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

NCT07737886 | Not Yet Recruiting

• 1 other identifier: VR-SPINE-PILOT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

virtual reality; scoliosis; children; pain; anxiety; mobilization

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  This will be measured post-intervention (immediately after returning to bed following mobilization), and 14 days post-operative.

Secondary Outcomes (5)

• Child Pain

  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

  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)

  This will be assessed before repositioning to bed (T2), on day 1.

• Administration of narcotic analgesics

  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

  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.

Study Arms (2)

Virtual reality Distraction

EXPERIMENTAL

Use of virtual reality after first mobilisation during 15 minutes.

Device: Virtual Reality

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.

Other: Standard medical treatment

Interventions

Virtual Reality DEVICE

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.

Virtual reality Distraction

Standard medical treatment OTHER

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

Standard Treatment

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents aged 10 to 17 years hospitalized for corrective scoliosis surgery
• Stable medical condition
• Able to communicate in both French and English.

You may not qualify if:

• Documented photosensitive epilepsy
• Severe cognitive deficits, preventing assent
• Prone to motion sickness.
• The investigators will also recruit a sample of (HCP):
• Closely implicated in the care of participants.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

St. Justine's Hospital

Montreal, Quebec, H1T 3C5, Canada

Location

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MeSH Terms

Conditions

Scoliosis; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Sylvie Le May, PhD

CONTACT

514-345-4931; sylvie.lemay@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A pilot randomized open label within-subject design will be first conducted. A within-subject design is similar to a cross-over design but without a washout period. This design will allow patients to serve as their own control since it is the sequence of the exposure to the intervention that is randomized not the patients/parents themselves.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)