- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02697266
The Effects of Night Call on Intellectual Performance
Individual Coping Strategies After Night Calls: Effects on Performing Clinical and Cognitive Tasks
Study Overview
Detailed Description
This is a prospective study evaluating the reaction time among attending anesthesiologists, and anesthesiology residents who take night shift call and are suffering from sleep deprivation. Investigators plan to examine clinical performance by measuring reaction times using a 10 minute psychomotor vigilance test device on physicians in training as well as experienced physicians in pre and post call situations.
All subjects will be informed of the scope and purpose of the study.
- Attending Anesthesiologists: Gender, age, years of experience, years of employment at the institution, hours of sleep and circadian rhythm will be taken into effect.
- Residents/Fellows: Gender, age, years of experience, years of employment at the institution and circadian rhythm will be taken into effect.
All study subjects will be asked to fill a questionnaire regarding demographic data, coping strategy Index.
- Baseline instruments; including demographics, and coping strategy indicator (CSI), will be administrated.
- Reaction time, mood and simple cognitive test will be measured at approximately 7 am of a regular day, (when the subject is not on call).
- Reaction time, mood and simple cognitive test will be measured at approximately 7 am of after a call night.
This proposal attempts to examine the impact of night shift on mood, cognitive and motor task performance in physicians as compared to regular hours.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Staff Attending Anesthesiologist who takes night shift call
- Anesthesiology residents who take night shift call
Exclusion Criteria:
- Staff unwilling to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Post-call anesthesiologists
Attending anesthesiologists, and Anesthesiology residents
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This is an observational study.
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Regular-shift anesthesiologists
Attending anesthesiologists, and Anesthesiology residents
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This is an observational study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction time
Time Frame: Regular Day and Post-call shifts - Through study completion, an average of one year.
|
We plan to measure reaction times via a 10-minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device.
The PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurements.
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Regular Day and Post-call shifts - Through study completion, an average of one year.
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Visual Analog Scale
Time Frame: Regular Day and Post-call shifts - Through study completion, an average of one year.
|
Subjective sleepiness and alertness (and other parameters) will be measured via the Visual Analog Scale (VAS).
This Questionnaire consists of several 100 millimeter lines, each of which is labeled at one end with the words "not at all" and the other end with the word "extremely".
Centered under each line are the test adjectives which are as follows: "alert, able to concentrate, " anxious", "energetic", "feel confident", "irritable", "Jittery/nervous", "sleepy", and "talkative".
The participants indicate the point on the line, which corresponded to the way they feel along the continuum at the time the test is taken.
The score for each item consists of a number of millimeters from the left side of the line to the location at which the participants placed their mark.
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Regular Day and Post-call shifts - Through study completion, an average of one year.
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Profile of mood states
Time Frame: Regular Day and Post-call shifts - Through study completion, an average of one year.
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Subjective evaluations of mood will be made with the Profile of Mood States (POMS).
The POMS is a 65-Item questionnaire which, when scored according to the specific templates, measures affect or mood on scales: 1) Tension-Anxiety, 2) Depression-dejection, 3) anger-hostility, 4) vigor-activity, 5) fatigue-inertia, and 6) confusion-bewilderment.
Factor scores on each scale will be analyzed.
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Regular Day and Post-call shifts - Through study completion, an average of one year.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coping Strategy Indicator (CSI):
Time Frame: Regular-shift - Through study completion, an average of one year.
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This is the self-report measure of three fundamental modes of coping that has demonstrated considerable psychometric strength.
The CSI first instructs responders to select a recent stressful event from their lives and briefly describe it.
Then, responders read a list of 33 specific coping behaviors, indicating the extent to which each was used to deal with the problem.
Responders are summed to form three scales: problem solving, seeking social support and avoidance.
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Regular-shift - Through study completion, an average of one year.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB14-00143
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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