StressNCT03929627
Stress in Medical Staff and Controls
An observational study of Stress, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Cortisol awakening response
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 30 Apr 2017to 20 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- female and male participants aged 25-65 years
- for Group 1: Affiliation to medical staff
- for Group 2: No Affiliation to medical staff
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stress
- Being tested
- Cortisol awakening response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortisol awakening responseOther
Also called Heart rate variability measurement; questionnaires, spiroergometry, laboratory analysis
Cortisol awakening response
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: Cortisol awakening response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol 1
Measurement of salivary cortisol right after awakening
Measured: Measurement of salivary cortisol right after awakening within 24 hour testing period
Cortisol 2
Measurement of salivary cortisol 30 minutes after awakening
Measured: Measurement of salivary cortisol 30 minutes after awakening within 24 hour testing period
Cortisol 3
Measurement of salivary cortisol at 10 am
Measured: Measurement of salivary cortisol at 10 am within 24 hour testing period
Cortisol 4
Measurement of salivary cortisol at 4 pm
Measured: Measurement of salivary cortisol at 4 pm within 24 hour testing period
Cortisol 5
Measurement of salivary cortisol before going to sleep
Measured: Measurement of salivary cortisol before going to sleep within 24 hour testing period
Secondary outcomes (1)
Score of the Work ability Index
Comparison of the score of the Work ability Index
Measured: once at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start30 Apr 2017
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Federal Ministry of Defence
- Responsible party
- Principal investigator, Michael Sponder, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929627
- Sponsor's protocol ID
- 1939/2016
- Status last verified
- Oct 2023
- First submitted
- 31 Aug 2017
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available only for the study team
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress in Medical Staff and Controls
- ClinicalTrials.gov ID
- NCT03929627
- Acronym / sponsor ID
- 1939/2016
- Conditions
- Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Austrian Federal Ministry of Defence
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Medical personnell | – | Other: Cortisol awakening responseGroup 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 - Control | – | Other: Cortisol awakening responseGroup 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- female and male participants aged 25-65 years
- for Group 1: Affiliation to medical staff
- for Group 2: No Affiliation to medical staff
Key exclusion criteria (8 listed)
- Age <25 or >65 years
- Body weight >130 kg
- Current pregnancy
- Anamnestic current infectious or oncologic disease
- Disability to perform a bicycle stress test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cortisol awakening responseAlso: Heart rate variability measurement; questionnaires, spiroergometry, laboratory analysisCortisol awakening response | Other | Group 1 - Medical personnell, Group 2 - Control |
Primary outcome
Cortisol 1
Time frame: Measurement of salivary cortisol right after awakening within 24 hour testing period
Measurement of salivary cortisol right after awakening
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
Cortisol 3
Time frame: Measurement of salivary cortisol at 10 am within 24 hour testing period
Measurement of salivary cortisol at 10 am
Cortisol 4
Time frame: Measurement of salivary cortisol at 4 pm within 24 hour testing period
Measurement of salivary cortisol at 4 pm
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
1 secondary outcome
Score of the Work ability Index
Time frame: once at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No. Data is available only for the study team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol 1 (time frame: Measurement of salivary cortisol right after awakening within 24 hour testing period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.