Human Factors Analysis in VR for Burn Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00409552
First received: December 8, 2006
Last updated: September 2, 2009
Last verified: September 2009
  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

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409552

Contacts
Contact: Mark D. Wiederhold, MD, PhD, MBA (858)642-0267 mwiederhold@vrphobia.com

Sponsors and Collaborators
Investigators
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

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014