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
Recruitment status was Recruiting
Sponsor:
Weill Medical College of Cornell University
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
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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 Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013