VR for Pediatric Burn Dressing Changes

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-03-03

Brief Summary

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This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the control. One researcher administered VR and observed pain while another researcher administered post-trial survey that measured child's perceived pain and VR experience. Nurses were asked to report the clinical utility.

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Detailed Description

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Conditions

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Pain Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, three-group between subject randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Researchers and nurses did not know the group assignment until immediately prior to intervention. Following the dressing change procedure, a second researcher, blinded to the group assignment, asked participants a post-assessment that included questions about child and guardian perceived pain and subjective VR experience.

Study Groups

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Active VR

Participants in the active VR group played a virtual reality game entitled "Virtual River Cruise". In this game, an otter floats down a river on a boat and players activate snow-blowing statues along the shore by focusing on them. The statues will emit snow if they are correctly aimed at by the child, and a thermometer placed in the front of the boat shows decreased temperatures as more snowflakes are blown. As feedback to reinforce continued engagement, a scoreboard placed beside the thermometer will show children the number of statues he/she has activated. Additionally, as the temperature drops, snow and ice will start piling up on the boat and its surroundings, providing an enhanced "cooling" experience for pediatric burn patients. Children interact with the immersive virtual reality environment by tilting their head, minimizing potential interference with the dressing change procedure.

Group Type EXPERIMENTAL

Virtual reality game as adjunctive pain management tool

Intervention Type OTHER

A smart phone virtual reality-based pain alleviation tool (VR-PAT).

Passive VR

Participants in the passive VR group were immersed in the same virtual reality environment as the active VR group, without any interactions with the VR game.

Group Type EXPERIMENTAL

Virtual reality game as adjunctive pain management tool

Intervention Type OTHER

A smart phone virtual reality-based pain alleviation tool (VR-PAT).

Standard Care Control

Participants in the standard group received routinely used distraction tools provided in the clinical setting, such as iPads, music, books, and/or talking.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality game as adjunctive pain management tool

A smart phone virtual reality-based pain alleviation tool (VR-PAT).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* children age 6-17 years (inclusive)
* admitted or seen in the outpatient clinic for a burn injury
* spoke English as primary language

Exclusion Criteria

* a severe burn on the face or head that prevented the utilization of the VR
* cognitive or motor impairment that prevented valid administration of study measures
* visual or hearing impairments that prevented interaction with the VR environment
* did not have a legal guardian present to give consent

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No