VR for Burn Dressing Changes at Home

Nationwide Children's Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Burns; Acute Pain; Procedural Pain

Treatments: Device: VR-PAT

Study type: Interventional

Funder types: Other

Identifiers

NCT04548635

STUDY00000450

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

VR-PAT

Experimental group

Description:

Virtual Reality administered during burn dressing changes

Treatment:

Device: VR-PAT

Control

No Intervention group

Description:

Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed).