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

NCT04365335 | Completed

• 2 other identifiers: 2020-COVID19-112020-A01058-31
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Occupational Stress

Outcome Measures

Primary Outcomes (2)

• Professional burnout

  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.

  21 days after enrollment (Day 21)

• Mindfulness level

  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).

  Day 1

Secondary Outcomes (7)

• Perceived stress level following the emotional stimulation

  Day 1

• Parasympathetic flexibility evolution during emotional recall

  Day 1

• Sympathetic tone at rest

  Day 1

• Corticotropic activation at rest

  Day 1

• Mood disorders (anxiety / depression)

  Day 1

Interventions

Assessment of work-related stress BEHAVIORAL

Assessment of burnout, mindfulness, interoceptive awareness, anxiety, post-traumatic stress disorder, coping flexibility and sleep through questionnaires.

Saliva sample collection BIOLOGICAL

Saliva sample is collected before and after emotional stimulation in order to measure resting-state allostatic load biomarkers: DHEA, cortisol and chromogranine A levels

Cardiac and electrodermal recordings OTHER

Electrocardiogram and electrodermal activity (tonic and phasic) is collected at rest and after emotional stimulation.

Assessment of behavioral response to emotional stimulation BEHAVIORAL

Emotional stimulation involves asking the participants to remember a recent event related to the COVID-19 crisis that has been emotionally difficult for them. Perceived stress, situational awareness and emotions is assessed after emotional stimulation through questionnaires.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of people who have been deployed to serve at the mobile intensive care unit in Mulhouse (France) during the Covid-19 crisis.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead
• Institut de Recherche Biomedicale des Armees: collaborator

Study Sites (1)

Elément Militaire de Réanimation (EMR)

Mulhouse, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva sample

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: April 25, 2020
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

FR (1)