About this trial
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.
The 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.
Primary 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents aged 10 to 17 years hospitalized for corrective scoliosis surgery
Stable medical condition
Able to communicate in both French and English.
Disqualifiers
Documented photosensitive epilepsy
Severe cognitive deficits, preventing assent
Prone to motion sickness.
Trial design
Crossover
Treatments tested in this trial
Virtual Reality
DeviceChildren 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.
Standard medical treatment
Other interventionStandard post-surgical care includes multimodal analgesia, parental presence (if desired), and routine reassurance practices.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment Rate
Recruitment feasibility using a participant recruitment log. All eligible children will be approached for the study. The target is that at least 50% of participants agree to participate.
Completion Rate
Protocol feasibility assessed using case report form (CRF) documentation. The procedure will be considered feasible if 90% of participants successfully complete the study procedures and assessments.
Acceptability of IVR among patients and HCP
This will be assessed using the Treatment Acceptability \& Preference (TAP), a 5- point Likert scale (0="not at all" and 4= "very much"), by both HCP and children and through interview feedback (qualitative).
Satisfaction regarding VR intervention
Children's and HCPs' satisfaction levels will be assessed using a 0-10 Verbal Numerical Rating Scale (VNRS), with 0 = low and 10 = high.
Secondary outcomes
Child Pain
Pain measured using the 0-10 Verbal Numerical Rating Scale (VNRS), where 0="no pain" and 10="worst pain".
Children's anxiety
Measured using an adapted 0-10 Verbal Numerical Rating Scale (VNRS), with 0 = low and 10 = high.
Time tolerated in the armchair (minutes)
The duration of time that the child tolerates mobilization in the armchair will be measured.
Administration of narcotic analgesics
Administration of narcotic analgesics before and after the chair mobilizations and in the following subsequent 2 hours.
Sponsors and contacts
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