Virtual Reality Analgesia for Brief Thermal Pain

Pain, Acute Clinical Trial

Official title:

Virtual Reality Analgesia for Brief Thermal Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130307
• Other study ID #: STUDY00013916
• Status: Completed
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: June 3, 2022

Study information

• Verified date: August 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• 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 highly immersive VR system makes VR significantly more effective/powerful compared to a less immersive VR system, vs. No VR, for reducing pain during quantitative sensory testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• 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

• 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 The following temporary inclusion/exclusion criterion will exist only as long as required or appropriate for COVID pandemic conditions.

COVID-19 precautions. Vaccinated: Individuals are considered fully vaccinated 2 weeks after the second dose in a 2-dose series (e.g., Pfizer or Moderna) or 2 weeks after a single-dose vaccine (e.g., Johnson & Johnson).

All students and researchers must wear masks at all times during the study, and participants and researchers must provide proof of full vaccination for full participation.

If participants do not have proof of vaccination or are unvaccinated, they are still free to sign up for the study. They are invited. They can still earn the extra credit by reading educational materials, in person, during their scheduled time slot. If unvaccinated, or if they have no proof of vaccination, we request that students provide proof of a negative COVID-19 test from the UW test site at the faculty lounge, dated within 24 hours of the study (non-vaccinated students need a recent negative COVID-19 test from the UW before participating in the non-VR educational materials option.

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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

The following temporary inclusion/exclusion criterion will exist only as long as required or appropriate for COVID pandemic conditions.

COVID-19 precautions. Vaccinated: Individuals are considered fully vaccinated 2 weeks after the second dose in a 2-dose series (e.g., Pfizer or Moderna) or 2 weeks after a single-dose vaccine (e.g., Johnson & Johnson).

All students and researchers must wear masks at all times during the study, and participants and researchers must provide proof of full vaccination for full participation.

If participants do not have proof of vaccination or are unvaccinated, they are still free to sign up for the study. They are invited. They can still earn the extra credit by reading educational materials, in person, during their scheduled time slot. If unvaccinated, or if they have no proof of vaccination, we request that students provide proof of a negative COVID-19 test from the UW test site at the faculty lounge, dated within 24 hours of the study.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Behavioral:
• virtual reality game
participants interact with a computer generated world

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (2)

Al-Ghamdi NA, Meyer WJ 3rd, Atzori B, Alhalabi W, Seibel CC, Ullman D, Hoffman HG. Virtual Reality Analgesia With Interactive Eye Tracking During Brief Thermal Pain Stimuli: A Randomized Controlled Trial (Crossover Design). Front Hum Neurosci. 2020 Jan 23;13:467. doi: 10.3389/fnhum.2019.00467. eCollection 2019. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst pain, baseline, participant's rating of "worst pain" during baseline measure	Baseline, Worst pain rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain	Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)
Primary	participant's rating of "worst pain" during test phase	Test phase, Worst pain rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain	Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)
Secondary	Baseline, participants rating of "time spent thinking about pain"	Baseline Time thinking, Single a single graphic rating scale, 0 = none of the time, 10 = all of the time	Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)
Secondary	Test Phase, participants rating of "time spent thinking about pain" during test phase	Test phase, Time rating, using a single graphic rating scale, 0 = none of the time, 10 = all of the time	Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)
Secondary	Baseline, participants rating of "pain unpleasantness"	Baseline, Unpleasant rating, using single graphic rating scale, 0 = not unpleasant at all, 10 = excruciatingly unpleasant	Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)
Secondary	Test phase, participants rating of "pain unpleasantness" during test phase	Test phase, pain unpleasantness, 0 = not unpleasant at all, 10 = excruciatingly unpleasant	Immediately after each single 10 second test stimulus (< 10 minutes after baseline pain rating)
Secondary	Baseline, participants rating of "Fun" during baseline	Baseline fun, 0 = no fun at all, 10 = extremely fun	Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)
Secondary	Test Phase, participants ratings of "Fun" during test phase	Test phase fun, 0 = no fun at all, 10 = extremely fun	Immediately after each single 10 second test stimulus (< 10 minutes after baseline fun rating)
Secondary	Baseline pain intensity: participants ratings of pain intensity during brief pair of 10 sec stimuli	Baseline, pain intensity rating using a single graphic rating scale, 0 = no pain, 10 = excruciating pain	Immediately after a single 10 second test (no more than 10 minutes before the subsequent test stiim)
Secondary	Accuracy on the odd number task during No VR, Low tech VR and High tech VR	participants accuracy on the attention demanding "odd number" task (Hoffman, 2021)	No pain during this measure, measured within 10 minutes after the QST measures are completed.