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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101264
• Other study ID #: 23-064-CCMC
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: Connecticut Children's Medical Center
• Contact: David Hersh, MD
• Phone: 8605458373
• Email: dhersh[@]connecticutchildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Virtual Reality Intervention
Participants will be given a virtual reality (VR) intervention following corrective scoliosis surgery for adolescent idiopathic scoliosis. The VR intervention will utilize a commercial device manufactured by Oculus. The intervention will utilize a software that simulates a low-physical load environment for the user. Starting on postoperative day 1, the participant will receive a 20-minute VR intervention 30 minutes prior to each physical therapy session. There will be two physical therapy sessions daily. Outcome measures will be assessed before and after every VR intervention and after the physical therapy session. The VR interventions will continue for each postoperative day until the participant is discharged from the hospital.

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center	University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average subjective pain level on the 10-point Wong-Baker FACES pain scale	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.	3 times daily postoperatively until hospital discharge (up to 60 days postoperatively)
Secondary	Total amount of administered opioids during the post-operative period	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.	From post-operative day 1 until hospital discharge (up to 60 days postoperatively)
Secondary	Average daily activity levels during the post-operative period measured through actigraphy.	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.	Post-operative day 1 until hospital discharge (up to 60 days postoperatively)
Secondary	Average number of physical therapy sessions prior to receiving clearance by physical therapy staff	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.	Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively)