Virtual Reality Analgesia for Brief Thermal Pain

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT05130307
Collaborator
(none)
48
1
2
1.3
37.5

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 game
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 highly immersive VR system makes VR significantly more effective/powerful compared to a less immersive VR system, vs. No VR, for reducing pain during quantitative sensory testing.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A Mixed Model repeated measures ANOVA or non-parametric tests if appropriate will be conducted on worst pain ratings. Within subjects crossover design, VR treatment order randomized (some participants receive order 1 Low Tech VR + High Tech VR = Arm 1, some participants receive order 2 High Tech VR + Low Tech VR) = Arm 2. . Treatment order 1: Low Tech/less interactive Virtual Reality for 1st brief pain stimulus+ washout period + High Tech for 2nd brief pain stimulus. Treatment order 2: High Tech/more interactive VR for 1st brief pain stimulus + washout period + Low Tech for 2nd brief pain stimulus (Arm 2)..A Mixed Model repeated measures ANOVA or non-parametric tests if appropriate will be conducted on worst pain ratings. Within subjects crossover design, VR treatment order randomized (some participants receive order 1 Low Tech VR + High Tech VR = Arm 1, some participants receive order 2 High Tech VR + Low Tech VR) = Arm 2. . Treatment order 1: Low Tech/less interactive Virtual Reality for 1st brief pain stimulus+ washout period + High Tech for 2nd brief pain stimulus. Treatment order 2: High Tech/more interactive VR for 1st brief pain stimulus + washout period + Low Tech for 2nd brief pain stimulus (Arm 2)..
Masking:
Single (Participant)
Masking Description:
Although no deception is involved, participants who receive VR will remain unaware of the immersiveness of the VR systems they are receiving.
Primary Purpose:
Basic Science
Official Title:
Virtual Reality Analgesia for Brief Thermal Pain
Actual Study Start Date :
Apr 25, 2022
Actual Primary Completion Date :
Jun 3, 2022
Actual Study Completion Date :
Jun 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Order 1

Treatment order 1: Low Tech (less interactive) Virtual Reality for 1st pain stimulus+ High Tech for 2nd pain stimulus

Behavioral: virtual reality game
participants interact with a computer generated world

Active Comparator: Treatment Order 2

Treatment order 2: High Tech VR (more interactive) for 1st pain stimulus + Low Tech for 2nd pain stimulus.

Behavioral: virtual reality game
participants interact with a computer generated world

Outcome Measures

Primary Outcome Measures

  1. Worst pain, baseline, participant's rating of "worst pain" during baseline measure [Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)]

    Baseline, Worst pain rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain

  2. participant's rating of "worst pain" during test phase [Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)]

    Test phase, Worst pain rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain

Secondary Outcome Measures

  1. Baseline, participants rating of "time spent thinking about pain" [Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)]

    Baseline Time thinking, Single a single graphic rating scale, 0 = none of the time, 10 = all of the time

  2. Test Phase, participants rating of "time spent thinking about pain" during test phase [Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)]

    Test phase, Time rating, using a single graphic rating scale, 0 = none of the time, 10 = all of the time

  3. Baseline, participants rating of "pain unpleasantness" [Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)]

    Baseline, Unpleasant rating, using single graphic rating scale, 0 = not unpleasant at all, 10 = excruciatingly unpleasant

  4. Test phase, participants rating of "pain unpleasantness" during test phase [Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)]

    Test phase, pain unpleasantness, 0 = not unpleasant at all, 10 = excruciatingly unpleasant

  5. Baseline, participants rating of "Fun" during baseline [Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)]

    Baseline fun, 0 = no fun at all, 10 = extremely fun

  6. Test Phase, participants ratings of "Fun" during test phase [Immediately after each single 10 second test stimulus (< 10 minutes after baseline fun rating)]

    Test phase fun, 0 = no fun at all, 10 = extremely fun

  7. Baseline pain intensity: participants ratings of pain intensity during brief pair of 10 sec stimuli [Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)]

    Baseline, pain intensity rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain

  8. Accuracy on the odd number task during No VR, Low tech VR and High tech VR [No pain during this measure, measured within 10 minutes after the QST measures are completed.]

    participants accuracy on the attention demanding "odd number" task (Hoffman, 2021)

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

  • 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 The following temporary inclusion/exclusion criterion will exist only as long as required or appropriate for COVID pandemic conditions.

COVID-19 precautions. Vaccinated: Individuals are considered fully vaccinated 2 weeks after the second dose in a 2-dose series (e.g., Pfizer or Moderna) or 2 weeks after a single-dose vaccine (e.g., Johnson & Johnson).

All students and researchers must wear masks at all times during the study, and participants and researchers must provide proof of full vaccination for full participation.

If participants do not have proof of vaccination or are unvaccinated, they are still free to sign up for the study. They are invited. They can still earn the extra credit by reading educational materials, in person, during their scheduled time slot. If unvaccinated, or if they have no proof of vaccination, we request that students provide proof of a negative COVID-19 test from the UW test site at the faculty lounge, dated within 24 hours of the study (non-vaccinated students need a recent negative COVID-19 test from the UW before participating in the non-VR educational materials option.

-

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

The following temporary inclusion/exclusion criterion will exist only as long as required or appropriate for COVID pandemic conditions.

COVID-19 precautions. Vaccinated: Individuals are considered fully vaccinated 2 weeks after the second dose in a 2-dose series (e.g., Pfizer or Moderna) or 2 weeks after a single-dose vaccine (e.g., Johnson & Johnson).

All students and researchers must wear masks at all times during the study, and participants and researchers must provide proof of full vaccination for full participation.

If participants do not have proof of vaccination or are unvaccinated, they are still free to sign up for the study. They are invited. They can still earn the extra credit by reading educational materials, in person, during their scheduled time slot. If unvaccinated, or if they have no proof of vaccination, we request that students provide proof of a negative COVID-19 test from the UW test site at the faculty lounge, dated within 24 hours of the study.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • University of Washington

Investigators

  • Principal Investigator: Hunter Hoffman, M.S., Ph.D., University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hunter Hoffman, Affiliate Assistant Professor, Psychology, University of Washington
ClinicalTrials.gov Identifier:
NCT05130307
Other Study ID Numbers:
  • STUDY00013916
First Posted:
Nov 23, 2021
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hunter Hoffman, Affiliate Assistant Professor, Psychology, University of Washington
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022