Attention Fatigue, Attention RestorationRESTARTNCT04528862
Reducing Error in ER Settings Through Attention Restoration Theory
A study testing Nature slides and Urban slides in people with Attention Fatigue, Attention Restoration, run by Virginia Commonwealth University.
Trial summary
The purpose of this research study is to find out about how looking at different types of pictures can affect people's attention spans. Attention Restoration Theory (ART) suggests that there are two types of attention. One type (directed attention) can become tired and cause people to make mistakes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Fatigue, Attention Restoration
- What is being tested?
- Nature slides and Urban slides
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to May 2021
- 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
- Emergency Medicine Resident of any PGY level. (1-5)
Who cannot join
- Anybody under the age of 18
- Pregnancy
About this study
Official title: RESTART Trials: Reducing Error in ER Settings Through Attention Restoration Theory
The purpose of this research study is to find out about how looking at different types of pictures can affect people's attention spans. Attention Restoration Theory (ART) suggests that there are two types of attention. One type (directed attention) can become tired and cause people to make mistakes. The other type (involuntary attention) gives directed attention a chance to rest, so people make less mistakes. Certain types of pictures are good at capturing involuntary attention. We think that capturing involuntary attention will help emergency physicians make less mistakes on tests of attention. This study will allow us to learn more about it.
Read the detailed description
In this study, participants will be asked to do the following things:
- Before their usual shift in the emergency department, arrive ten minutes early to rate their mood and complete a Digit Span Backwards (DSB) task that tests their memory of different sets of numbers.
- Five hours into their shift, they will take a ten minute break.
- During this break, they will be randomly assigned to view either a picture presentation of nature slides or urban slides.
- After the presentation, they will complete the Digit Span Backwards task again, they will rate their mood again, then return to their shift.
Participation in this study will last up to 30 minutes. Approximately fifty individuals will participate in this study.
- Conditions
- Attention Fatigue, Attention Restoration
- Being tested
- Nature slides, Urban slides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature slidesBehavioural
participants will view a presentation of nature slides
Urban slidesBehavioural
participants will view a presentation of urban slides
| Study group | Role | What they receive |
|---|---|---|
| Nature | Experimental | Not described Receives: Behavioral: Nature slides |
| Urban | Sham comparator | Not described Receives: Behavioral: Urban slides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory
Working memory will be assessed using the Digit Span test. Participants are read a sequence of numbers and asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). Number of correctly repeated numbers is summed to yield a score ranging from 0 to 28. Higher scores indicated better working memory
Measured: 5 hours
Positive mood
Positive mood will be assess using the positive affect (PA) scale of the Positive and Negative Affect Schedule (PANAS). The PA scale consists of 10 adjectives which are rated on a 5 point scale from slightly or not at all to extremely. Items are summed to yield a score ranging from 10 to 50 with higher number indicating higher affect.
Measured: 5 hours
Negative mood
Negative mood will be assess using the negative affect (NA) scale of the PANAS. The NA scale consists of 10 adjectives which are rated on a 5 point scale from slightly or not at all to extremely. Items are summed to yield a score ranging from 10 to 50 with higher number indicating higher affect.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study startApr 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Due to logistical issues the study as designed was determined to not be feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Fatigue, Attention RestorationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Miller, DO, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528862
- Sponsor's protocol ID
- HM20019844
- Acronym
- RESTART
- Status last verified
- Apr 2021
- First submitted
- 24 Aug 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTART Trials: Reducing Error in ER Settings Through Attention Restoration Theory
- ClinicalTrials.gov ID
- NCT04528862
- Acronym / sponsor ID
- RESTART / HM20019844
- Conditions
- Attention Fatigue, Attention Restoration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to logistical issues the study as designed was determined to not be feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 27 Aug 2020 (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.
The purpose of this research study is to find out about how looking at different types of pictures can affect people's attention spans. Attention Restoration Theory (ART) suggests that there are two types of attention. One type (directed attention) can become tired and cause people to make mistakes. The other type (involuntary attention) gives directed attention a chance to rest, so people make less mistakes. Certain types of pictures are good at capturing involuntary attention. We think that capturing involuntary attention will help emergency physicians make less mistakes on tests of attention. This study will allow us to learn more about it.
Detailed description
In this study, participants will be asked to do the following things:
- Before their usual shift in the emergency department, arrive ten minutes early to rate their mood and complete a Digit Span Backwards (DSB) task that tests their memory of different sets of numbers.
- Five hours into their shift, they will take a ten minute break.
- During this break, they will be randomly assigned to view either a picture presentation of nature slides or urban slides.
- After the presentation, they will complete the Digit Span Backwards task again, they will rate their mood again, then return to their shift.
Participation in this study will last up to 30 minutes. Approximately fifty individuals will participate in this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature | Experimental | Behavioral: Nature slides |
| Urban | Sham comparator | Behavioral: Urban slides |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Emergency Medicine Resident of any PGY level. (1-5)
Key exclusion criteria (2 listed)
- Anybody under the age of 18
- Pregnancy
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 |
|---|---|---|
| Nature slidesparticipants will view a presentation of nature slides | Behavioural | Nature |
| Urban slidesparticipants will view a presentation of urban slides | Behavioural | Urban |
Primary outcome
Working memory
Time frame: 5 hours
Working memory will be assessed using the Digit Span test. Participants are read a sequence of numbers and asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). Number of correctly repeated numbers is summed to yield a score ranging from 0 to 28. Higher scores indicated better working memory
Positive mood
Time frame: 5 hours
Positive mood will be assess using the positive affect (PA) scale of the Positive and Negative Affect Schedule (PANAS). The PA scale consists of 10 adjectives which are rated on a 5 point scale from slightly or not at all to extremely. Items are summed to yield a score ranging from 10 to 50 with higher number indicating higher affect.
Negative mood
Time frame: 5 hours
Negative mood will be assess using the negative affect (NA) scale of the PANAS. The NA scale consists of 10 adjectives which are rated on a 5 point scale from slightly or not at all to extremely. Items are summed to yield a score ranging from 10 to 50 with higher number indicating higher affect.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No
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.
Stephen Miller, DO principal investigator
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
A study testing Nature slides and Urban slides in people with Attention Fatigue, Attention Restoration, run by Virginia Commonwealth University.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Working memory (time frame: 5 hours). The study lists 3 primary outcomes in all. 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 23 Apr 2021.