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

Primary Purpose

Biomarkers of Stress in Emergency Physicians

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Comparison of biomarkers of stress
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Biomarkers of Stress in Emergency Physicians focused on measuring Stress, occupation, biomarkers, emergency, physicians

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

biomarkers of stress

Arm Description

Comparison of biomarkers of stress in emergency physicians working a 24-hour shift or a 14-hour night shift

Outcomes

Primary Outcome Measures

Putative biomarkers of stress include heart rate variability (urinary and salivary steroids, saliva immunogobulin A, ...)
These biomarkers will be collected in emergency physicians

Secondary Outcome Measures

perceived stress measured using visual analog scale (VAS)
perceived fatigue (VAS)
sleep duration (hours)
sleep quality (VAS)
workload within the emergency department during the shifts

Full Information

First Posted
May 24, 2013
Last Updated
June 7, 2013
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Association des Médecins des Urgences de Clermont-Ferrand, Université d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT01874704
Brief Title
Comparison of Biomarkers of Stress in Emergency Physicians Working a 24-hour Shift or a 14-hour Night Shift - the JOBSTRESS Randomized Trial
Acronym
JOBSTRESS
Official Title
Comparison of Biomarkers of Stress in Emergency Physicians Working a 24-hour Shift or a 14-hour Night Shift - the JOBSTRESS Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Association des Médecins des Urgences de Clermont-Ferrand, Université d'Auvergne

4. Oversight

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biomarkers of Stress in Emergency Physicians
Keywords
Stress, occupation, biomarkers, emergency, physicians

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
biomarkers of stress
Arm Type
Other
Arm Description
Comparison of biomarkers of stress in emergency physicians working a 24-hour shift or a 14-hour night shift
Intervention Type
Behavioral
Intervention Name(s)
Comparison of biomarkers of stress
Primary Outcome Measure Information:
Title
Putative biomarkers of stress include heart rate variability (urinary and salivary steroids, saliva immunogobulin A, ...)
Description
These biomarkers will be collected in emergency physicians
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
perceived stress measured using visual analog scale (VAS)
Time Frame
at day 1
Title
perceived fatigue (VAS)
Time Frame
at day 1
Title
sleep duration (hours)
Time Frame
at day 1
Title
sleep quality (VAS)
Time Frame
at ady 1
Title
workload within the emergency department during the shifts
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain CHAMOUX
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28271382
Citation
Dutheil F, Marhar F, Boudet G, Perrier C, Naughton G, Chamoux A, Huguet P, Mermillod M, Saadaoui F, Moustafa F, Schmidt J. Maximal tachycardia and high cardiac strain during night shifts of emergency physicians. Int Arch Occup Environ Health. 2017 Aug;90(6):467-480. doi: 10.1007/s00420-017-1211-5. Epub 2017 Mar 7.
Results Reference
derived

Learn more about this trial

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

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