[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stress-psychological\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stress-psychological":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,51,85,120,158,183,214,241,288,319,347,377,416,446,471,499,533,560,594,639,661,686,716,739,785],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":26,"briefSummary":28,"conditions":29,"keywords":38,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100623836","fascial-yoga-in-menopausal-women-100623836",false,"NCT07401810","Fascial Yoga in Menopausal Women","The Effect of Fascial Yoga on Perceived Stress, Cognitive Control, and Cognitive Flexibility in Menopausal Women","FascialYogaM","Inclusion Criteria:\n\n* Female participants aged 45-65 years\n* In the menopausal period, defined as at least 12 months since the last menstrual period\n* Able to read and understand Turkish and to complete self-report questionnaires\n\nExclusion Criteria:\n\n* Current or past diagnosis of a psychiatric disorder or ongoing psychiatric treatment\n* Regular use of antidepressant, anxiolytic, or corticosteroid medications\n* History of cancer or currently receiving active oncological treatment\n* Participation in facial yoga or similar yoga-based programs within the past 6 months\n* Any medical condition that may prevent safe participation in mild physical activity\n* Incomplete attendance to intervention sessions or incomplete outcome data during the study period",true,"FEMALE","45 Years","65 Years",{"count":23,"type":24},100,"ESTIMATED","INTERVENTIONAL",[27],"NA","Aim:\n\nThe aim of this study is to evaluate the effects of a structured fascial yoga-based behavioral intervention on perceived stress, cognitive control, and cognitive flexibility in menopausal women. The study aims to determine whether a non-pharmacological and non-invasive behavioral intervention can support psychological and cognitive functioning and reduce perceived stress in menopausal women.\n\nDesign:\n\nThis study is designed as a randomized controlled, pretest-posttest experimental study with a post-intervention follow-up assessment. Eligible participants will be randomly assigned to either the intervention group or the control group receiving usual care. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up to evaluate both the immediate and sustained effects of the intervention.\n\nMethod:\n\nA total of 100 menopausal women aged 45-65 years will be recruited from the menopause outpatient clinic and randomly assigned to either the intervention group or the control group. The intervention group will participate in a 12-week online fascial yoga program consisting of two 60-minute sessions per week.\n\nIn this study, fascial yoga is defined as a fascia-focused, non-pharmacological, and non-invasive behavioral intervention that includes myofascial release techniques, breath regulation, body awareness, and basic yoga practices to support stress regulation and cognitive functioning. The program will include myofascial release techniques, basic yoga postures suitable for all physical fitness levels, and structured breathing exercises. All sessions will be conducted online in a group format, and no audio or video recordings will be taken.\n\nThe control group will continue to receive routine outpatient care during the study period. After completion of the follow-up assessments, the fascial yoga program will be offered to participants in the control group upon request.\n\nData will be collected at three time points: at baseline before the intervention, immediately after completion of the 12-week intervention, and at the follow-up assessment 8 weeks after the intervention. Perceived stress, cognitive control, and cognitive flexibility will be assessed using validated self-report questionnaires.\n\nHypotheses:\n\nH1: Menopausal women participating in the fascial yoga intervention will show a significant reduction in perceived stress levels compared with the control group at post-intervention and follow-up assessments.\n\nH2: Menopausal women participating in the fascial yoga intervention will show a significant improvement in cognitive control and cognitive flexibility compared with the control group at post-intervention and follow-up assessments.",[30,31,32,33,34,35,36,37],"Menopause","Stress, Psychological","Cognitive Flexibility","Nonpharmacological Interventions","Randomized Controlled Trial","Cognitive Control","Perceived Stress","Yoga",[30,36,32,35,37],"NOT_YET_RECRUITING","2026-06-15",{"date":42,"type":43},"2026-06-17","ACTUAL",{"date":45,"type":24},"2026-07-01",{"date":47,"type":24},"2027-06-01",{"name":49,"class":50},"Marmara University","OTHER",{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":18,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":25,"phases":64,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100641703","mother3sense-study-100641703","NCT07651592","MOTHER3SENSE Study","Effects of Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions","MOTHER3SENSE","Inclusion Criteria:\n\n* Term newborns born between 37 and 42 weeks of gestation\n* Newborns without respiratory, cardiac, metabolic, neurological, or infectious diseases\n* Newborns not requiring oxygen therapy, phototherapy, or intravenous treatment\n* Newborns scheduled to undergo a routine heel lance procedure (metabolic screening or blood sampling)\n* Mothers willing to participate in the study\n* Written informed consent provided by the parent or legal guardian\n* Normal vital signs before the procedure (heart rate, respiratory rate, and oxygen saturation within normal limits)\n\nExclusion Criteria:\n\n* Preterm (\\\u003C37 weeks) or post-term (\\>42 weeks) newborns\n* Presence of congenital anomalies or neurological disorders\n* Requirement for oxygen therapy, phototherapy, or intravenous treatment\n* Respiratory, cardiac, metabolic, neurological, or infectious disease\n* Abnormal vital signs before the procedure\n* Parent or legal guardian refusal to provide informed consent","ALL","0 Days","28 Days",{"count":63,"type":24},120,[27],"This randomized controlled trial aims to compare the effects of maternal voice, touch, and scent on pain and stress levels in newborns during a routine heel lance procedure. Newborns will be randomly assigned to one of three intervention groups or a control group. Pain and stress responses will be assessed using validated neonatal pain and physiological measures. The findings of this study may help identify effective, low-cost, and non-pharmacological interventions that can be used to reduce pain and stress in newborns during routine clinical procedures.",[67,31],"Neonatal Pain",[69,70,71,72,73,74,75],"Newborn","Maternal","Voice","Touch","Scent","Heel Lance","pain","2026-06-11",{"date":78,"type":43},"2026-06-16",{"date":45,"type":24},{"date":81,"type":24},"2026-10-30",{"name":83,"class":50},"Kilis 7 Aralik University",1,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":25,"phases":95,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":84},"100642634","self-help-plus-sh-for-stress-reduction-in-social-service-workers-a-pilot-rct-100642634","NCT07644949","Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT","Feasibility and Preliminary Effectiveness of WHO Self-Help Plus (SH+) for Stress Reduction Among Social Service Workers: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Currently employed (permanent, contracted, or temporary staff) at an institution under the Istanbul Provincial Directorate of Family and Social Services\n* Able to read and write in Turkish\n* Willing to participate voluntarily\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Imminent suicide risk, screened at baseline (T0) via PHQ-9 item 9; participants scoring 2 or higher are not enrolled and are immediately referred to a mental health professional\n* Active psychosis, severe substance use disorder, or severe intellectual disability\n* An acute medical condition that would preclude participation\n* Planned extended leave (e.g., maternity or unpaid leave) during the study period","18 Years",{"count":94,"type":24},50,[27],"This is a two-arm, stratified cluster-randomized controlled pilot trial evaluating the feasibility and preliminary effectiveness of the World Health Organization's Self-Help Plus (SH+) intervention for stress reduction among social service workers employed by the Istanbul Provincial Directorate of Family and Social Services (ASHP). Four institutions (clusters) are randomized 1:1, stratified by service type, to receive either SH+ plus Enhanced Care as Usual (ECAU) or ECAU only, with a target of 50 participants (25 per arm). The primary aim is to assess feasibility indicators (recruitment, session attendance, retention, and acceptability) to inform a future full-scale definitive trial. Preliminary effects on perceived stress and related mental health and well-being outcomes are examined as secondary outcomes.",[98,31,99,100],"Stress, Psychological, Occupational","Psychological Distress","Burnout, Professional",[102,103,104,105,106,107,108,109,110],"Self-Help Plus","SH+","social service workers","universal prevention","cluster randomized trial","pilot study","Acceptance and Commitment Therapy","Turkey","social care workers","2026-06-09",{"date":113,"type":43},"2026-06-12",{"date":115,"type":24},"2026-07",{"date":117,"type":24},"2026-11",{"name":119,"class":50},"Istanbul Medeniyet University",{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":25,"phases":129,"briefSummary":130,"conditions":131,"keywords":136,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100633150","ai-guided-relaxation-for-hemodialysis-anxiety-100633150","NCT07522944","AI-Guided Relaxation for Hemodialysis Anxiety","Artificial Intelligence-Guided Relaxation Interventions for Reducing Anxiety and Enhancing Coping Strategies in Patients Undergoing Hemodialysis","Inclusion Criteria:\n\nAdult patients aged 18 years or older Confirmed diagnosis of end-stage renal disease (ESRD) receiving maintenance hemodialysis for at least 3 months to ensure treatment stability Conscious, oriented, and able to communicate effectively Documented baseline anxiety at a mild-to-moderate level confirmed on initial screening using the GAD-7 or HADS prior to enrollment Adequate visual and auditory functions sufficient to interact with the AI-guided relaxation platform Willing to participate and provide written informed consent prior to enrollment\n\nExclusion Criteria:\n\nHistory of epilepsy, chronic vertigo, or seizure disorders, as AI or VR visual stimuli may trigger adverse episodes Severe cognitive impairment or diagnosed psychiatric disorders such as dementia or schizophrenia that prevent comprehension of or adherence to study instructions Acute medical complications or hemodynamic instability occurring during the dialysis session Severe visual impairment or blindness precluding use of the digital relaxation interface Skin infections or injuries on the face or head preventing comfortable use of a headset where applicable Currently enrolled in any other psychological or relaxation intervention study",{"count":128,"type":24},60,[27],"This study aims to evaluate whether a relaxation program guided by Artificial Intelligence (AI) can help reduce anxiety and improve coping mechanisms for patients receiving maintenance hemodialysis. Patients undergoing dialysis often face significant psychological stress and physical discomfort. This research uses a randomized controlled trial (RCT) with a parallel-group, pretest-posttest controlled design to compare patient well-being before and after using the AI-guided intervention.\n\nParticipants will engage with an AI system designed to provide personalized relaxation techniques during their dialysis sessions. The study uses a mixed-methods approach. Quantitative: Researchers will use standardized scales to measure changes in anxiety levels, depression, coping strategies, and perceived relaxation. Qualitative: Researchers will conduct interviews with participants to understand their personal experiences, how they engaged with the AI technology, and how it influenced their ability to manage the stress of their treatment.",[132,133,134,135,31],"Renal Insufficiency, Chronic","Anxiety","Relaxation Therapy","Maintenance Hemodialysis",[137,138,139,99,133,140,141,134,142,143,144,145,146],"Hemodialysis, Hospital","Renal Dialysis","End-Stage Renal Disease (ESRD)","Artificial Intelligence","Digital Health","Mindfulness-Based Interventions","Coping Skills","AI-Guided Intervention","Virtual Reality (VR)","Immersive Technology","RECRUITING","2026-05-07",{"date":150,"type":43},"2026-05-12",{"date":152,"type":43},"2026-03-29",{"date":154,"type":24},"2026-05-30",{"name":156,"class":50},"Alexandria University",2,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":25,"phases":167,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100639706","positive-psychology-based-psychoeducation-for-psychological-flexibility-and-perceived-stress-in-university-students-100639706","NCT07579767","Positive Psychology Based Psychoeducation for Psychological Flexibility and Perceived Stress in University Students","The Effect of a Multi-Component Positive Psychology-Based Psychoeducation Program on Psychological Flexibility and Perceived Stress in University Students: A Controlled Pretest-Posttest Study","Inclusion Criteria:\n\n1. Being a first-year undergraduate student in the Department of Nursing at Harran University.\n2. Volunteering to participate in the study and providing informed consent.\n3. Having no reading, comprehension, or communication difficulty that would prevent completion of the data collection tools.\n4. Being 18 years of age or older.\n\nExclusion Criteria:\n\n1. Receiving regular psychotherapy or psychoeducation during the same academic period.\n2. Having participated in a structured positive psychology-based psychoeducation or intervention program within the last 6 months.\n3. Having a history of psychiatric hospitalization within the last 3 months or having an acute psychiatric crisis or instability that would make participation in the sessions inappropriate.",{"count":166,"type":24},66,[27],"This study will test whether an 8-week multi-component positive psychology-based psychoeducation program can reduce perceived stress and improve psychological flexibility among first-year undergraduate nursing students. Eligible students who provide informed consent will be randomly assigned to either an intervention group or a waitlist control group. The intervention group will attend weekly 60-75 minute psychoeducation sessions including brief psychoeducation, experiential exercises, shared reflection, and home practice assignments. The waitlist control group will continue their usual routine during the study period and will not receive any intervention before post-test assessment. Outcomes will be assessed at baseline and immediately after the 8-week program using the Perceived Stress Scale-14 and the Acceptance and Action Questionnaire-II.",[31,170],"Psychological Flexibility",[172,173,36,170,174],"Positive Psychology","Psychoeducation","University Students","2026-05-05",{"date":150,"type":43},{"date":178,"type":24},"2026-05-15",{"date":180,"type":24},"2026-07-31",{"name":182,"class":50},"Harran University",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":25,"phases":193,"briefSummary":194,"conditions":195,"keywords":199,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":84},"100560122","daoist-zhanzhuang-and-human-flourishing-100560122","NCT06573034","Daoist Zhanzhuang and Human Flourishing","Standing Like a Tree: Effects and Mechanisms of Daoist Zhanzhuang on Human Flourishing","Z-Flo","Inclusion Criteria:\n\n1. young adults aged between 18 and 25 years old when they enroll;\n2. be willing and available (e.g., intend to remain in Charlotte or the surrounding area or willing to travel to UNCC campus for in person visits) to participate to 12 month study;\n3. able to stand for 30 minutes;\n4. scoring above 18 on the Perceived Stress Scale (moderate stress); and\n5. able to read, speak and understand English.\n\nExclusion Criteria:\n\n1. experience of qigong-related practice in the past 5 years;\n2. reporting regular medication use that directly modulates immune system functioning (e.g., steroids, cytokine inhibitors, high levels of non-steroidal anti-inflammatory medication, chemotherapy, etc.) or sedates the nervous system (e.g., benzodiazepines, anti-epileptics, tranquilizers, etc.) or alters heart rate (e.g., beta blockers, calcium channel blocker, stimulants, etc.);\n3. self-reported illicit drug use in the past 3 months or substance dependence over the past month (e.g., alcohol binge drinking 2+ days\u002Fweek, using tobacco or nicotine products 5+ days\u002Fweek, cannabis and related products 2+ days\u002Fweek, etc.);\n4. physical impairment that does not allow them to stand for 30 mins (e.g., severe obesity, need wheel-chair or equipment to assist with walking, recent injury that limits standing, etc.), and\n5. severe mental health conditions that could prevent regular practice (e.g., hospitalized in the past 12 months for mental health condition).","25 Years",{"count":63,"type":24},[27],"This project investigates the impact of Daoist Zhanzhuang (sometimes spelled as Chan Chuang) on human flourishing, and explores the physiological, psychological, and spiritual mechanisms. This study will be a two-arm randomized controlled trial, with mixed-methods and repeated-measures assessment of outcome variables. The two arms will include an active control condition (i.e., sham wall squat) and the Daoist Zhanzhuang condition. Outcome variables will include physiological measures of heart rate variability and inflammatory biomarkers, psychological scales of human flourishing variables, phenomenological interviews of mystical experiences, and daily ecological momentary assessment of human flourishing and mysticism. Randomly assigned into two conditions, 120 participants will complete a three-week intensive practice phase with 9 in-person sessions, followed by a nine-week self-guided practice phase with 4 in-person check-in sessions, and 3 follow-up practice and assessment sessions. Complete assessment (physiological measures, psychological scales, and phenomenological interviews) will be administered at five time points: T1 at about two weeks before the intervention, T2 at the end of the three-week intensive practice, T3 at the end of the 3-month intervention, T4 at the 6-month follow-up, and T5 at the 12-month follow-up. In addition, daily ecological momentary assessment of flourishing variables and practice-induced experiences will be administered daily after the practice for the entire 3-month intervention period.",[196,31,197,198],"Stress, Physiological","Inflammatory Response","Well-Being, Psychological",[200,201,202,203,204],"Human Flourishing","Daoist Zhanzhuang (Chan Chuang)","Heart Rate Variability","Immune Function","Mysticism","2026-04-27",{"date":207,"type":43},"2026-05-01",{"date":209,"type":43},"2024-08-29",{"date":211,"type":24},"2027-07",{"name":213,"class":50},"University of North Carolina, Charlotte",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":59,"minAge":20,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":25,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100516315","mindwalk-intervention-for-older-south-asian-caregivers-of-people-with-cognitive-disabilities-cd-100516315","NCT06002919","MindWalk Intervention for Older South Asian Caregivers of People With Cognitive Disabilities (CD)","MindWalk: A Mindful Walking Intervention for Older South Asian Family Caregivers of People With Cognitive Disabilities (CD) With Perceived Psychological Stress","Inclusion Criteria:\n\n* Older South Asian family caregivers (45 years or older) caring for a person with cognitive disability of any age\n* Self-reported insufficient physical activity (defined as participating in moderate physical activity less than 60 min\u002Fweek) and not engaged in mindfulness training\n* Self-reporting of experiencing psychological stress;\n* Own a smartphone with a data plan or Bluetooth-enabled device (e.g., tablets such as iPad) to sync data from the Fitbit tracker to the Fitbit app and to receive text messages\n* Ability to speak, understand, read and write English; ability to provide informed consent\n\nExclusion Criteria:\n\n* Non-South Asian caregivers\n* Caregivers less than 45 years old\n* Having self-reported sufficient physical activity (defined as participating in moderate physical activity more than 60 min\u002Fweek) and engaged in some form of mindfulness training\n* Not owning a smartphone with a data plan or Bluetooth-enabled device (e.g., tablets such as iPad)\n* Mobility limitation\n* Taking medications or other behavioral treatment for stress reduction; acute or chronic diseases at baseline\n* Inability to understand, speak, read, and write English\n* Inability to provide informed consent",{"count":94,"type":24},[27],"Older South Asian family caregivers experience elevated psychological stress and limited physical activity (PA) due to caregiving responsibilities and additional factors such as lack of access to services, cultural\u002Flinguistic barriers, stigma and discrimination. South Asian family caregivers are especially underserved and are a growing ethnic group in the US. Both PA and cognitive training (CT) have shown to improve cognitive function in older adults who experience cognitive function decline because of psychological stress. However, there are no studies using this approach for this population. We propose a randomized control trial pilot study to address this gap. Driven by a Community Advisory Committee (CAC) we will develop this 12-week mindful walking intervention using a participatory methodology in partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the PA of walking and the CT through mindfulness. We will recruit fifty participants and will randomly and equally assign 25 people to the intervention and 25 people to the control group. The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability. The primary aim of the proposed pilot study is to evaluate the feasibility and acceptability of the protocol and intervention implementation. A secondary aim will evaluate the intervention to examine preliminary efficacy in reduction of psychological stress, improvement in cognitive function, increase in physical activity, and increased self-efficacy (self-efficacy for coping with stress, self-efficacy for physical activity, and overall self-efficacy). The findings of this pilot project will provide evidence-based data to support a larger scale study proposal for future funding such as the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) field initiative award, or the National Institute of Health (NIH) Research Project Grant (R21 NIH Exploratory\u002FDevelopmental Research Grant Award) award, especially National Institute on Aging (NIA) grants.",[31,225],"Cognitive Decline",[227,228,229,230,231,232],"Caregiver of a person with cognitive disability","Perceived psychological stress","Cognitive Function","Mindful Walking","Physical Activity","Self-efficacy",{"date":207,"type":43},{"date":235,"type":43},"2023-10-31",{"date":237,"type":24},"2026-12-31",{"name":239,"class":50},"University of Illinois at Chicago",8,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":252,"conditions":253,"keywords":267,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":286,"locationsCount":157},"100585203","health-surveillance-at-constructor-university-bremen-cub-and-among-haw-hamburg-employees-100585203","NCT06899308","Health Surveillance at Constructor University Bremen (CUB) and Among HAW-Hamburg Employees","Health Surveillance at Constructor University Bremen (CUB) to Assess Students' and HAW-Hamburg Employees' Health and Wellbeing - Explanatory Sequential Mixed-Methods Approach","CUB-HS2025","Inclusion Criteria:\n\n* English language skills\n* Reading and writing skills\n* Internet access\n* Student status\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* Illiteracy\n* Massively limited cognitive abilities ( i.e. linguistic components of the digital offerings must be able to be used, and questionnaires completed, or interviews participated in) and severe psychiatric disorders (e.g., severe depression)",{"count":250,"type":24},363,"OBSERVATIONAL","The aim of Health Surveillance is to analyze and describe the state of health of students at Constructor University, key influencing factors and individual resources by using mixed-method design.",[254,133,255,256,257,31,258,259,260,261,262,263,264,265,266],"Social Isolation or Loneliness","Anxiety Depression (Mild or Not Persistent)","Health Behavior","Observational Study","Emotional Stress","Life Stress","Psychological Stress","Stress, Emotional","Stress (Psychology)","Substance Abuse","Substance Addiction","Substance Dependence","Substance Use",[268,269,270,271,272,273,274,232,275,276,277,278,279,280],"Healthy students","Health literacy","Disability","Age","Gender","Study characteristics","PHQ-4","Satisfaction with Life Scale (SWLS)","Subjective health status","Student satisfaction","UCLA-LS","HEI-Stress","Mixed Method","2026-04-25",{"date":207,"type":43},{"date":284,"type":43},"2025-03-17",{"date":237,"type":24},{"name":287,"class":50},"Jacobs University Bremen gGmbH",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":59,"minAge":191,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":25,"phases":298,"briefSummary":299,"conditions":300,"keywords":303,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":84},"100632100","effect-of-electroacupuncture-with-local-anesthesia-on-pain-and-stress-during-impacted-lower-third-molar-surgery-100632100","NCT07509294","Effect Of Electroacupuncture With Local Anesthesia On Pain And Stress During Impacted Lower Third Molar Surgery","Effect Of Electroacupuncture As An Adjunct To Local Anesthesia On Perioperative Pain And Stress During Ambulatory Surgical Extraction Of Impacted Lower Third Molars","EASE","Inclusion Criteria:\n\n* Adults aged 25-35 years\n* ASA physical status I-II\n* Indication for ambulatory surgical extraction of an impacted lower third molar\n* Ability to understand the study procedures and provide written informed consent\n* Willingness to comply with study procedures, including saliva sampling protocol\n* Ability to abstain from food, beverages, and oral hygiene procedures for at least 1 hour prior to saliva sampling\n\nExclusion Criteria:\n\n* Pregnancy\n* Epilepsy\n* Presence of a pacemaker or other active electronic implant\n* Coagulation disorders\n* Active infection at the site of acupuncture\n* Systemic inflammatory diseases\n* Oral inflammatory conditions (e.g., gingivitis or periodontitis)\n* Hyposalivation\n* Chronic opioid use\n* Psychiatric conditions that may affect pain or stress assessment\n* Use of nonsteroidal anti-inflammatory drugs, corticosteroids, or antibiotics within 7 days prior to the procedure\n* Menstruation at the time of saliva sampling\n* Inability or unwillingness to comply with study procedures","35 Years",{"count":128,"type":24},[27],"This randomized controlled trial investigates the effect of electroacupuncture as an adjunct to local anesthesia on perioperative pain and stress during ambulatory surgical extraction of impacted lower third molars. Participants will be randomized into three groups: electroacupuncture, sham acupuncture, and control. Pain intensity and perceived stress will be assessed using validated scales, while biological stress and nociceptive markers (salivary cortisol, alpha-amylase, and substance P), as well as hemodynamic parameters (blood pressure and heart rate), will be measured. The study aims to provide an integrated evaluation of the effects of electroacupuncture on subjective, biological, and physiological indicators of perioperative response in oral surgery.",[301,31,302],"Postoperative Pain","Impacted Lower Third Molar",[304,305,306,307,308,309],"Electroacupuncture","Dental Anxiety","Third Molar Surgery","Cortisol","Alpha-Amylase","Substance P","2026-03-28",{"date":312,"type":43},"2026-04-03",{"date":314,"type":24},"2026-04-20",{"date":316,"type":24},"2026-12-18",{"name":318,"class":50},"University of Zagreb",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":4},"100631490","occupational-balance-time-management-and-stress-in-double-major-students-100631490","NCT07501364","Occupational Balance, Time Management and Stress in Double Major Students","The Relationship Between Occupational Balance, Time Management and Perceived Stress in University Students Enrolled in a Double Major Program","Inclusion Criteria:\n\n* Voluntarily agreeing to participate in the study\n* Being an undergraduate university student.\n* Being actively enrolled in a double major program.\n* Having been enrolled in the double major program for at least one semester.\n* Having Turkish reading and comprehension skills.\n* Having no history of psychiatric diagnosis.\n\nExclusion Criteria:\n\n* Inactive enrollment in a double major program\n* Enrollment in an associate degree double major program\n* Incomplete or incorrectly completed questionnaires","30 Years",{"count":328,"type":24},150,"This study aims to examine the relationship between occupational balance, time management, and perceived stress in university students enrolled in a double major program. Participants who voluntarily agree to participate and meet the inclusion criteria will complete online questionnaires assessing their socio-demographic characteristics, occupational balance, time management skills, and perceived stress levels.",[331,332,31],"Occupational Balance","Time Management",[334,335,336,337],"Double major students","Occupational balance","Time management","Perceived stress","2026-03-26",{"date":340,"type":43},"2026-03-30",{"date":342,"type":24},"2026-04-01",{"date":344,"type":24},"2026-04-10",{"name":346,"class":50},"Medipol University",{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":59,"minAge":355,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":25,"phases":357,"briefSummary":358,"conditions":359,"keywords":362,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":157},"100630057","virtual-reality-based-transitional-care-for-icu-survivors-100630057","NCT07482722","Virtual Reality-Based Transitional Care for ICU Survivors","Impact of a Virtual Reality-Based Transitional Care Program on Heart Rate Variability, Pain, Relocation Stress, and Unplanned ICU Readmission Among Adult ICU Survivors: A Randomized Controlled Trial","VRICU","Inclusion Criteria:\n\n* Age 20 years or older\n* Adult patients admitted to the intensive care unit (ICU)\n* Planned transfer from ICU to the general ward\n* Able to communicate and provide informed consent or have a legal representative provide consent\n\nExclusion Criteria:\n\n* Severe cognitive impairment or delirium preventing participation\n* Severe visual or hearing impairment interfering with VR use\n* Hemodynamic instability requiring immediate life-saving intervention\n* Isolation precautions prohibiting device use\n* Participation in another interventional study that may affect outcomes","20 Years",{"count":328,"type":24},[27],"This study aims to evaluate the effectiveness of a virtual reality (VR)-based transitional care program for adult survivors of intensive care unit (ICU) care. ICU survivors frequently experience relocation stress, anxiety, pain, and physiological instability after transfer from the ICU to general wards, which may increase the risk of unplanned ICU readmission.\n\nParticipants will be randomly assigned to receive either standard transitional care or additional VR-based intervention sessions during their ICU stay. The VR intervention is designed to provide psychological support, environmental orientation, and stress reduction.\n\nPrimary outcomes include short-term physiological indicators within 48 hours after ICU transfer. Secondary outcomes include pain, relocation stress, and unplanned ICU readmission within 7 days.",[360,31,361],"Critical Illness","Intensive Care Units",[363,364,365,202,366,367,34],"Virtual Reality","ICU Survivors","Relocation Stress","Transitional Care","Unplanned ICU Readmission","2026-03-16",{"date":370,"type":43},"2026-03-19",{"date":372,"type":24},"2026-03-09",{"date":374,"type":24},"2027-02",{"name":376,"class":50},"Mackay Memorial Hospital",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":18,"sex":59,"minAge":21,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":25,"phases":386,"briefSummary":387,"conditions":388,"keywords":400,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":4},"100628685","feasibility-of-breathwork-intervention-with-older-adults-after-knee-surgery-100628685","NCT07464860","Feasibility of Breathwork Intervention With Older Adults After Knee Surgery","A Box Breathing Intervention and the Surgical Stress Response in Older Adults Undergoing Total Knee Arthroplasty: A Randomized Controlled Feasibility Trial","Adults aged 65 years or older of any sex, gender and ethnic background who meet the following criteria will be eligible to enroll in the present study:\n\nInclusion Criteria:\n\n* scheduled for elective TKA within the next week to two months (can be second knee, but cannot be a revision of the original knee)\n* self-reported good health, including denial of debilitating illness that may affect participation in or be potentially exacerbated by deep, controlled breathing (i.e., chronic obstructive pulmonary disorder \\[COPD\\], symptomatic or advanced heart failure, complete heart block, glaucoma, epilepsy)\n* denial of conditions that alter cortisol release or that require corticosteroid therapy (i.e., Cushing's syndrome, Addison's disease, pituitary tumors, adrenal gland tumors, asthma)\n* denial of severe psychiatric or cognitive conditions that warrant the need for a durable power of attorney (DPOA)\n* able to understand written and verbal English.\n\nExclusion Criteria:\n\n* currently taking oral, injectable, intranasal, topical, or inhaled corticosteroid medications (i.e., prednisone, hydrocortisone, dexamethasone, methylprednisolone, methylprednisolone acetate, triamcinolone, betamethasone, mometasone, fluticasone, budesonide, clobetasol)\n* do not have the technology requirements to complete data collection (i.e., participant does not have a smartphone, tablet, laptop, or desktop computer; lack of reliable internet)\n\nThe following exclusion criteria may affect participants' ability to remain in the study following enrollment:\n\n• Development of complications during surgery that require prolonged hospitalization into Postoperative Day (POD) 2 (e.g., postoperative intubation and ventilation requirements, intractable pain, intractable nausea\u002Fvomiting, signs of infection or sepsis)",{"count":385,"type":24},32,[27],"Postoperative complications after surgical procedures, including following total knee arthroplasty (TKA), have a negative impact on the health and well-being of surgical patients. Older adults (≥65 years) are particularly vulnerable to postoperative complications and their associated morbidities due to the biological aging process. Older adults comprise nearly half of surgical patients worldwide, and this number is expected to increase in the next 10-20 years as the aging population continues to grow. TKA is the most common procedure undergone by older adults, and the rate of TKA procedures is also expected to rise. Despite perioperative guidelines and protocols to prevent postoperative complications, the prevalence of postoperative complications following TKA is approximately 12%. Given these statistics, millions of older adults undergoing TKA may be at risk for postoperative complications and their associated morbidities in the coming decades. Therefore, additional interventions are needed to combat postoperative complications in this population.\n\nThe body's natural response to surgery, also known as the surgical stress response (SSR), contributes to postoperative complications through complex mechanisms involving the autonomic nervous system (ANS). Increased sympathetic nervous system (SNS) activity, or the body's fight-or-flight response, causes dysregulation in feedback systems that regulate the stress response, potentially leading to poorer outcomes. Interventions, such as breathwork, that induce the parasympathetic nervous system (PNS), or the body's rest-and-digest response, have been shown to balance the ANS, regulate stress biology, and improve outcomes. This study will examine the feasibility of adding a breathwork intervention (Box Breathing), compared to an attention control, to standard perioperative care for older adults undergoing TKA. This study will also examine the proof of concept that Box Breathing, compared to an attention control, may help regulate the SSR by assessing an objective measure of stress-related biology, diurnal cortisol rhythm, and gathering self-report information on pain, anxiety, depression, and quality of recovery following TKA.",[389,390,391,392,393,394,395,396,134,307,301,397,398,399],"Surgical Stress Response","Stress Physiological","Stress Physiology","Stress Psychological","Breathing Techniques","Breathing Exercises","Hypothalamic Pituitary Adrenal","Relaxation","Postoperative Anxiety","Postoperative Depression","Quality of Recovery (QoR-15)",[389,401,402,403,394,393,404,301,397,398,405,406],"Total Knee Arthroplasty","Hypothalamic-Pituitary-Adrenal Axis","Breathwork","Postoperative Complications","Quality of Recovery","Diurnal Cortisol Rhythm","2026-03-06",{"date":409,"type":43},"2026-03-11",{"date":411,"type":24},"2026-04-06",{"date":413,"type":24},"2026-09-30",{"name":415,"class":50},"University of Arizona",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":25,"phases":426,"briefSummary":427,"conditions":428,"keywords":431,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":84},"100575352","building-community-resilience-program-100575352","NCT06771167","Building Community Resilience Program","NYC Community Engagement Alliance (NYCEAL) Against COVID-19 Disparities","BCR","Inclusion Criteria:\n\n* Able to consent\n* Able to fill out the screening RedCap short survey\n* Have access to a computer or smart gadget that will allow participant to be able to join the zoom call\n* English speaking\n* Living in NYC (5 boroughs)\n* 18+ years of age (no upper bound age limit)\n* Working with an NYCEAL CBO participating in BCR programming\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Incapacitated to an extent that they are unable to comprehend a conversation or communicate effectively in a group setting\n* Unable to consent to be part of the study\n* Does not have access to a computer or smart gadget that will allow participant to be able to join the zoom call\n* Does not speak English\n* Not living in NYC\n* Not 18+ years of age\n* Not working with an NYCEAL CBO participating in BCR programming",{"count":425,"type":24},168,[27],"Established in 2021, NYCEAL consists of approximately 40 organizational partners and 120 Community Health Workers (CHWs). Over the next four years (2024-2028), NYCEAL will work with this network to implement the following intervention: Building Community Resilience Program (BCR). To assess the impact of this intervention, an implementation research framework will be used, and pre- and post-surveys conducted, and other process evaluation measures collected. Changes in outcomes measures such as stress, resilience, overall wellbeing, and other related outcomes for participants in the BCR program will be measured for community healthcare workers and\u002For frontline workers that receive educational workshops.",[429,430,31],"Resilience, Psychological","Burnout, Psychological",[432,433,434,435,436,437],"Resilience","Community Health Workers","Burnout","Emotional Well-Being","Educational Workshops","Community-Based Organizations","2026-03-05",{"date":372,"type":43},{"date":441,"type":43},"2024-12-11",{"date":443,"type":24},"2027-11-15",{"name":445,"class":50},"Icahn School of Medicine at Mount Sinai",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":25,"phases":455,"briefSummary":456,"conditions":457,"keywords":461,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":467,"leadSponsor":469,"locationsCount":4},"100614475","yoga-meditation-and-mindful-eating-intervention-in-university-students-100614475","NCT07280078","Yoga, Meditation and Mindful Eating Intervention in University Students","Evaluation of a Yoga, Meditation and Mindful Eating Intervention for the Control of Stress, Anxiety, Depression, and Mindfulness in University Students","Yoga-UDEA","Inclusion Criteria:\n\n* Undergraduate students enrolled in the curso \"Yoga, Meditation, and Mindful Eating\" at the Faculty of Pharmaceutical and Food Sciences (CIFAL), University of Antioquia.\n* Willing to participate voluntarily and complete all study assessments.\n* Able to attend the full program (32 hours over one academic semester).\n\nExclusion Criteria:\n\n* Students currently practicing yoga or meditation regularly.\n* Pregnant women or participants with any medical condition that prevents safe participation in yoga practice.\n* Individuals with severe psychiatric disorders requiring pharmacological treatment.",{"count":128,"type":24},[27],"The aim of this study is to learn whether a program that combines yoga, meditation, and mindful eating can help reduce stress, anxiety, and depression, and improve mindfulness in university students.\n\nThe main questions the study aims to answer are:\n\n* Does participating in yoga, meditation, and mindful eating sessions lower students' levels of stress, anxiety, and depression?\n* Does the program improve students' mindfulness and general well-being?\n\nWhat will happen in the study:\n\nParticipants will:\n\n* Attend weekly sessions of yoga, meditation, and mindful eating for 32 hours total.\n* Practice physical postures (Asanas), breathing exercises (Pranayama), relaxation, and meditation.\n* Receive short lessons about mindful nutrition and healthy lifestyle habits.\n* Complete questionnaires before and after the program to measure stress, anxiety, depression, and mindfulness.",[31,133,458,459,460],"Depression","Mindfulness","Well-being",[462],"Yoga, Meditation, Stress, Psychological; Anxiety; Well-being; Mindful Eating; Psychological","2026-02-16",{"date":465,"type":43},"2026-02-18",{"date":115,"type":24},{"date":468,"type":24},"2026-08",{"name":470,"class":50},"Universidad de Antioquia",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":19,"minAge":92,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":25,"phases":480,"briefSummary":481,"conditions":482,"keywords":486,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":4},"100620255","self-affirmation-intervention-after-mastectomy-100620255","NCT07355244","Self-Affirmation Intervention After Mastectomy","The Effect of Self-Affirmation Skills on Pain, Depression, Anxiety, and Stress in Patients Undergoing Mastectomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Female patients who have undergone mastectomy surgery\n* Able to speak and understand Turkish\n* Provides informed consent and agrees to participate voluntarily\n\nExclusion Criteria:\n\n* Diagnosed psychiatric disorder\n* Hearing impairment that prevents listening to the audio intervention",{"count":479,"type":24},42,[27],"This randomized controlled trial aims to evaluate the effect of a structured self-affirmation intervention on pain, depression, anxiety, and stress levels in patients undergoing mastectomy. The study will be conducted in two parallel groups, with the intervention group listening to an audio recording of positive self-affirmation statements. Primary outcomes will be assessed using the Visual Analog Scale and the Depression Anxiety Stress Scale (DASS-21). The goal is to provide evidence-based strategies to reduce psychosocial burden after mastectomy.",[483,484,485,458,31],"Breast Neoplasms","Mastectomy; Lymphedema","Pain",[487,488,489,133,458],"Mastectomy","Breast Cancer","Stress","2026-01-12",{"date":492,"type":43},"2026-01-21",{"date":494,"type":24},"2026-01-01",{"date":496,"type":24},"2026-12-01",{"name":498,"class":50},"Muş Alparslan University",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":59,"minAge":506,"maxAge":507,"enrollmentInfo":508,"targetDuration":4,"studyType":25,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":84},"100615630","personalized-music-therapy-for-preterm-infants-100615630","NCT07295106","Personalized Music Therapy for Preterm Infants","Evaluation of the Effects of Personalized Music Therapy on Preterm Infants Admitted to the Neonatal Intensive Care Unit (NICU) and on Parental Stress: A Pilot Randomized Crossover Controlled Trial","Inclusion Criteria:\n\n* Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of Azienda Ospedaliera di Perugia, Santa Maria della Misericordia, Perugia (Italy) at the time of enrollment.\n* Gestational age at birth 28+0 to 36+6 weeks.\n* Age at enrollment: 5 to 15 days.\n* Stable vital signs at enrollment per unit policy.\n* Apgar score at 5 minutes ≥ 7.\n* Birth weight appropriate for gestational age, between the 50th and 90th percentile.\n* Written informed consent from parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n* Post-operative status at the time of enrollment.\n* One or more of the following: intraventricular hemorrhage, necrotizing enterocolitis, sepsis, significant pulmonary disease, or neonatal anemia.\n* Congenital anomalies.\n* Hypersensitivity or intolerance to sound.\n* Maternal history of drug and\u002For alcohol misuse during pregnancy.\n* Lack of parental consent.","5 Days","15 Days",{"count":509,"type":24},20,[27],"Preterm infants in the Neonatal Intensive Care Unit (NICU) face environmental and clinical stressors that may affect physiological stability and development. This pilot randomized crossover study tests Personalized Music Therapy (PMT) based on recorded parental voices versus Quiet Rest. Outcomes include tissue oxygenation index (TOI) via near-infrared spectroscopy (NIRS) and heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2). Each infant completes two Periods (PMT and Quiet Rest) in randomized order, separated by a 2-day washout. Parental stress is measured at discharge using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU). Findings inform feasibility, variance estimates, and protocol refinements for a larger trial.",[513,31],"Infant, Premature",[515,516,517,518,519,520,521,522,523],"Neonatal Intensive Care Unit","NICU","Music Therapy","Parental Voice","Tissue Oxygenation Index (TOI)","Respiratory Rate","Near-Infrared Spectroscopy (NIRS)","Heart Rate","Oxygen Saturation","2025-12-16",{"date":526,"type":43},"2025-12-19",{"date":528,"type":43},"2025-10-13",{"date":530,"type":24},"2026-03",{"name":532,"class":50},"Fabrizio Faina",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":18,"sex":59,"minAge":540,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":25,"phases":543,"briefSummary":544,"conditions":545,"keywords":547,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":84},"100612575","virtual-reality-based-360-clinic-walkthrough-for-reducing-examination-anxiety-in-preschool-children-100612575","NCT07255365","Virtual Reality-Based 360° Clinic Walkthrough for Reducing Examination Anxiety in Preschool Children","VIRTUAL REALITY-BASED 360° CLINIC WALKTHROUGH: EFFECTS ON EXAMINATION ANXIETY AND PHYSICIAN EXAMINATION EASE IN CHILDREN","Inclusion Criteria:\n\n* Children aged 3 to 5.5 years (36-66 months)\n* Clinically stable and presenting for routine outpatient physical examination\n* Able to engage with a short audiovisual VR\u002F360° video\n* Written informed consent from a parent or legal guardian\n* Verbal assent from the child when appropriate\n\nExclusion Criteria:\n\n* Severe neurodevelopmental delay or communication difficulty\n* Autism spectrum disorder or significant behavioral dysregulation\n* History of epilepsy or photosensitivity\n* Visual or hearing impairment preventing VR use\n* Acute illness requiring urgent intervention\n* Body temperature ≥ 38.0°C at presentation\n* Previous exposure to VR or 360° clinic simulations\n* Concomitant sedative medication use\n* Refusal of participation by parent or child","36 Months","66 Months",{"count":23,"type":24},[27],"This prospective, double-blind, randomized controlled trial investigates whether a short, 360° virtual reality (VR) pre-examination walkthrough can reduce anxiety, behavioral distress, and physiological stress responses in preschool children undergoing routine outpatient physical examination. A total of 100 children aged 3-5.5 years were randomized to either a VR group, which viewed a 3-minute real-clinic 360° video via VR goggles, or a control group, which experienced routine waiting only. Primary outcome measures include the Face-Legs-Activity-Cry-Consolability (FLACC) score and crying duration during examination. Secondary outcomes include heart and respiratory rate changes, Wong-Baker Faces Pain Rating Scale (WBS) scores, parent satisfaction, and physician-rated examination ease. The study aims to determine whether immersive, procedure-specific VR preparation can improve examination experience and cooperation while reducing stress for both children and caregivers.",[133,31,546],"Fear",[548,549,550],"pediatric physical examination","examination anxiety","behavioral distress","2025-11-30",{"date":553,"type":43},"2025-12-05",{"date":555,"type":43},"2025-11-20",{"date":557,"type":24},"2025-12-31",{"name":559,"class":50},"Berker Okay",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":18,"sex":59,"minAge":4,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":25,"phases":569,"briefSummary":570,"conditions":571,"keywords":577,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":4},"100611065","the-effect-of-laughter-yoga-on-individual-and-organizational-outcomes-in-nurse-managers-100611065","NCT07235735","The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers","The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers: A Longitudinal Study","Inclusion Criteria:\n\n* Currently working as a nurse manager\n* Having at least six months of managerial experience\n* Continuing to serve as a nurse manager throughout the study period\n\nExclusion Criteria:\n\n* Having previously received laughter yoga training\n* Use of medications affecting general health components during the study (e.g., for depression, anxiety)\n* Being pregnant\n* Experiencing an acute stressful life event, such as the death of a close relative\n* Having undergone abdominal surgery within the past 6 months",{"count":568,"type":24},80,[27],"The goal of this clinical trial is to learn if laughter yoga can improve both individual and organizational outcomes in nurse managers. The main questions it aims to answer are:\n\n* Does laughter yoga lower burnout and stress levels in nurse managers?\n* Does laughter yoga improve work-life quality and job performance?\n* Does laughter yoga help nurse managers make better decisions and solve problems more effectively?\n* Does laughter yoga lower compassion fatigue and support positive approaches to workplace conflict? Researchers will compare a laughter yoga group with a control group to see if there are meaningful differences.\n\nParticipants will:\n\n* Join structured laughter yoga sessions for a defined period (weekly sessions).\n* Complete surveys before and after the program about stress, burnout, work-life quality, decision-making, problem solving, job performance, compassion fatigue, and conflict approaches.\n* Continue their usual work while attending sessions.",[100,31,572,573,574,575,576],"Compassion Fatigue","Quality of Life","Decision Making","Problem Solving","Work Performance",[578,579,434,489,580,574,575,581,572,582,583,584],"Nurse Managers","Laughter Yoga","Work-Life Balance","Job Performance","Conflict Management","Organizational Outcomes","Professional Development","2025-11-17",{"date":587,"type":43},"2025-11-19",{"date":589,"type":24},"2025-12-11",{"date":591,"type":24},"2026-03-17",{"name":593,"class":50},"Zonguldak Bulent Ecevit University",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":18,"sex":59,"minAge":191,"maxAge":602,"enrollmentInfo":603,"targetDuration":4,"studyType":25,"phases":605,"briefSummary":606,"conditions":607,"keywords":611,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":638},"100609887","foundational-programs-to-combat-clinician-stress-100609887","NCT07220421","Foundational Programs to Combat Clinician Stress","Evaluate Foundational Wellness Programs to Help Reduce Clinician Burnout and Improve Professional Fulfilment in Health Care Professionals.","FACCTS","Inclusion Criteria:\n\n* 25-70 years of age,\n* UPHS or MGH clinician (physician, APP, CRNP, PA, psychologist),\n* Access to smart phone and internet,\n* Ability to give informed consent,\n* Interested in wearing an Oura ring and being part of a study to evaluate breath and meditation-derived exercises,\n* Willing to do relaxation exercise every day for 4 weeks.\n\nExclusion Criteria:\n\n* Currently maintaining a regular\u002Fdaily mind-body program practice (eg. meditation, yoga or breathing techniques),\n* Atrial fibrillation,\n* Pacemaker\u002Fdefibrillator,\n* Untreated or severe obstructive sleep apnea (AHI\\>=30),\n* History of diaphragm paralysis,\n* Unable or unwilling to complete the workshop,\n* Severe chronic obstructive pulmonary disease (COPD),\n* Severe valvular heart disease,\n* Prior or planned chest\u002Fabdominal or nasal\u002Ffacial surgery within 6 months,\n* Severe psychiatric illness (e.g. schizophrenia, schizoaffective disorder, bipolar disorder), active substance use, seizure disorder or major somatic illness (uncontrolled hypertension, lung disease, liver disease, cancer or heart disease).","70 Years",{"count":604,"type":24},180,[27],"This is a prospective, randomized, controlled clinical trial in which clinicians from University of Pennsylvania Health Systems (UPHS) including Penn Medicine- Lancaster General Health (LGH) and Massachusetts General Hospital (MGH) are offered a well-known program to help reduce clinician burnout: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation Intervention.",[100,31,196,608,609,610],"Psychological Well-Being","Mind-Body Therapies","Work Related Stress",[612,613,614,615,616,617,618,619,620,458,133,621,202,432,622,623,624,625,626,627,628],"Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation","Stress Reduction","Healthcare Professional Burnout","Workplace Wellbeing","Work Life Balance","Physician","Healthcare Provider","Cognitive Performance","Cognitive Attention","Sleep","Social Connection","Self-Valuation","Professional Fulfilment","Medical Errors","Physician Turnover","Healthcare Economics","Occupational Burnout","2025-10-21",{"date":631,"type":43},"2025-10-23",{"date":633,"type":43},"2025-09-15",{"date":635,"type":24},"2026-05",{"name":637,"class":50},"Lancaster General Hospital",6,{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":25,"phases":647,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":657,"leadSponsor":659,"locationsCount":84},"100607431","testing-adapted-self-help-plus-sh-for-stress-and-well-being-in-international-students-at-a-us-university-100607431","NCT07188467","Testing Adapted Self-Help Plus (SH+) for Stress and Well-Being in International Students at a U.S. University","Implementing a Scalable Mental Health Intervention for International Students: A Pilot Study of Digitized Self-Help Plus","Inclusion Criteria:\n\n* Enrolled as an international student at The New School\n* Age 18 years or older\n* Willing to provide informed consent and complete study assessments\n* Score of ≥3 on the PHQ-4, indicating at least mild distress\n* Sufficient English proficiency to comprehend intervention materials\n\nExclusion Criteria:\n\n* Severe psychiatric conditions requiring immediate intervention (e.g., active psychosis, severe mood disorders)\n* Visual, hearing, or neurocognitive impairments that prevent engagement with the intervention\n* Having an advanced degree in psychology or mental health-related fields (to prevent prior knowledge bias)\n* Score of 2 or higher on PHQ-4 Item 3 or Item 4 (frequent thoughts of self-harm or severe distress)",{"count":94,"type":24},[27],"The goal of this clinical trial is to learn if an adapted version of Self-Help Plus (SH+), a stress management program developed by the World Health Organization, can reduce stress and improve well-being in international students at a U.S. university. The main questions it aims to answer are:\n\nDoes SH+ reduce perceived stress, anxiety, and depressive symptoms in international students? Does SH+ improve feelings of social support, self-efficacy, and adjustment in a new cultural environment?\n\nParticipants will:\n\nAttend a two-day in-person workshop that includes animated videos, interactive activities, and group discussions.\n\nComplete three surveys (before the workshop, right after, and six weeks later) about stress, mood, and well-being.\n\nOptionally, take part in a short interview to share feedback about their experience.",[31,650,651,652],"Depression and\u002For Anxiety in the Mild-to-moderate Range","Loneliness","Adjustment, Psychological","2025-10-07",{"date":655,"type":43},"2025-10-09",{"date":653,"type":43},{"date":658,"type":24},"2026-01",{"name":660,"class":50},"The New School",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":4,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":59,"minAge":92,"maxAge":668,"enrollmentInfo":669,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":4},"100606406","halitosis-sleep-and-mental-health-in-bariatric-surgery-candidates-100606406","NCT07175142","Halitosis, Sleep and Mental Health in Bariatric Surgery Candidates","Assessment of Psychological Distress, Sleep Quality, and Halitosis in Patients With Obesity: Protocol for an Observational Study in the Preoperative Period of Bariatric Surgery","Inclusion Criteria:\n\n* Adults ≥18 years with a diagnosis of obesity\n* Referred for psychological care at the \"Rosinha Viegas\" Interprofessional Outpatient Clinic during preoperative preparation for bariatric surgery (Brazilian public health system - SUS)\n\nExclusion Criteria:\n\n* Individuals with cognitive or neurological limitations that impair understanding or participation in the assessment procedures\n\nIndividuals who refuse or withdraw consent","90 Years",{"count":670,"type":24},110,"This study aims to evaluate psychological distress, sleep quality, and halitosis in obese patients during the preoperative period of bariatric surgery. A total of 110 adults will be assessed using validated questionnaires and a portable halitosis detector. The results may contribute to improving strategies for comprehensive care in this population.",[673,674,675,676,31],"Obesity","Bariatric Surgery Candidate","Halitosis","Sleep Disorder","2025-09-09",{"date":679,"type":43},"2025-09-16",{"date":681,"type":24},"2025-10-01",{"date":683,"type":24},"2026-06-30",{"name":685,"class":50},"University of Nove de Julho",{"id":687,"slug":688,"hasResults":12,"nctId":689,"briefTitle":690,"officialTitle":691,"acronym":692,"eligibilityCriteria":693,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":694,"targetDuration":4,"studyType":25,"phases":696,"briefSummary":697,"conditions":698,"keywords":704,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":710,"completionDateStruct":712,"leadSponsor":714,"locationsCount":84},"100551077","building-emotional-awareness-and-mental-health-beam-2024-2027-100551077","NCT06455397","Building Emotional Awareness and Mental Health (BEAM) 2024-2027","Implementing BEAM: An mHealth Tool to Prevent Mental Health Problems and Improve Developmental Outcomes in Young Children","BEAM","Inclusion Criteria:\n\n1. Moderate to severe symptoms of depression, anxiety, parenting stress, and\u002For anger (as measured by the PHQ-9, GAD-7, PSI, and PROMIS-Anger). Those who do not have moderate to severe symptoms will meet with a member of the program research team to determine eligibility. This eligibility decision will be based on clinical judgement, ensuring that those with need can participate.\n2. Being a parent or primary caregiver of any gender to an 24- to 71-month-old (i.e., 2-5 year old) child.\n3. Living in Manitoba.\n4. Able to participate in check ins (15 to 60 minutes) via Zoom, phone, direct messaging with a parent peer coach.\n5. 18 years or older.\n6. Able to understand\u002Fread\u002Fspeak in English.\n7. Willing to complete four 45-min questionnaires.\n8. At eligibility screening, a question asks if participants have access to an electronic device for viewing videos and participating in Zoom meetings. Participants who do not have access will be asked to contact the research team. The team may be able to accommodate a limited number of participants by providing relevant devices for the duration of the study.\n9. Participants have IP addresses within Manitoba, Canada, as determined by IP address in REDCap at time of eligibility screener questionnaire completion. Participants will be required to securely upload a photo that includes both a valid piece of Manitoba government identification and the participant's face (i.e., a 'selfie').\n\nExclusion Criteria:\n\n1. Living outside of Manitoba.\n2. Being a parent or primary caregiver to a child outside of the ages of 24- to 71-months (i.e., 2-5 years).\n3. Previously participated in an earlier BEAM trial.\n4. Parents who report self-harm that required medical attention within the past six months or a suicide attempt within the past year will be ineligible to participate in BEAM unless the participant is engaged in individual therapy that attends to this acute risk level with one of the following professionals for the duration of the BEAM program: psychiatrist, psychologist, social worker, or psychotherapist. The research team will email all prospective participants who are pending eligibility to schedule a phone call. This call will determine whether it is feasible to connect the participant with an individual therapist to manage specific needs before engaging in the BEAM program, and discuss if the BEAM program is the right fit for the participant's present needs.\n\nCo-parents will be permitted to participate in BEAM regardless of current mental health challenges. Therefore, co-parents are only subject to inclusion criterion (3) and criteria (5-9). Instead of meeting inclusion criteria (2), parenting partners must be a \"co-parent (e.g., the child's mom, dad, step-parent) or other primary caregiver (e.g., the child's grandma, cousin, uncle, auntie)\" to the corresponding participant's 24- to 71-month-old (i.e., 2-5 year old) child. Co-parents will not receive the same pre-trial screening as parent participants, and thus will not be subject to exclusion criteria.",{"count":695,"type":24},400,[27],"Children are highly sensitive to adversity during their first five years of life, with exposure to chronic parental mental illness (MI) consistently linked to socio-emotional impairments and mental health problems in children. Children born during the COVID-19 pandemic were exposed to unprecedented level of parental distress, with parental MI reported at three times the pre-pandemic rates. This situation underscored a pressing need for scalable solutions to foster positive mental health and developmental outcomes for a generation of children. In response, the investigators developed the Building Emotional Awareness and Mental Health (BEAM) program, an innovative mobile health (mHealth) solution for parents of young children. Clinical trials to date evaluating BEAM have shown promising results, demonstrating reductions in parent depression, anxiety, and harsh parenting practices. This trial involves an effectiveness-implementation hybrid design with co-primary aims of (1) determining BEAM's effectiveness in improving child mental health and developmental outcomes, and (2) evaluating the implementation of BEAM in the community through metrics such as feasibility, acceptability, and uptake. The secondary aim of this trial is to measure BEAM's effectiveness in improving long-term biopsychosocial family outcomes using administrative data. A final exploratory aim of this trial will measure the cost-utility of delivering BEAM relative to extant health programming.\n\nThis trial will evaluate the effectiveness of implementing the BEAM intervention in the community with a sample of 400 parent participants with a child aged 24-71 months. Study participants will complete 12 weeks of psychoeducation modules in the BEAM app, with access to an online social support forum and check ins with a peer coach. Assessments of parent and child symptoms will occur at pre-test before BEAM begins (T1), immediately after the last week of the BEAM intervention (post-test, T2), 6-month follow-up (T3), and 12-month follow-up (T4).\n\nBeginning in 2025, the trial offers participants the option to invite one parenting partner to join them in the program. A parenting partner is defined as a co-parent (e.g., the child's mother, father, or step-parent) or another primary caregiver (e.g., a grandparent, cousin, uncle, or aunt). Each participant may invite one such individual, hereafter referred to as a \"co-parent.\" Co-parents will have access to the BEAM intervention and all its features, with the exception of peer coaching. Co-parents will be eligible to complete the same outcome measures at the same timepoints as participants. Three differences that will separate co-parents from participants are: (1) co-parents will not be asked to complete the ASQ:2-SE or ASQ-3 secondary outcome measures; (2) co-parents will not have access to peer coaching, and (3) co-parents will not be required to be experiencing moderate to severe symptoms of depression, anxiety, parenting stress, and\u002For anger. (Please see Eligibility \\> Eligibility Criteria for the less restrictive inclusion and exclusion criteria for co-parents.) Co-parents will not be counted toward the trial sample size of n=400, and will not be included in primary analyses. Instead, co-parent data will be used in sub-studies to address exploratory research questions.\n\nThe BEAM program offers a promising solution to addressing elevated parental mental health symptoms, parenting stress, and related child functioning concerns. The present implementation trial aims to extend the groundwork established by an open pilot trial and RCT of the BEAM program, in a next step of testing BEAM's readiness for nationwide scaling.",[699,700,701,31,702,703],"Depression, Anxiety","Anger","Parenting","Parent-Child Relations","Child Development",[701,705,458,133,173,706],"Mental health","App-based intervention","2025-06-13",{"date":709,"type":43},"2025-06-18",{"date":711,"type":43},"2024-03-11",{"date":713,"type":24},"2027-06",{"name":715,"class":50},"Leslie E. Roos",{"id":717,"slug":718,"hasResults":12,"nctId":719,"briefTitle":720,"officialTitle":720,"acronym":4,"eligibilityCriteria":721,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":21,"enrollmentInfo":722,"targetDuration":4,"studyType":25,"phases":723,"briefSummary":724,"conditions":725,"keywords":726,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":730,"lastUpdatePostDateStruct":731,"startDateStruct":733,"completionDateStruct":735,"leadSponsor":737,"locationsCount":84},"100566561","stress-inoculation-training-sit-an-evidence-based-military-aligned-psychological-performance-and-health-sustainment-prototype-100566561","NCT06656780","Stress Inoculation Training (SIT): An Evidence-Based, Military Aligned Psychological Performance and Health Sustainment Prototype","Inclusion Criteria:\n\n* US Navy service members on Active Duty or Reserve status\n* be fluent in English.\n* be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.\n* have access to a SmartPhone, computer, or tablet to utilize and access the virtual classroom.\n* agree to undergo psychometric and operational performance testing and participate in ongoing assessments throughout the study duration.\n* be willing to comply with all study procedures, able to complete all assessments independently, and available for the duration of the study (with reasonable accommodations for military operational demands as they arise).\n\nExclusion Criteria:\n\n* Active suicidal ideation as assessed by the Investigator at screening or as identified during the study.\n* Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease\u002Fdementia as assessed by the Investigator.\n* Active severe substance abuse as assessed by the investigator in accordance with The Diagnostic and Statistical Manual of Mental Illnesses (DSM-5) Substance Abuse Disorder criteria, or presence of illicit substance abuse.\n* They are currently undergoing another form of treatment other than supportive therapy (\\>2 times per month).\n* Any other condition\u002Fsituation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.",{"count":63,"type":24},[27],"The purpose of this study is to demonstrate the feasibility of augmenting existing\u002Ftraditional Navy military training with the manualized SIT Core Protocol (CP) utilizing the established augmentation procedure set as measured by feasibility, utility, and satisfaction metrics (CSQ-8) and to examine the relative effectiveness of the SIT-CP by comparison to standard military training in a controlled trial examining outcomes of stress tolerance, psychological health, resilience and occupational performance in Sailors undergoing DCA Firefighting Training (pre- to post-training), while collecting implementation data.",[31],[727,728,729],"Psychological health","resilience","Warfighter performance","2025-06-11",{"date":732,"type":43},"2025-06-12",{"date":734,"type":24},"2025-08-31",{"date":736,"type":24},"2027-06-30",{"name":738,"class":50},"The University of Texas Health Science Center, Houston",{"id":740,"slug":741,"hasResults":12,"nctId":742,"briefTitle":743,"officialTitle":744,"acronym":745,"eligibilityCriteria":746,"healthyVolunteers":18,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":747,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":748,"conditions":749,"keywords":757,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":776,"lastUpdatePostDateStruct":777,"startDateStruct":779,"completionDateStruct":781,"leadSponsor":783,"locationsCount":84},"100579648","global-survey-on-newborns-hospitalisation-and-parental-experiences---the-hope-study-100579648","NCT06827028","Global Survey on Newborns' HOspitalisation and Parental Experiences - the HOPE Study","Global Survey on Newborns' HOspitalisation and Parental Experiences","HOPE","Inclusion Criteria:\n\nParent or caregiver of a newborn infant born on January 1, 2023, or thereafter, who received\u002Fis receiving special\u002Fintensive care starting within the first week of life such as oxygen therapy or other respiratory support, incubator treatment, intravenous infusions, treatment of (suspected) sepsis, pneumonia, necrotising enterocolitis, malformations, jaundice, nutritional\u002Ffeeding problems, hypoglycemia, etc.\n\nExclusion Criteria:\n\n* Other family members than parents\u002F(primary) caregivers\n* Parents of newborns that did not receive special\u002Fintensive care starting within the first week of life\n* Parents or caregivers of infants born before 1 January 2023\n* Persons with insufficient proficiency of one of the languages of the questionnaire",{"count":23,"type":24},"This study aims to explore parents' experiences and emotional burdens related to their newborn's hospital stay using an online survey. Our target population consists of parents of newborns born preterm, with low birthweight, or critically ill. Particularly the presence of infant- and family-centred developmental care (IFCDC) principles as well as support through political framework conditions will be investigated.",[513,750,751,752,753,133,546,31,754,755,756],"Infant, Low Birth Weight","Parents","Life Change Events","Needs Assessment","Uncertainty","Emotions","Caregiver Burden",[758,759,760,761,516,762,763,764,765,753,766,751,767,768,769,770,771,772,773,774,775],"Parental needs","Infant- and Family-centred developmental care","IFCDC","EFCNI","Global Parent Survey","Breastfeeding","Breastfeeding support","Politics","HRQoL","Infant, Newborn","Family","Family Support","Family Health","Intensive Care, Neonatal","Patient-Centered Care","Infant Care","Surveys and Questionnaires","Health Care Surveys","2025-04-24",{"date":778,"type":43},"2025-04-27",{"date":780,"type":24},"2025-09-01",{"date":782,"type":24},"2027-12-31",{"name":784,"class":50},"Global Foundation for the Care of Newborn Infants",{"id":786,"slug":787,"hasResults":12,"nctId":788,"briefTitle":789,"officialTitle":790,"acronym":791,"eligibilityCriteria":792,"healthyVolunteers":12,"sex":59,"minAge":92,"maxAge":4,"enrollmentInfo":793,"targetDuration":4,"studyType":25,"phases":795,"briefSummary":796,"conditions":797,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":806,"lastUpdatePostDateStruct":807,"startDateStruct":809,"completionDateStruct":811,"leadSponsor":812,"locationsCount":814},"100431588","evaluation-of-primary-care-behavioral-health-pcbh-with-the-addition-of-self-help-cbt---a-randomized-multicenter-trial-100431588","NCT04900064","Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial","Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial for Superiority and Non-superiority Comparisons of Effects on Patients' Everyday Function, Symptoms, and Experiences","KAIROS","Inclusion Criteria:\n\n* All patients from age 18 who seek care at the PCC, who are deemed to be suitable for Behavioural Health interventions and booked to the mental health professionals at the PCC, according to screening methods and\u002For clinical assessments made by health care personnel at the PCC, will be included. This broad criteria reflects the naturalistic setting where decisions of clinicians, rather than highly standardized criteria, are the basis for inclusion.\n\nExclusion Criteria:\n\n* Does not speak Swedish well enough to fill out questionnaires or to receive self-help CBT in Swedish.\n* Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.",{"count":794,"type":24},1242,[27],"In this multicenter study, the investigators want to find out if an addition of an diagnostic assessment and possibility of treatment with guided self-help CBT can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH which uses contextual assessment and brief interventions. In addition to this, the study will investigate the overall effect of PCBH on both patient and organisation level outcomes.",[798,799,458,800,801,802,434,803,31,804,259,805,99],"Panic Disorder","Social Anxiety Disorder","Hypochondriasis","Insomnia","Generalized Anxiety Disorder","Adjustment Disorders","Obsessive-Compulsive Disorder","Life Style Induced Illness","2025-04-08",{"date":808,"type":43},"2025-04-11",{"date":810,"type":43},"2021-06-14",{"date":237,"type":24},{"name":813,"class":50},"Linnaeus University",4]