Water-friendly Virtual Reality and Brief Thermal Pain

October 23, 2021 updated by: Hunter Hoffman, University of Washington
Using immersive virtual reality as a form of pain distraction during a brief "painful but tolerable" temperature.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

92

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, 98195
        • University of Washington (public not eligible for participation)

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: HUNTER HOFFMAN, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

January 30, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 23, 2021

Last Verified

October 1, 2021

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)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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