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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00409552 |
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 I Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment |
Estimated Enrollment: | 500 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Virtual Reality with head display
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Behavioral: Virtual Reality based distraction
Participants will undergo virtual reality based distraction using the head display while they go through the pain process.
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2: Active Comparator
Virtual Reality with flat projection display
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Behavioral: VR with flat projection display
VR with flat projection display
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3: Active Comparator
non-interactive video with head display
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Behavioral: non-interactive video with head display
non-interactive video with head display
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4: Active Comparator
non-interactive video with flat projection display
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Behavioral: non-interactive video with with flat projection display
non-interactive video with with flat projection display
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5: No Intervention
No distraction
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark D. Wiederhold, MD, PhD, MBA | (858)642-0267 | mwiederhold@vrphobia.com |
Principal Investigator: | Mark D Wiederhold, MD, PhD, FACP | VRMC |
Responsible Party: | The Virtual Reality Medical Center ( Mark D. Wiederhold ) |
Study ID Numbers: | N44DA-5-7744 |
Study First Received: | December 8, 2006 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00409552 History of Changes |
Health Authority: | United States: Federal Government |
Burns Pain |