Human Factors Analysis in VR for Burn Treatment
Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment
1 other identifier
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 pain
Started Nov 2009
Typical duration for phase_1 pain
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
First Submitted
Initial submission to the registry
December 8, 2006
CompletedFirst Posted
Study publicly available on registry
December 11, 2006
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 12, 2017
September 1, 2009
1.1 years
December 8, 2006
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain rating reduction
Following each trial
Study Arms (5)
1
EXPERIMENTALVirtual Reality with head display
2
ACTIVE COMPARATORVirtual Reality with flat projection display
3
ACTIVE COMPARATORnon-interactive video with head display
4
ACTIVE COMPARATORnon-interactive video with flat projection display
5
NO INTERVENTIONNo distraction
Interventions
Participants will undergo virtual reality based distraction using the head display while they go through the pain process.
non-interactive video with with flat projection display
Eligibility Criteria
You may qualify if:
- Age 18-65, male or female, any ethnicity as long as candidates can understand and read English adequately.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D Wiederhold, MD, PhD, FACP
VRMC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2006
First Posted
December 11, 2006
Study Start
November 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 12, 2017
Record last verified: 2009-09