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

Occupational Stress Clinical Trial

— AUTONOMIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365335
• Other study ID #: 2020-COVID19-11
• Secondary ID: 2020-A01058-31
• Status: Completed
• Start date: April 25, 2020
• Est. completion date: June 12, 2020

Study information

• Verified date: March 2021
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Occupational Stress

Intervention

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

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

Other:
• Cardiac and electrodermal recordings
Electrocardiogram and electrodermal activity (tonic and phasic) is collected at rest and after emotional stimulation.

Behavioral:
• Assessment of behavioral response to emotional stimulation
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.

Locations

Country	Name	City	State
France	Elément Militaire de Réanimation (EMR)	Mulhouse

Sponsors (2)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées	Institut de Recherche Biomedicale des Armees

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Perceived stress level following the emotional stimulation	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.	Day 1
Secondary	Parasympathetic flexibility evolution during emotional recall	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.	Day 1
Secondary	Sympathetic tone at rest	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.	Day 1
Secondary	Corticotropic activation at rest	Corticotropic activation at rest is assessed through the DHEA/cortisol level ratio	Day 1
Secondary	Mood disorders (anxiety / depression)	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.	Day 1
Secondary	Post-traumatic stress disorder	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.	Day 1
Secondary	Sleep quality	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.	Day 1