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Feasibility, Acceptability, and Preliminary Effects of Virtual Reality for Pain, Anxiety and Recovery Enhancement of Children Post-scoliosis Surgical Repair

NCT07737886 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-30

No results posted yet for this study

Summary

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.

Conditions

  • Scoliosis Patients

Interventions

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.

OTHER

Standard medical treatment

Standard post-surgical care includes multimodal analgesia, parental presence (if desired), and routine reassurance practices.

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-05-31
Completion
2028-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07737886 on ClinicalTrials.gov