DistractionNCT06615245
Measuring Attention During Immersive Virtual Reality Distraction
A study testing No VR vs. immersive high tech VR in people with Distraction, run by Hunter Hoffman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distraction
- What is being tested?
- No VR vs. immersive high tech VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 24 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Distraction
- Being tested
- No VR vs. immersive high tech VR, Plausible control vs immersive High Tech VR
- Keywords
- virtual reality, distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No VR vs. immersive high tech VRBehavioural
No VR vs. immersive High Tech VR
Plausible control vs immersive High Tech VRBehavioural
plausible control condition vs. immersive high tech VR
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Plausible control vs immersive High Tech VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy on an attention demanding cognitive test
Number of correct responses on a divided attention task
Measured: 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
Graphic rating scale measures of patients illusion of "being there" in virtual reality.
Measured: measured immediately after each two minute VR session.
graphic rating scale subjective pain ratings
n = 20 participants report how much pain they experienced during No VR vs. during High Tech VR.
Measured: immediately after each brief Quantitative Sensory Testing thermal heat stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Oct 2024
- Primary completion24 Nov 2024
- Study completion24 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DistractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- within subject repeated measures design with treatment order randomized
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Hoffman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hunter Hoffman, University of Washington
- Investigators
- Hunter G Hoffman, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615245
- Sponsor's protocol ID
- UWashington
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Magic Bowl Low Tech Vs. High Tech Immersive Virtual Reality Distraction
- ClinicalTrials.gov ID
- NCT06615245
- Acronym / sponsor ID
- UWashington
- Conditions
- Distraction
- Keywords
- virtual reality, distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hunter HoffmanUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 24 Nov 2024 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- within subject repeated measures design with treatment order randomized
| Arm | Type | Receives |
|---|---|---|
| n = 16 participants: No VR condition vs. Immersive VR | Sham comparator | Behavioral: No VR vs. immersive high tech VRParticipants 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. |
| n = 20 participants: plausible control (see through VR) condition vs. immersive High Tech VR | Active comparator | Behavioral: Plausible control vs immersive High Tech VR20 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No VR vs. immersive high tech VRNo VR vs. immersive High Tech VR | Behavioural | n = 16 participants: No VR condition vs. Immersive VR |
| Plausible control vs immersive High Tech VRplausible control condition vs. immersive high tech VR | Behavioural | n = 20 participants: plausible control (see through VR) condition vs. immersive High Tech VR |
Primary outcome
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
2 secondary outcomes
graphic rating scale presence ratings
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hunter G Hoffman, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No VR vs. immersive high tech VR in people with Distraction, run by Hunter Hoffman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.