- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06615245
Measuring Attention During Immersive Virtual Reality Distraction
A Magic Bowl Low Tech Vs. High Tech Immersive Virtual Reality Distraction
Brief Summary
Using a repeated measures within-subject design with treatment order randomized, with healthy volunteers, this study will measure how much immersive Virtual Reality (VR) reduces performance on a simple attention demanding task during No VR vs. High Tech VR (for one group of 16 participants), and during a plausible control see through VR vs. High Tech VR (for another group of 20 participants).
The primary aim is to explore whether a highly immersive VR system makes VR significantly more attention demanding/distracting, compared to No VR, and compared to a less immersive VR system (a plausible controlled see through goggles).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Healthy college student volunteers will participate in a repeated measure within subject trial studying attention using a divided attention paradigm.
One group of participants (16 healthy volunteers) will perform a simple attention demanding task during No VR for 2 minutes and they will perform the attention demanding task again during High Tech VR for 2 minutes.
Another group of 20 healthy volunteers will perform a simple attention demanding task during a less immersive see through VR (a plausible control condition) for 2 minutes and they will also perform the attention demanding task again during immersive High Tech VR for 2 minutes (treatment order randomized). This group will also rate their pain and anxiety during Quantitative Sensory Testing very brief thermal heat stimuli during No VR vs. during immersive high tech VR.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Currently enrolled in a course at the University of Washington Psychology Dept., participating in the University of Washington (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 who 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., not 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: n = 16 participants: No VR condition vs. Immersive VR
Participants will perform a simple attention demanding task during No VR for 2 minutes, and again during a Immersive High Tech Virtual Reality game distraction.
They will also rate how distracted they were and how hard it was to concentrate on the attention demanding task during each 2 minute task.
|
No VR vs. immersive High Tech VR
|
|
Active Comparator: n = 20 participants: plausible control (see through VR) condition vs. immersive High Tech VR
20 healthy volunteer participants will perform a simple attention demanding task during a plausible control (see through) VR for 2 minutes, and again during an immersive High Tech Virtual Reality distraction (treatment order randomized).
They will also rate how distracted they were and how hard it was to concentrate on the attention demanding task during the 2 minute tasks.
During Phase 2 they will also rate their pain and anxiety during a brief thermal stimulus Quantitative Sensory Testing) during No VR vs. during immersive High Tech VR.
|
plausible control condition vs. immersive high tech VR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
accuracy on an attention demanding cognitive test
Time Frame: for n = 16, responses will be made 15 seconds after the VR condition vs. 15 seconds after the No VR during 2 minute sessions. For n = 20 subjects responses will be made 15 s after the plausible control condition, and 15 seconds after the immersive VR.
|
Number of correct responses on a divided attention task
|
for n = 16, responses will be made 15 seconds after the VR condition vs. 15 seconds after the No VR during 2 minute sessions. For n = 20 subjects responses will be made 15 s after the plausible control condition, and 15 seconds after the immersive VR.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
graphic rating scale presence ratings
Time Frame: measured immediately after each two minute VR session.
|
Graphic rating scale measures of patients illusion of "being there" in virtual reality.
|
measured immediately after each two minute VR session.
|
|
graphic rating scale subjective pain ratings
Time Frame: immediately after each brief Quantitative Sensory Testing thermal heat stimulus
|
n = 20 participants report how much pain they experienced during No VR vs. during High Tech VR.
|
immediately after each brief Quantitative Sensory Testing thermal heat stimulus
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Graphic Rating Scale Difficulty performing the task and difficulty concentrating
Time Frame: immediately after each 2 minute session
|
subjective ratings of difficulty performing the simple attention task
|
immediately after each 2 minute session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hunter G Hoffman, Ph.D., University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UWashington
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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