Clinical trial NCT01812655: 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
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Wound Care
Pain
Keywords: pain
anxiety
children
adolescents
burn
virtual reality
distraction
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Arkansas Children's Hospital Research Institute
name: Arkansas Biosciences Institute
name: Arkansas Children's Hospital Burn Center
First posted: 2013-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Self-reported Wound Care Procedure Pain Score
timeFrame: Within the first 20 minutes following completion of the burn wound care procedure
Secondary outcomes:
measure: Desire for Distraction
timeFrame: Post-procedure (approximately 30-75 minutes)
measure: Engagement With Distraction and Belief in Distraction's Efficacy
timeFrame: Post-procedure (approximately 30-75 minutes)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: Arkansas Children's Hospital Research Institute
name: Debra A Jeffs, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.