NCT02697266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

December 21, 2015

Last Update Submit

September 8, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Secondary Outcomes (1)

  • Coping Strategy Indicator (CSI):

    Regular-shift - Through study completion, an average of one year.

Study Arms (2)

Post-call anesthesiologists

Attending anesthesiologists, and Anesthesiology residents

Other: No intervention

Regular-shift anesthesiologists

Attending anesthesiologists, and Anesthesiology residents

Other: No intervention

Interventions

This is an observational study.

Post-call anesthesiologistsRegular-shift anesthesiologists

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty-four attending anesthesiologists and anesthesiology residents

You may qualify if:

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

You may not qualify if:

  • Staff unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Haleh Saadat, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Complementary and Alternative Medicine

Study Record Dates

First Submitted

December 21, 2015

First Posted

March 3, 2016

Study Start

March 1, 2014

Primary Completion

April 1, 2016

Study Completion

September 1, 2016

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations