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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Stress in Medical Staff and Controls

Clinicaltrials.gov identifier NCT03929627

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted February 24, 2021

Study Description

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:Stress
  • Intervention/Treatment: Other: Cortisol awakening response
  • Phase: N/A
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 Design
  • 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 2017
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: August 2022
Groups and Cohorts
Groups/Cohorts 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
: 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
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 25 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • 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 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

Contacts and Locations
Contacts

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

Locations

Austria
Medical University of Vienna
Vienna

Sponsors and Collaborators

Medical University of Vienna

Austrian Federal Ministry of Defence

More Information
  • Responsible Party: 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: February 24, 2021
  • Last Verified: February 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: Data is available only for the study team
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No