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Stress in Medical Staff and Controls

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ClinicalTrials.gov Identifier: NCT03929627
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Austrian Federal Ministry of Defence
Information provided by (Responsible Party):
Michael Sponder, Medical University of Vienna

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.

Condition or disease Intervention/treatment
Stress Other: Cortisol awakening response

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.


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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Other
Time Perspective: Other
Official Title: Stress in Medical Staff and Controls
Actual Study Start Date : April 30, 2017
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 1, 2021


Group/Cohort Intervention/treatment
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.
Other: Cortisol awakening response
Cortisol awakening response
Other Name: Heart rate variability measurement; questionnaires, spiroergometry, laboratory analysis

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.
Other: Cortisol awakening response
Cortisol awakening response
Other Name: Heart rate variability measurement; questionnaires, spiroergometry, laboratory analysis




Primary Outcome Measures :
  1. Cortisol 1 [ Time Frame: Measurement of salivary cortisol right after awakening within 24 hour testing period ]
    Measurement of salivary cortisol right after awakening

  2. Cortisol 2 [ Time Frame: Measurement of salivary cortisol 30 minutes after awakening within 24 hour testing period ]
    Measurement of salivary cortisol 30 minutes after awakening

  3. Cortisol 3 [ Time Frame: Measurement of salivary cortisol at 10 am within 24 hour testing period ]
    Measurement of salivary cortisol at 10 am

  4. Cortisol 4 [ Time Frame: Measurement of salivary cortisol at 4 pm within 24 hour testing period ]
    Measurement of salivary cortisol at 4 pm

  5. Cortisol 5 [ Time Frame: Measurement of salivary cortisol before going to sleep within 24 hour testing period ]
    Measurement of salivary cortisol before going to sleep


Secondary Outcome Measures :
  1. Score of the Work ability Index [ Time Frame: once at inclusion ]
    Comparison of the score of the Work ability Index


Other Outcome Measures:
  1. Score of the Effort-Reward Imbalance Questionnaire (ERI) [ Time Frame: once at inclusion ]
    Comparison of the score of the Effort-Reward Imbalance Questionnaire (ERI) by Siegrist

  2. Heart rate variability [ Time Frame: once at inclusion over 24 hours, measurement of the parameters every 10 minutes ]
    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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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929627


Contacts
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Contact: Michael Sponder 00434040046510 michael.sponder@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Michael Sponder, Dr.       michael.sponder@meduniwien.ac.at   
Sub-Investigator: Michael Sponder, Dr.         
Sponsors and Collaborators
Medical University of Vienna
Austrian Federal Ministry of Defence

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Responsible Party: Michael Sponder, Principal investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03929627     History of Changes
Other Study ID Numbers: 1939/2016
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data is available only for the study team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents