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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

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)

MedlinePlus related topics:   Burns   

U.S. FDA Resources

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

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:
    Other: Virtual Reality (VR)
    See above
Show detailed description  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

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

Study placed in the following topic categories:
Burns
Wounds and Injuries
Disorders of Environmental Origin
Pain

ClinicalTrials.gov processed this record on August 21, 2008




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