Virtual Reality in Burn Pain Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00593086
First received: December 26, 2007
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Burns
Pain
Procedure: Pain management
Other: Standard of care/no virtual reality game

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Use of Virtual Reality Video Games to Control Procedural Pain During Burn Wound Care

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: June 2007
Study Completion Date: June 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Standard of care pain management
Procedure: Pain management
Pain mamagement for burn care procedures.
Other Name: Snow World or Standard of care
Other: Standard of care/no virtual reality game
no intervention for standard of care
Other Name: Standard of care
Experimental: B
SnoWorld Virtual Reality Game
Procedure: Pain management
Pain mamagement for burn care procedures.
Other Name: Snow World or Standard of care

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593086

Locations
United States, Texas
USAISR
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Christopher Maani, MD United States Army Institute of Surgical Research
  More Information

Publications:
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00593086     History of Changes
Other Study ID Numbers: H-06-024
Study First Received: December 26, 2007
Last Updated: February 25, 2013
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
wound care

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 23, 2014