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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04245475
Other study ID # STUDY00007801
Secondary ID R01GM042725
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2020
Est. completion date April 30, 2021

Study information

Verified date October 2021
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Reality psychological pain reduction
attention distraction

Locations

Country Name City State
United States University of Washington (public not eligible for participation) Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other participants rating of "fun" using a single graphic rating scale, 0 = no fun, 10 = extremely fun. immediately after each single 10 second quantitative sensory test stimulus during a single visit
Primary 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 participants rating of "time spent thinking about pain" using a single graphic rating scale, 0 = none of the time, 10 = all of the time immediately after each single 10 second quantitative sensory test stimulus during a single visit
Secondary participants rating of "pain unpleasantness " using a single graphic rating scale, 0 = no pain, 10 = excruciating pain immediately after each single 10 second quantitative sensory test stimulus during a single visit
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