Virtual Reality Analgesia for Brief Thermal Pain

Study Overview
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Brief Summary
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Using immersive virtual reality as a form of pain distraction during a brief painful but tolerable temperature.

Detailed Description
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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.

Official Title
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Virtual Reality Analgesia for Brief Thermal Pain

Conditions
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Pain, Acute

Intervention / Treatment
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* Behavioral: virtual reality game


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)..
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Order 1<br>Treatment order 1: Low Tech (less interactive) Virtual Reality for 1st pain stimulus+ High Tech for 2nd pain stimulus | Behavioral: virtual reality game<br>* participants interact with a computer generated world<br>|
| Active Comparator: Treatment Order 2<br>Treatment order 2: High Tech VR (more interactive) for 1st pain stimulus + Low Tech for 2nd pain stimulus. | Behavioral: virtual reality game<br>* participants interact with a computer generated world<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst pain, baseline, participant's rating of worst pain during baseline measure | Baseline, Worst pain rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain | Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim) | 
| participant's rating of worst pain during test phase | Test phase, Worst pain rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain | Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline, participants rating of time spent thinking about pain | Baseline Time thinking, Single a single graphic rating scale, 0 = none of the time, 10 = all of the time | Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim) | 
| Test Phase, participants rating of time spent thinking about pain during test phase | Test phase, Time rating, using a single graphic rating scale, 0 = none of the time, 10 = all of the time | Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating) | 
| Baseline, participants rating of pain unpleasantness | Baseline, Unpleasant rating, using single graphic rating scale, 0 = not unpleasant at all, 10 = excruciatingly unpleasant | Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim) | 
| Test phase, participants rating of pain unpleasantness during test phase | Test phase, pain unpleasantness, 0 = not unpleasant at all, 10 = excruciatingly unpleasant | Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating) | 
| Baseline, participants rating of Fun during baseline | Baseline fun, 0 = no fun at all, 10 = extremely fun | Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim) | 
| Test Phase, participants ratings of Fun during test phase | Test phase fun, 0 = no fun at all, 10 = extremely fun | Immediately after each single 10 second test stimulus (< 10 minutes after baseline fun rating) | 
| Baseline pain intensity: participants ratings of pain intensity during brief pair of 10 sec stimuli | Baseline, pain intensity rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain | Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim) | 
| Accuracy on the odd number task during No VR, Low tech VR and High tech VR | participants accuracy on the attention demanding odd number task (Hoffman, 2021) | No pain during this measure, measured within 10 minutes after the QST measures are completed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain control