NCT04334083

Brief Summary

Emergency medicine is a unique specialty focusing on a breadth of acute care, on demand . Shift work is also a fundamental component of emergency medicine, and is associated with chronic stress, including stress at work. Consequently, stress may lead to symptoms of mental exhaustion, physical fatigue, detachment from work, and feelings of diminished competence . Emergency physicians (EPs) are exposed to a complex interplay between stress (life-and-death emergencies - a defining characteristic of their job), sleep deprivation, and fatigue due to repeated changes in, and duration of shifts. Work-related exhaustion can lead to various physical and psychological symptoms, and also may be associated with delayed decision-making . The combined effects of stress and fatigue can impact on job performance, often resulting in otherwise preventable medical errors. Moreover, prolonged stress may expose EPs to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease. All these contribute to the premature departure of EPs to other specialties. Furthermore, low HRV has been associated with stress, burnout, and is linked with an increased risk of cardiovascular diseases. This project proposes to evaluate if life-and-death emergencies or specific situations will induce abrupt changes in HRV among emergency physicians. Moreover, we would like to compare reactions between being an actor (EPs) and being a spectator and assess the role of expertise and habituation to stressful emergency situations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

February 17, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

March 25, 2020

Last Update Submit

December 28, 2023

Conditions

Keywords

Heart rate variabilitystresscortisol

Outcome Measures

Primary Outcomes (2)

  • heart rate variability at night work

    measure of abrupt changes in HRV signals during 14 hours

    from 18:30 to 8:30, during the 14 hours of the night shift

  • heart rate variability at day work

    measure of abrupt changes in HRV signals during 10 hours

    from 8:30 to 18:30, during the 10 hours of the day shift

Secondary Outcomes (67)

  • Stress

    18:30, baseline of the night shift

  • Fatigue

    at 18:30, baseline of the night shift

  • Stress

    at 8h30, at the end of the night shift

  • Fatigue

    at 8:30, at the end of the night shift

  • Stress

    at 8:30, 24 hours after the end of night shift

  • +62 more secondary outcomes

Study Arms (2)

Emergency physicians

EXPERIMENTAL

actors during the work

Behavioral: Comparison of biomarkers of stress

medical externship student

EXPERIMENTAL

spectator during the emergency physician work

Behavioral: Comparison of biomarkers of stress

Interventions

Emergency will be followed during a night shift and the rest day et during a day shift and the rest day. They will be observed by a medical externship student. We will assess the role of expertise and habituation to stressful emergency situations.

Emergency physiciansmedical externship student

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency physicians from the emergency department of CHU Clermont-Ferrand will be accompanied by a medical externship student.
  • Ability to give a written informed consent.

You may not qualify if:

  • Participant refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Frédéric Dutheil

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2020

First Posted

April 6, 2020

Study Start

February 17, 2022

Primary Completion

December 21, 2023

Study Completion

December 21, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations