- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04245475
Water-friendly Virtual Reality and Brief Thermal Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will use Quantitative Sensory Testing (computer-controlled brief 10 second thermal pain stimuli) in healthy college students.
The primary aim is to conduct a randomized, controlled study with healthy volunteers to explore whether interacting with virtual objects in VR via a high tech interactive VR system makes VR significantly more effective/powerful compared to a less immersive passive VR system, vs. No VR, for reducing pain during quantitative sensory testing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington (public not eligible for participation)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Currently enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
- Able to read, write and comprehend English
- Able to complete study measures
- Willing to follow our UW approved instructions
- 18 years of age or older
Exclusion Criteria:
- People how have already previously participated in this same study (e.g., last quarter) are not eligible to participate again.
- Not enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
- Not be able to read, write and comprehend English
- Younger than 18 years of age.
- Not capable of completing measures
- Not capable of indicating pain intensity,
- Not capable of filling out study measures,
- Extreme susceptibility to motion sickness,
- Seizure history,
- Unusual sensitivity or lack of sensitivity to pain,
- Sensitive skin,
- sensitive feet,
- migraines,
- Diabetes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
No treatment, side study to test the assumptions of our quantitative sensory testing pain paradigm
|
|
|
Active Comparator: Low Tech/passive Virtual Reality first
Low Tech VR first brief test phase thermal stimulus + High Tech VR during a second test phase pain stimulus
|
attention distraction
|
|
Experimental: High Tech/interactive Virtual Reality first
High Tech/Interactive VR during first brief test phase thermal stimulus + Low Tech VR during a second brief thermal stimulus.
|
attention distraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
participants rating of "worst pain "
Time Frame: immediately after each single 10 second test phase quantitative sensory test stimulus during a single visit
|
using a single graphic rating scale, 0 = no pain, 10 = excruciating pain
|
immediately after each single 10 second test phase quantitative sensory test stimulus during a single visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
participants rating of "time spent thinking about pain"
Time Frame: immediately after each single 10 second quantitative sensory test stimulus during a single visit
|
using a single graphic rating scale, 0 = none of the time, 10 = all of the time
|
immediately after each single 10 second quantitative sensory test stimulus during a single visit
|
|
participants rating of "pain unpleasantness "
Time Frame: immediately after each single 10 second quantitative sensory test stimulus during a single visit
|
using a single graphic rating scale, 0 = no pain, 10 = excruciating pain
|
immediately after each single 10 second quantitative sensory test stimulus during a single visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
participants rating of "fun"
Time Frame: immediately after each single 10 second quantitative sensory test stimulus during a single visit
|
using a single graphic rating scale, 0 = no fun, 10 = extremely fun.
|
immediately after each single 10 second quantitative sensory test stimulus during a single visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: HUNTER HOFFMAN, PhD, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00007801
- R01GM042725 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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