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VR for Pediatric Burn Dressing Changes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04544631
Enrollment
90
Registered
2020-09-10
Start date
2016-12-01
Completion date
2019-03-03
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Pain

Keywords

Pediatrics, Burns, Pain, Virtual Reality

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.

Interventions

OTHERVirtual reality game as adjunctive pain management tool

A smart phone virtual reality-based pain alleviation tool (VR-PAT).

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Researchers and nurses did not know the group assignment until immediately prior to intervention. Following the dressing change procedure, a second researcher, blinded to the group assignment, asked participants a post-assessment that included questions about child and guardian perceived pain and subjective VR experience.

Intervention model description

A prospective, three-group between subject randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Observed painDuring 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 painDuring 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

MeasureTime frameDescription
VR experience self-reported by patient and parentsDuring 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 patientDuring 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.
Nurse reported feasibility of VR in clinical burn wound careDuring 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026