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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00593086
Other study ID # H-06-024
Secondary ID
Status Completed
Phase N/A
First received December 26, 2007
Last updated February 25, 2013
Start date June 2007
Est. completion date June 2012

Study information

Verified date February 2013
Source United States Army Institute of Surgical Research
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date June 2012
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Pain management
Pain mamagement for burn care procedures.
Other:
Standard of care/no virtual reality game
no intervention for standard of care

Locations

Country Name City State
United States USAISR Fort Sam Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care 48 hours No
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