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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03422952
Other study ID # 2017-00561
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2017
Est. completion date November 1, 2018

Study information

Verified date November 2018
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Stress reactions in emergency physicians will be measures using cortol-awakening-reaction, heart-rate-variability and standardised stress questionnaires


Description:

In a field study with within-subject design, there will be conducted the hormonal and physiological stress strain of emergency physicians working in rescue helicopters or van on different days of service on different headquarters. The investigation of the parameter of stress will be conducted on two days of rescue service, on two days of clinical service and as a control on two days off. The quantification of the hormonal stress strain will be carried out with the cortisol awakening response, there will be conducted 3 saliva samples with identical interval after getting up within 30 minutes. While the labour time on the rescue service and on the clinical service and the whole day off, the heart rate variability will show the degree of physiological stress. This will be measured with a pulse-belt on the chest, which the participant will carry the whole day. In addition, participants will fill out a set of questionnaire on the first day of measurement.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Medical Doctor working in rescue helicopter or van

Exclusion Criteria:

- Metabolic disease

- Autoimmune disease

- Heart disease

- Blood disease

- Mental disease

- Endocrinologic disease

- BMI>30

- >10 cigarettes/day

- Taking cortisone medication

Study Design


Locations

Country Name City State
Switzerland Bern University Hospital and University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Possible factors that may affect the measured parameter Monitoring the health status and workload:
BMI kg/m2 Heartrate bpm Bloodpressure mmHg Body-Temperature °C Time working h
six days
Primary Cortisol-awakening-response (CAR) Differences on the CAR on rescue services, clinical services and on days off. 30 min each day, six days
Primary Heart rate variability Continuous measurement six days
Primary Stress questionnaire Subjective perceived strain with questionnaires with validated scores of stress first day
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