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

Not Applicable

Recruiting

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Device: Virtual Reality Intervention

• Registration Number: NCT06101264
• Lead Sponsor: Connecticut Children's Medical Center

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. A retrospective chart review will also be performed on patients with idiopathic scoliosis who have undergone corrective surgery to serve as a historical control for the study. The retrospective arm of the study only includes patients who have not received a VR intervention.

Study Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-26
• Study Start: 2024-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality Intervention	Virtual Reality Intervention	Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.

Primary Outcome Measures

Name	Time	Method
Average subjective pain level on the 10-point Wong-Baker FACES pain scale	3 times daily postoperatively until hospital discharge (up to 60 days postoperatively)	The Wong-Baker FACES pain scale is a validated and widely used tool to assess subjective pain levels in children and adults. 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 each virtual reality intervention and after every physical therapy session. The assessed pain level at each time point will be averaged across each day and across all of the participants.

Secondary Outcome Measures

Name	Time	Method
Average daily activity levels during the post-operative period measured through actigraphy.	Post-operative day 1 until hospital discharge (up to 60 days postoperatively)	During the post-operative stage, the participants will wear an actigraphy watch. This device will measure the participant's activity levels throughout the day. Following discharge, the daily average activity level will be calculated.
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)	In the postoperative stage, each participant will receive two physical therapy sessions daily. Physical therapy sessions will continue daily until the participant is given clearance by the physical therapy team. To assess the mobilization of participants postoperatively, the total number of physical therapy sessions the participants attend prior to receiving clearance will be noted. The number of total attended physical therapy sessions during the postoperative stage will be averaged across all participants.
Total amount of administered opioids during the post-operative period	From post-operative day 1 until hospital discharge (up to 60 days postoperatively)	Opioid utilization will be assessed by calculating the total inpatient dose of opioids administered (as documented in the electronic medical record) during the post-operative period, starting from post-operative day 1 until hospital discharge.

Trial Locations

Locations (1)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States