Virtual Reality for Burn Wound Care Pain Control

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00663013
First received: April 17, 2008
Last updated: January 3, 2011
Last verified: January 2011
  Purpose

The investigators propose to study the effects of virtual reality (VR) on patients' pain perception during burn wound care. Such variables include psychiatric diagnosis and standard pain coping (i.e. pain catastophizer vs. non-pain catastrophizer).Aims: The investigators intend to evaluate the use of virtual reality in pain distraction for burn patients undergoing burn wound care. To that end our aims are: 1) To determine if pain perception will be less during the portion of the procedure in which the patient is immersed in the VR session in comparison to the portion of wound care which will occur without VR immersion. 2) To determine if anticipatory anxiety will be less for the portion of wound care that includes the virtual reality in comparison to the portion without virtual reality. 3) To determine if current psychiatric diagnosis, especially acute stress disorder and depression, is related to higher pain perception and greater decrease in pain with the virtual reality distraction. 4) To determine if being a "pain catastrophizer" is related to higher pain perception and greater benefits from the


Condition Intervention
Pain
Anxiety
Other: Virtual Reality

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virtual Reality for Burn Wound Care Pain Control

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • pain perception [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • anticipatory anxiety [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • current psychiatric diagnosis, is related to pain [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • "pain catastrophizing" is related to higher pain perception and greater benefits from the VR [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: October 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The first treatment session will involve 5-7 minutes of burn wound care while distracted by VR, and 5-7 minutes of burn wound care without the distraction of VR. The second session of burn wound care (performed within the next 3 days) will involve 5-7 minutes of burn wound care without the distraction of VR, and 5-7 minutes of burn wound care with the distraction of VR. The treatment order will be randomized.
Other: Virtual Reality
Virtual reality (VR) gives patients an illusion of going into the 3-D computer generated environment/virtual world. During VR, the subject wears a head-mounted virtual reality helmet that positions two goggle-sized miniature LCD computer screens close to the subject's eyes. Position tracking devices keep the computer informed of changes in the patient's head location. An electro-magnetic head orientation device feeds the x, y, z coordinates of the patient's head to the computer, which can quickly change what the patient sees in virtual reality accordingly. The scenery in VR changes as the patient moves her head orientation (e.g., virtual objects in front of the patient in VR get closer as the patient, wearing the VR helmet, leans forward in the real world).
Other Name: SnowWorld Multigen-Paradigm Inc, SimWright Inc
Active Comparator: 2
The first treatment session will involve 5-7 minutes of burn wound care while distracted by VR, and 5-7 minutes of burn wound care without the distraction of VR. The second session of burn wound care (performed within the next 3 days) will involve 5-7 minutes of burn wound care without the distraction of VR, and 5-7 minutes of burn wound care with the distraction of VR. The treatment order will be randomized.
Other: Virtual Reality
Virtual reality (VR) gives patients an illusion of going into the 3-D computer generated environment/virtual world. During VR, the subject wears a head-mounted virtual reality helmet that positions two goggle-sized miniature LCD computer screens close to the subject's eyes. Position tracking devices keep the computer informed of changes in the patient's head location. An electro-magnetic head orientation device feeds the x, y, z coordinates of the patient's head to the computer, which can quickly change what the patient sees in virtual reality accordingly. The scenery in VR changes as the patient moves her head orientation (e.g., virtual objects in front of the patient in VR get closer as the patient, wearing the VR helmet, leans forward in the real world).
Other Name: SnowWorld Multigen-Paradigm Inc, SimWright Inc

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 12-100years
  • Minimum burn wound size of 2% total body surface area (TBSA) excluding head and dominant hand
  • Be able to sit upright independently in bed
  • Minimum pain rating of 4/10 on a Visual Analog Scale (only using the most painful extremity).
  • Able to consent to the study

Exclusion Criteria:

  • Known history of motion sickness
  • Seizures
  • Migraines
  • Current psychosis, dementia, or delirium
  • Current blindness and/or deafness that significantly affects their ability to experience the VR
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663013

Contacts
Contact: Roger W Yurt, MD FACS 2127465410 ryurt@med.cornell.edu
Contact: Angela Rabbitts, RN MS 2127465881 anr2002@med.cornell.edu

Locations
United States, New York
New York Presbyterian Hospital, WRH Burn Center Recruiting
New York, New York, United States, 10065
Contact: Roger W Yurt, MD FACS    212-746-5410    ryurt@med.cornell.edu   
Principal Investigator: Roger W Yurt, MD FACS         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Roger W Yurt, MD FACS Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: R. W Yurt, MD,FACS, NewYork-Presbyterian Hospital-Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00663013     History of Changes
Other Study ID Numbers: 0701008961
Study First Received: April 17, 2008
Last Updated: January 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
burn
pain
anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Burns
Mental Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on April 15, 2014