- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04053556
Cognitive Performance After a Night Shift in Internal Medicine Residents
Evaluation on the Effect on Cognition and Emotional Exhaustion With a Change of Long Night Shift System Versus Reduced Night Shift in Residents of Internal Medicine
Study Overview
Status
Detailed Description
The investigators conducted a cross sectional study during the 2014-2016 period in a high complexity school hospital in Buenos Aires. Second and third year Internal Medicine residents who consented to participate were included.
A neurologist conducted a cognitive evaluation to the residents who had done 24 hours shifts (with sleep deprivation) within 6 hours of its end.
Auditory memory deficit was evaluated (PASAT - Paced Auditory Serial Addition Test), verbal fluency (FAS), direct and indirect Digit-Span, Rey auditory verbal learning test (RAVLT) and Continuous Performance Test 2 (CPT2).
Results were presented as means of standardized scores (z score) with their interquartile range (IQR).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Capital Federal
-
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
- Hospital Italiano de Buenos Aires, Peron 4190
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Internal Medicine residents on the second or third year of formation.
Exclusion Criteria:
- Denial to participate in the study or to the informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological evaluation using Paced Auditory Serial Addition Test (PASAT)
Time Frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
Post on-call cognition assessment
|
Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
Burn Out
Time Frame: through study completion, an average of one year
|
Maslach questionaire filled by participant
|
through study completion, an average of one year
|
Conners Continuous Performance Test 2 (CPT)
Time Frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
Post on-call attention test
|
Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
Rey auditory verbal learning test (RAVLT)
Time Frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
Post on-call cognition assessment
|
Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
F-A-S test
Time Frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
Post on-call verbal fluency
|
Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
Direct and indirect digit span
Time Frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
Post on-call short-term verbal memory
|
Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: through study completion, an average of one year
|
Questionaire filled by participant
|
through study completion, an average of one year
|
Collaborators and Investigators
Investigators
- Study Chair: Diego H Giunta, MD, Hospital Italiano de Buenos Aires
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2489
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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