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OpenTrials
Completed

NCT Number: NCT03929627

Stress in Medical Staff and Controls

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.

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Key information

Conditions

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cortisol awakening response

Other

Cortisol awakening response

Other names: Heart rate variability measurement; questionnaires, spiroergometry, laboratory analysis

Primary outcomes

  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 outcomes

  1. Score of the Work ability Index

    Time frame: once at inclusion

    Comparison of the score of the Work ability Index

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Austrian Federal Ministry of Defence

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2019
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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