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Virtual Reality Hypnosis for Chronic Pain Reduction (VRHChP)

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Hypnosis for chronic pain
Virtual Reality Distraction for Chronic Pain
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 13 - 75 years
  • Able to complete subjective evaluations of pain
  • English-speaking
  • Able to communicate orally

Exclusion Criteria:

  • Age less than 13 years or greater than 75 years
  • Incapable of indicating subjective evaluation of pain
  • Non-English-speaking (Virtual Reality Hypnosis only available in English)
  • Demonstrating delirium, psychosis, or Organic Brain Disorder
  • Unable to communicate verbally
  • Significant developmental disability
  • Extreme susceptibility to motion sickness
  • Significant head/or neck injury
  • Pregnant women

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Virtual Reality Hypnosis

Virtual Reality Distraction

Arm Description

Virtual Reality Hypnosis for chronic pain

Virtual Reality Distraction for Chronic Pain

Outcomes

Primary Outcome Measures

Pain and anxiety
The subjects will answer questions regarding pain and anxiety at the time of their clinic visit, before and after experiencing virtual reality. Then the subject will be followed for up to one month.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2010
Last Updated
May 10, 2017
Sponsor
University of Washington
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT01099657
Brief Title
Virtual Reality Hypnosis for Chronic Pain Reduction
Acronym
VRHChP
Official Title
Virtual Reality Hypnosis for Chronic Pain Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We would like to determine how well hypnosis works when induced through virtual reality medium for patients who have suffered a major burn injury in the past two years and suffer from chronic pain. These patients are coming back to the outpatient burn and plastic clinic at Harborview Medical Center for routine follow-up. We think that patients will find VR-Hypnosis interesting, and it will help them relax and feel less pain.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Hypnosis
Arm Type
Experimental
Arm Description
Virtual Reality Hypnosis for chronic pain
Arm Title
Virtual Reality Distraction
Arm Type
Experimental
Arm Description
Virtual Reality Distraction for Chronic Pain
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Hypnosis for chronic pain
Intervention Description
At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Hypnosis. After VRH, the will again answer Pain and anxiety questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Distraction for Chronic Pain
Intervention Description
At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Distraction. After VRD, the will again answer Pain and anxiety questionnaires.
Primary Outcome Measure Information:
Title
Pain and anxiety
Description
The subjects will answer questions regarding pain and anxiety at the time of their clinic visit, before and after experiencing virtual reality. Then the subject will be followed for up to one month.
Time Frame
pre and post VR and then up to one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 13 - 75 years Able to complete subjective evaluations of pain English-speaking Able to communicate orally Exclusion Criteria: Age less than 13 years or greater than 75 years Incapable of indicating subjective evaluation of pain Non-English-speaking (Virtual Reality Hypnosis only available in English) Demonstrating delirium, psychosis, or Organic Brain Disorder Unable to communicate verbally Significant developmental disability Extreme susceptibility to motion sickness Significant head/or neck injury Pregnant women
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
Undecided

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Virtual Reality Hypnosis for Chronic Pain Reduction

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