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

Completed

• Conditions: Occupational Stress

• Registration Number: NCT04365335
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-24
• Study Start: 2020-04-25
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Primary Completion: 2020-06-12
• Study Completion: 2020-06-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Professional burnout	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	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 Outcome Measures

Name	Time	Method
Perceived stress level following the emotional stimulation	Day 1	Perceived stress level is assessed with the Perceived Stress Scale (PSS). It is a 14 item scale. Each item is rated from 0 to 5 ("never" to "very often"). The total score ranges from 0 to 56 with higher scores indicating greater perceived stress.
Sympathetic tone at rest	Day 1	The activity of the sympathetic tone is assessed by the measurement of the resting state salivary Chromogranin A.; Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall.; The activity of the sympathetic tone is assessed by the measurement of the resting salivary Chromogranin A.
Corticotropic activation at rest	Day 1	Corticotropic activation at rest is assessed through the DHEA/cortisol level ratio
Sleep quality	Day 1	Sleep quality is assesses thanks to the Leeds Sleep Evaluation questionnaire (LEEDS). It consists of ten visual analogue scales assessing four aspects of sleep: (i) quality of falling asleep and degree of drowsiness, (ii) quality of sleep, (iii) quality of wakefulness, and (iv) quality of post-wakefulness and performance.
Mood disorders (anxiety / depression)	Day 1	The Hospital Anxiety and Depression Scale (HAD-s32) is used to assess mood disorders in the general non-psychiatric population. It is used to discriminate between anxiety and depression. Scores greater than 11 are indicative of charcaterized anxiety/depression.
Post-traumatic stress disorder	Day 1	Post-traumatic disorder is assessed with the PCL-5. It is a 20-item self-administered questionnaire representing DSM-5 PTSD diagnosis symptoms rated by the subject on a scale from 0 ("not at all") to 4 ("extremely") during the past month. Scores range from 0 to 80. A score greater than of 33 evokes the presence of post-traumatic stress disorder.
Parasympathetic flexibility evolution during emotional recall	Day 1	Parasympathetic flexibility is assessed through dynamic electro-physiological analysis of cardiac and electrodermal conductance recordings.; Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall.

Trial Locations

Locations (1)

Elément Militaire de Réanimation (EMR); 🇫🇷 Mulhouse, France