VR-PAT During Home Burn Dressings

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2027-12-01

Brief Summary

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This study will evaluate the effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.

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Detailed Description

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In this two-group randomized clinical trial, participants will be randomly assigned to either the VR-PAT intervention group or control group (standard distraction techniques available in the home). Participants and caregivers in both groups will perform daily burn dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Participants 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 Injuries Pediatric ALL

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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Intervention Group

Participants will be using the VR-PAT during burn dressings.

Group Type EXPERIMENTAL

VR-PAT

Intervention Type OTHER

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

Control Group

Participants will not be using the VR-PAT during burn dressings (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 OTHER

Other Intervention Names

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Virtual Reality

Eligibility Criteria

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Inclusion Criteria

* Being treated for acute burn injury
* Age 6-17 years, inclusive
* Receiving their first outpatient clinic dressing change or being discharged from the ED or inpatient burn unit
* Have a dressing that requires daily changes at home for at least 7 days after their first outpatient appointment or discharge from the hospital (ED or inpatient)
* Patient and family caregivers can communicate (read and write) using English or Spanish
* Reported at least moderate or worse NRS pain score of ≥3 (NRS 0-10 with 10 being worst pain) from the most recent dressing change.

Exclusion Criteria

* Any wounds that may interfere with study procedures
* 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, prisoners, or currently pregnant
* Suspected child abuse
* Families who do not have access to a VR compatible smartphone.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No