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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00261690
Other study ID # 13289-C
Secondary ID R01GM042725
Status Completed
Phase Phase 2/Phase 3
First received December 2, 2005
Last updated April 17, 2013
Start date February 2002
Est. completion date March 2012

Study information

Verified date June 2012
Source National Institute of General Medical Sciences (NIGMS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Using Virtual Reality as a form of Distraction during Burn Care.


Description:

The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' procedural burn pain.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 60 Years
Eligibility 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

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 problem with pain during wound care.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Reality Distraction
Using virtual reality distraction during a procedure

Locations

Country Name City State
United States University of Washington; Harborview Medical Center Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
National Institute of General Medical Sciences (NIGMS) National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Garcia-Palacios, A., Hoffman, H.G., Cain, V., Tininenko, J., Schmidt, A., Villa-Martin, H., and Patterson, D.R., (2004). Using virtual reality to help reduce pain during severe burn wound-care procedures. In MacLachlan, M., and Gallagher, P., Eds Enabling

Hoffman HG, Patterson DR, Magula J, Carrougher GJ, Zeltzer K, Dagadakis S, Sharar SR. Water-friendly virtual reality pain control during wound care. J Clin Psychol. 2004 Feb;60(2):189-95. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary We use GRS, McGill to measure the outcome. once a day No
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