Comparison of Biomarkers of Stress in Emergency Physicians Working a 24-hour Shift or a 14-hour Night Shift - the JOBSTRESS Randomized Trial (JOBSTRESS)

June 7, 2013 updated by: University Hospital, Clermont-Ferrand
A stressful state can lead to symptoms of mental exhaustion, physical fatigue, medical errors, and also increase coronary heart disease. Emergency physicians subjectively complain of stress related to changes in work shifts. Several potential biomarkers of stress have been described, but never investigated in emergency physician, who may represent a good model of stress due to the complex interplay between stress (life-and-death emergencies, which is the defining characteristic of their job), lack of sleep and fatigue due to repeated changes in shifts.The aim of this study was to compare biomarkers in emergency physicians working a 24-hour shift (24hS) or a 14-hour night shift (14hS), and in those working a control day (clerical work on return from leave). We also followed these markers three days following each shift (D3/24hS and D3/14hS).

Study Overview

Detailed Description

A stressful state can lead to symptoms of mental exhaustion and physical fatigue, detachment from work, and feelings of diminished competence. One of the health consequences of chronic stress at work is an increased risk of coronary heart disease. Emergency physicians subjectively complain of stress related to changes in work shifts. In occupational medicine, no marker of stress or fatigue has achieved consensus. Several potential biomarkers of stress have been described, but never investigated in emergency physician, who may represent a good model of stress due to the complex interplay between stress (life-and-death emergencies, which is the defining characteristic of their job), lack of sleep and fatigue due to repeated changes in shifts.The aim of this study was to compare HRV in emergency physicians working a 24-hour shift (24hS) or a 14-hour night shift (14hS), and in those working a control day (clerical work on return from leave). We will also follow these markers three days following each shift (D3/24hS and D3/14hS).

The psychological consequences of shifts will be assessed in terms of perceived stress and fatigue using visual analog scales. Potential biomarkers will be assessed through urine and saliva collections. Heart rate variability will be measured using 5-lead electrocardiogram. Psychological questionnaires will be completed only once during the control day. The workload during each shift will be estimated by: the total number of entries, the number of admissions, the number of outpatients (collected by computer), and the number of life-and- death emergencies (given by the emergency physician). Sleep duration, including naps, will be assessed by questionnaire (bed time - wake time) on the three-day tracking of each shift and on the control day.

Shift randomization: Latin squares were used to randomize the pattern of shifts and control day (24hS then 14hS then control day or any other combination).

Gaussian distribution of the data wil be tested by the Kolmogorov-Smirnov test. Data will be presented as mean ± standard deviation (SD). Comparisons between shifts will be made with ANOVA. Relationships between data will be assessed by Pearson correlation. Significance will be accepted at the p<0.05 level. Statistical procedures will be performed using SPSS Advanced Statistics software (SPSS Inc., Chicago, IL).

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • emergency physician

Exclusion Criteria:

  • endocrine disease, pregnancy, recent extraprofessional deleterious life event (such as death of a near relative, divorce), any current illness, drugs used to modulate inflammatory diseases (corticosteroids, anti-inflammatory drugs, immunomodulatory drugs), or any drugs with a chronotropic effect taken over the previous six months (beta blockers, diltiazem, verapamil, anxiolytics or antidepressants).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: biomarkers of stress
Comparison of biomarkers of stress in emergency physicians working a 24-hour shift or a 14-hour night shift

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Putative biomarkers of stress include heart rate variability (urinary and salivary steroids, saliva immunogobulin A, ...)
Time Frame: at day 1
These biomarkers will be collected in emergency physicians
at day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
perceived stress measured using visual analog scale (VAS)
Time Frame: at day 1
at day 1
perceived fatigue (VAS)
Time Frame: at day 1
at day 1
sleep duration (hours)
Time Frame: at day 1
at day 1
sleep quality (VAS)
Time Frame: at ady 1
at ady 1
workload within the emergency department during the shifts
Time Frame: at day 1
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alain CHAMOUX, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 7, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0154
  • 2009-A01309-48

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.

Clinical Trials on Biomarkers of Stress in Emergency Physicians

Clinical Trials on Comparison of biomarkers of stress

3
Subscribe