An interventional study of Virtual Reality and Standard medical treatment in Scoliosis Patients, sponsored by St. Justine's Hospital. Not yet recruiting at 1 site in Canada. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Treatment
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.
BACKGROUND Adolescent idiopathic scoliosis is a three-dimensional spinal deformity of unknown cause. It is often called 'adolescent' because it is most commonly diagnosed during adolescence. However, scoliosis can be viewed as a condition that exists from birth through adulthood and can be identified at any age. Idiopathic scoliosis is the most common spinal deformity seen in adolescents over 10 years old, accounting for about 80% of cases. This deformity is characterized by a Cobb angle greater than 10 degrees when measured on an anterior-posterior radiograph. Its prevalence among patients aged 10 to 18 years ranges from 2% to 4%.
Scoliosis management entails observation for small curvature (10 - 25 degrees), bracing for moderate curvature and surgical stabilization for curvature greater than 45 degrees. Although the incidence of surgical management is small, it is associated with substantial acute postoperative pain and notable psychological distress, including anxiety and depressive symptoms, for a significant subset of patients. Prospective trajectory studies show that many adolescents report moderate to severe pain in the immediate postoperative period that gradually declines over weeks, yet a non-trivial minority experience persistent postsurgical pain and pain-related interference. Anxiety and depression are more prevalent in AIS than in the general adolescent population and are linked with longer hospital length of stay after posterior spinal fusion. Qualitative work also indicates that concerns about body image, treatment efficacy, and loss of control around the time of surgery contribute to heightened anxiety in adolescents with AIS.
Preoperative pain and anxiety are strong predictors of both acute and longer-term postoperative pain in AIS, forming a continuum from pre- to postsurgical experiences. Higher baseline pain, anxiety, and pain catastrophizing are associated with more intense early postoperative pain, greater risk of persistent postsurgical pain at 6-12 months, and poorer health-related quality of life. Sex differences appear relevant: girls constitute the majority of AIS cases and tend to exhibit higher emotional distress and more tightly interconnected anxiety-depression symptom networks than boys. After posterior spinal fusion, female adolescents report higher average pain scores in the first 48 hours and at initial physical therapy compared with males, despite similar surgical characteristics and analgesic regimens, suggesting that female patients may require more proactive perioperative pain and psychological support.
Early postoperative mobilization, embedded within multimodal "rapid recovery" pathways, plays an important role in modulating pain, anxiety, and overall recovery after AIS surgery. Protocols that promote sitting, standing, and assisted ambulation within the first 24 hours, combined with scheduled non-opioid and rescue opioid analgesia, have been associated with reduced daily pain scores, fewer opioid-related side effects, earlier functional recovery, and shorter length of stay, without worsening pain or increasing readmissions. Given that opioids are commonly associated with adverse effects such as nausea, constipation, pruritus, drowsiness, and, less frequently, respiratory depression, multimodal and opioid-sparing regimens in AIS aim to reduce both pain intensity and opioid-related morbidity to facilitate earlier mobilization and recovery. By helping adolescents safely resume movement, early mobilization can lessen fear of movement and perceived fragility and may indirectly reduce anxiety and depressive symptoms that otherwise prolong hospitalization. Clinical pathways now explicitly list early mobilization as a key objective to standardize care, minimize opioid exposure, and support both physical and psychological recovery after AIS fusion.
Considering the familiarity that adolescents have with immersive gaming, VR-based interventions may help adolescents with AIS better tolerate early postoperative mobilisation by concurrently targeting pain and anxiety. Guided-relaxation and distraction-based VR sessions have shown transient reductions in postoperative pain intensity, pain unpleasantness, and anxiety in children and adolescents, with the greatest benefit in those with higher anxiety sensitivity. Systematic reviews and meta-analyses in pediatric populations indicate that VR distraction during medical procedures produces moderate-to-large reductions in pain and anxiety, supporting its use as a non-pharmacological tool alongside multimodal analgesia. Emerging perioperative trials suggest that integrating VR into early mobilization or physiotherapy can facilitate engagement, preserve or improve respiratory and functional parameters, and address fear of movement (kinesiophobia), which are all relevant to optimizing early post-fusion recovery in AIS.
Despite advances in perioperative care, adolescents undergoing spinal fusion for scoliosis continue to experience clinically significant pain and anxiety, particularly during early mobilization, which can hinder participation in physiotherapy and delay functional recovery. Immersive virtual reality has shown small-to-moderate, short-term benefits for postoperative pain and anxiety in mixed pediatric surgical populations, and emerging evidence suggests it is feasible, acceptable, and safe as an adjunct during early mobilization. However, only one published pilot study and a few ongoing or protocol-stage trials have specifically examined VR in adolescents after scoliosis fusion, with limited data focused on pain and anxiety associated with physiotherapy sessions. This major evidence gap, combined with the high symptom burden and the potential of VR to enhance engagement with early rehabilitation, justifies a pilot randomized controlled trial to assess feasibility, safety, and preliminary efficacy of VR-assisted early mobilization for postsurgical pain and anxiety management in this population.
Therefore, this pilot randomized controlled trial aims to better understand the feasibility, acceptability, and satisfaction with a VR intervention in reducing pain and anxiety and improving tolerance to early post-surgical mobilization in adolescent idiopathic scoliosis patients.
OBJECTIVES
The main objectives are:
METHODS Mixed-methods Pilot Randomized Controlled Trial This project is a pilot initiative because it introduces an innovative element in the treatment of postoperative pain, anxiety, and tolerance to mobilization in adolescents post-corrective scoliosis. First, to the best of our knowledge, VR games have not been used in previous studies to manage pain, anxiety, and facilitate early mobilization in such children. Second, children undergoing SS appear to have had little to no exposure to such technologies in a hospital setting, despite experiencing a very painful recovery, making this an ideal population to assess the feasibility, acceptability, and preliminary effects of this intervention. These factors provide a unique opportunity to test this novel therapy.
The quantitative component consists of a two-arm parallel-group RCT in which participants are randomized (1:1) to either a) the VR intervention plus standard care or b) standard care alone. The qualitative component uses a descriptive qualitative design to explore acceptability, satisfaction, and feasibility from both children and healthcare professionals (HCP).
The RCT is designed to evaluate feasibility, acceptability, recruitment capacity, data-collection procedures, intervention delivery, and preliminary clinical trends. Findings will inform the refinement of the intervention and determine the appropriateness and parameters (sample size, outcomes, procedures) for a fully powered RCT. Randomization will be performed using simple allocation sequences generated by a biostatistician not involved in data collection. Outcome assessors will be blinded to group allocation whenever possible.
RECRUITMENT Convenience sampling will be used to recruit participants on the surgical unit at CHU Sainte-Justine and health care professionals involved in postsurgical care (physicians, nurses, and physical therapists).
Sample size justification A total of 24 children will be recruited, which represents about 50% of the annual surgical cases at CHUSJ. This provides sufficient precision to estimate feasibility outcomes (e.g., an acceptability rate of 90% with 5% alpha). Although not powered for effectiveness, assuming a standard deviation of 2.0 points on a 0-10 Verbal Numerical Rating Scale (VNRS), this sample is expected to provide 80% power to detect a reduction in pain of 2.0 points if differences in pain score emerge.
Procedures All adolescents scheduled for scoliosis surgery will be approached during their presurgical visit and asked to participate. The presurgical visit entails a virtual reality tour of the surgical theatre and a meeting with the IPS to answer patients' questions.
Participants in both groups will receive standard postoperative care (multimodal analgesia, parental presence (if desired), routine reassurance practices). The VR group will receive standard usual care \& VR game during the first mobilization to an armchair. The control group will receive only standard care.
OUTCOME MEASURES Study feasibility will be assessed using recruitment and study logs documenting participant enrollment, retention, protocol adherence, and intervention completion. Acceptability and satisfaction will be evaluated using the Treatment Acceptability and Preference (TAP) Scale and 0-10 Verbal Numerical Rating Scales completed by children and healthcare professionals. Pain, anxiety, time spent in the armchair, analgesic administration, and side effects will be collected using standardized rating scales, study forms, and medical chart review. Semi-structured interviews will also be conducted with a subsample of participants and healthcare professionals; interview data will be analyzed using NVivo, and findings will be integrated with quantitative results through data triangulation to provide a comprehensive assessment of the intervention.
Interventions:
Participants interact with the game by using eye-tracking technology integrated into the headset to direct laser beams toward virtual targets. This feature minimizes the need for head movements, making the intervention more comfortable for patients recovering from surgery while also helping to reduce the risk of cybersickness.
Inclusion Criteria:
Exclusion Criteria:
The investigators will also recruit a sample of (HCP):
Inclusion:
-Closely implicated in the care of participants.
Use of virtual reality after first mobilisation during 15 minutes.
Device: Virtual Reality
Standard care as per the unit's protocol will serve as the control after the first or the second mobilization after surgery.
Other: Standard medical treatment
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.
Standard post-surgical care includes multimodal analgesia, parental presence (if desired), and routine reassurance practices.
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.
Time frame: Through study completion, around one week.
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.
Time frame: Through study completion, around one week
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).
Time frame: Post-intervention (immediately after returning to bed following mobilization)
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.
Time frame: This will be measured post-intervention (immediately after returning to bed following mobilization), and 14 days post-operative.
Child Pain
Pain measured using the 0-10 Verbal Numerical Rating Scale (VNRS), where 0="no pain" and 10="worst pain".
Time frame: This will be assessed at baseline (T0), after mobilization, before starting VR game (T1), before repositioning to bed (T2), & post-intervention (immediately after returning to bed following mobilization, T3), on day 1.
Children's anxiety
Measured using an adapted 0-10 Verbal Numerical Rating Scale (VNRS), with 0 = low and 10 = high.
Time frame: This will be assessed at baseline (T0), after mobilization, before starting VR game (T1), before repositioning to bed (T2), and post-intervention (immediately after returning to bed following mobilization, T3), on day 1.
Time tolerated in the armchair (minutes)
The duration of time that the child tolerates mobilization in the armchair will be measured.
Time frame: This will be assessed before repositioning to bed (T2), on day 1.
Administration of narcotic analgesics
Administration of narcotic analgesics before and after the chair mobilizations and in the following subsequent 2 hours.
Time frame: This will be assessed at baseline (T0), after mobilization, before starting VR game (T1), before repositioning to bed (T2), post-intervention (immediately after returning to bed following mobilization, T3) and in the subsequent 2 hours, on day 1.
Side effects
Side effects in both groups at all time points.
Time frame: This will be assessed at baseline (T0), after mobilization, before starting VR game (T1), before repositioning to bed (T2), & post-intervention (immediately after returning to bed following mobilization, T3), on day 1.
Plan to share: No
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St. Justine's Hospital