[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649696":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":53,"collaborators":26,"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":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"St. Justine's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual reality Distraction","EXPERIMENTAL","Use of virtual reality after first mobilisation during 15 minutes.",[13],"Device: Virtual Reality",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Treatment","ACTIVE_COMPARATOR","Standard care as per the unit's protocol will serve as the control after the first or the second mobilization after surgery.",[19],"Other: Standard medical treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Virtual Reality","Children play using a VR headset, while a physiotherapist interacts via a connected tablet, creating a cooperative experience. The 15-30-minute session takes place in a relaxing, magical jungle environment where players explore the island together to uncover treasures, collect items, and interact with non-threatening creatures. The game emphasizes collaboration and communication to achieve shared objectives and a positive experience. The design prioritizes accessibility, relaxation, and distraction to reduce pain and anxiety during early mobilization.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard medical treatment","Standard post-surgical care includes multimodal analgesia, parental presence (if desired), and routine reassurance practices.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Sylvie Le May, PhD","CONTACT","514-345-4931","4938","sylvie.lemay@umontreal.ca",[39],{"facility":5,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Montreal","Quebec","H1T 3C5","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-73.58781,45.50884,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Sylvie Le May","Principal Investigator","100649696","feasibility-acceptability-and-preliminary-effects-of-virtual-reality-for-pain-anxiety-and-recovery-enhancement-of-children-post-scoliosis-surgical-repair-100649696",false,"NCT07737886","Feasibility, Acceptability, and Preliminary Effects of Virtual Reality for Pain, Anxiety and Recovery Enhancement of Children Post-scoliosis Surgical Repair","Feasibility, Acceptability, and Preliminary Effects of Virtual Reality for Pain, Anxiety and Recovery Enhancement of Children Post-Scoliosis Surgical Repair: A Pilot Randomized Controlled Parallel Trial (VR-SPINE)","VR-SPINE","Inclusion Criteria:\n\n* Adolescents aged 10 to 17 years hospitalized for corrective scoliosis surgery\n* Stable medical condition\n* Able to communicate in both French and English.\n\nExclusion Criteria:\n\n* Documented photosensitive epilepsy\n* Severe cognitive deficits, preventing assent\n* Prone to motion sickness.\n\nThe investigators will also recruit a sample of (HCP):\n\nInclusion:\n\n-Closely implicated in the care of participants.","ALL","10 Years","17 Years",{"count":69,"type":70},24,"ESTIMATED","INTERVENTIONAL",[73],"NA","Adolescent idiopathic scoliosis is the most common spinal deformity in adolescents and frequently requires surgical intervention when curvature becomes severe. Although surgical correction improves long-term outcomes, the immediate postoperative period is often characterized by significant pain and anxiety, particularly during early mobilization, which can delay participation in physiotherapy and recovery. Virtual reality (VR) has emerged as a promising non-pharmacological intervention for reducing pain and anxiety in pediatric medical settings through immersive distraction and guided engagement.\n\nThe VR-SPINE study is a mixed-methods pilot randomized controlled trial designed to evaluate the feasibility, acceptability, and preliminary clinical effects of a VR-based intervention during early postoperative mobilization in adolescents undergoing scoliosis surgery. 24 participants aged 10-17 years undergoing corrective scoliosis surgery will be recruited at CHU Sainte-Justine and randomized to either VR plus standard postoperative care or standard care alone. The VR intervention consists of a collaborative therapeutic game played during the first postoperative mobilization to an armchair, designed to promote relaxation, distraction, and engagement with physiotherapy.\n\nPrimary outcomes include the feasibility of recruitment and implementation, as well as acceptability and satisfaction among participants and healthcare professionals. Secondary outcomes include postoperative pain, anxiety, tolerance to mobilization, analgesic use, and adverse effects. Qualitative interviews with a subset of participants and healthcare professionals will further explore perceived barriers, facilitators, and the clinical experience of using VR during early recovery.",[76],"Scoliosis Patients",[78,79,80,81,82,83],"virtual reality","scoliosis","children","pain","anxiety","mobilization","NOT_YET_RECRUITING","2026-07-27",{"date":87,"type":88},"2026-07-30","ACTUAL",{"date":90,"type":70},"2026-07",{"date":92,"type":70},"2028-06-30",{"name":5,"class":6},1]