Virtual Reality Analgesia for Pediatric Burn Survivors

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

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-13

Study Completion Date

2017-01-03

Brief Summary

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Many children with large severe burns report severe pain during burn wound cleaning. The current study explores whether adjunctive immersive Virtual Reality distraction may help reduce the intensity of pain experienced by children during burn wound cleaning by taking the patient's mind off their pain.

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Detailed Description

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All patients always receive their usual pain medications. Using a within-subjects, within-wound care design, in the current study, pediatric patients being treated for severe burn injuries will receive music distraction during some portions of their wound care (active comparator condition), and they will receive what we predict will be an unusually strong distraction, immersive virtual reality (the experimental treatment) during other comparable portions of the same wound cleaning sessions. During virtual reality, each patient will look into virtual reality goggles, and will play a simple cartoon-like virtual reality game SnowWorld during burn wound cleaning. After each wound care session, the patient will rate how much pain they experienced during wound care during No VR (music only) compared to how much pain they experienced during wound care during virtual reality, on each study day, for up to 10 study days per patient. Treatment order randomized.

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Within-subject design with repeated measures, with random assignment to initial treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Blinding can be challenging in behavioral studies. To help control for demand characteristics, the current study uses an active comparator "music distraction" vs. the experimental treatment condition "immersive virtual reality".

Study Groups

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virtual reality distraction (Yes VR)

In addition to their standard pain medications, patients will play a virtual realty game named SnowWorld during some portions of their burn wound cleaning procedure, on each study day.

Group Type EXPERIMENTAL

virtual reality distraction (Yes VR)

Intervention Type BEHAVIORAL

music distraction (No VR condition)

In addition to their standard pain medications, patients will listen to music during comparable portions of their burn wound cleaning procedure, on each study day.

Group Type ACTIVE_COMPARATOR

music distraction (No VR)

Intervention Type BEHAVIORAL

Interventions

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virtual reality distraction (Yes VR)

Intervention Type BEHAVIORAL

music distraction (No VR)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Compliant and able to complete subjective evaluations,
* A minimum of 10% of total burned surface area,
* No history of psychiatric (DSM-III-R Axis I) disorder(s),
* Not demonstrating delirium, psychosis or any form of organic brain disorder,
* Able to communicate verbally in English or Spanish,
* Admitted to UTMB/Shriners, 6-17 years of age.

Exclusion Criteria

* No wound cleaning sessions required.
* Less than 10% of total burned surface area.
* History of psychiatric (DSM-III-R Axis I) disorder(s).
* Demonstrating delirium, psychosis or organic brain disorder.
* Unable to communicate verbally in English or Spanish.
* History of significant cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal, or genitourinary impairment.
* Receiving prophylaxis for alcohol or drug withdrawal,
* Developmental disability, Younger than 6 years; older than 17 years,
* Burns of eyes, eyelids or face so severe they preclude the use of VR,
* Worst pain intensity of less than 5 on a 0 to 10 scale, during baseline No VR wound care Day 1.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No