- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929627
Stress in Medical Staff and Controls
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Michael Sponder
- Phone Number: 00434040046510
- Email: michael.sponder@meduniwien.ac.at
Study Locations
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Vienna, Austria, 1090
- Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1 - Medical personnell
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.
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Cortisol awakening response
Other Names:
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Group 2 - Control
Group 2 consists of 70 participants and is recruited from the General non-medical staff of the Austrian Federal Ministry of Defence and Sports, Austrian Armed Forces.
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Cortisol awakening response
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortisol 1
Time Frame: Measurement of salivary cortisol right after awakening within 24 hour testing period
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Measurement of salivary cortisol right after awakening
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Measurement of salivary cortisol right after awakening within 24 hour testing period
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Cortisol 2
Time Frame: Measurement of salivary cortisol 30 minutes after awakening within 24 hour testing period
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Measurement of salivary cortisol 30 minutes after awakening
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Measurement of salivary cortisol 30 minutes after awakening within 24 hour testing period
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Cortisol 3
Time Frame: Measurement of salivary cortisol at 10 am within 24 hour testing period
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Measurement of salivary cortisol at 10 am
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Measurement of salivary cortisol at 10 am within 24 hour testing period
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Cortisol 4
Time Frame: Measurement of salivary cortisol at 4 pm within 24 hour testing period
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Measurement of salivary cortisol at 4 pm
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Measurement of salivary cortisol at 4 pm within 24 hour testing period
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Cortisol 5
Time Frame: Measurement of salivary cortisol before going to sleep within 24 hour testing period
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Measurement of salivary cortisol before going to sleep
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Measurement of salivary cortisol before going to sleep within 24 hour testing period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of the Work ability Index
Time Frame: once at inclusion
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Comparison of the score of the Work ability Index
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once at inclusion
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of the Effort-Reward Imbalance Questionnaire (ERI)
Time Frame: once at inclusion
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Comparison of the score of the Effort-Reward Imbalance Questionnaire (ERI) by Siegrist
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once at inclusion
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Heart rate variability
Time Frame: once at inclusion over 24 hours, measurement of the parameters every 10 minutes
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Measurement of low frequencies (LF) and high frequencies (HF) by heart rate variability measurement for 24h.
The measurement runs for 24h, a median value of the 24h-measurement will be provided.
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once at inclusion over 24 hours, measurement of the parameters every 10 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1939/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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