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Virtual Reality Analgesia for Brief Thermal Pain

Primary Purpose

Pain, Acute

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

virtual reality game

About this trial

This is an interventional basic science trial for Pain, Acute focused on measuring Pain control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Order 1

Treatment Order 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Baseline, participants rating of "pain unpleasantness"

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 phase

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

Baseline, participants rating of "Fun" during baseline

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

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

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

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

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)

Full Information

NCT ID

NCT05130307

First Posted

November 1, 2021

Last Updated

August 19, 2022

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT05130307

Brief Title

Virtual Reality Analgesia for Brief Thermal Pain

Official Title

Virtual Reality Analgesia for Brief Thermal Pain

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

April 25, 2022 (Actual)

Primary Completion Date

June 3, 2022 (Actual)

Study Completion Date

June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Acute

Keywords

Pain control

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

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.

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Order 1

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment Order 2

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

virtual reality game

Intervention Description

participants interact with a computer generated world

Primary Outcome Measure Information:

Title

Worst pain, baseline, participant's rating of "worst pain" during baseline measure

Description

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

Time Frame

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

Title

participant's rating of "worst pain" during test phase

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

Test Phase, participants rating of "time spent thinking about pain" during test phase

Description

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

Time Frame

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

Title

Baseline, participants rating of "pain unpleasantness"

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

Baseline, participants rating of "Fun" during baseline

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

Baseline pain intensity: participants ratings of pain intensity during brief pair of 10 sec stimuli

Description

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

Time Frame

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

Title

Accuracy on the odd number task during No VR, Low tech VR and High tech VR

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hunter Hoffman, M.S., Ph.D.

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Aggregated data will be provided upon request on a case by case basis (e.g., for meta-analyses).

IPD Sharing Time Frame

any time after publication

IPD Sharing Access Criteria

meta-analysis

Citations:

PubMed Identifier

32038200

Citation

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.

Results Reference

background

PubMed Identifier

34021173

Citation

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.

Results Reference

background

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Virtual Reality Analgesia for Brief Thermal Pain

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