Water-friendly Virtual Reality and Brief Thermal Pain

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT04245475
Collaborator
National Institute of General Medical Sciences (NIGMS) (NIH)
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Study Details

Study Description

Brief Summary

Using immersive virtual reality as a form of pain distraction during a brief "painful but tolerable" temperature.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Reality psychological pain reduction
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Within subjects crossover design, VR treatment order randomized (some participants receive Low Tech VR + High Tech VR, some participants receive High Tech VR + Low Tech VR) and some participants receive No VR in a side study to test the assumptions of our QST testing pain paradigm. No Virtual Reality (no treatment control side data to test QST paradigm assumptions). Low Tech/passive Virtual Reality for 1st pain stimulus+High Tech for 2nd pain stimulus High Tech/interactive VR for 1st pain stimulus +Low Tech for 2nd pain stimulus.Within subjects crossover design, VR treatment order randomized (some participants receive Low Tech VR + High Tech VR, some participants receive High Tech VR + Low Tech VR) and some participants receive No VR in a side study to test the assumptions of our QST testing pain paradigm. No Virtual Reality (no treatment control side data to test QST paradigm assumptions). Low Tech/passive Virtual Reality for 1st pain stimulus+High Tech for 2nd pain stimulus High Tech/interactive VR for 1st pain stimulus +Low Tech for 2nd pain stimulus.
Masking:
Single (Outcomes Assessor)
Masking Description:
Some of the instructions for the outcome measure will be presented to the participants via a computer.
Primary Purpose:
Basic Science
Official Title:
Water-friendly Virtual Reality and Brief Thermal Pain
Actual Study Start Date :
Jan 30, 2020
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

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

Behavioral: Virtual Reality psychological pain reduction
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.

Behavioral: Virtual Reality psychological pain reduction
attention distraction

Outcome Measures

Primary Outcome Measures

  1. participants rating of "worst pain " [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

Secondary Outcome Measures

  1. participants rating of "time spent thinking about pain" [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

  2. participants rating of "pain unpleasantness " [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

Other Outcome Measures

  1. participants rating of "fun" [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington (public not eligible for participation) Seattle Washington United States 98195

Sponsors and Collaborators

  • University of Washington
  • National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Hunter Hoffman, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hunter Hoffman, Research Scientist: Radiology, Psychology, Engineering, University of Washington
ClinicalTrials.gov Identifier:
NCT04245475
Other Study ID Numbers:
  • STUDY00007801
  • R01GM042725
First Posted:
Jan 29, 2020
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hunter Hoffman, Research Scientist: Radiology, Psychology, Engineering, University of Washington
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2021