VR for Pediatric Burn Dressing Changes

Not Applicable

Completed

• Conditions: Pain; Burns

• Registration Number: NCT04544631
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-03
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Observed pain	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.
Patient self-reported pain	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.

Secondary Outcome Measures

Name	Time	Method
Nurse reported feasibility of VR in clinical burn wound care	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".
VR experience self-reported by patient and parents	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"
Simulator sickness symptoms of patient	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".