Virtual Reality After Pediatric Scoliosis Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2021-12-01

Brief Summary

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

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Detailed Description

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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

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Scoliosis Idiopathic Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual reality device

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.

Group Type EXPERIMENTAL

Applied VR

Intervention Type DEVICE

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.

iPad device

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.

Group Type ACTIVE_COMPARATOR

Apple iPad

Intervention Type DEVICE

The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.

Interventions

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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.

Intervention Type DEVICE

Apple iPad

The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No