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Human Factors Analysis in VR for Burn Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409552
First Posted: December 11, 2006
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Enrollment: 10
Study Start Date: November 2009
Study Completion Date: December 2010
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409552


Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Mark D Wiederhold, MD, PhD, FACP VRMC
  More Information

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00409552     History of Changes
Other Study ID Numbers: N44DA-5-7744
First Submitted: December 8, 2006
First Posted: December 11, 2006
Last Update Posted: January 12, 2017
Last Verified: September 2009

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