Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions

NCT04517136 | Unknown

• 2 other identifiers: 2020-COVID19-282020-A01937-32
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Stress is underpinned by a biological reaction of the organism allowing the production of energy to respond to a change in the environment (or stressor). Stress reaction is expressed in behavioural, cognitive, emotional and physiological terms. This biological response is non-specific because it is the same regardless of the stressor. Its evolution over time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome (GAS) which comprises three successive phases. (i) The first phase, known as the alarm phase, corresponds to the activation of all biological mechanisms according to a trend regulation, allowing a rapid response to the stressor. (ii) The second phase of resistance which adjusts the stress response to the intensity of the perceived aggression according to a constant regulation. (iii) When the aggression disappears, a recovery phase dominated by the return of the parasympathetic brake allows a return to homeostasis (eustress). The "primum movens" of all pathologies is therefore the inability of the individual to adapt his stress response in duration and/or intensity to the course of the phases of the GAS (distress). The perception of not being in control of the situation contributes to the perceived stress and constitutes a well-established risk of distress. It is a risk factor for the emergence of burnout. It induces a biological cost called allostatic cost. Allostasis is a concept that characterizes the process of restoring homeostasis in the presence of a physiological challenge. The term "allostasis" means "achieving stability through change", and refers in part to the process of increasing sympathetic activity and corticotropic axis to promote adaptation and restore homeostasis. Allostasis works well when allostasis systems are initiated when needed and turned off when they are no longer required. Restoring homeostasis involves effective functioning of the parasympathetic system. However, when the allostasis systems remain active, such as during chronic stress, they can cause tissue burnout and accelerate pathophysiological processes. The perception of uncontrollability depends on the stress situation, the psychological and physiological characteristics of the subject and his or her technical skills in responding to the stressors of the situation. In particular, subjects with a high level of mindfulness are more accepting of uncontrollability and less likely to activate the stress response. The COVID-19 pandemic situation is a situation characterized by many uncertainties about the individual, family and work environment and the risk of COVID infection. Healthcare workers, like the military, are high-risk occupations that are particularly exposed to these uncertainties in the course of their work and continue to work in an uncertain situation. These professionals are described as a population at risk of occupational/operational burnout that the level of burnout operationalises. This ancillary study in a population of civilian and military non-healthcare workers will complement the study conducted among military health care workers. It will make it possible to isolate the specificity of each profession (civilian or military, healthcare personnel or not) with regard to the risk of burnout in the COVID context. The objective of this project is to evaluate the impact of the perception of non-control in the operational burnout of experts in their field of practice and to study the psychological and physiological mechanisms mediating the relationship between the subject's characteristics, perceived non-control and burnout.

Conditions

Covid19; SARS-CoV Infection; Burnout, Caregiver; Burnout, Professional

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: Dehydroepiandrosterone (DHEA), cortisol and chromogranin A levels

Cardiac and electrodermal recordings DEVICE

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 working working i) at the "Groupement Hospitalier de la Région de Mulhouse Sud Alsace" (GHRMSA) during the COVID-19 crisis * people of the "Groupement Commando Montagne" (GCM) deployed in Mali in June 2020.

You may qualify if:

• Volunteer personnel i) working at the "Groupement Hospitalier de la Région de Mulhouse Sud Alsace" (GHRMSA) during the COVID-19 crisis OR ii) of the "Groupement Commando Montagne" (GCM) deployed in Mali in June 2020.

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

Study Sites (1)

Groupement Hospitalier Régional de Mulhouse Sud Alsace

Mulhouse, 68100, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva sample

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Caregiver Burden; Burnout, Professional

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Occupational Stress; Occupational Diseases; Burnout, Psychological

Study Design

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

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 18, 2020
• Study Start: September 14, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

FR (1)