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H2O VR for Burns 2015 (H2OWC)

Primary Purpose

Pain, Burn

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Snowworld
Virtual Reality slides of nature
Control standard nurse wound care
Sponsored by
National Institute of General Medical Sciences (NIGMS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring VRD

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Virtual Reality Snowworld

Virtual Reality slides of nature

Control standard nurse wound care

Arm Description

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

The subjects will see several slides of the nature through virtual reality goggles 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 and anxiety" as measured by Graphic Rating Scale
Pain and anxiety is being measured

Secondary Outcome Measures

Full Information

First Posted
March 31, 2016
Last Updated
June 4, 2020
Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT02729259
Brief Title
H2O VR for Burns 2015
Acronym
H2OWC
Official Title
Water Friendly Virtual Reality for Burns
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborators
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to find additional methods to reduce pain during wound care. In this study the investigators use virtual reality (a form of distraction) in addition to pain medication during a burn wound care.
Detailed Description
This study will employ a randomized within-subjects design. There are three different conditions in this study. By randomization, the participants will experience at least two of the conditions and likely all three, depending on the number of their wound care sessions. All subjects will always receive all their usual pain medications for all treatment conditions. The three conditions are: High Tech Virtual Reality (VRD), Low Tech Virtual Reality (Nature Slides), and standard wound care (no VR). The subjects will be randomly assigned to receive some portions of their wound care sessions during High Tech Virtual Reality (VRD), some portions during Low Tech Virtual Reality (Nature Slides), and some portions with standard wound care, no virtual reality. The treatment orders will be randomized. After each treatment condition the investigators will ask subjects one pain question about their pain intensity during the most recent treatment condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Burn
Keywords
VRD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Snowworld
Arm Type
Other
Arm Description
The subjects will receive Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
Arm Title
Virtual Reality slides of nature
Arm Type
Other
Arm Description
The subjects will see several slides of the nature through virtual reality goggles 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 Snowworld
Intervention Description
The subjects will receive Virtual Reality Snowworld during their wound care procedure. The nurse will be doing their wound care.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality slides of nature
Intervention Description
The subjects will receive Virtual Reality Slides of Nature during their wound care procedure. The nurse will be doing 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 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
8 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 of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

H2O VR for Burns 2015

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