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

Pain Clinical Trial

Official title:

Comparison of Virtual Reality and Passive Distraction on Burn Wound Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01812655
• Other study ID #: 109422
• Status: Terminated
• Phase: N/A
• First received: March 13, 2013
• Last updated: August 5, 2013
• Start date: June 2010
• Est. completion date: April 2012

Study information

• Verified date: August 2013
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUniversity of Arkansas for Medical Sciences < United States of America:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Burns
• Pain
• Wound Care

Intervention

Device:
• Virtual Reality

Other:
• Passive Distraction

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (4)

Lead Sponsor	Collaborator
University of Arkansas	Arkansas Biosciences Institute, Arkansas Children's Hospital Burn Center, Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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)	No