Study in the Use of Virtual Reality as an Adjunct to Pain Control in Burn Patients

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, December 2007

First Received: December 26, 2007 Last Updated: January 10, 2008 History of Changes

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00591448

Purpose

The purpose of this study is to evaluate the use of Virtual Reality (VR) technology during Physical Therapy (PT) and/or Occupational Therapy (OT) for patients with burns. Research questions: Do patients have increased joint Range of Motion (ROM) and reduced pain when using VR during PT compared to PT/OT when VR is not used? Do scores on an imaging ability scale correlate with the effects of VR when used with PT/OT? Do adults and children differ in their ability to engage in the virtual world?

Condition	Intervention
Burn	Other: Virtual Reality (VR)

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Crossover Assignment
Official Title:	Improvement of Pain Management in Burn Patients Using Virtual Reality in Conjunction With Standard Opioids and Sedatives

Resource links provided by NLM:

MedlinePlus related topics: Burns

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Improved pain scores [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

There are no secondary outcomes [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Intervention Details:

See above

Show Detailed Description

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Able to complete subjective evaluations of pain
English-speaking
Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
Able to communicate orally
Pain associated with PT/OT
Age six years and above

Exclusion Criteria:

Incapable of indicating subjective evaluation of pain
Non-English-speaking
Severe head or neck injury or other medical conditions that prohibit patient from wearing VR helmet.
Demonstrating delirium, psychosis, or Organic Brain Disorder
Unable to communicate verbally
Significant developmental disability
Extreme susceptibility to motion sickness
Reports having no pain/full range of motion during physical therapy
Seizure disorder
Frostbite

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591448

Contacts

Contact: Lee Faucher, MD	608-262-6246	faucher@surgery.wisc.edu
Contact: Michael Schurr, MD	608-262-6246	schurr@surgery.wisc.edu

Locations

United States, Wisconsin
United States	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Lee Faucher, MD 608-262-6246 faucher@surgery.wisc.edu
Contact: Michael Schurr, MD 608-262-6246 schurr@surgery.wisc.edu

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Lee Faucher, MD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin ( Lee D. Faucher )
Study ID Numbers:	H-2006-0380
Study First Received:	December 26, 2007
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00591448 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin
Pain

Additional relevant MeSH terms:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on July 06, 2009