Stress in Medical Staff and Controls

Stress Clinical Trial

Official title:

Stress in Medical Staff and Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929627
• Other study ID #: 1939/2016
• Status: Completed
• Start date: April 30, 2017
• Est. completion date: October 20, 2023

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Other:
• Cortisol awakening response
Cortisol awakening response

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Austrian Federal Ministry of Defence

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Score of the Effort-Reward Imbalance Questionnaire (ERI)	Comparison of the score of the Effort-Reward Imbalance Questionnaire (ERI) by Siegrist	once at inclusion
Other	Heart rate variability	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.	once at inclusion over 24 hours, measurement of the parameters every 10 minutes
Primary	Cortisol 1	Measurement of salivary cortisol right after awakening	Measurement of salivary cortisol right after awakening within 24 hour testing period
Primary	Cortisol 2	Measurement of salivary cortisol 30 minutes after awakening	Measurement of salivary cortisol 30 minutes after awakening within 24 hour testing period
Primary	Cortisol 3	Measurement of salivary cortisol at 10 am	Measurement of salivary cortisol at 10 am within 24 hour testing period
Primary	Cortisol 4	Measurement of salivary cortisol at 4 pm	Measurement of salivary cortisol at 4 pm within 24 hour testing period
Primary	Cortisol 5	Measurement of salivary cortisol before going to sleep	Measurement of salivary cortisol before going to sleep within 24 hour testing period
Secondary	Score of the Work ability Index	Comparison of the score of the Work ability Index	once at inclusion