NCT01874704

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

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

April 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

May 24, 2013

Last Update Submit

June 7, 2013

Conditions

Keywords

Stress, occupation, biomarkers, emergency, physicians

Outcome Measures

Primary Outcomes (1)

  • Putative biomarkers of stress include heart rate variability (urinary and salivary steroids, saliva immunogobulin A, ...)

    These biomarkers will be collected in emergency physicians

    at day 1

Secondary Outcomes (5)

  • perceived stress measured using visual analog scale (VAS)

    at day 1

  • perceived fatigue (VAS)

    at day 1

  • sleep duration (hours)

    at day 1

  • sleep quality (VAS)

    at ady 1

  • workload within the emergency department during the shifts

    at day 1

Study Arms (1)

biomarkers of stress

OTHER

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

Behavioral: Comparison of biomarkers of stress

Interventions

biomarkers of stress

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • emergency physician

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alain CHAMOUX

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2013

First Posted

June 11, 2013

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2011

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations