Virtual Reality in Burn Pain Management - Full Text View

Sponsored by:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00593086

Purpose

To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn patients experiencing severe procedural pain during wound care.

Condition	Intervention
Burns Pain	Other: Commercial virtual reality game- Snow World Other: Standard of care/no virtual reality game

MedlinePlus related topics: Burns

Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	The Use of Virtual Reality Video Games to Control Procedural Pain During Burn Wound Care

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:

There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	June 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A	Other: Standard of care/no virtual reality game no intervention for standard of care
B: Active Comparator Snow World virtual Reality Game	Other: Commercial virtual reality game- Snow World commercial device

Detailed Description:

This is a prospective, randomized cross-over study of the safety and effectiveness of the use of a virtual reality distraction intervention to management procedural pain during burn wound care. Up to 20 subjects will be enrolled until 12 complete the study.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or oler with thermal injury
Understands English
patient perception of previous wound care procedural pain is greater than 6 on a numeric pain scal of 0-10 where 0= no pain and 10=worst pain ever experienced
ability to use a computer mouse or hit the space bar on a computer keyboard

Exclusion Criteria:

unhealed burned wounds on face, neck or head
history of severe susceptibility to motion sickness
presence of open woun ds to the hands that cannot be covered with a dressing while operating the control button
patients who report a feeling of anxiety or discomfort while viewing the Snow World software on a computer without the helmet

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593086

Contacts

Contact: Christopher Maani, MD	210-916-1044	christopher.maani@amedd.army.mil
Contact: Annette R McClinton, RN, MA	210-916-2834	annette.mcclinton@amedd.army.mil

Locations

United States, Texas
USAISR	Recruiting
Fort Sam Houston, Texas, United States, 78234
Principal Investigator: Christopher Maani, MD

Sponsors and Collaborators

United States Army Institute of Surgical Research

Investigators

Principal Investigator:

Christopher Maani, MD

United States Army Institute of Surgical Research

More Information

Publications:

Patterson DR, Hoffman HG, Weichman SA, Jensen MP, Sharar SR. Optimizing control of pain from severe burns: a literature review. Am J Clin Hypn. 2004 Jul;47(1):43-54. Review. No abstract available.

Responsible Party:	USAISR ( Christopher Maani, CPT, MC )
Study ID Numbers:	H-06-024
Study First Received:	December 26, 2007
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00593086
Health Authority:	United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:

wound care

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin
Pain
Cocaine

ClinicalTrials.gov processed this record on January 16, 2009