VR for Pediatric Burn Dressing Changes

August 21, 2024 updated by: Henry Xiang, Nationwide Children's Hospital

Active and Passive Virtual Reality Distraction for Pain Management During Pediatric Burn Dressing Changes

This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the control. One researcher administered VR and observed pain while another researcher administered post-trial survey that measured child's perceived pain and VR experience. Nurses were asked to report the clinical utility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • children age 6-17 years (inclusive)
  • admitted or seen in the outpatient clinic for a burn injury
  • spoke English as primary language

Exclusion Criteria:

  • a severe burn on the face or head that prevented the utilization of the VR
  • cognitive or motor impairment that prevented valid administration of study measures
  • visual or hearing impairments that prevented interaction with the VR environment
  • did not have a legal guardian present to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active VR
Participants in the active VR group played a virtual reality game entitled "Virtual River Cruise". In this game, an otter floats down a river on a boat and players activate snow-blowing statues along the shore by focusing on them. The statues will emit snow if they are correctly aimed at by the child, and a thermometer placed in the front of the boat shows decreased temperatures as more snowflakes are blown. As feedback to reinforce continued engagement, a scoreboard placed beside the thermometer will show children the number of statues he/she has activated. Additionally, as the temperature drops, snow and ice will start piling up on the boat and its surroundings, providing an enhanced "cooling" experience for pediatric burn patients. Children interact with the immersive virtual reality environment by tilting their head, minimizing potential interference with the dressing change procedure.
Other: Virtual reality game as adjunctive pain management tool
A smart phone virtual reality-based pain alleviation tool (VR-PAT).
Experimental: Passive VR
Participants in the passive VR group were immersed in the same virtual reality environment as the active VR group, without any interactions with the VR game.
Other: Virtual reality game as adjunctive pain management tool
A smart phone virtual reality-based pain alleviation tool (VR-PAT).
No Intervention: Standard Care Control
Participants in the standard group received routinely used distraction tools provided in the clinical setting, such as iPads, music, books, and/or talking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observed pain
Time Frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Researcher observed pain of patient based on the Face Legs Activity Cry and Consolability behavioral pain assessment tool (FLACC-r), using 0,1,2 numerical scale for category of face, legs, activity, cry, and consolability. Total scores range from 0-10 with higher scores indicating more pain.
During outpatient burn dressing change, on average lasting about 15 minutes.
Patient self-reported pain
Time Frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome.
During outpatient burn dressing change, on average lasting about 15 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VR experience self-reported by patient and parents
Time Frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Self-reported virtual reality experience using patient and parent survey questions (5-6 survey items) about their experience in using virtual reality during burn wound care. Questions are a mixture of yes/no and a 100 Visual Analog Scale (VAS) with 0 being "Not at All" and 100 being "Very Much"
During outpatient burn dressing change, on average lasting about 15 minutes.
Simulator sickness symptoms of patient
Time Frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Simulator sickness symptoms using the Simulator Sickness Questionnaire (SSQ), which has 15 survey items with possible choices of "None", "Slight", "Moderate", and "Severe".
During outpatient burn dressing change, on average lasting about 15 minutes.
Nurse reported feasibility of VR in clinical burn wound care
Time Frame: During outpatient burn dressing change, on average lasting about 15 minutes.
Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from "not at all" to "very easy".
During outpatient burn dressing change, on average lasting about 15 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Henry Xiang, MD, MPH, PhD, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

March 3, 2019

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB16-00444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD are confidential patient data so we are not allowed to share the data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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