VR for Burn Dressing Changes at Home

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2021-06-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burns Acute Pain Procedural Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VR-PAT

Virtual Reality administered during burn dressing changes

Group Type EXPERIMENTAL

VR-PAT

Intervention Type DEVICE

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VR-PAT

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

Intervention Type DEVICE

Other Intervention Names

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Virtual Reality

Eligibility Criteria

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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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No