Virtual Reality for Burn Wound Care Pain Control
1 other identifier
interventional
12
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Oct 2007
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJanuary 4, 2011
January 1, 2011
2.6 years
April 17, 2008
January 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
pain perception
immediate
anticipatory anxiety
immediate
current psychiatric diagnosis, is related to pain
immediate
"pain catastrophizing" is related to higher pain perception and greater benefits from the VR
immediate
Study Arms (2)
1
ACTIVE COMPARATORThe 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.
2
ACTIVE COMPARATORThe 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Presbyterian Hospital, WRH Burn Center
New York, New York, 10065, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roger W Yurt, MD FACS
Weill Medical College of Cornell University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 17, 2008
First Posted
April 21, 2008
Study Start
October 1, 2007
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
January 4, 2011
Record last verified: 2011-01