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Clinical Trials/NCT04365335
NCT04365335
Completed
Not Applicable

Stress Biomarkers Leading to Professional Burnout Among People Involved in a Mobile Intensive Care Unit During the COVID-19 Pandemic

Direction Centrale du Service de Santé des Armées1 site in 1 country50 target enrollmentApril 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Occupational Stress
Sponsor
Direction Centrale du Service de Santé des Armées
Enrollment
50
Locations
1
Primary Endpoint
Professional burnout
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study is aiming at investigating whether professional burnout in people involved in the mobile intensive care unit (in French: Element Mobile de Réanimation, EMR) in Mulhouse (France) can be predicted upstream by a low mindfulness level (as a protective factor) or by a dysregulation of stress pathways with a high level of perceived stress towards an emotional event (psychological index of allostatic load), i.e. an early and silent dysfunctional physiological response (measured by the electrophysiological and biological measurements of allostasis load and parasympathetic brake).

It is part of a global approach aiming at identifying levers to prevent the allostatic load of occupational stress related to large-scale health crises.

Registry
clinicaltrials.gov
Start Date
April 25, 2020
End Date
June 12, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Direction Centrale du Service de Santé des Armées
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Volunteer staff member of the Mulhouse mobile intensive care unit (in French: Elément mobile de réanimation, EMR), including military reservists.

Exclusion Criteria

  • Pregnant or breastfeeding woman,
  • Person deprived of liberty by a judicial or administrative decision,
  • Person subject to a legal protection measure or unable of giving consent
  • Intercurrent pathology with inability to work
  • History of psychiatric disorder or cardiac pathology

Outcomes

Primary Outcomes

Professional burnout

Time Frame: 21 days after enrollment (Day 21)

Professional burnout is measured at D21 by the Burnout Measure Short Version (BMS) questionnaire It is a 10-item questionnaire used to assess burnout regardless of the occupational category. Each item is rated from 0 to 6 ("never" to "always"). An average score (sum/10) below 2.4 indicates a very low degree of burnout exposure; a score between 2.5 and 3.4 indicates a low degree of burnout exposure; a score between 3.5 and 4.4 indicates the presence of burnout; a score between 4.5 and 5.4 indicates a high degree of burnout exposure; a score above 5.5 indicates a very high degree of burnout exposure.

Mindfulness level

Time Frame: Day 1

Mindfulness level is assessed at D0 thanks to the Freiburg Mindfulness Inventory. It is a 14 item scale. Each item is rated from 1 to 4 ("almost never" to "almost always"). The total score is between 14 and 56. The mean value in a population of young adults under 36 years of age is 38.5 (+/- 5.1 standard deviation).

Secondary Outcomes

  • Perceived stress level following the emotional stimulation(Day 1)
  • Sympathetic tone at rest(Day 1)
  • Corticotropic activation at rest(Day 1)
  • Sleep quality(Day 1)
  • Mood disorders (anxiety / depression)(Day 1)
  • Post-traumatic stress disorder(Day 1)
  • Parasympathetic flexibility evolution during emotional recall(Day 1)

Study Sites (1)

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