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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Virtual Reality and Passive Distraction on Burn Wound Care

Conditions
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Burns, Wound Care, Pain

Intervention / Treatment
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* Device: Virtual Reality
* Other: Passive Distraction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescents, pain, anxiety, children, burn, virtual reality, distraction