NCT06615245

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2024

Completed
Last Updated

December 6, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

September 23, 2024

Last Update Submit

December 3, 2024

Conditions

Keywords

virtual realitydistraction

Outcome Measures

Primary Outcomes (1)

  • accuracy on an attention demanding cognitive test

    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 Outcomes (2)

  • graphic rating scale presence ratings

    measured immediately after each two minute VR session.

  • graphic rating scale subjective pain ratings

    immediately after each brief Quantitative Sensory Testing thermal heat stimulus

Other Outcomes (1)

  • Graphic Rating Scale Difficulty performing the task and difficulty concentrating

    immediately after each 2 minute session

Study Arms (2)

n = 16 participants: No VR condition vs. Immersive VR

SHAM COMPARATOR

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.

Behavioral: No VR vs. immersive high tech VR

n = 20 participants: plausible control (see through VR) condition vs. immersive High Tech VR

ACTIVE COMPARATOR

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.

Behavioral: Plausible control vs immersive High Tech VR

Interventions

No VR vs. immersive High Tech VR

n = 16 participants: No VR condition vs. Immersive VR

plausible control condition vs. immersive high tech VR

n = 20 participants: plausible control (see through VR) condition vs. immersive High Tech VR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Study Officials

  • Hunter G Hoffman, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Each participant will eventually get to try virtual reality, but participants will not be informed that some people receive a more immersive virtual reality than other people. In other words, participants will remain blind to the high tech vs. Low tech VR manipulation.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: within subject repeated measures design with treatment order randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Principle Investigator, Sr. Research Scientist

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 26, 2024

Study Start

October 1, 2024

Primary Completion

November 24, 2024

Study Completion

November 24, 2024

Last Updated

December 6, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

de-identified individual data regarding participants gender, age, their accuracy on the simple attention task, and subjective ratings of difficulty performing the simple attention task, will be available upon to researchers who provide a methodologically sound proposal

Time Frame
data set and data dictionary will be available indefinitely, beginning when the paper is officially published
Access Criteria
Researchers who provide a methodologically sound proposal (e.g, for meta-analysis).

Locations