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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014