Water-friendly Virtual Reality and Brief Thermal Pain

NCT ID: NCT04245475

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-30

Study Completion Date

2021-04-30

Brief Summary

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

Detailed Description

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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 high tech interactive VR system makes VR significantly more effective/powerful compared to a less immersive passive VR system, vs. No VR, for reducing pain during quantitative sensory testing.

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Within subjects crossover design, VR treatment order randomized (some participants receive Low Tech VR + High Tech VR, some participants receive High Tech VR + Low Tech VR) and some participants receive No VR in a side study to test the assumptions of our QST testing pain paradigm.

1. No Virtual Reality (no treatment control side data to test QST paradigm assumptions).
2. Low Tech/passive Virtual Reality for 1st pain stimulus+High Tech for 2nd pain stimulus
3. High Tech/interactive VR for 1st pain stimulus +Low Tech for 2nd pain stimulus.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Some of the instructions for the outcome measure will be presented to the participants via a computer.

Study Groups

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Control Group

No treatment, side study to test the assumptions of our quantitative sensory testing pain paradigm

Group Type NO_INTERVENTION

No interventions assigned to this group

Low Tech/passive Virtual Reality first

Low Tech VR first brief test phase thermal stimulus + High Tech VR during a second test phase pain stimulus

Group Type ACTIVE_COMPARATOR

Virtual Reality psychological pain reduction

Intervention Type BEHAVIORAL

attention distraction

High Tech/interactive Virtual Reality first

High Tech/Interactive VR during first brief test phase thermal stimulus + Low Tech VR during a second brief thermal stimulus.

Group Type EXPERIMENTAL

Virtual Reality psychological pain reduction

Intervention Type BEHAVIORAL

attention distraction

Interventions

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Virtual Reality psychological pain reduction

attention distraction

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Hunter Hoffman

Research Scientist: Radiology, Psychology, Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hunter Hoffman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington (public not eligible for participation)

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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 DERIVED
PMID: 34021173 (View on PubMed)

Other Identifiers

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R01GM042725

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007801

Identifier Type: -

Identifier Source: org_study_id