Virtual Reality Analgesia for Brief Thermal Pain

NCT05130307 | Completed

• 1 other identifier: STUDY00013916
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Acute

Keywords

Pain control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

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

  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

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

• Baseline, participants rating of "pain unpleasantness"

  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

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

• Baseline, participants rating of "Fun" during baseline

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

Study Arms (2)

Treatment Order 1

EXPERIMENTAL

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

Behavioral: virtual reality game

Treatment Order 2

ACTIVE COMPARATOR

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

Behavioral: virtual reality game

Interventions

virtual reality game BEHAVIORAL

participants interact with a computer generated world

Treatment Order 1; Treatment Order 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

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

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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.

  PMID: 32038200 BACKGROUND

• 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.

  PMID: 34021173 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Hunter Hoffman, M.S., Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Although no deception is involved, participants who receive VR will remain unaware of the immersiveness of the VR systems they are receiving.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Assistant Professor, Psychology

Model Details: 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)..

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 23, 2021
• Study Start: April 25, 2022
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: any time after publication
• Access Criteria: meta-analysis

Locations

US (1)