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OpenTrials
Completed

NCT Number: NCT05130307

Virtual Reality Analgesia for Brief Thermal Pain

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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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.

Treatment and study plan

Virtual Reality Game

Behavioral

participants interact with a computer generated world

Primary outcomes

  1. 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)

    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

    Time frame: 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 outcomes

  1. Baseline, participants rating of "time spent thinking about pain"

    Time frame: 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

    Time frame: 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"

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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