Back to resultsComparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents
Primary Purpose
Burns, Wound Care, Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Passive Distraction
Sponsored by
About this trial
This is an interventional supportive care trial for Burns focused on measuring pain, anxiety, children, adolescents, burn, virtual reality, distraction
Eligibility Criteria
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
Sites / Locations
- Arkansas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Virtual Reality
Passive distraction
UC provided by the nurses
Arm Description
Virtual reality using a software program designed for burn patients during burn wound care
watching a movie
Outcomes
Primary Outcome Measures
Self-reported Wound Care Procedure Pain Score
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).
Secondary Outcome Measures
Desire for Distraction
Participants were asked "I wanted to be distracted from during my treatment today." (Agree-Disagree) from the Post-Procedure Questionnaire
Engagement With Distraction and Belief in Distraction's Efficacy
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)
Full Information
NCT ID
NCT01812655
First Posted
March 13, 2013
Last Updated
August 5, 2013
Sponsor
University of Arkansas
Collaborators
Arkansas Children's Hospital Research Institute, Arkansas Biosciences Institute, Arkansas Children's Hospital Burn Center
1. Study Identification
Unique Protocol Identification Number
NCT01812655
Brief Title
Comparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents
Official Title
Comparison of Virtual Reality and Passive Distraction on Burn Wound Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Early termination of study due to fewer subjects available than expected resulting in small sample size.
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Arkansas Children's Hospital Research Institute, Arkansas Biosciences Institute, Arkansas Children's Hospital Burn Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Wound Care, Pain
Keywords
pain, anxiety, children, adolescents, burn, virtual reality, distraction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Virtual reality using a software program designed for burn patients during burn wound care
Arm Title
Passive distraction
Arm Type
Active Comparator
Arm Description
watching a movie
Arm Title
UC provided by the nurses
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Type
Other
Intervention Name(s)
Passive Distraction
Primary Outcome Measure Information:
Title
Self-reported Wound Care Procedure Pain Score
Description
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).
Time Frame
Within the first 20 minutes following completion of the burn wound care procedure
Secondary Outcome Measure Information:
Title
Desire for Distraction
Description
Participants were asked "I wanted to be distracted from during my treatment today." (Agree-Disagree) from the Post-Procedure Questionnaire
Time Frame
Post-procedure (approximately 30-75 minutes)
Title
Engagement With Distraction and Belief in Distraction's Efficacy
Description
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)
Time Frame
Post-procedure (approximately 30-75 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra A Jeffs, PhD, RN
Organizational Affiliation
Arkansas Children's Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
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Comparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents
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