[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"procedural-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:procedural-pain":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,49,79,103,143,169,192,223,250,273,304,332,354,374,394,421,444,472,495,519,544,567],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100577496","cervical-preparation-for-same-day-dilation--evacuation-100577496",false,"NCT06799052","Cervical Preparation for Same-Day Dilation & Evacuation","Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators","Inclusion Criteria:\n\n* Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)\n* Able to provide informed consent\n* English- or Spanish-speaking\n* Singleton intrauterine pregnancy\n\nExclusion Criteria:\n\n* Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators\n* Fetal demise or known fetal anomaly\n* BMI \\>45\n* Incarceration or other inability to give informed consent\n* Decide to undergo cervical preparation overnight prior to next-day D\\&E",true,"FEMALE","16 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \\& Evacuation (D\\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure.\n\nThe primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\\&E operative time.\n\nSecondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.",[27,28,29],"Abortion, Second Trimester","Procedural Pain","Procedural Complication",[31,32,33,34,35],"Cervical Dilation and Evacuation (D&E)","Transcervical single-balloon catheter","Osmotic dilators","Adequate dilation","Patient satisfaction","RECRUITING","2026-06-29",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2025-06-12",{"date":44,"type":21},"2026-12",{"name":46,"class":47},"Boston Medical Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100643983","distraction-cards-versus-emotion-regulation-toy-squeezing-during-intramuscular-vaccination-in-preschool-children-100643983","NCT07669961","Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children","The Effect of Using Distraction Card and Squeezing Emotion-Regulation Toy on Pain and Pain-Related Fear During Intramuscular Vaccination in Children Aged 4-7 Years: A Single-Center, Parallel-Group, Randomized Experimental Study","Inclusion Criteria:\n\n* Child aged 4-7 years\n* Child with need or plan for intramuscular vaccination\n\nExclusion Criteria:\n\n* Child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory \u002F cardiac arrest) or genetic disease\n* Child with use of opioids, narcotics, analgesics or sedatives in the last 24 hours before the procedure","ALL","4 Years","7 Years",{"count":60,"type":21},68,[24],"This single-center, parallel-group, randomized experimental study will compare the effects of two active non-pharmacological interventions - distraction-card use and emotion-regulation toy squeezing - on procedural pain and pain-related fear during intramuscular tetanus vaccination in children aged 4-7 years. Eligible children will be randomized to either the distraction-card group or the emotion-regulation toy-squeezing group. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale, and pain-related fear will be assessed using the Children's Fear Scale before, during, and after the intramuscular injection procedure.\n\nHypotheses\n\n* H1a: There is a difference between the groups in mean Wong-Baker FACES scores during the procedure.\n* H1b: There is a difference between the groups in mean Children's Fear Scale scores during the procedure.",[28,64],"Pain-related Fear",[66,67,68,69,70],"child","pediatric nursing","intramuscular vaccination","distraction methods","active distraction","2026-06-25",{"date":37,"type":40},{"date":74,"type":40},"2026-06-21",{"date":76,"type":21},"2026-11-20",{"name":78,"class":47},"Mersin University",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":16,"sex":56,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":48},"100643917","cartoon-watching-versus-ball-squeezing-during-venous-blood-sampling-in-children-100643917","NCT07669948","Cartoon Watching Versus Ball Squeezing During Venous Blood Sampling in Children","The Effect of Cartoon Watching and Ball Squeezing on Pain and Pain-Related Fear During Venous Blood Sampling in Children Aged 6-9 Years: A Single-Center, Parallel-Group, Randomized Experimental Study","Inclusion Criteria:\n\n* Child aged 6-9 years\n* Child with need or plan for intravenous\u002Fvenous blood sampling\n\nExclusion Criteria:\n\n* Child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory \u002F cardiac arrest) or genetic disease\n* Child with use of opioids, narcotics, analgesics or sedatives in the last 24 hours before the procedure","6 Years","9 Years",{"count":60,"type":21},[24],"This single-center, parallel-group, randomized experimental study will compare the effects of two non-pharmacological distraction\u002Fcoping interventions - cartoon watching and ball squeezing - on procedural pain and pain-related fear during venous blood sampling in children aged 6-9 years. The study will be conducted in the Pediatric Blood Collection Unit of Mersin University Hospital. Eligible children will be randomized to either the cartoon-watching group or the ball-squeezing group. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale, and pain-related fear will be assessed using the Children's Fear Scale before, during, and after venous blood sampling.\n\nHypotheses\n\n* H1a: There is a difference between groups in mean WB-FACES scores during the procedure.\n* H1b: There is a difference between groups in mean CFS scores during the procedure.",[28,64],[66,67,93,94,95,96,97],"venous blood sampling","venipuncture","cartoon watching","stress ball","non-pharmacological intervention",{"date":37,"type":40},{"date":74,"type":40},{"date":101,"type":21},"2026-08-07",{"name":78,"class":47},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":56,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":48},"100626800","teas-for-sedation-during-ercp-a-multicenter-trial-with-mechanistic-substudy-100626800","NCT07440342","TEAS for Sedation During ERCP: A Multicenter Trial With Mechanistic Substudy","Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Conscious Sedation for Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Sham-Controlled, Multicenter Trial With Mechanistic Substudy","TEAS-ERCP-MC","1\\. Inclusion Criteria:\n\n1. Patients aged 18-85 years scheduled for elective diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP) for pancreaticobiliary indications.\n2. American Society of Anesthesiologists (ASA) physical status classification I, II, or III.\n3. Body mass index (BMI) between 18 and 30 kg\u002Fm².\n4. Willing and able to provide written informed consent.\n\n2\\. Exclusion Criteria:\n\n1. Known allergy or contraindication to meperidine, diazepam, or any other medication used in the protocol.\n2. Chronic use of benzodiazepines or opioids (regular use more than three times per week in the preceding three months).\n3. Severe cardiopulmonary, hepatic, or renal dysfunction (e.g., New York Heart Association class III or IV heart failure, uncontrolled chronic obstructive pulmonary disease, estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m², active liver disease).\n4. Anticipated difficult airway (Mallampati score IV, mouth opening \\\u003C3 cm, thyromental distance \\\u003C6 cm).\n5. Untreated or severe obstructive sleep apnea requiring continuous positive airway pressure therapy.\n6. Pregnancy or breastfeeding.\n7. Psychiatric or cognitive disorders precluding cooperation or valid assessment (e.g., severe anxiety, cognitive impairment).\n8. Pre-induction resting heart rate \\\u003C50 beats per minute or second-degree or higher atrioventricular block.\n9. Conditions predisposing to aspiration (e.g., gastric outlet obstruction, previous esophageal or gastric surgery with delayed emptying).\n10. Previous exposure to transcutaneous electrical acupoint stimulation or knowledge of TEAS that could compromise blinding for the sham procedure.\n11. Skin lesions, infections, or electronic implants at or near the proposed acupoint locations.\n12. Inability to provide informed consent.\n\n3\\. Dropout Criteria:\n\n1. Requirement for conversion to general anesthesia due to failed sedation or clinical necessity.\n2. Occurrence of a serious adverse event related to the study intervention (e.g., severe allergic reaction, hemodynamic collapse).\n3. Life-threatening deterioration during endoscopy (e.g., uncontrolled bleeding, respiratory failure, cardiac arrest).\n4. Voluntary withdrawal of consent by participant or legal representative at any time.\n5. Occurrence of a major ERCP-related complication (e.g., perforation, major bleeding, severe pancreatitis) requiring surgical or intensive care intervention.\n6. Principal investigator-identified safety risks (e.g., sepsis, acute liver failure).","18 Years","85 Years",{"count":114,"type":21},130,[24],"1. The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS), a non-invasive therapy that applies mild electrical current to specific points on the skin, can help patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) better tolerate the procedure and experience fewer complications related to sedation. It will also explore the underlying neuro-endocrine-immune mechanisms by measuring changes in serum biomarkers.\n2. The main questions the study aims to answer are:\n\n(1)Does TEAS reduce the incidence of sedation-related adverse events (such as low blood oxygen, low blood pressure, or breathing problems) during ERCP? (2)Does TEAS improve patient comfort and reduce the need for additional sedative medications during the procedure? (3)Does TEAS lead to faster recovery and higher patient and physician satisfaction? (4) Does TEAS modulate the neuro-endocrine-immune network, as reflected by changes in serum β-endorphin, cortisol, TNF-α, and IL-6 levels?\n\n3.Researchers will compare two approaches:\n\n1. Active TEAS: Electrical stimulation at specific points on the legs and arms before and during ERCP.\n2. Sham TEAS: Pads placed on the same points but no electrical stimulation delivered (the device appears active).\n\n4.All participants will receive standard conscious sedation with meperidine and diazepam, which is commonly used for ERCP in many centers. Participants will be randomly assigned to one of the two groups. The study will measure sedation-related complications, pain levels, medication requirements, recovery times, satisfaction scores, and changes in serum biomarkers (β-endorphin, cortisol, TNF-α, IL-6).",[118,119,28,120],"Endoscopic Retrograde Cholangiopancreatography","Conscious Sedation Adverse Event","Sedation-related Complications",[122,123,124,125,126,127,128,129,130,131,132],"Transcutaneous Electrical Acupoint Stimulation","ERCP","Conscious Sedation","Diazepam","Sedation-Related Adverse Events","Acupuncture","Non-Pharmacological Intervention","Neuro-endocrine-immune Mechanisms","Inflammatory Cytokines","Cortisol","β-endorphin","NOT_YET_RECRUITING","2026-06-14",{"date":136,"type":40},"2026-06-16",{"date":138,"type":21},"2026-09-01",{"date":140,"type":21},"2027-10-01",{"name":142,"class":47},"Beijing 302 Hospital",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":16,"sex":56,"minAge":86,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100643043","the-effect-of-rhythmc-skn-tappng-and-internal-vbraton-appled-proxmal-to-the-procedure-ste-on-pan-and-fear-percepton-durng-pedatrc-perpheral-venpuncture-100643043","NCT07650591","THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE","THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE: A RANDOMİZED CONTROLLED TRİAL","Inclusion Criteria:\n\n* Being between 6 and 12 years of age\n\nRequiring a peripheral venipuncture procedure\n\nHaving written informed consent from the parents\n\nHaving verbal assent from the child\n\nBeing able to speak and understand Turkish\n\nHaving a cognitive development level appropriate for age\n\nAbsence of any chronic pain condition\n\nExclusion Criteria:\n\n* Refusing to participate in the study or wishing to withdraw at any stage\n\nDevelopment of complications during the procedure\n\nHaving used analgesics within the last 24 hours\n\nHaving previously participated in the same study\n\nImpaired skin integrity at the procedure site\n\nHaving a neurological or psychiatric diagnosis","12 Years",{"count":152,"type":21},126,[24],"What is this study about, in short?\n\nThis study looks at simple, no-cost ways to reduce the pain and fear that children aged 6-12 feel when they have blood drawn at the hospital. Two methods are being tested:\n\n* A nurse lightly and rhythmically tapping with their fingertips just above the spot where the needle will go (\"rhythmic skin tapping\").\n* The child making an \"mmmm\" humming sound while the blood is being drawn (\"internal vibration\" or \"humming\").\n\nThese methods need no medicine and no device, so they can be used easily in any hospital. The study aims to find out whether these two methods really reduce pain and fear, by comparing them with a group that receives no extra method.\n\nWhy is this study being done? Drawing blood is one of the most common painful procedures in children. Fear of needles is very common and can even lead a person to avoid health care later in life. So it matters to make the blood-draw experience easier for children.\n\nSome methods used to reduce pain have practical limits:\n\n* Numbing creams must be applied 30-60 minutes before the procedure; they are not practical in urgent situations and add cost.\n* Special devices that give cold and vibration can work, but they can be expensive, are not always available, and need care for hygiene.\n\nFor these reasons, there is a need for simple methods that cost nothing, need no device, and can be applied easily in any setting. This study tests exactly that.\n\nHow do the methods work? (Simple science) Both methods rest on an idea called the \"Gate Control Theory\": in our body, the sense of touch and vibration competes with the sense of pain on the way to the brain. Gentle touch or mild vibration can act like a \"gate\" that partly blocks the pain signal from reaching the brain.\n\n* Rhythmic skin tapping: Gentle, rhythmic tapping with the fingers may help \"close the gate,\" so the pain is felt less.\n* Internal vibration (humming): The \"mmmm\" sound creates a mild vibration in the body. It can also stimulate the calming part of the nervous system, which may lower the heart rate and stress. Taking an active part in the procedure also gives the child a sense of control.\n\nWho can take part in the study?\n\nCan take part:\n\n* Children aged 6-12 years\n* Children who will have a blood draw\n* Children whose parent has given written permission and who themselves agree verbally\n* Children who can understand and speak Turkish\n* Children whose cognitive development is appropriate for their age\n* Children who do not have an ongoing (chronic) pain condition\n\nCannot take part, or will be withdrawn:\n\n* Children who do not want to take part, or wish to withdraw at any stage\n* Children who develop a complication (an unexpected medical problem) during the procedure\n* Children who have used a painkiller within the last 24 hours\n* Children who have already taken part in this study before\n* Children whose skin is broken at the site where the needle will go\n* Children who have a neurological or psychiatric diagnosis\n\nWhat will happen if my child takes part?\n\nThe blood draw will happen anyway because it is medically needed. The study only adds the method used during the draw and a short measurement afterward. Step by step:\n\n* Your child is placed by computer, at random (like drawing lots), into one of three groups. No one can choose the group in advance; this is called \"randomization\" and it keeps the comparison fair.\n* The blood draw is done as usual. The only difference is the method used, depending on your child's group.\n* Right after the procedure, the child is shown two short picture scales: one for pain, with faces ranging from smiling to crying (0-10), and one for fear, also made of faces (0-4).\n* A short form collects details such as age, sex, and any previous blood-draw experience.\n* No extra needle, medicine, or laboratory test is done beyond the routine blood draw.\n\nThe three groups are:\n\nGroup What is done in this group?\n\n1. Rhythmic skin tapping Gentle, rhythmic tapping with the fingertips just above the needle site.\n2. Internal vibration (humming) The child is asked to make an \"mmmm\" humming sound during the blood draw.\n3. Control group The blood draw is done as usual, with no extra method. This group is the comparison point used to measure the effect of the other two methods.\n\nWhere and when will the study take place?\n\n* Place: Kepez State Hospital Blood Collection Outpatient Clinic (Antalya, Türkiye).\n* Data collection period: June 2026 - June 2027. The total study duration is about 12 months.\n* Planned number of participants: 126 children in total (42 in each group). This number was set in advance by a statistical calculation so the results would be reliable.\n\nTaking part is completely voluntary\n\n* Your child does not have to take part. Even if you agree, you may withdraw at any time without giving a reason.\n* Not taking part, or withdrawing, will not affect the health care your child receives in any way.\n* Your child may also say they do not want the method; the child's decision is",[28,156,157,158,159,160],"Acute Pain","Needle-Related Pain and Distress","Fear","Anxiety","Phlebotomy","2026-06-12",{"date":136,"type":40},{"date":164,"type":21},"2026-07",{"date":166,"type":21},"2027-06",{"name":168,"class":47},"Akdeniz University",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":16,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":4},"100636218","stress-ball-and-empathic-verbal-tactile-interventions-for-reducing-anxiety-and-pain-in-mammography-and-breast-ultrasonography-a-randomized-trial-100636218","NCT07562828","Stress Ball and Empathic Verbal-Tactile Interventions for Reducing Anxiety and Pain in Mammography and Breast Ultrasonography: A Randomized Trial","Effects of Stress Ball Use and Empathic Verbal Communication With Therapeutic Touch on Anxiety and Pain Perception in Women Undergoing Mammography and Breast Ultrasonography: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Female participants aged 18 years and older\n* Scheduled to undergo mammography and breast ultrasonography\n* Undergoing these imaging procedures for the first time\n* Literate (able to read and understand study materials)\n* No sensory or motor impairment affecting the upper extremities (hands\u002Farms)\n* Willing to participate and able to provide written informed consent\n\nExclusion Criteria:\n\n* Previous experience of mammography or breast ultrasonography\n* Presence of any cognitive impairment that may affect understanding or communication\n* Presence of any physical disability that may interfere with participation\n* Hearing or visual impairment that may hinder communication or completion of study procedures\n* Refusal to participate or inability to provide informed consent",{"count":177,"type":21},122,[24],"This prospective, randomized controlled trial aims to determine the effects of stress ball use and empathic verbal communication with therapeutic touch on anxiety and pain perception in women undergoing mammography and breast ultrasonography. The study will be conducted between May and September 2026 at Istanbul Bakırköy Dr. Sadi Konuk Training and Research Hospital.\n\nA total of 122 women meeting the inclusion criteria will be randomly assigned into three groups: stress ball group (n=41), empathic verbal communication with touch group (n=41), and control group (n=40). Women in the stress ball group will be instructed to use a soft stress ball before and during the procedure. Participants in the empathic verbal-tactile group will receive structured verbal empathy combined with therapeutic touch. The control group will receive routine care without additional intervention.\n\nData will be collected before and after the procedures using a Descriptive Characteristics Form, the State-Trait Anxiety Inventory, and a Numerical Rating Scale for pain assessment. The findings of this study are expected to provide evidence on the effectiveness of non-pharmacological interventions in reducing anxiety and pain during breast imaging procedures.",[181,28,182],"Procedural Anxiety","Breast Imaging","2026-04-25",{"date":185,"type":40},"2026-05-01",{"date":187,"type":21},"2026-05-04",{"date":189,"type":21},"2026-09-30",{"name":191,"class":47},"Istanbul University",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":56,"minAge":86,"maxAge":150,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":207,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":4},"100635146","comparison-of-needle-free-injection-and-conventional-syringe-for-tooth-extractions-in-children-100635146","NCT07548892","Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children","Comparison of Needle-Free Injection and Conventional Syringe in Tooth Extractions in Children: Effects on Pain, Anxiety, and Vital Signs","Inclusion Criteria:\n\n* Being between 6-12 years of age\n* Having a primary tooth to be extracted with buccal and lingual anesthesia\n* Being in category 2, 3, or 4 according to the Frankl Behavior Scale\n* Being systemically healthy\n* No known history of allergy to local anesthetics\n* No antibiotic use in the last month and no analgesic use in the last 12 hours\n* Not having acute dental pain\n* Having sufficient cognitive ability to understand the anxiety assessment scales\n* Voluntary participation with written parental consent\n\nExclusion Criteria:\n\n* Being under 6 years of age or over 12 years of age\n* Displaying category 1 behavior according to the Frankl scale\n* Presence of severe acute dental infection or a condition requiring emergency intervention\n* Presence of a requirement for surgical extraction in the tooth indicated for extraction\n* Incomplete root development of the underlying permanent tooth\n* History of systemic disease (for example heart disease, uncontrolled asthma, epilepsy, diabetes)\n* Inability to use pain\u002Fanxiety scales due to neurological or developmental disorder\n* History of allergic reaction to local anesthetics or other drugs used\n* Presence of hypersensitivity to odors or inhalation intolerance\n* Refusal of participation by the child or parent",{"count":200,"type":21},60,[24],"The goal of this clinical trial is to learn whether a needle-free injection system can make tooth extraction less stressful for children than a conventional dental syringe. The study will include healthy children 6 to 12 years old who need a primary tooth extraction with buccal and lingual local anesthesia. The main questions are whether the needle-free method can lower anxiety, lower pain, and reduce changes in vital signs compared with the conventional syringe.\n\nResearchers will randomly assign participants to 1 of 2 groups. One group will receive local anesthesia with a needle-free jet injection system. The other group will receive local anesthesia with a conventional syringe and a 27-gauge dental needle. In both groups, a topical lidocaine spray will be used before the injection, and the same anesthetic solution will be given. All tooth extractions will be performed by the same clinician using standard clinical procedures.\n\nParticipants' anxiety, pain, and vital signs will be checked before the procedure, after anesthesia, and after tooth extraction. Anxiety will be measured with the Face Image Scale (FIS). Pain will be measured with the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Wong-Baker Faces Pain Rating Scale (WBS). Vital signs will include systolic and diastolic blood pressure, heart rate, and oxygen saturation. No blood, saliva, or tissue samples will be collected, and no audio or video recording will be made.",[204,205,28,206],"Tooth Extraction","Dental Anxiety","Anesthesia, Dental",[208,209,204,210,211,205,212,213],"Needle-Free Injection","Conventional Syringe","Pediatric Dentistry","Local Anesthesia","Pain Perception","Vital Signs","2026-04-23",{"date":216,"type":40},"2026-04-29",{"date":218,"type":21},"2026-04-15",{"date":220,"type":21},"2026-12-31",{"name":222,"class":47},"Ondokuz Mayıs University",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":248,"locationsCount":48},"100571661","oral-surgery-virtual-reality-glasses-study-100571661","NCT06723158","Oral Surgery Virtual Reality Glasses Study","Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery","Inclusion Criteria:\n\n* Patients requiring IV sedation for oral surgery procedure\n* Patients able to understand the use of virtual reality glasses and provide informed consent\u002Fassent\n* Patients classified as American Society of Anesthesiologists (ASA) I or II\n* No reported substance use within the previous 24 hours\n* No reported excessive alcohol consumption\n* Willingness to wear eye protection\n* Willingness to use certified interpreters if required\n* A legal guardian must accompany minors\n\nExclusion Criteria:\n\n* Patient with hearing aids or severe hearing impairment\n* Patient with blindness or significant visual impairment that is not corrected by contact lenses\n* Patients with cognitive impairments determined and assessed by the researchers\n* Pregnant women or women who could be pregnant based on self reporting\n* Patients unable to tolerate virtual reality glasses due to motion sickness or other issues\n* Patients with history of seizures or epilepsy per self report\n* Patients who cannot tolerate VR glasses due to discomfort or a medical emergency that arises during the procedure","65 Years",{"count":232,"type":21},80,[24],"The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses.\n\nThis study has two primary objectives.\n\n1. To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure.\n2. To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure.\n\n80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).",[181,28],[237,238,239,240,241],"Virtual reality glasses","Non emergent oral surgery","IV sedation","Patient Health Questionnaire (PHQ)","Generalized Anxiety Disorder (GAD)","2026-04-01",{"date":244,"type":40},"2026-04-07",{"date":246,"type":40},"2025-11-18",{"date":164,"type":21},{"name":249,"class":47},"Boston University",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":16,"sex":56,"minAge":111,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":4},"100625432","intravenous-nalbuphine-versus-lidocaine-for-prevention-of-propofol-injection-pain-100625432","NCT07422558","Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain","Comprasion of Intravenous Nalbuphine Versus Lidocaine in Reducing Propofol -Induced Injection Pain During General Surgery Procedure","Inclusion Criteria:\n\n* Age 18-60 years\n\n  * Either male or female\n  * ASA physical status I or II\n  * Scheduled for elective general surgery under general anesthesia using propofol\n\nExclusion Criteria:\n\n* Known hypersensitivity to propofol, nalbuphine, or lidocaine\n\n  * Emergency surgery\n  * Use of analgesics prior to surgery\n  * Pregnant women\n  * Lactating women","60 Years",{"count":259,"type":21},92,[24],"Propofol is a commonly used intravenous anesthetic agent, but its administration is frequently associated with injection pain, causing patient discomfort and agitation. Various pharmacological agents have been used to reduce this pain, including nalbuphine and lidocaine; however, results from previous studies remain conflicting. This randomized clinical trial aims to compare the effectiveness of intravenous nalbuphine versus intravenous lidocaine in reducing the frequency of propofol-induced injection pain in patients undergoing elective general surgery procedures.",[28],"2026-02-13",{"date":265,"type":40},"2026-02-20",{"date":267,"type":21},"2026-03-01",{"date":269,"type":21},"2026-08-01",{"name":271,"class":272},"Hayatabad Medical Complex","OTHER_GOV",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":56,"minAge":111,"maxAge":230,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":288,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":300,"leadSponsor":302,"locationsCount":48},"100622736","palm-stimulator-use-during-peripheral-venous-catheterization-100622736","NCT07387497","Palm Stimulator Use During Peripheral Venous Catheterization","The Effect of Palm Stimulator Use During Peripheral Venous Catheterization on Pain, Fear, and Procedural Satisfaction in Cancer Patients Receiving Chemotherapy","Inclusion Criteria:\n\n* Aged 18-65 years.\n* Receiving chemotherapy treatment via peripheral venous catheter (PVC).\n* Cognitively capable of communicating and responding to pain, fear, and satisfaction scales.\n* Volunteering to participate and providing written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of chemotherapy-induced peripheral neuropathy or diabetic neuropathy.\n* Presence of active infection, open wound, scar tissue, or edema in the palm.\n* Use of analgesic medication within 4-6 hours before the procedure.\n* History of hemiplegia or movement restriction in the extremity to be used for the procedure.",{"count":281,"type":21},90,[24],"Purpose: The purpose of this study is to evaluate the effectiveness of a \"Palm Stimulator\" (a handheld device with blunt protrusions) in reducing pain, fear, and anxiety during peripheral venous catheterization (IV insertion) in adult cancer patients receiving chemotherapy.\n\nMethods: This is a randomized controlled clinical trial. Participants will be randomly assigned to either the Experimental Group or the Control Group.\n\nExperimental Group: During the IV insertion process, patients will hold and squeeze the Palm Stimulator in the palm of their non-procedural hand. The device is designed to provide intense tactile (touch) stimulation based on the \"Gate Control Theory.\" Control Group: Patients will receive the standard routine care for IV insertion without any additional intervention.\n\nData Collection: Pain intensity will be measured using the Visual Analog Scale (VAS), while fear and anxiety levels will be assessed through VAS scales before and after the procedure. Patient satisfaction with the device will also be recorded.\n\nExpected Outcome: The investigators hypothesize that the use of the Palm Stimulator will significantly decrease procedural pain and fear while increasing patient satisfaction compared to standard care. This study aims to provide a low-cost, non-pharmacological, and easy-to-use tool for oncology nurses to improve patient comfort during invasive procedures.",[28,285,286,159,287],"Cancer","Fear Needles","Catheterization, Peripheral Venous",[289,290,291,292,293,294,295],"Procedural Pain Management","Peripheral Venous Catheterization","Patient Satisfaction","Palm Stimulator","Oncology Nursing","Needle Fear","Tactile Stimulation","2026-02-04",{"date":298,"type":40},"2026-02-06",{"date":265,"type":21},{"date":301,"type":21},"2026-07-30",{"name":303,"class":47},"Zeliha CENGİZ",{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":16,"sex":311,"minAge":312,"maxAge":112,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":48},"100508052","phase-4-self-adjusted-nitrous-oxide-a-feasibility-study-in-the-setting-of-vasectomy-100508052","NCT05895383","Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy","SANO-VAS","Inclusion Criteria:\n\n1. Scheduled for vasectomy\n2. Aged 21 to 85 years\n3. Suitable for receipt of inhaled nitrous oxide\u002Foxygen\n4. Access to an email and computer\n\nExclusion Criteria:\n\n1. Perioral facial hair impeding good mask seal\n2. Cognitive impairment that impedes ability to complete survey questions\n3. Intent to use benzodiazepines or opioids \"as needed\" for purposes of vasectomy\n4. Has any of the following medical conditions, which contraindicate use of nitrous oxide:\n\n   1. Inner ear, bariatric or eye surgery within the last 2 weeks,\n   2. Current emphysematous blebs,\n   3. Severe B-12 deficiency,\n   4. Bleomycin chemotherapy within the past year,\n   5. Heart attack within the past year,\n   6. Stroke within the past year,\n   7. Class III or higher heart failure.","MALE","21 Years",{"count":314,"type":21},35,[316],"PHASE4","This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.",[28,319,181],"Pain Catastrophizing",[321,322,323,324],"vasectomy","nitrous oxide","experience of care","ambulatory",{"date":298,"type":40},{"date":327,"type":40},"2023-05-24",{"date":329,"type":21},"2027-01-30",{"name":331,"class":47},"Beth Israel Deaconess Medical Center",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":56,"minAge":4,"maxAge":111,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":351,"locationsCount":353},"100570303","trauma-informed-procedural-pain-intervention-refinement-of-an-evidence-based-protocol-100570303","NCT06705491","Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol","TIPPI-R","Inclusion Criteria:\n\n* Patient is receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic.\n* Patient has been diagnosed with an oncology diagnosis.\n* Patient and family are English-speaking.\n* Patient is between the ages 0-18.\n\nExclusion Criteria:\n\n* Families not proficient in English.\n* Patient is 19 years or older.\n* Patient is not receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic.\n* Patient does not have an oncology diagnosis.\n* Patient and family have any CPS involvement.",{"count":340,"type":21},100,[24],"The Trauma-Informed Procedural Pain Intervention (TIPPI-R) has been developed as a standardized way to provide education and teach evidence-based strategies for managing pain and distress that may occur during pediatric cancer treatment. The purpose of this clinical trial study is to test how helpful TIPPI-R is in supporting children and families manage pain and distress during the initial stages of cancer treatment. The main questions this study aims to answer are:\n\n* Does TIPPI-R increase use of helpful pain coping strategies for pediatric cancer patients?\n* Does TIPPI-R help lower perceived pain intensity during initial stages of cancer treatment?\n* Does TIPPI-R increase patient and family confidence in coping with pain and distress during cancer treatment?\n\nResearchers will compare pain experiences and use of pain coping strategies for families who receive the TIPPI-R intervention and families who receive standard of care to see if TIPPI-R decrease pain and distress during the initial stages of cancer treatment.\n\nParticipants will:\n\n* Complete surveys to measure pain and distress within 5 weeks of initial diagnosis (Time 1)\n* Either receive the TIPPI-R intervention or standard of care\n* Complete surveys to measure pain and distress 4 weeks after initial consent or TIPPI-R intervention delivery (Time 2)",[28,344],"Cancer-related Pain","2026-01-28",{"date":347,"type":40},"2026-01-30",{"date":349,"type":40},"2025-02-07",{"date":44,"type":21},{"name":352,"class":47},"University of Louisville",4,{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":16,"sex":56,"minAge":57,"maxAge":86,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":372,"locationsCount":4},"100591643","effects-of-rain-stick-and-musical-egg-on-pain-fear-and-anxiety-100591643","NCT06983093","Effects of Rain Stick and Musical Egg on Pain, Fear and Anxiety","Effects of Rain Stick and Musical Egg on Pain, Fear and Anxiety During Blood Collection in Children Aged 4-6: A Randomized Controlled Trial","Inclusion Criteria:\n\n* The child must be between 4-6 years old\n* The child must not have acute pain\n* The child must not have mental or auditory disabilities\n* The child must not have confusion\n* The child and parent must agree to participate in the study\n\nExclusion Criteria:\n\n* The child must be under 4 years old and over 6 years old\n* The child's body temperature must be 38°C or above\n* The child must have used an analgesic medication in the last 24 hours before the application",{"count":362,"type":21},120,[24],"This research will be conducted in a pre-test-post-test parallel group randomized controlled experimental study model to determine the effects of rain stick and musical egg applied during blood collection on pain, fear and anxiety in children aged 4-6.\n\nResearch Hypotheses H1: The mean pain scores of the children in the rain stick group are lower than the mean scores of the children in the control group.\n\nH2: The mean fear scores of the children in the rain stick group are lower than the mean scores of the children in the control group.\n\nH3: The mean anxiety scores of the children in the rain stick group are lower than the mean scores of the children in the control group.\n\nH4: The mean pain scores of the children in the musical egg group are lower than the mean scores of the children in the control group.\n\nH5: The mean fear scores of the children in the musical egg group are lower than the mean scores of the children in the control group.\n\nH6: The mean anxiety scores of the children in the musical egg group are lower than the mean scores of the children in the control group.",[28,181,286],"2026-01-02",{"date":368,"type":40},"2026-01-06",{"date":370,"type":21},"2025-12-31",{"date":370,"type":21},{"name":373,"class":47},"Hakkari Universitesi",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":16,"sex":56,"minAge":381,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":393,"locationsCount":4},"100616935","the-effect-of-two-different-types-of-hourglasses-on-pain-fear-and-anxiety-100616935","NCT07312084","The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety","The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety During Blood Collection in Children: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Being between 5 and 10 years old,\n* Agreeing to participate in the research by applying to the blood collection unit,\n* Written consent being obtained from the parent,\n* Physical and mental development being appropriate for the age.\n\nExclusion Criteria:\n\n* Being outside the specified age range,\n* Having a serious chronic disease or hematological disorder,\n* Having developed serious trauma or intense anxiety due to a previous blood draw,\n* Refusal to participate in the study or failure to obtain parental consent,\n* Psychiatric or neurological disorders that may affect the implementation of the study.","5 Years","10 Years",{"count":362,"type":21},[24],"This research will be conducted as a pre-test-post-test parallel group randomized controlled experimental study to determine the effects of two different types of hourglasses (liquid gel-based hourglass and sand-based hourglass) used for distraction during blood collection in children aged 5-10 years on pain, fear, and anxiety and the comparative effectiveness of these methods.\n\nResearch Hypotheses H1: The mean pain, fear, and anxiety scores of children who used a liquid gel-based hourglass during blood collection were significantly lower than the mean scores of children in the control group.\n\nH2: The mean pain, fear, and anxiety scores of children who used a sand-based hourglass during blood collection were significantly lower than the mean scores of children in the control group.\n\nH3: The use of a liquid gel-based hourglass and a sand-based hourglass during blood collection had different effects on the mean pain, fear, and anxiety scores of children.",[387,158,159,181,28],"Pain","2025-12-16",{"date":370,"type":40},{"date":391,"type":21},"2026-02-01",{"date":220,"type":21},{"name":373,"class":47},{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":56,"minAge":86,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":408,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":419,"locationsCount":48},"100539426","vr-pat-and-fnirs-to-identify-cns-biomarkers-of-pain-100539426","NCT06303687","VR-PAT and fNIRS to Identify CNS Biomarkers of Pain","Imaging Pain in a Virtual World: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children","Inclusion Criteria:\n\n1. Being treated for acute burn injury\n2. Age 6-17 years, inclusive\n3. Admitted to NCH burn unit for treatment\n4. Have a dressing that requires daily changes over 3 days\n5. Patient and family caregivers can communicate (read and write) using English\n\nExclusion Criteria:\n\n1. Any wounds that may interfere with study procedures\n2. Vision, hearing, or cognitive\u002Fmotor impairments preventing valid administration of study measures\n3. History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras\n4. Minors in foster care, prisoners, or currently pregnant\n5. Suspected child abuse\n6. Unable to communicate in English","17 Years",{"count":353,"type":21},[24],"This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).",[156,406,28,407],"Pediatric ALL","Burns",[409,410,411,387,412,413],"Virtual Reality","VR","fNIRS","Biomarker","Neuroimaging","2025-11-19",{"date":416,"type":40},"2025-11-24",{"date":164,"type":21},{"date":44,"type":21},{"name":420,"class":47},"Nationwide Children's Hospital",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":56,"minAge":4,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":48},"100607597","early-phase-1-intranasal-versus-intravenous-fentanyl-for-procedural-analgesia-in-preterm-neonates-100607597","NCT07190625","Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates","Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm neonates with gestational age between 28 and 36 weeks gestation.\n* Undergoing painful procedures such as central venous access insertion, elective endotracheal intubation, and lumbar puncture.\n\nExclusion Criteria:\n\n* known contraindications for fentanyl use, such as fentanyl hypersensitivity and liver failure.\n* Known contraindication for intranasal administration of drugs (choanal atresia, nasal mucosal erosion, and epistaxis)\n* Post-surgical patients.\n* Patients sedated by fentanyl infusion \u002F midazolam infusion.\n* Evidence of neurological disease with disturbed conscious level, such as intraventricular hemorrhage grade III or IV, hypoxic ischemic encephalopathy, or inborn error of metabolism.","28 Days",{"count":430,"type":21},75,[432],"EARLY_PHASE1","Pain in neonatal life has profound long-term developmental impacts, so pain control is crucial. The intranasal (IN) route is a minimally invasive method for rapidly delivering fentanyl to provide short-term analgesia and sedation in adults and pediatrics, but few data exist about its use in neonates. Meanwhile, intravenous fentanyl is widely used in sedation and pain management.\n\nUsing intranasal fentanyl as an analgesic in preterm neonates may provide a rapid, effective, noninvasive route for administration.",[28],"2025-09-26",{"date":437,"type":40},"2025-10-01",{"date":439,"type":40},"2023-12-24",{"date":441,"type":21},"2026-06-01",{"name":443,"class":47},"Ain Shams University",{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":48},"100600204","virtual-reality-for-pain-control-in-us-guided-obstetric-needle-procedures-100600204","NCT07094451","Virtual Reality for Pain Control in US-Guided Obstetric Needle Procedures","Virtual Reality for Pain Control During US-guided Needle Procedures in Obstetric Patients: A Prospective Pilot Study","Inclusion criteria:\n\n* Age ≥18\n* English-speaking\n* Undergoing ultrasound-guided needle procedure at Mount Sinai\n\nExclusion criteria:\n\n* History of seizures\n* Severe motion sickness",{"count":452,"type":21},50,[24],"This is a single-site randomized controlled pilot study at Mount Sinai Hospital evaluating the effect of virtual reality on procedural pain and anxiety in obstetric patients undergoing ultrasound-guided needle procedures. Patients will be randomized to receive either VR or standard care during the procedure and complete validated questionnaires assessing pain, anxiety, intervention acceptability, and satisfaction.",[28],[457,458,459,460,461,462],"Virtual reality","Procedural anxiety","Ultrasound-guided","Obstetric patients","Non-pharmacologic pain control","Immersive distraction","2025-07-23",{"date":465,"type":40},"2025-07-30",{"date":467,"type":40},"2025-07-02",{"date":469,"type":21},"2027-03-30",{"name":471,"class":47},"Icahn School of Medicine at Mount Sinai",{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":11,"sex":56,"minAge":111,"maxAge":230,"enrollmentInfo":480,"targetDuration":4,"studyType":22,"phases":481,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":48},"100586276","virtual-reality-adjunct-for-procedural-pain-and-anxiety-management-in-burn-wound-care-100586276","NCT06913270","Virtual Reality Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care","Efficacy of Virtual Reality as an Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care: A Single-Center, Randomized Controlled Trial","VR-Burn","Inclusion Criteria:\n\nAdult burn patients (18-65 years) with confirmed partial-thickness burns. Scheduled for routine dressing changes. Able to provide informed consent. Baseline pain score of ≥4\u002F10 during a dressing change session.\n\nExclusion Criteria:\n\nPatients with cognitive impairment preventing comprehension of the intervention.\n\nHistory of severe motion sickness or visual impairments that preclude the use of VR devices.\n\nPatients with contraindications to standard analgesic care.",{"count":340,"type":21},[24],"This randomized controlled trial is designed to evaluate the efficacy of immersive virtual reality (VR) as an adjunct to standard analgesia during dressing changes in adult burn patients. The study compares an intervention group receiving standard care combined with an immersive VR distraction (using a head-mounted display displaying an engaging virtual environment) versus a control group receiving standard care plus non-VR distraction (watching a nature video on a tablet). The primary outcomes include procedural pain intensity measured by the Visual Analog Scale (VAS) and anxiety levels measured by the State-Trait Anxiety Inventory (STAI). Secondary outcomes include patient satisfaction and physiological parameters (heart rate and blood pressure) recorded during the procedure. This trial addresses the critical gap of heterogeneity and small sample sizes noted in previous VR studies for burn care pain management (Dascal et al., 2017).",[407,484,28,485],"Burn Wound","Anxiety Acute","2025-03-30",{"date":488,"type":40},"2025-04-06",{"date":490,"type":21},"2025-04-12",{"date":492,"type":21},"2026-05-25",{"name":494,"class":47},"Al Hayah University In Cairo",{"id":496,"slug":497,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":11,"sex":56,"minAge":111,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":517,"locationsCount":4},"100580478","phase-4-to-explore-the-optimal-dose-of-dexmedetomidine-for-skull-pin-fixation-in-intracranial-surgery-100580478","NCT06837818","To Explore the Optimal Dose of Dexmedetomidine for Skull Pin Fixation in Intracranial Surgery","Inclusion Criteria:\n\n* Must be at least 18 years old and less than 80 years old, with ASA I\\~III. Patients who are expected to undergo intracranial surgery for skull pin fixation.\n\nExclusion Criteria:\n\n* Patients under the age of 18, patients over 80, those who have not signed a consent form, those with ASA class IV or higher, those who are allergic to dexmedetomidine or propofol or remifentanil, sever bradycardia (HR\\\u003C40 bpm), hypotension (\\\u003C90\u002F60 mmHg) and hypertension crisis (180\u002F110 mmHg), and emergency patients, etc.","80 Years",{"count":503,"type":21},40,[316],"Skull pin fixation is commonly used in intracranial surgery, which can increase the surgical field of view. Because skull pin fixation is a very irritating and painful medical treatment, it often results in tachycardia (\\>150-160 beats per min, bpm) and high blood pressure (BP) (\\>200\u002F120 mmHg). Many strategies to reduce this painful stimulation include oral gabapentin, local injection of local anesthetics, scalp nerve blockade, and deepening the depth of anesthesia. Oral gabapentin must take 2 hr before surgery with many adverse effects such as nausea and vomiting. Local injection of local anesthetics and scalp nerve blockade require injections by neurosurgeons. Due to the manpower and time constraints, neurosurgeons cannot perform the two techniques. Therefore, it depends on anesthesiologists to prescribe more anesthetics to attenuate this intensity painful stimulation. Usually anesthesiologists will give propofol, opioids (fentanyl, alfentanil or remifentanil), α2 agonist (dexmedetomidine or clonidine), add inhalation anesthetics (sevoflurane or desflurane), and finally even use b-blocker to reduce hemodynamic instability (hyperdynamics).\n\nDexmedetomidine mainly produces a sedative effect by activating α2 adrenergic receptors in the central nervous system. Its α2:α1 ratio is 1620:1, showing high affinity for α2 receptors. Unlike other hypnotic drugs during death, dexmedetomidine keeps the patient in an awakenable state and does not affect respiratory function during sedation. Therefore, general anesthesia can be enhanced, providing sedation and analgesia and improving sleep quality.\n\nTarget-controlled infusion (TCI) pump systems can automatically adjust drug infusion rates based on the patient's weight, age, and other physiological parameters to achieve more precise drug concentrations. It can maintain a stable drug concentration and reduce the impact of drug fluctuations on patients, especially when long-term anesthesia or sedation is required. Therefore, using a TCI pump system to administer dexmedetomidine can ensure that the concentration we want can be accurately achieved when performing skull pin fixation. Our hospital has routinely used the Dyck mode of the TCI pump system to infuse dexmedetomidine 0.2-0.4 ng\u002Fml during intracranial surgery.\n\nIn view of this, we wanted to observe patients undergoing intracranial surgery with skull pin fixation using the Dyck mode by the TCI pump system under the monitoring of analgesic nociceptive index and hemodynamics. In order to find out the most appropriate dexmedetomidine concentration during skull pin fixation to reduce hemodynamic fluctuations and insufficient pain management as a basis for future anesthesia.",[28],[508,509,510],"Skull pin fixation","dexmedetomidine","Target-controlled infusion","2025-02-19",{"date":513,"type":40},"2025-02-20",{"date":515,"type":21},"2025-03-01",{"date":370,"type":21},{"name":518,"class":47},"Kaohsiung Medical University Chung-Ho Memorial Hospital",{"id":520,"slug":521,"hasResults":11,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":11,"sex":56,"minAge":58,"maxAge":526,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":48},"100460458","impact-of-virtual-reality-in-hematology-and-oncology-during-invasive-procedures-in-children-adolescents-and-young-adults-from-7-to-less-than-25-years-old-100460458","NCT05275881","Impact of Virtual Reality in Hematology and Oncology During Invasive Procedures in Children, Adolescents and Young Adults, from 7 to Less Than 25 Years Old","Impact of Virtual Reality in Hematology and Oncology for the Management of Pain During Invasive Procedures in Children, Adolescents and Young Adults, 7 to Under 25 Years in a Pilot Study","Inclusion Criteria:\n\n* Patients aged 7 to strictly under 25\n* Follow-ups for hematological or oncological pathology\n* With a lumbar puncture or to connection to an implantable chamber\n* Patient understanding French\n* Consent of parents or guardians with parental authority.\n* Child informed and having given his assent\n\nExclusion Criteria:\n\n* Children with cognitive impairment\n* Children in absolute emergency situations\n* Children with a contraindication to a virtual reality headset (psychiatric pathology, vestibular and proprioceptive disorders, unbalanced epilepsy, impaired vision, hearing aids, claustrophobia, recent lesions of the eyes, face or scalp)\n* Children who have already participated in the clinical investigation\n* Refusal to participate in the study\n* Patients not benefiting from a social security system or not benefiting from it by the intermediary of a third person","24 Years",{"count":200,"type":21},[24],"This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children and young adults with cancer. Patients age from 7 to under 25 years whose treatement protocols required a lumbure puncture and a chemotherapy by implantable venous access will be randomly assigned to virtual reality or treatement as usual (nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine). We expect the same benefit by using VR as usual intervention.",[409,531,285,387,28],"Pediatrics",[409,531,533,387,534],"Cancerology","Invasive Acts","2024-12-10",{"date":537,"type":40},"2024-12-16",{"date":539,"type":40},"2022-10-13",{"date":541,"type":21},"2026-12-13",{"name":543,"class":47},"Poitiers University Hospital",{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":56,"minAge":111,"maxAge":501,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":555,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":48},"100559374","phase-4-to-explore-the-optimal-dose-of-alfentanil-for-skull-pin-fixation-in-intracranial-surgery-100559374","NCT06563297","To Explore the Optimal Dose of Alfentanil for Skull Pin Fixation in Intracranial Surgery","To Explore the Optimal Dose of Alfentanil for Skull Pin Fixation Under Surgical Pleth Index Monitor in Intracranial Surgery","Inclusion Criteria:\n\n* Must be at least 18 years old and less than 80 years old\n* With anesthesia risk grade below grade three (including grade three) (ASA I\\~III)\n* Patients who are expected to undergo intracranial surgery for skull pin fixation\n\nExclusion Criteria:\n\n* Those with anesthesia risk classification ASA class IV or higher\n* Those who are allergic to alfentanil or propofol drugs\n* Emergency patients",{"count":503,"type":21},[316],"Forty patients were enrolled, and all patients used total intravenous anesthesia (alfentanil-propofol based TIVA) as anesthesia induction and maintenance. According to our experience, patients who underwent intracranial surgery for skull pin fixation used alfentanil 100 ng\u002Fml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by EEG, maintaining a value of 40-60), first start with alfentanil 100 ng\u002Fml, and use the up and down method as adjust 25 ng\u002Fml of concentration of alfentanil each time. An SPI higher than 80 and hyperdynamics (the increased HR and MBP up 20% of baseline or HR\\>100bpm and ABP\\>180\u002F100mmHg) indicates insufficient analgesia, therefore increase it by 25 ng\u002Fml at the next patient; an SPI lower than 80 and stable hemodynamics (the changes of HR and MBP within 20% of baseline or HR\\\u003C50bpm and ABP\\\u003C90\u002F50mmHg) indicates that analgesia is acceptable, and the next patient will decrease it by 25 ng\u002Fml during skull pin fixation. If the analgesia is inadequate, increase alfentanil concentration will be prescribed. On the other hand, if analgesia is adequate, however hyperdynamics was noted, beta blocker or calcium channel blocker will be prescribed. If hypotension (ABP\\\u003C90\u002F50 mmHg) or bradycardia (HR\\\u003C50 bpm) occur, we first stop alfentanil infusion and treated with ephedrine or atropine, respectively.\n\nData collection: HR, MBP, SPI, BIS, systolic pressure variation (SPV), pulse pressure variation (PPV) , concentrations of propofol and alfentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.",[28],[556,557,558],"alfentanil","pain","surgical pleth index","2024-08-19",{"date":561,"type":40},"2024-08-20",{"date":563,"type":21},"2024-08-13",{"date":565,"type":21},"2024-12-31",{"name":518,"class":47},{"id":568,"slug":569,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":16,"sex":56,"minAge":573,"maxAge":312,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":133,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":4},"100554862","pain-elimination-and-anxiety-control-through-experiential-virtual-reality-100554862","NCT06504602","Pain Elimination and Anxiety Control Through Experiential Virtual Reality","Inclusion Criteria:\n\n* Children and adolescents 8-21 years old undergoing IV placement .\n\n  * Ability to understand study procedures and to comply with them for the entire length of the study.\n  * Participants and caregiver speaking English or Spanish.\n\nExclusion Criteria:\n\n* Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).\n\n  * Participants receiving narcotics, opioids, or anxiolytics 8 hours prior (Tylenol and ibuprofen do not count).\n  * Participants with pain so significant that consent\u002Fassent is not possible (decision based on treating clinician evaluation).\n  * Critically ill Participants (ESI 1).","8 Years",{"count":575,"type":21},96,[24],"The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\n* Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?\n* Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?\n\nIf there is a comparison group: Researchers will compare active group to passive group and standard of care.\n\nParticipants will randomized into active virtual reality, passive virtual reality or standard of care arms.",[28,181],"2024-07-16",{"date":581,"type":40},"2024-07-18",{"date":583,"type":21},"2024-09-01",{"date":585,"type":21},"2025-03-15",{"name":587,"class":47},"Children's Hospital Los Angeles"]