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

NCT06101264 | Completed Results DMC FDA Device

• 1 other identifier: 23-064-CCMC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• Average Change in Subjective Pain Level Using a 10 Point Likert Scale

  This tool uses a 10-point scale that ranges from 0 (no pain) to 10 (worst possible pain). Pain will be assessed using this tool before and after every physical therapy session. The change in pain before and after each physical therapy session will be calculated and averaged across each patient.

  2 times daily postoperatively until hospital discharge (up to 60 days postoperatively)

Secondary Outcomes (2)

• Total Amount of Administered Opioids During the Post-operative Period

  From post-operative day 1 until hospital discharge (up to 60 days postoperatively)

• Average Number of Physical Therapy Sessions Prior to Receiving Clearance by Physical Therapy Staff

  Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively)

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Device: Virtual Reality

Control

EXPERIMENTAL

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

Device: Control

Interventions

Control DEVICE

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

Control

Virtual Reality 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.

Virtual Reality

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• University of Connecticut: collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Limitations and Caveats

This study allocation of patients to the control group if they declined participation in the virtual reality sessions and is such not a true randomized controlled trial. Further, our prospective study has a small sample size as it is intended as a pilot study.

Results Point of Contact

• Title: Prabhath Mannam
• Organization: University of Connecticut School of Medicine

pmannam@uchc.edu

8607092371

Study Officials

• David Hersh, MD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 26, 2023
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)