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The Effects of Night Call on Intellectual Performance

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ClinicalTrials.gov Identifier: NCT02697266
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Haleh Saadat, Nationwide Children's Hospital

Study Description
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Brief Summary:
The purpose of the current proposal will be to examine the clinical performance of both physicians in training as well as experienced faculty in pre and post call situations. Groups will be matched for gender, age, experience and employment duration during regular hours versus immediate post call hour.

Condition or disease Intervention/treatment
Sleep Deprivation Other: No intervention

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.

  1. Attending Anesthesiologists: Gender, age, years of experience, years of employment at the institution, hours of sleep and circadian rhythm will be taken into effect.
  2. 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.

  1. Baseline instruments; including demographics, and coping strategy indicator (CSI), will be administrated.
  2. 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).
  3. 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 Design
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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Individual Coping Strategies After Night Calls: Effects on Performing Clinical and Cognitive Tasks
Study Start Date : March 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
Post-call anesthesiologists
Attending anesthesiologists, and Anesthesiology residents
 Other: No intervention
This is an observational study.
Regular-shift anesthesiologists
Attending anesthesiologists, and Anesthesiology residents
 Other: No intervention
This is an observational study.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Profile of mood states [ Time Frame: Regular Day and Post-call shifts - Through study completion, an average of one year. ]
    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.


Secondary Outcome Measures :
  1. Coping Strategy Indicator (CSI): [ Time Frame: Regular-shift - Through study completion, an average of one year. ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Twenty-four attending anesthesiologists and anesthesiology residents
Criteria

Inclusion Criteria:

  • Staff Attending Anesthesiologist who takes night shift call
  • Anesthesiology residents who take night shift call

Exclusion Criteria:

  • Staff unwilling to participate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697266


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Haleh Saadat
Investigators
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Principal Investigator: Haleh Saadat, MD Nationwide Children's Hospital
More Information
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Responsible Party: Haleh Saadat, Director of Complementary and Alternative Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02697266    
Other Study ID Numbers: IRB14-00143
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
 Nervous System Diseases
Neurologic Manifestations
Mental Disorders