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Human Factors Analysis in VR for Burn Treatment

Primary Purpose

Pain, Chronic Pain

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Virtual Reality based distraction
VR with flat projection display
non-interactive video with head display
non-interactive video with with flat projection display
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    1

    2

    3

    4

    5

    Arm Description

    Virtual Reality with head display

    Virtual Reality with flat projection display

    non-interactive video with head display

    non-interactive video with flat projection display

    No distraction

    Outcomes

    Primary Outcome Measures

    Pain rating reduction

    Secondary Outcome Measures

    Full Information

    First Posted
    December 8, 2006
    Last Updated
    January 11, 2017
    Sponsor
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00409552
    Brief Title
    Human Factors Analysis in VR for Burn Treatment
    Official Title
    Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Chronic Pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Virtual Reality with head display
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Virtual Reality with flat projection display
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    non-interactive video with head display
    Arm Title
    4
    Arm Type
    Active Comparator
    Arm Description
    non-interactive video with flat projection display
    Arm Title
    5
    Arm Type
    No Intervention
    Arm Description
    No distraction
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual Reality based distraction
    Intervention Description
    Participants will undergo virtual reality based distraction using the head display while they go through the pain process.
    Intervention Type
    Behavioral
    Intervention Name(s)
    VR with flat projection display
    Intervention Description
    VR with flat projection display
    Intervention Type
    Behavioral
    Intervention Name(s)
    non-interactive video with head display
    Intervention Description
    non-interactive video with head display
    Intervention Type
    Behavioral
    Intervention Name(s)
    non-interactive video with with flat projection display
    Intervention Description
    non-interactive video with with flat projection display
    Primary Outcome Measure Information:
    Title
    Pain rating reduction
    Time Frame
    Following each trial

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark D Wiederhold, MD, PhD, FACP
    Organizational Affiliation
    VRMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Human Factors Analysis in VR for Burn Treatment

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