Virtual Reality After Pediatric Scoliosis Surgery (VRAS-PS)

University of North Carolina (UNC)

Status: Completed

Conditions: Pain, Postoperative; Scoliosis Idiopathic

Treatments: Device: Apple iPad; Device: Applied VR

Study type: Interventional

Funder types: Other

Identifiers

NCT04584970

20-0696

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects age 11 - 17 years of age
• Patients undergoing idiopathic scoliosis surgery on Enhanced Recovery after Surgery (ERAS) spine protocol (which includes postoperative PCA)

Exclusion criteria

• Patient/caregiver refusal
• Patients with developmental delay
• Patients with seizure disorder
• Non-English-speaking patients
• Patients with daily opioid use >/= two weeks
• Patients with uncorrected visual or hearing impairment
• Patients admitted to pediatric intensive care unit on postoperative day #1

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Virtual reality device

Experimental group

Description:

Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games.

Treatment:

Device: Applied VR

iPad device

Active Comparator group

Description:

Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games.

Treatment:

Device: Apple iPad