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Virtual Reality for Burn Wound Care Pain Control

Primary Purpose

Pain, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring burn, pain, anxiety

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Presbyterian Hospital, WRH Burn CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

pain perception
anticipatory anxiety
current psychiatric diagnosis, is related to pain
"pain catastrophizing" is related to higher pain perception and greater benefits from the VR

Secondary Outcome Measures

Full Information

First Posted
April 17, 2008
Last Updated
January 3, 2011
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00663013
Brief Title
Virtual Reality for Burn Wound Care Pain Control
Official Title
Virtual Reality for Burn Wound Care Pain Control
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
burn, pain, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
SnowWorld Multigen-Paradigm Inc, SimWright Inc
Intervention Description
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).
Primary Outcome Measure Information:
Title
pain perception
Time Frame
immediate
Title
anticipatory anxiety
Time Frame
immediate
Title
current psychiatric diagnosis, is related to pain
Time Frame
immediate
Title
"pain catastrophizing" is related to higher pain perception and greater benefits from the VR
Time Frame
immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roger W Yurt, MD FACS
Phone
2127465410
Email
ryurt@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Rabbitts, RN MS
Phone
2127465881
Email
anr2002@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger W Yurt, MD FACS
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital, WRH Burn Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger W Yurt, MD FACS
Phone
212-746-5410
Email
ryurt@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Roger W Yurt, MD FACS

12. IPD Sharing Statement

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Virtual Reality for Burn Wound Care Pain Control

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