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

NCT ID: NCT01812655

Last Updated: 2013-08-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-04-30

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.

Detailed Description

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Conditions

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Burns Wound Care Pain

Keywords

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pain anxiety children adolescents burn virtual reality distraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Virtual Reality

Virtual reality using a software program designed for burn patients during burn wound care

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type DEVICE

Passive distraction

watching a movie

Group Type ACTIVE_COMPARATOR

Passive Distraction

Intervention Type OTHER

UC provided by the nurses

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality

Intervention Type DEVICE

Passive Distraction

Intervention Type OTHER

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role collaborator

Arkansas Biosciences Institute

UNKNOWN

Sponsor Role collaborator

Arkansas Children's Hospital Burn Center

UNKNOWN

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Debra A Jeffs, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Hospital Research Institute

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

Other Identifiers

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109422

Identifier Type: -

Identifier Source: org_study_id