Clinical trial NCT03929627: Stress in Medical Staff and Controls
Official title: Stress in Medical Staff and Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Austrian Federal Ministry of Defence
First posted: 2019-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of 140 female and male participants aged 25-65 years.

* Group 1 consists of 70 participants belonging to medical staff of the Medical University of Vienna/University Hospital of Vienna and is divided into subgroups consisting of medical technical assistants, nurses, assistant physicians and physicians.
* Group 2 consists of 70 participants and is recruited from the general staff of the Austrian Federal Ministry of Defence and Sports, Austrian Armed Forces.

Brief summary: It is expected that medical personnel is exposed to more work-related psychic stress compared to controls and that this burden manifests itself by an increased activity level of the resulting in higher cortisol levels and a decreased HRV. In addition, one is interested in the stress-response/coping strategies of the individuals and believe that regular physical activity might "buffer" the influence of stress on the HPAA-hormones and HRV.

Detailed description: Background Medical personnel is increasingly exposed to psychological stress e.g. caused by work intensification combined with time pressure, fear of job loss, lacking appreciation and/or freedom of decision, causing psychopathological or psychosomatic symptoms involving, inter alia, the cardiovascular system. The aims of the present study are the investigation of the current amount of work-related psychological stress, its perception and underlying reasons, as well as applied recovering strategies (e.g. physical activity) in Austrian health care professionals and in controls.

Material and methods In total, 140 female and male participants (70 participants belong to medical staff; 70 participants belong to non-medical staff) between the ages of 25-65 years will be recruited. The individual stress perception will be evaluated using questionnaires (e.g. Trier Inventory for Chronic Stress, TICS; Brief Symptom Inventory, BSI-18, Short Work Evaluation). 24h salivary cortisol (at 5 time points) and heart rate variability (HRV) measurement will be performed to objectify the influence of stress on the physical body. The physical activity level will be tested by performing a cardiopulmonary exercise test (bicycle spiroergometry).

Expected results From the present study the investigators expects insight into: first, the individual perception of work-related psychological stress among health care professionals compared to the controls; second, the association of occupational stress, HRV and laboratory stress parameters and third, the role of a good physical performance on psychological stress perception.

Eligibility criteria: Inclusion Criteria:

* female and male participants aged 25-65 years
* for Group 1: Affiliation to medical staff
* for Group 2: No Affiliation to medical staff

Exclusion Criteria:

* Age \<25 or \>65 years
* Body weight \>130 kg
* Current pregnancy
* Anamnestic current infectious or oncologic disease
* Disability to perform a bicycle stress test
* Atrial fibrillation
* Pace maker/ICD implantation
* Current cortison and/or dexamethasone therapy

Primary outcomes:
measure: Cortisol 1
timeFrame: Measurement of salivary cortisol right after awakening within 24 hour testing period
measure: Cortisol 2
timeFrame: Measurement of salivary cortisol 30 minutes after awakening within 24 hour testing period
measure: Cortisol 3
timeFrame: Measurement of salivary cortisol at 10 am within 24 hour testing period
measure: Cortisol 4
timeFrame: Measurement of salivary cortisol at 4 pm within 24 hour testing period
measure: Cortisol 5
timeFrame: Measurement of salivary cortisol before going to sleep within 24 hour testing period
Secondary outcomes:
measure: Score of the Work ability Index
timeFrame: once at inclusion
Other outcomes:
measure: Score of the Effort-Reward Imbalance Questionnaire (ERI)
timeFrame: once at inclusion
measure: Heart rate variability
timeFrame: once at inclusion over 24 hours, measurement of the parameters every 10 minutes
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: