Receiving first-line intravenous anticancer therapy (chemotherapy or immunotherapy or a combination of both) in the daycare unit (adjuvant, neoadjuvant, or palliative).\n* Weighting at least 55 kg during obtaining the informed consent. (At least 54 kg before the intervention).\n* Able to complete study assessments.\n* Speaks Arabic or English.\n* Signs Informed consent.\n\nExclusion Criteria for patients:\n\n* Prior psychological treatment or psychotherapy (confirmed psychological diagnosis, history of psychotropic medications and previous psychotherapy).\n* Currently hospitalized in inpatient units.\n* Patients on daily anticancer infusions.\n* Positive fall risk assessment.\n* Open wounds and recent surgeries\u002F stoma.\n* Enrolled in any other device study or clinical trial during data collection.\n* History of:\n\n  * Diabetes mellitus\n  * Respiratory disorders,\n  * Claustrophobia (Miller et al 2003) Because of the possibility for altered sensory perception,\n  * Patients who had a diagnosis of peripheral neuropathy or fibromyalgia (Vinson et al. 2020)\n  * Cognitive impairment\n\nEligibility criteria for the nurse's population:\n\nDay Care Unit nurses will be recruited by convenient sampling and feedback will be sought per patient per visit. The reason to this is because the same nurses maybe caring for multiple patients using the WBs and each patient will provide a different experience for the nurses caring for those patients. Only nurses who agree to complete the study questionnaire will be included.",{"count":492,"type":22},152,[25],"Protocol Title: Protocol Title: The Effect of using Weighted Blanket on anxiety, stress, depression and comfort level among Patients with cancer undergoing intravenous (IV) anticancer therapy and its feasibility of use by nurses compared to routine care; a Randomized controlled study.\n\nStudy Tools: VAS-A, ESAS-R, DASS-21 and comfort level scale will be used to study the patients' population. A survey will be used to assess the feasibility of using the weighted blankets on patients receiving IV anticancer therapy.\n\nMethodology: Consented patients will be stratified per gender then randomized to either ARM1: The interventional arm, Weighted blanket, or ARM2: The control arm, Standard of care. (Regular blanket). The weighted blanket will be administered in the two cycles of IV anticancer therapy for the interventional arm, exploring the temporal trajectory of anxiety, depression, and psychological distress, and investigating the potential of a weighted blanket intervention to mitigate these symptoms. The tools will be administered according to the study protocol. Day Care Unit nurses will be assessed on how feasible they think the blankets are for patients. Expected Outcome: WB is expected to reduce the anxiety in patients undergoing IV anticancer therapy and reduce the nurses' burden when caring for those patients.",[496,90,28],"Solid Cancers",[498,499,93,500,501,502,503],"blankets","cancer","depression","comfort","intravenous infusion","non-pharmacological intervention","2026-06-14",{"date":506,"type":39},"2026-06-17",{"date":508,"type":39},"2025-12-25",{"date":480,"type":22},{"name":511,"class":75},"Sultan Qaboos Comprehensive Cancer Center",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":56,"sex":17,"minAge":519,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":529,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":4},"100540003","exploring-ptsd-symptoms-barriers-and-facilitators-to-mindfulness-100540003","NCT06311188","Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness","Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness-based Stress Reduction for Justice-Involved Black\u002FAfrican American Female Adolescents and Parents\u002FCaregivers","Inclusion Criteria:\n\n* Black girls aged 14-18\n* Black girls with a misdemeanor and\u002For felony charge in their lifetime\n* Positive PTSD screen (PC-PTSD score of 2 or more; if more than one JI BAFA are from the same family, the investigators will recruit the girl with the highest PTSD score)\n* Black girls report juvenile justice involvement within 12 months prior\n* Black girls live with a P\u002FC (mothers, fathers, and other caregivers\u002Flegal guardians) who will also participate in the study\n* Parents\u002FCaregivers nominated by the girls to participate in the study who are between the ages of 18 and 90 years of age\n* Legal\u002F social services providers \u002F educators who work with the population.\n\nExclusion Criteria:\n\n* Prisoners per the IRB definition\n* Black girls who are younger than 14 and older than 18\n* Severe cognitive delay so the youth cannot complete the assessment instruments, as measured using the Montreal Cognitive Assessment (MoCA)\n* Active psychosis requiring a greater level of care \\[Structured Clinical Interview for DSM Disorders (SCID)\\]. Screening for the study will take place prior to consent\u002Fassent of the study participants\n* Parents\u002FCaregivers who are not nominated by the girls to participate in the study who are not between the ages of 18 and 90 years of age\n* Legal\u002F social services providers \u002F educators who have been working with the population for less than three years.","14 Years","90 Years",{"count":522,"type":22},90,[25],"The purpose of this study is to investigate justice-involved Black\u002FAfrican American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents\u002Fcaregivers' (P\u002FCs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention.",[28,526,527,528],"Trauma","PTSD","HPA",[530,531,532,533],"Nonrandomized trial","Black girls","Legal system involvement","Cortisol Biomarker","2026-06-12",{"date":421,"type":39},{"date":537,"type":22},"2026-07-08",{"date":539,"type":22},"2027-01-31",{"name":541,"class":75},"University of Michigan",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":56,"sex":17,"minAge":57,"maxAge":83,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":555,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":562,"leadSponsor":564,"locationsCount":47},"100564314","exercise-effects-on-the-neurobiology-underlying-stress-related-eating-behaviors-in-veterans-100564314","NCT06627569","Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans","Exercise Effects on the Neurobiology Underlying Stress-Related Eating Behaviors in Veterans","Inclusion Criteria:\n\n* Veterans 18-75 years old\n* BMI of 25 or greater\n* Physically inactive\n* Able to attend study visits in person in Aurora, CO\n\nExclusion Criteria:\n\n* Currently pregnant\n* History of bariatric surgery\n* Current eating disorder\n* Current treatment with appetite-altering medications (e.g., GLP-1 agonists)\n* Contraindication to MRI (weight \\> 500 lbs; claustrophobia; metal or electronic devices in the body)\n* Cardiovascular disease, chronic kidney disease, pulmonary disease, or diabetes\n* Unable to exercise due to cardiac, pulmonary, neurologic, or orthopedic reasons",{"count":550,"type":22},132,[25],"The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses.",[554,28],"Overweight\u002FObesity",[556,557,28,558],"Overweight","Obesity","Eating","2026-06-11",{"date":475,"type":39},{"date":70,"type":22},{"date":563,"type":22},"2030-08-30",{"name":565,"class":566},"VA Office of Research and Development","FED",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":224,"minAge":57,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":580,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":47},"100642067","the-effect-of-virtual-reality-based-intervention-on-anxiety-stress-and-pain-in-women-undergoing-colposcopy-a-randomized-controlled-trial-100642067","NCT07650422","The Effect of Virtual Reality-Based Intervention on Anxiety, Stress, and Pain in Women Undergoing Colposcopy: A Randomized Controlled Trial","Colposcopy","Inclusion Criteria:\n\nBe 18 years of age or older, Have colposcopy scheduled due to a cervical cytology result of LSIL, HSIL, ASC-US, or HPV positivity, Be able to read and understand Turkish, Provide voluntary written informed consent -\n\nExclusion Criteria:\n\nDiagnosis of a mental disorder Severe visual impairment, claustrophobia, cognitive impairment History of severe motion sickness (cybersickness) associated with virtual reality use Use of anxiolytic\u002Fanalgesic medication prior to the procedure Individuals with severe cognitive impairment or communication difficulties\n\n\\-",{"count":60,"type":22},[25],"Due to its invasive nature, the colposcopy procedure can cause high levels of anxiety, stress, pain, and nausea in women. The uncertainty surrounding the condition to be diagnosed, combined with the discomfort caused by the procedure itself, creates significant psychological stress in women and can negatively impact their compliance with diagnosis and treatment. Therefore, it is believed that applying Virtual Reality (VR) technology-one of the distraction techniques-as a non-pharmacological method for women undergoing colposcopy could be effective in reducing pain and anxiety by diverting their cognitive attention away from the procedure's negative stimuli. Although there are many studies in the literature using VR technology, no study has been found that examines the effect of VR-based interventions on anxiety, stress, and pain levels in women undergoing colposcopy. Therefore, this study will be one of the first randomized controlled trials to examine the multidimensional effects of virtual reality (anxiety, stress, pain) in women undergoing colposcopy. The findings will contribute to the widespread adoption of non-pharmacological nursing interventions in clinical practice. The aim of this study is to comprehensively evaluate the effect of a virtual reality (VR)-based intervention on anxiety, stress, and pain levels in women undergoing colposcopy and to determine its efficacy compared to standard care.",[578,31,28,572,579],"Virtual Reality-Based Intervention","Women",[579,572,578,31,28,116],"2026-06-10",{"date":421,"type":39},{"date":584,"type":39},"2026-02-01",{"date":586,"type":22},"2026-10-01",{"name":588,"class":75},"Osmaniye Korkut Ata University",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":23,"phases":596,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":47},"100557314","a-randomized-controlled-trial-to-assess-the-impact-of-live-and-recorded-music-based-interventions-on-pre-operative-stress-mood-pain-and-biomarkers-in-neurosurgical-patients-music-star-trial-100557314","NCT06536504","A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)","Inclusion Criteria\n\n1\\) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.\n\nExclusion Criteria\n\n1. Patient is unable or unwilling to provide informed consent.\n2. Patient is deaf or hearing-disabled.\n3. Patient is less than 18 years in age.\n4. Patient was previously enrolled in the study.\n5. Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.\n6. Subjects on contact isolation precautions.",{"count":550,"type":22},[25],"The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.",[28,116],{"date":534,"type":39},{"date":601,"type":39},"2024-12-19",{"date":603,"type":22},"2029-03-01",{"name":605,"class":75},"M.D. Anderson Cancer Center",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":56,"sex":224,"minAge":57,"maxAge":614,"enrollmentInfo":615,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":617,"conditions":618,"keywords":619,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":626,"completionDateStruct":627,"leadSponsor":629,"locationsCount":4},"100642063","the-impacts-of-ashwagandha-supplementation-on-diurnal-cortisol-and-stress-among-women-100642063","NCT07647081","The Impacts of Ashwagandha Supplementation on Diurnal Cortisol and Stress Among Women","Female Adversity and Biology: Stress Reduction","FAB:SR","Inclusion Criteria:\n\n1. Female, ages 18-45\n2. No hormonal birth control\n3. Identify as having a regular sleep schedule (eg. sleep by 1am and wake by 9am)\n4. Identify as having a regular menstrual period between 27-32 days apart on average\n5. PSS score of 14 (moderate stress) or greater\n6. No expected changes in stress levels over the next 3 months and agree to not initiate any new stress-reduction behaviors before study start or during the study\n\nExclusion Criteria:\n\n1. Diagnosed major depressive disorder or generalized anxiety disorder in the last 3 months, any liver, kidney, or thyroid disorder\u002Fdysfunction\u002Finjury, or diabetes\n2. Using any medication related to cortisol or HPA function such as corticosteroids, antidepressants, anti-psychotics, CNS-depressants (benzodiazepines, non-benzodiazepine sedatives, barbiturates, anti-convulsants, anesthetics), thyroid medications, diabetic medications, or immunosuppressants\n3. Taken any form of ashwagandha within the last 3 months\n4. Daily use of alcohol, nicotine, or other substances\n5. Who are pregnant, planning to become pregnant, breastfeeding, or have had a hysterectomy\n6. Abnormal liver function test value(s) at screening","45 Years",{"count":139,"type":22},[25],"The purpose of this project is to better understand the role of ashwagandha on the stress response and wellbeing among healthy, stressed women.",[28],[305,620,621,622,623],"women","ashwagandha","cortisol","female","2026-06-09",{"date":475,"type":39},{"date":211,"type":22},{"date":628,"type":22},"2027-05",{"name":630,"class":75},"Oklahoma State University Center for Health Sciences",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":56,"sex":17,"minAge":57,"maxAge":357,"enrollmentInfo":638,"targetDuration":4,"studyType":23,"phases":640,"briefSummary":641,"conditions":642,"keywords":643,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":651,"locationsCount":653},"100617963","assessing-mb-spirit-for-psychological-well-being-100617963","NCT07325448","Assessing MB-Spirit for Psychological Well-being","Assessing MB-Spirit: A Novel Intervention for Promoting Spiritual Development and Psychological Well-being","Inclusion Criteria:\n\n* Understands English\n* Able to attend all 8 classes\n* Able to travel to Boston for MRI scans\n\nExclusion Criteria:\n\n* claustrophobia, pregnancy, head trauma, metallic implants or devices contraindicating MRI, left-handed, conditions that alter cerebral blood flow or metabolism (e.g. stroke), current use of psychotropic medications, lifetime history of suicidality, homicidally, self-destructive acts, schizophrenia or psychosis.",{"count":639,"type":22},44,[25],"The goal of this clinical trial is to test two new behavioral interventions designed to reduce stress and improve spiritual well-being in stressed adults. The main questions it aims to answer are:\n\n1. Can the program decrease stress and improve spiritual well-being?\n2. What brain changes accompany participation in the programs?\n\nParticipants will:\n\n1. Be randomized to either a live online course that meets for 90 minutes every week for 8-weeks, or to a self-paced program. In the self-paced program, participants will receive materials once a week and can work through them at their own pace. Both programs are designed to decrease stress and improve well-being.\n2. Complete questionnaires before and after the course.\n3. Complete and interview before and after the course.\n4. A subset of people will be randomized to complete an MRI scan of their brain before and after the course.\n\nParticipants will be randomized to either take the course right away, or be put on a wait-list. Those on the wait-list will undergo the testing at 2 timepoints before they start the program.",[28],[305,644,645,646],"MRI","spirituality","well-being",{"date":559,"type":39},{"date":649,"type":39},"2026-03-15",{"date":452,"type":22},{"name":652,"class":75},"Sara W Lazar",2,{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":56,"sex":224,"minAge":661,"maxAge":463,"enrollmentInfo":662,"targetDuration":4,"studyType":272,"phases":4,"briefSummary":664,"conditions":665,"keywords":668,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":681,"leadSponsor":683,"locationsCount":47},"100642790","temple-massager-system-study-in-women-ages-35-65-100642790","NCT07639658","Temple Massager System Study in Women Ages 35-65","Temple Massager System: Impact on Anxiety, Emotional Wellbeing, and Quality of Life in Women Aged 35-65","Inclusion Criteria:\n\n* Female, aged 35-65 years old, inclusive\n* Self-reported experience of daily stress, anxiety, tension headaches, facial tension, or TMJ-related discomfort\n* Headache frequency of 2 or more per week (self-reported)\n* If taking any prescription medication including SSRIs, anxiolytics, sleep medications, hormonal therapies, or blood pressure medications, must be on a stable dose for at least 4 weeks prior to study enrollment and throughout the course of the study\n* In good general health at the time of screening (Investigator discretion)\n* Able to read and understand English\n* Able to read, understand, and provide informed consent\n* Able to use a personal smartphone or tablet and access the study platform for daily data entry\n* Able to receive shipment of the study product at an address within the United States\n* Willing and able to use the Temple Massager System daily for 4 weeks\n\nExclusion Criteria:\n\n* No personal smartphone or tablet, no internet access, or unwilling to use the study platform\n* Known allergy or sensitivity to lavender oil, mango butter, shea butter, arnica, or St. John's Wort (Note: lavender sensitivity alone is not exclusionary; an aromatherapy sensitivity protocol applies)\n* Active skin infection or open wounds on the face or temple area\n* Diagnosed trigeminal neuralgia or other cranial nerve pathology\n* Diagnosed vascular issues affecting the head or face: temporal arteritis, aneurysm, or cerebrovascular malformations\n* Bleeding disorders: history of easy bruising or bleeding in the face\u002Fhead area, or current use of prescribed blood thinners (anticoagulants) such as Warfarin or Eliquis\n* Any surgery on the jaw, temples, or face within the last 6 months\n* Active inflammation: current redness, swelling, or extreme tenderness specifically over the temple arteries\n* Current use of prescription headache medications (triptans, topiramate, muscle relaxants, beta-blockers for migraine prophylaxis, or other prescription medications taken primarily for headache management)\n* Participants currently taking any prescribed medication for sleep or anxiety must be on a stable dose (no dose changes within the past 30 days) to be eligible; participants not on a stable dose are excluded\n* Current participation in another interventional study\n* Diagnosed Generalized Anxiety Disorder (GAD)\n* Currently pregnant, planning to become pregnant during the study period, or breastfeeding\n* Planned surgical procedure during the study period\n* Significant illness, disease, or condition which, in the opinion of the Principal Investigator, may impact the ability to participate in the study or impact the study outcomes\n* Unlikely for any reason to be able to comply with the study or considered unsuited for participation by the Principal Investigator","35 Years",{"count":663,"type":22},48,"The goal of this observational study is to learn how the Temple Massager System affects stress, emotional wellbeing, sleep, and quality of life in women aged 35 to 65.\n\nThe Temple Massager System is a non-electric, drug-free hand-held device used for self-massage of the temple area. The system also includes a body lotion and an optional lavender aromatherapy. It is sold as a general wellness product.\n\nThe main questions this study aims to answer are:\n\nDoes daily use of the Temple Massager System lower self-reported stress and improve emotional wellbeing over 4 weeks? Does daily use improve self-reported sleep quality and overall quality of life?\n\nThis is a single-arm observational study. There is no placebo or comparison group. Researchers will compare how participants feel before they start using the device to how they feel after 4 weeks of daily use.\n\nParticipants will:\n\nReceive a Temple Massager System at no cost Complete a 1-week baseline period before using the device Use the device once a day for at least 5 minutes for 4 weeks Answer short daily questions about device use, headaches, and over-the-counter medication use Complete weekly check-in surveys about stress, mood, and sleep Complete longer surveys at the start and end of the study Keep the device after the study ends\n\nThe study runs for 5 weeks per participant and takes place entirely from home through a secure app-based platform. No clinic visits are required.",[666,28,151,667],"Tension Headaches","Quality of Life",[669,670,671,672,673,674,675,676,677],"Stress relief","Wellness","Massage device","Temple massage","Facial tension","Relaxation","Women's Health","Decentralized trial","Observational study","2026-06-05",{"date":581,"type":39},{"date":581,"type":22},{"date":682,"type":22},"2026-09-30",{"name":684,"class":685},"MOQ Collective, Ltd","INDUSTRY",{"id":687,"slug":688,"hasResults":12,"nctId":689,"briefTitle":690,"officialTitle":691,"acronym":4,"eligibilityCriteria":692,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":693,"targetDuration":4,"studyType":23,"phases":694,"briefSummary":695,"conditions":696,"keywords":697,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":704,"completionDateStruct":705,"leadSponsor":707,"locationsCount":4},"100637798","effectiveness-of-a-sound-bowl-meditation-on-caregiver-stress-and-anxiety-100637798","NCT07626320","Effectiveness of a Sound Bowl Meditation on Caregiver Stress and Anxiety","Effectiveness of a Sound Bowl Meditation on Caregiver Stress and Anxiety: A Pilot Study","Inclusion Criteria:\n\n1. Adults age 18 years and older\n2. Primary, unpaid caregiver of a family member (spouse, sibling, parent, child, etc.) or an unrelated adult (friend) who is chronically ill and\u002For disabled\n3. Primary, unpaid caregiver has provided care to family member or an unrelated adult for a minimum of six months\n4. Normal hearing capacity with or without corrective hearing aids\n5. Availability and willingness to participate in the six week sound bowl meditation intervention\n6. Access to a smartphone or personal electronic tablet with adequate WiFi access and a personal email\n7. Willingness and ability to download the MyCap app to complete study surveys\n\nExclusion Criteria:\n\n1. Professional and\u002For paid caregivers\n2. Inability to read and\u002For understand English (consent, study instructions, and questionnaires in English)",{"count":359,"type":22},[25],"Being a primary caregiver for a family member or friend can be physically and emotionally demanding leaving little time for the unpaid caregiver's professional pursuits, personal appointments, and self-care. Primary caregivers are often overwhelmed, and experience stress, anxiety, depression, and sleep disturbances. Passive activities that require no physical or mental exertion may provide support and can help improve overall well-being. Sounds from crystal sound bowls and other instruments combined with guided meditations have been found to promote relaxation and to reduce stress and anxiety. Participants can sit in a chair or lie on a yoga mat, supported by pillows and blankets, to enhance comfort and rest. Eye masks can also be used to minimize light and promote peacefulness. The purpose of this study is to assess if a weekly Sound Bowl Meditation, offered over the course of 6 weeks and provided by a certified Sound Bowl practitioner, can help decrease caregiver stress and anxiety related to the role as a primary caregiver.",[28,31],[698,699,700,93,701],"caregiver","family caregiver","caregiver stress","caregiver anxiety","2026-06-03",{"date":678,"type":39},{"date":586,"type":22},{"date":706,"type":22},"2027-06-01",{"name":708,"class":75},"Ohio State University"]