VR for Pediatric Burn Dressing Changes

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544631
• Other study ID #: IRB16-00444
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: March 3, 2019

Study information

• Verified date: April 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 3, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Pain

Intervention

Other:
• Virtual reality game as adjunctive pain management tool
A smart phone virtual reality-based pain alleviation tool (VR-PAT).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

References & Publications (3)

Jain S, Armstrong M, Luna J, Thakkar RK, Fabia R, Groner JI, Noffsinger D, Ni A, Nelson E, Xiang H. Features of virtual reality impact effectiveness of VR pain alleviation therapeutics in pediatric burn patients: A randomized clinical trial. PLOS Digit He — View Citation

Vest E, Armstrong M, Olbrecht VA, Thakkar RK, Fabia RB, Groner JI, Noffsinger D, Tram NK, Xiang H. Association of Pre-procedural Anxiety With Procedure-Related Pain During Outpatient Pediatric Burn Care: A Pilot Study. J Burn Care Res. 2023 May 2;44(3):61 — View Citation

Xiang H, Shen J, Wheeler KK, Patterson J, Lever K, Armstrong M, Shi J, Thakkar RK, Groner JI, Noffsinger D, Giles SA, Fabia RB. Efficacy of Smartphone Active and Passive Virtual Reality Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed pain	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.
Primary	Patient self-reported pain	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	VR experience self-reported by patient and parents	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.
Secondary	Simulator sickness symptoms of patient	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.
Secondary	Nurse reported feasibility of VR in clinical burn wound care	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.