NCT04584970

Virtual Reality After Pediatric Scoliosis Surgery

Evaluation of Virtual Reality Intervention After Pediatric Idiopathic Scoliosis Surgery to Reduce Postoperative Pain and Opioid Consumption

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.

Detailed description

Purpose: To evaluate postoperative pain scores and postoperative opioid use in pediatric idiopathic scoliosis surgical patients using virtual reality (VR) as a method of immersive distraction compared with standard electronic use postoperatively. Participants: Patients age 11-17 undergoing idiopathic scoliosis surgery on Enhanced Recovery After Surgery (ERAS) spine protocol at our institution. Procedures (methods): Participants will be randomized to intervention arm (VR) or control arm (iPad). Baseline pain and anxiety scores will be assessed. On postoperative day 1, each patient will receive a visit by the research assistant who will assess pain scores, PCA use, etc. The intervention group will be offered a VR device for up to 30 minutes. The control group will be offered an iPad for up to 30 minutes. This visit will be performed twice on postoperative day 1. Follow up survey will be conducted at 48-72 hours and 7-10 days postoperatively.

Conditions

• Scoliosis Idiopathic
• Pain, Postoperative

Interventions

Type	Name	Description
DEVICE	Applied VR	The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.
DEVICE	Apple iPad	The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.

Timeline

• Start date: 2020-12-08
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-10-14
• Last updated: 2022-09-16
• Results posted: 2022-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study