- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01812655
Comparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents
Comparison of Virtual Reality and Passive Distraction on Burn Wound Care
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Debra A Jeffs, PhD, RN, Arkansas Children's Hospital Research Institute
Publications and helpful links
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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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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