Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population

NCT ID: NCT06101264

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-06-01

Brief Summary

The purpose of this study is to assess the effect of virtual reality on subjective post-operative pain, total inpatient narcotic administration, and mobilization with physical therapy in pediatric patients who have undergone surgical correction for idiopathic scoliosis.

Detailed Description

All pediatric patients (ages 13-18) at Connecticut Children's Medical Center undergoing corrective scoliosis surgery for idiopathic scoliosis are eligible and will be approached for consent and inclusion into the study. This is a prospective pilot study, and all enrolled patients will receive a virtual reality (VR) intervention using a commercially available device manufactured by Oculus. The VR software will simulate a low physical load environment, such as an underwater space exploration game. Starting on postoperative day 1, the prospective cohort will undergo a 20-minute VR session 30 minutes prior to each physical therapy session. There will be two physical therapy sessions scheduled daily for the participant. Outcome measures will be assessed before and after the VR session and after the physical therapy session. The following procedures will continue daily until the participant is cleared for hospital discharge. Patients that met study eligibility but elected not to participate in the VR intervention were analyzed as the control group.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality

Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

Patients will undergo a 20 minute virtual reality session prior to each physical therapy session following spinal fusion for adolescent idiopathic scoliosis. Virtual reality sessions will continue until functionally cleared by physical therapy.

Control

Patients not receiving virtual reality intervention following corrective surgery for idiopathic scoliosis.

Group Type: EXPERIMENTAL

Control

Intervention Type: DEVICE

Control patients following spinal fusion for adolescent idiopathic scoliosis that receive no virtual reality sessions.

Interventions

Control

Control patients following spinal fusion for adolescent idiopathic scoliosis that receive no virtual reality sessions.

Intervention Type: DEVICE

Virtual Reality

Patients will undergo a 20 minute virtual reality session prior to each physical therapy session following spinal fusion for adolescent idiopathic scoliosis. Virtual reality sessions will continue until functionally cleared by physical therapy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All pediatric patients (ages 13-18) at Connecticut Children's undergoing surgical correction for idiopathic scoliosis over a span of 12 months

Exclusion Criteria

• History of seizures
• Cognitive developmental delay precluding participation in VR
• Head or neck surgery that does not allow a head-mounted display to be worn safely
• Chronic pain requiring the daily use of opioids for more than 2 weeks prior to the procedure
• Non-English speakers
• Side effects during screening
• Patients with vagal nerve stimulators, cardiac pacemakers, and/or cochlear implants that may receive interference from the VR device

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Connecticut

OTHER

Sponsor Role: collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Hersh, MD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Center

Locations

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

23-064-CCMC

Identifier Type: -

Identifier Source: org_study_id