- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593086
Virtual Reality in Burn Pain Management
February 25, 2013 updated by: United States Army Institute of Surgical Research
The Use of Virtual Reality Video Games to Control Procedural Pain During Burn Wound Care
To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn patients experiencing severe procedural pain during wound care.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Sam Houston, Texas, United States, 78234
- USAISR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Standard of care pain management
|
Pain mamagement for burn care procedures.
Other Names:
no intervention for standard of care
Other Names:
|
Experimental: B
SnoWorld Virtual Reality Game
|
Pain mamagement for burn care procedures.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christopher Maani, MD, United States Army Institute of Surgical Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
January 11, 2008
First Posted (Estimate)
January 14, 2008
Study Record Updates
Last Update Posted (Estimate)
February 27, 2013
Last Update Submitted That Met QC Criteria
February 25, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-06-024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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