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VR High Tech Pain Control Burn Wound Care (VRH2O)

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.
 
ClinicalTrials.gov Identifier: NCT02427659
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
David R. Patterson, National Institute of General Medical Sciences (NIGMS)

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
Pain Burn Behavioral: Virtual Reality Distraction Behavioral: Audio (sound of nature) Behavioral: Control standard nurse wound care Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 : November 2011
Actual Primary Completion Date : November 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: VRD

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.

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.




Primary Outcome Measures :
  1. "Pain" as measured by McGill Short Form Pain Questionnaire [ Time Frame: up to an hour ]
    Pain is being measured

  2. "Pain" as measured by Nurse Graphic Rating Scale [ Time Frame: up to 3 hours ]
    Pain is being measured.

  3. "Pain and anxiety" as measured by Graphic Rating Scale [ Time Frame: up to an hour ]
    Pain and anxiety is being measured



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02427659


Locations
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United States, Washington
University of Washington; Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: David R. Patterson, Ph.D. University fo Washington
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Responsible Party: David R. Patterson, Professor, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT02427659    
Other Study ID Numbers: 41673
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by David R. Patterson, National Institute of General Medical Sciences (NIGMS):
VRD
Virtual Reality as Distraction during Procedure
Burn Wound Care
Additional relevant MeSH terms:
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Burns
Wounds and Injuries