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Water-friendly Virtual Reality and Brief Thermal Pain

Primary Purpose

Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality psychological pain reduction
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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.

Sites / Locations

  • University of Washington (public not eligible for participation)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control Group

Low Tech/passive Virtual Reality first

High Tech/interactive Virtual Reality first

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

participants rating of "worst pain "
using a single graphic rating scale, 0 = no pain, 10 = excruciating pain

Secondary Outcome Measures

participants rating of "time spent thinking about pain"
using a single graphic rating scale, 0 = none of the time, 10 = all of the time
participants rating of "pain unpleasantness "
using a single graphic rating scale, 0 = no pain, 10 = excruciating pain

Full Information

First Posted
January 23, 2020
Last Updated
October 23, 2021
Sponsor
University of Washington
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04245475
Brief Title
Water-friendly Virtual Reality and Brief Thermal Pain
Official Title
Water-friendly Virtual Reality and Brief Thermal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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 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.

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
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. No Virtual Reality (no treatment control side data to test QST paradigm assumptions). Low Tech/passive Virtual Reality for 1st pain stimulus+High Tech for 2nd pain stimulus High Tech/interactive VR for 1st pain stimulus +Low Tech for 2nd pain stimulus.
Masking
Outcomes Assessor
Masking Description
Some of the instructions for the outcome measure will be presented to the participants via a computer.
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No treatment, side study to test the assumptions of our quantitative sensory testing pain paradigm
Arm Title
Low Tech/passive Virtual Reality first
Arm Type
Active Comparator
Arm Description
Low Tech VR first brief test phase thermal stimulus + High Tech VR during a second test phase pain stimulus
Arm Title
High Tech/interactive Virtual Reality first
Arm Type
Experimental
Arm Description
High Tech/Interactive VR during first brief test phase thermal stimulus + Low Tech VR during a second brief thermal stimulus.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality psychological pain reduction
Intervention Description
attention distraction
Primary Outcome Measure Information:
Title
participants rating of "worst pain "
Description
using a single graphic rating scale, 0 = no pain, 10 = excruciating pain
Time Frame
immediately after each single 10 second test phase quantitative sensory test stimulus during a single visit
Secondary Outcome Measure Information:
Title
participants rating of "time spent thinking about pain"
Description
using a single graphic rating scale, 0 = none of the time, 10 = all of the time
Time Frame
immediately after each single 10 second quantitative sensory test stimulus during a single visit
Title
participants rating of "pain unpleasantness "
Description
using a single graphic rating scale, 0 = no pain, 10 = excruciating pain
Time Frame
immediately after each single 10 second quantitative sensory test stimulus during a single visit
Other Pre-specified Outcome Measures:
Title
participants rating of "fun"
Description
using a single graphic rating scale, 0 = no fun, 10 = extremely fun.
Time Frame
immediately after each single 10 second quantitative sensory test stimulus during a single visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hunter Hoffman, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington (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
Undecided
IPD Sharing Plan Description
undecided
Citations:
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
derived

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Water-friendly Virtual Reality and Brief Thermal Pain

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