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VRH2O: VR High Tech Pain Control Burn Wound Care

Sponsor
National Institute of General Medical Sciences (NIGMS) (NIH)
Overall Status
Completed
CT.gov ID
NCT02427659
Collaborator
(none)
8
Enrollment
1
Location
3
Arms
69
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Using virtual reality as a form of distraction for pain during wound care. Virtual reality involves looking into a set of goggles and then moving through a computer-simulated world.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Reality Distraction
  • Behavioral: Audio (sound of nature)
  • Behavioral: Control standard nurse wound care
 N/A

Detailed Description

This study has three different groups. Patients will be randomly assigned to one of three groups (two treatments and one control). Treatment for Group 1 is Virtual Reality Distraction during wound care. Group 2 will listen to an audio recording called "Sounds of Nature". Group 3 will be the control group.

Subjects in all three groups will receive the following questionnaires:

Graphic Rating Scale McGill Short-Form pain questionnaire Sullivan Catastrophization scale (only on Day 1/Baseline) The Nurse GRS

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Other
Official Title:
High Technology Pain Control During Burn Wound Care
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Virtual Reality Distraction

The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.

Behavioral: Virtual Reality Distraction
The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
Other Names:
  • VRD

    		•
    Other: Audio (sounds of nature)

    The subjects will listen to an audio recording called "Sounds of Nature" during their wound care. The nurse will be doing the wound care.

    Behavioral: Audio (sound of nature)
    The subjects will listen to an audio recording called "Sounds of Nature" during their wound care.
    Other: control standard nurse wound care

    The subjects will receive their standard care during wound care. The nurse will be doing the wound care.

    Behavioral: Control standard nurse wound care
    The subjects will receive their standard care during wound care. The nurse will be doing the wound care.

    Outcome Measures

    Primary Outcome Measures

    1. "Pain" as measured by McGill Short Form Pain Questionnaire [up to an hour]

      Pain is being measured

    2. "Pain" as measured by Nurse Graphic Rating Scale [up to 3 hours]

      Pain is being measured.

    3. "Pain and anxiety" as measured by Graphic Rating Scale [up to an hour]

      Pain and anxiety is being measured

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age greater than or equal to 18 years

    • Compliant and able to complete questionnaires

    • No history of psychiatric disorder

    • Not demonstrating delirium, psychosis or any form of Organic Brain Disorder

    • Able to communicate verbally

    • English-speaking

    Exclusion Criteria:

    • Age less than 18 years

    • Not capable of indicating pain intensity

    • Not capable of filling out study measures

    • Evidence of traumatic brain injury

    • History of psychiatric disorder

    • Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems

    • Unable to communicate orally

    • Receiving prophylaxis for alcohol or drug withdrawal

    • Developmental disability

    • Any face/head/neck injuries that interfere with the use of Virtual Reality equipment

    • Non-English Speaking

    • Extreme susceptibility to motion sickness

    • Seizure history

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Washington; Harborview Medical Center Seattle Washington United States 98104

    Sponsors and Collaborators

    • National Institute of General Medical Sciences (NIGMS)

    Investigators

    • Principal Investigator: David R. Patterson, Ph.D., University fo Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David R. Patterson, Professor, National Institute of General Medical Sciences (NIGMS)
    ClinicalTrials.gov Identifier:
    NCT02427659
    Other Study ID Numbers:
    • 41673
    First Posted:
    Apr 28, 2015
    Last Update Posted:
    Mar 13, 2019
    Last Verified:
    Mar 1, 2019
    Keywords provided by David R. Patterson, Professor, National Institute of General Medical Sciences (NIGMS)
    VRD
    Virtual Reality as Distraction during Procedure
    Burn Wound Care
    Additional relevant MeSH terms:
    Burns

    Study Results

    No Results Posted as of Mar 13, 2019