NCT04245475

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 30, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

January 23, 2020

Last Update Submit

October 23, 2021

Conditions

Pain, Acute

Keywords

pain control

Outcome Measures

Primary Outcomes (1)

  • participants rating of "worst pain "

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

    immediately after each single 10 second test phase quantitative sensory test stimulus during a single visit

Secondary Outcomes (2)

  • participants rating of "time spent thinking about pain"

    immediately after each single 10 second quantitative sensory test stimulus during a single visit

  • participants rating of "pain unpleasantness "

    immediately after each single 10 second quantitative sensory test stimulus during a single visit

Other Outcomes (1)

  • participants rating of "fun"

    immediately after each single 10 second quantitative sensory test stimulus during a single visit

Study Arms (3)

Control Group

NO INTERVENTION

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

Low Tech/passive Virtual Reality first

ACTIVE COMPARATOR

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

Behavioral: Virtual Reality psychological pain reduction

High Tech/interactive Virtual Reality first

EXPERIMENTAL

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

Behavioral: Virtual Reality psychological pain reduction

Interventions

Virtual Reality psychological pain reductionBEHAVIORAL

attention distraction

High Tech/interactive Virtual Reality firstLow Tech/passive Virtual Reality first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington (public not eligible for participation)

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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: 34021173DERIVED

MeSH Terms

Conditions

Acute PainAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Hunter Hoffman, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Some of the instructions for the outcome measure will be presented to the participants via a computer.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist: Radiology, Psychology, Engineering

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 29, 2020

Study Start

January 30, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

US(1)