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Virtual Reality Analgesia for Brief Thermal Pain

Virtual Reality Analgesia for Brief Thermal Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05130307
Enrollment
48
Registered
2021-11-23
Start date
2022-04-25
Completion date
2022-06-03
Last updated
2022-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute

Keywords

Pain control

Brief summary

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

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.

Interventions

participants interact with a computer generated world

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Although no deception is involved, participants who receive VR will remain unaware of the immersiveness of the VR systems they are receiving.

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)..

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Worst pain, baseline, participant's rating of worst pain during baseline measureImmediately 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
participant's rating of worst pain during test phaseImmediately 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

MeasureTime frameDescription
Baseline, participants rating of pain unpleasantnessImmediately 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
Test phase, participants rating of pain unpleasantness during test phaseImmediately 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
Baseline, participants rating of Fun during baselineImmediately 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
Baseline, participants rating of time spent thinking about painImmediately 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
Baseline pain intensity: participants ratings of pain intensity during brief pair of 10 sec stimuliImmediately 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
Accuracy on the odd number task during No VR, Low tech VR and High tech VRNo 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)
Test Phase, participants ratings of Fun during test phaseImmediately after each single 10 second test stimulus (< 10 minutes after baseline fun rating)Test phase fun, 0 = no fun at all, 10 = extremely fun
Test Phase, participants rating of time spent thinking about pain during test phaseImmediately 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026