Human Factors Analysis in VR for Burn Treatment
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Chronic Pain |
Behavioral: Virtual Reality based distraction Behavioral: VR with flat projection display Behavioral: non-interactive video with head display Behavioral: non-interactive video with with flat projection display |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment |
- Pain rating reduction [ Time Frame: Following each trial ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Virtual Reality with head display
|
Behavioral: Virtual Reality based distraction
Participants will undergo virtual reality based distraction using the head display while they go through the pain process.
|
|
Active Comparator: 2
Virtual Reality with flat projection display
|
Behavioral: VR with flat projection display
VR with flat projection display
|
|
Active Comparator: 3
non-interactive video with head display
|
Behavioral: non-interactive video with head display
non-interactive video with head display
|
|
Active Comparator: 4
non-interactive video with flat projection display
|
Behavioral: non-interactive video with with flat projection display
non-interactive video with with flat projection display
|
|
No Intervention: 5
No distraction
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Mark D. Wiederhold, MD, PhD, MBA | (858)642-0267 | mwiederhold@vrphobia.com |
| Principal Investigator: | Mark D Wiederhold, MD, PhD, FACP | VRMC |
More Information
No publications provided
| Responsible Party: | Mark D. Wiederhold, The Virtual Reality Medical Center |
| ClinicalTrials.gov Identifier: | NCT00409552 History of Changes |
| Other Study ID Numbers: | N44DA-5-7744 |
| Study First Received: | December 8, 2006 |
| Last Updated: | September 2, 2009 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on May 23, 2013