VR for Burn Dressing Changes at Home

Nationwide Children's Hospital36 enrolled

Overview

This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT will report less pain during their dressing changes.

Subjects will be randomly assigned to either the VR-PAT intervention group or Control group. Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Subjects and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns Acute Pain Procedural Pain

Interventions

VR-PATDEVICE

Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pediatric patients age 5-17 years (inclusive) * receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution * have a dressing that requires daily changes at home for at least one week * can communicate orally Exclusion Criteria: * any wounds that may interfere with study procedures (i.e. face) * vision, hearing, or cognitive/motor impairments preventing valid administration of study measures * history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras * minors in foster care * suspected child abuse * unable to communicate in English * families who do not have access to a smartphone (due to the VR-PAT game requirements)

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Pain assessment during dressing changes.

1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome.

Time frame: 15-30 minutes during daily burn dressing changes for up to 7 days.

Observed VR experience.

caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire.

Time frame: Daily for 15-30 minutes burn dressing change for up to 7 days.

Self-reported VR experience.

1-10 rating scale of degree of realism, pleasure, and satisfaction with VR (VR-PAT arm only), with higher score meaning better outcome.

Time frame: Daily for 15-30 minutes burn dressing change for up to 7 days.

Secondary Outcomes

Burn-related medications

caregiver-reported name and dosage of medication provided for burn-related pain

Time frame: Daily for burn dressing change for up to 7 days.

Data from ClinicalTrials.gov

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