Human Factors Analysis in VR for Burn Treatment
Primary Purpose
Pain, Chronic Pain
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Virtual Reality based distraction
VR with flat projection display
non-interactive video with head display
non-interactive video with with flat projection display
Sponsored by
About this trial
This is an interventional supportive care trial for Pain
Eligibility Criteria
Inclusion Criteria:
- Age 18-65, male or female, any ethnicity as long as candidates can understand and read English adequately.
Exclusion Criteria:
- We will exclude participants who meet DSM-IV-TR criteria for alcohol or other substance abuse in the past year, or are currently using any recreational drugs, or taking more than 20 alcoholic drinks a week. In addition, the Beck Depression Inventory II (BDI-II) score must be less than 16, with no suicidal ideation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
1
2
3
4
5
Arm Description
Virtual Reality with head display
Virtual Reality with flat projection display
non-interactive video with head display
non-interactive video with flat projection display
No distraction
Outcomes
Primary Outcome Measures
Pain rating reduction
Secondary Outcome Measures
Full Information
NCT ID
NCT00409552
First Posted
December 8, 2006
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00409552
Brief Title
Human Factors Analysis in VR for Burn Treatment
Official Title
Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
A number of studies have shown that virtual reality (VR) can be used to distract patients from pain and anxiety during painful medical procedures for which medication provides inadequate relief. An inexpensive, commercially available VE could have significant impact in reducing perceived pain involved in a variety of medical procedures. The Virtual Reality Medical Center (VRMC) developed an engaging virtual world that proved to be effective in reducing reported pain ratings of participants experiencing several different forms of painful stimuli. The virtual world called Icy Cool World was found to successfully distract patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks to expand on these findings and examine the effectiveness as a pain distraction technique for a variety of acute and chronic pain etiologies. The main objective of the clinical investigation will be to expand on the findings from earlier studies and obtain a more comprehensive analysis regarding the clinical versatility of VR pain distraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Virtual Reality with head display
Arm Title
2
Arm Type
Active Comparator
Arm Description
Virtual Reality with flat projection display
Arm Title
3
Arm Type
Active Comparator
Arm Description
non-interactive video with head display
Arm Title
4
Arm Type
Active Comparator
Arm Description
non-interactive video with flat projection display
Arm Title
5
Arm Type
No Intervention
Arm Description
No distraction
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality based distraction
Intervention Description
Participants will undergo virtual reality based distraction using the head display while they go through the pain process.
Intervention Type
Behavioral
Intervention Name(s)
VR with flat projection display
Intervention Description
VR with flat projection display
Intervention Type
Behavioral
Intervention Name(s)
non-interactive video with head display
Intervention Description
non-interactive video with head display
Intervention Type
Behavioral
Intervention Name(s)
non-interactive video with with flat projection display
Intervention Description
non-interactive video with with flat projection display
Primary Outcome Measure Information:
Title
Pain rating reduction
Time Frame
Following each trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65, male or female, any ethnicity as long as candidates can understand and read English adequately.
Exclusion Criteria:
We will exclude participants who meet DSM-IV-TR criteria for alcohol or other substance abuse in the past year, or are currently using any recreational drugs, or taking more than 20 alcoholic drinks a week. In addition, the Beck Depression Inventory II (BDI-II) score must be less than 16, with no suicidal ideation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Wiederhold, MD, PhD, FACP
Organizational Affiliation
VRMC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Human Factors Analysis in VR for Burn Treatment
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