[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650065":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":91,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"VR Intervention Group","EXPERIMENTAL","Children in this arm will receive virtual reality (VR) distraction in addition to routine burn dressing care. The VR intervention will be initiated 2-3 minutes before the dressing change begins and will continue throughout the entire procedure. Children will wear a standalone VR headset with built-in speakers and a 3D display, viewing age-appropriate, interactive 3D content (e.g., games, underwater exploration, space adventures, or calming nature scenes). Children will be offered a choice of 2-3 VR experiences based on their preferences. The VR session may be paused if the child requests a break or experiences any adverse effects (nausea, dizziness, headache, or device discomfort). The researcher will remain present throughout the procedure to monitor the child's response and ensure safety.",[13,14],"Device: Virtual Reality (VR) Distraction","Other: Standard Burn Dressing Care",{"label":16,"type":6,"description":17,"interventionNames":18},"Standard Care Control Group","Children in this arm will receive routine burn dressing care according to standard institutional protocol. This includes pre-procedural analgesic administration (according to hospital protocol), psychological preparation by nursing staff, standard wound care procedures (wound cleansing, debridement, and dressing application), and pharmacological pain management as clinically indicated. No structured distraction or non-pharmacological interventions beyond standard nursing care will be provided to this group.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Virtual Reality (VR) Distraction","A commercially available standalone VR headset with built-in speakers and a 3D display will be used to deliver immersive, interactive, age-appropriate content. The device will be adjusted for each child's head size to ensure comfort and safety. Children will view content selected from a curated library including: interactive games (e.g., age-appropriate puzzles and engaging activities); exploration experiences (e.g., underwater worlds, space adventures); and calming environments (e.g., nature scenes, relaxing landscapes). Children will be offered a choice of 2-3 age-appropriate VR experiences based on their preferences and developmental level to maximize engagement. The VR intervention will be initiated 2-3 minutes before the dressing change begins and will continue throughout the entire procedure",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Burn Dressing Care","Routine burn dressing care provided according to standard institutional protocol at the Burns and Plastic Surgery Center, Mansoura University, Egypt. This includes: pre-procedural analgesic administration according to hospital protocol (e.g., oral or intravenous analgesics); psychological preparation by nursing staff; standard wound care procedures (wound cleansing, debridement, and dressing application); and pharmacological pain management as clinically indicated.",[16,9],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Ahmed Hashem El-Monshed, PHD","CONTACT","+201009976771","ahmed_elmonshed@mans.edu.eg",[37],{"facility":38,"status":25,"city":39,"state":25,"zip":25,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Burns and Plastic Surgery Center, Mansoura University","Al Mansurah","Egypt","EG",{"type":43,"coordinates":44},"Point",[45,46],31.38069,31.03637,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":51,"phoneExt":25,"email":52},"Ahmed El-Sabbagh, PhD","+20 50 22267011","president@mans.edu.eg",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ahmed Hashem El-Monshed","Assistant Professor of Psychiatric and Mental Health Nursing","100650065","virtual-reality-for-pain-and-fear-in-children-with-burns-100650065",false,"NCT07740980","Virtual Reality for Pain and Fear in Children With Burns","Does Virtual Reality Reduce Pain, Fear, and Behavioral Distress in Children During Burn Dressing Changes? A Randomized Controlled Trial","VR-PFB","Inclusion Criteria:\n\n* Children aged 6 to 12 years\n* Acute burn injury requiring a routine dressing change, either during inpatient hospitalization or during a scheduled outpatient clinic visit\n* Able to communicate verbally and follow simple instructions\n* Medically stable as determined by attending physician (no acute respiratory distress, hemodynamic instability, or active sepsis)\n* Written informed consent from parent\u002Fguardian\n* Verbal child assent (for children aged 7 years and older)\n\nExclusion Criteria:\n\n* Burns involving the face, head, or ears that prevent safe VR headset placement\n* Cognitive, motor, visual, or hearing impairments interfering with study participation\n* History of motion sickness, seizure disorder, or migraines triggered by visual stimuli\n* Inability to maintain sitting or semi-upright position during the procedure\n* Burns greater than 60% Total Body Surface Area (TBSA) or requiring intensive care admission","ALL","6 Years","12 Years",{"count":69,"type":70},80,"ESTIMATED","INTERVENTIONAL",[73],"NA","Burn injuries are very painful for children, especially during dressing changes when the wound is cleaned and re-bandaged. This procedure, while necessary, can cause pain, fear, and distress that may make children afraid of future treatments. Virtual reality (VR) is a technology that uses a headset to show an immersive, interactive 3D world. It can distract children from painful medical procedures.\n\nThis study aims to find out if using VR during burn dressing changes can reduce pain, fear, and behavioral distress in children aged 6 to 12 years. Half of the children will receive standard burn care plus VR distraction during their dressing change. The other half will receive standard care only.\n\nThe study will take place at the Burns and Plastic Surgery Center, Mansoura University, Egypt. Children will be recruited from both inpatient wards and outpatient clinics. Pain will be measured using a number scale, fear using a faces scale, and distress will be observed throughout the procedure.\n\nIt is expected that children who use VR will report less pain, show less fear, and display less distress during their dressing changes compared to children who receive standard care alone.",[76,77,78,79,80],"Burns","Pain, Procedural","Pain, Acute","Fear","Stress, Psychological",[82,83,84,85,86,87,88,89,90],"Virtual Reality","VR","Distraction","Burn Dressing Change","Pediatric Pain","Procedural Pain","Child Fear","Behavioral Distress","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-31",{"date":94,"type":95},"2026-08-03","ACTUAL",{"date":97,"type":70},"2026-08-01",{"date":99,"type":70},"2026-11-30",{"name":5,"class":6},1]