- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01099657
Virtual Reality Hypnosis for Chronic Pain Reduction (VRHChP)
May 10, 2017 updated by: Shelley A. Wiechman, University of Washington
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Harborview Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Hypnosis
Virtual Reality Hypnosis for chronic pain
|
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.
|
|
Experimental: Virtual Reality Distraction
Virtual Reality Distraction for Chronic Pain
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain and anxiety
Time Frame: pre and post VR and then up to one month
|
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.
|
pre and post VR and then up to one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
April 1, 2010
First Submitted That Met QC Criteria
April 6, 2010
First Posted (Estimate)
April 7, 2010
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 10, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31498
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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