Virtual Reality Analgesia for Brief Thermal Pain

NCT ID: NCT05130307

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2022-06-03

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Treatment Order 1

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

Group Type: EXPERIMENTAL

virtual reality game

Intervention Type: BEHAVIORAL

participants interact with a computer generated world

Treatment Order 2

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

Group Type: ACTIVE_COMPARATOR

virtual reality game

Intervention Type: BEHAVIORAL

participants interact with a computer generated world

Interventions

virtual reality game

participants interact with a computer generated world

Intervention Type: BEHAVIORAL

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.

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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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Hunter Hoffman

Affiliate Assistant Professor, Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32038200 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34021173 (View on PubMed)

Other Identifiers

STUDY00013916

Identifier Type: -

Identifier Source: org_study_id