AzTrials
AzTrials

Pain, AcuteNCT05130307

Virtual Reality Analgesia for Brief Thermal Pain

A study testing virtual reality game in people with Pain, Acute, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Using immersive virtual reality as a form of pain distraction during a brief "painful but tolerable" temperature. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pain, Acute
What is being tested?
virtual reality game
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
25 Apr 2022to 3 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.
  • -

Who cannot join

  • 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,
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington (only Psych students eligible, public not eligible for participation)

    Seattle, Washington, 98195

Other trials in United States

About this study

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

Read the 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.

Conditions
Pain, Acute
Being tested
virtual reality game
Keywords
Pain control
Medical subject headings
Acute Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual reality gameBehavioural

    participants interact with a computer generated world

Study groups in NCT05130307
Study groupRoleWhat they receive
Treatment Order 1ExperimentalTreatment order 1: Low Tech (less interactive) Virtual Reality for 1st pain stimulus+ High Tech for 2nd pain stimulus
Receives: Behavioral: virtual reality game
Treatment Order 2Active comparatorTreatment order 2: High Tech VR (more interactive) for 1st pain stimulus + Low Tech for 2nd pain stimulus.
Receives: Behavioral: virtual reality game

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)

  2. 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

    Measured: Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)

Secondary outcomes (8)

  1. 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

    Measured: Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)

  2. 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

    Measured: Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)

  3. Baseline, participants rating of "pain unpleasantness"

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

    Measured: Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)

  4. Test phase, participants rating of "pain unpleasantness" during test phase

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

    Measured: Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)

  5. Baseline, participants rating of "Fun" during baseline

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

    Measured: Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)

  6. Test Phase, participants ratings of "Fun" during test phase

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

    Measured: Immediately after each single 10 second test stimulus (< 10 minutes after baseline fun rating)

  7. 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

    Measured: Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)

  8. 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)

    Measured: No pain during this measure, measured within 10 minutes after the QST measures are completed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start25 Apr 2022
  3. Primary completion3 Jun 2022
  4. Study completion3 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05130307
Sponsor's protocol ID
STUDY00013916
Status last verified
Aug 2022
First submitted
1 Nov 2021
Last updated
24 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Aggregated data will be provided upon request on a case by case basis (e.g., for meta-analyses).

Publications

  • Al-Ghamdi NA, Meyer WJ 3rd, Atzori B, Alhalabi W, Seibel CC, Ullman D, Hoffman HG. Virtual Reality Analgesia With Interactive Eye Tracking During Brief Thermal Pain Stimuli: A Randomized Controlled Trial (Crossover Design). Front Hum Neurosci. 2020 Jan 23;13:467. doi: 10.3389/fnhum.2019.00467. eCollection 2019.

    PubMed 32038200

  • Hoffman HG. Interacting with virtual objects via embodied avatar hands reduces pain intensity and diverts attention. Sci Rep. 2021 May 21;11(1):10672. doi: 10.1038/s41598-021-89526-4.

    PubMed 34021173

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality game in people with Pain, Acute, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Worst pain, baseline, participant's rating of "worst pain" during baseline measure (time frame: Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05130307, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in