- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528862
Reducing Error in ER Settings Through Attention Restoration Theory (RESTART)
April 20, 2021 updated by: Virginia Commonwealth University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Emergency Medicine Resident of any PGY level. (1-5)
Exclusion Criteria:
- Anybody under the age of 18
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Nature
|
participants will view a presentation of nature slides
|
SHAM_COMPARATOR: Urban
|
participants will view a presentation of urban slides
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 hours
|
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.
|
5 hours
|
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.
|
5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Miller, DO, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 1, 2021
Primary Completion (ANTICIPATED)
May 1, 2021
Study Completion (ANTICIPATED)
May 1, 2021
Study Registration Dates
First Submitted
August 24, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (ACTUAL)
August 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 23, 2021
Last Update Submitted That Met QC Criteria
April 20, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20019844
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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