Comparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents

August 5, 2013 updated by: University of Arkansas

Comparison of Virtual Reality and Passive Distraction on Burn Wound Care

Relief of severe burn wound care pain may require both medications to relieve pain and non-medication interventions,such as distraction. Little is known about distraction's effectiveness. Virtual reality may be an effective distraction. The aims of this study are 1)to evaluate the effect of virtual reality (VR), a newer interactive kind of distraction, compared to passive distraction (PD) by watching a movie, and usual care (SC) that is provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to determine the relationship among anxiety, desire for distraction, and engagement with distraction on the pain.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergoing burn wound care in the Arkansas Children's Hospital (ACH) outpatient burn clinic;
  • first time visit to the ACH outpatient burn clinic or first clinic visit without conscious sedation;
  • adolescents ages 10 to 17 years;
  • English speaking;
  • absence of a history of motion sickness (motion sickness has been reported in some VR users);
  • absence of a seizure disorder (because prolonged immersion in VR may lead to seizures and vertigo in individuals with seizure disorders, these individuals will be excluded from the study);
  • absence of a cognitive developmental disability determined on prescreening by presence of a Section 504 accommodation plan or Title VIII individualized educational plan (IEP) in school. If the parent identifies the nature of the IEP or 504 plan as unrelated to a cognitive delay, then the child or adolescent will be included in the study.

Exclusion Criteria:

  • Burns that would interfere with study procedures
  • Incarcerated minors
  • Children in foster care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality
Virtual reality using a software program designed for burn patients during burn wound care
Active Comparator: Passive distraction
watching a movie
No Intervention: UC provided by the nurses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported Wound Care Procedure Pain Score
Time Frame: Within the first 20 minutes following completion of the burn wound care procedure
The acute pain experienced during the burn wound care procedure was measured on a 100mm visual analog scale called the Adolescent Pediatric Pain Tool through self-report by adolescents ages 10-17 years receiving outpatient burn wound care. The scale ranges from 0mm (No Pain) to 100mm (Worst Pain).
Within the first 20 minutes following completion of the burn wound care procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desire for Distraction
Time Frame: Post-procedure (approximately 30-75 minutes)
Participants were asked "I wanted to be distracted from during my treatment today." (Agree-Disagree) from the Post-Procedure Questionnaire
Post-procedure (approximately 30-75 minutes)
Engagement With Distraction and Belief in Distraction's Efficacy
Time Frame: Post-procedure (approximately 30-75 minutes)

For Engagement with Distraction,VR and PD participants were asked on the Post-testing Questionnaire: "Were you able to pay attention to the DVD or to the VR during your burn treatment?" (1=could not pay attention at all; 5=totally absorbed at all times)

For Belief in Distraction's Efficacy, VR and PD participants were asked on the Post-Procedure Questionnaire: "I believe that the distraction lessened my pain during my burn treatment today." (on a scale of 1=Distraction did not help to lessen my pain at all; 5=Distraction completely helped to lessen my pain at all times)

Post-procedure (approximately 30-75 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Debra A Jeffs, PhD, RN, Arkansas Children's Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Askay SW, Patterson DR. What are the psychiatric sequelae of burn pain? Curr Pain Headache Rep. 2008;12(2):94-97. Das DA, Grimmer KA, Sparnon AL, et al. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial. BMC Pediatr. 2005;5(1):1471-2431. Patterson DR, Weichman SA, Jensen MP, et al. Hypnosis delivered through immersive virtual reality for burn pain: a clinical case series. Int J Clin Exp Hypn. 2006;54(2):130-142. Hoffman HG, Chambers GT, Meyer WJ, et al. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann. Behav. Med. 2011;41(2):183-191. doi: 10.1007/s12160-010-9248-7. Smith JS, Smith KR, Rainey SL. The psychology of burn care. J Trauma Nurs. 2006;13(3):105-106.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109422

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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