The Effects of Night Call on Intellectual Performance

Sleep Deprivation Clinical Trial

Official title:

Individual Coping Strategies After Night Calls: Effects on Performing Clinical and Cognitive Tasks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697266
• Other study ID #: IRB14-00143
• Status: Completed
• Phase: N/A
• First received: December 21, 2015
• Last updated: September 8, 2016
• Start date: March 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Staff Attending Anesthesiologist who takes night shift call

• Anesthesiology residents who take night shift call

Exclusion Criteria:

• Staff unwilling to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Other:
• No intervention
This is an observational study.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Haleh Saadat

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction time	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.	Regular Day and Post-call shifts - Through study completion, an average of one year.	No
Primary	Visual Analog Scale	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.	Regular Day and Post-call shifts - Through study completion, an average of one year.	No
Primary	Profile of mood states	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.	Regular Day and Post-call shifts - Through study completion, an average of one year.	No
Secondary	Coping Strategy Indicator (CSI):	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.	Regular-shift - Through study completion, an average of one year.	No