Back to resultsVR High Tech Pain Control Burn Wound Care (VRH2O)
Primary Purpose
Pain, Burn
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Distraction
Audio (sound of nature)
Control standard nurse wound care
Sponsored by
About this trial
This is an interventional other trial for Pain focused on measuring VRD, Virtual Reality as Distraction during Procedure, Burn Wound Care
Eligibility 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
Sites / Locations
- University of Washington; Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Virtual Reality Distraction
Audio (sounds of nature)
control standard nurse wound care
Arm Description
The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
The subjects will listen to an audio recording called "Sounds of Nature" during their wound care. The nurse will be doing the wound care.
The subjects will receive their standard care during wound care. The nurse will be doing the wound care.
Outcomes
Primary Outcome Measures
"Pain" as measured by McGill Short Form Pain Questionnaire
Pain is being measured
"Pain" as measured by Nurse Graphic Rating Scale
Pain is being measured.
"Pain and anxiety" as measured by Graphic Rating Scale
Pain and anxiety is being measured
Secondary Outcome Measures
Full Information
NCT ID
NCT02427659
First Posted
March 31, 2015
Last Updated
March 11, 2019
Sponsor
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT02427659
Brief Title
VR High Tech Pain Control Burn Wound Care
Acronym
VRH2O
Official Title
High Technology Pain Control During Burn Wound Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Burn
Keywords
VRD, Virtual Reality as Distraction during Procedure, Burn Wound Care
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Distraction
Arm Type
Other
Arm Description
The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
Arm Title
Audio (sounds of nature)
Arm Type
Other
Arm Description
The subjects will listen to an audio recording called "Sounds of Nature" during their wound care. The nurse will be doing the wound care.
Arm Title
control standard nurse wound care
Arm Type
Other
Arm Description
The subjects will receive their standard care during wound care. The nurse will be doing the wound care.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Distraction
Other Intervention Name(s)
VRD
Intervention Description
The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
Intervention Type
Behavioral
Intervention Name(s)
Audio (sound of nature)
Intervention Description
The subjects will listen to an audio recording called "Sounds of Nature" during their wound care.
Intervention Type
Behavioral
Intervention Name(s)
Control standard nurse wound care
Intervention Description
The subjects will receive their standard care during wound care. The nurse will be doing the wound care.
Primary Outcome Measure Information:
Title
"Pain" as measured by McGill Short Form Pain Questionnaire
Description
Pain is being measured
Time Frame
up to an hour
Title
"Pain" as measured by Nurse Graphic Rating Scale
Description
Pain is being measured.
Time Frame
up to 3 hours
Title
"Pain and anxiety" as measured by Graphic Rating Scale
Description
Pain and anxiety is being measured
Time Frame
up to an hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Patterson, Ph.D.
Organizational Affiliation
University fo Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington; Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
VR High Tech Pain Control Burn Wound Care
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