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Completed

NCT Number: NCT04365335

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

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.

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Key information

Conditions

Occupational Stress Behavior Behavioral Symptoms Occupational Diseases Stress, Psychological

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elément Militaire de Réanimation (EMR)

Mulhouse, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. Perceived stress level following the emotional stimulation

    Time frame: 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.

  2. Parasympathetic flexibility evolution during emotional recall

    Time frame: 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.

  3. Sympathetic tone at rest

    Time frame: 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.

  4. Corticotropic activation at rest

    Time frame: Day 1

    Corticotropic activation at rest is assessed through the DHEA/cortisol level ratio

  5. Mood disorders (anxiety / depression)

    Time frame: 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.

  6. Post-traumatic stress disorder

    Time frame: 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.

  7. Sleep quality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Collaborators

  • Institut de Recherche Biomedicale des Armees

Registry information

Acronym: AUTONOMIC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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