Clinical trial NCT04245475: Water-friendly Virtual Reality and Brief Thermal Pain
Official title: Water-friendly Virtual Reality and Brief Thermal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: pain control
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-01-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.

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 purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: participants rating of "worst pain "
timeFrame: immediately after each single 10 second test phase quantitative sensory test stimulus during a single visit
Secondary outcomes:
measure: participants rating of "time spent thinking about pain"
timeFrame: immediately after each single 10 second quantitative sensory test stimulus during a single visit
measure: participants rating of "pain unpleasantness "
timeFrame: immediately after each single 10 second quantitative sensory test stimulus during a single visit
Other outcomes:
measure: participants rating of "fun"
timeFrame: immediately after each single 10 second quantitative sensory test stimulus during a single visit
Locations:
city: Seattle
country: United States
facility: University of Washington (public not eligible for participation)
state: Washington
Study officials:
affiliation: University of Washington
name: Hunter Hoffman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.