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

NCT01812655 | Terminated Results DMC

• 1 other identifier: 109422
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Wound Care; Pain

Keywords

pain; anxiety; children; adolescents; burn; virtual reality; distraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Desire for Distraction

  Post-procedure (approximately 30-75 minutes)

• Engagement With Distraction and Belief in Distraction's Efficacy

  Post-procedure (approximately 30-75 minutes)

Study Arms (3)

Virtual Reality

EXPERIMENTAL

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

Device: Virtual Reality

Passive distraction

ACTIVE COMPARATOR

watching a movie

Other: Passive Distraction

UC provided by the nurses

NO INTERVENTION

Interventions

Virtual Reality DEVICE

Virtual Reality

Passive Distraction OTHER

Passive distraction

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Burns that would interfere with study procedures
• Incarcerated minors
• Children in foster care

Sponsors & Collaborators

• University of Arkansas: lead
• Arkansas Children's Hospital Research Institute: collaborator
• Arkansas Biosciences Institute: collaborator
• Arkansas Children's Hospital Burn Center: collaborator

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Burns; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Limitations and Caveats

Early termination of study due to fewer subjects available than expected resulting in small sample size.

Results Point of Contact

• Title: Debra Jeffs, PhD, RN, Principal Investigator
• Organization: Arkansas Children's Hospital

jeffsda@archildrens.org

501-364-3239

Study Officials

• Debra A Jeffs, PhD, RN

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 18, 2013
• Study Start: June 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 6, 2013
• Results First Posted: August 6, 2013

Record last verified: 2013-08

Locations

US (1)