- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03422952
Stress Response in Emergency Among Physicians in Helicopter and Ambulance Based Emergency Medical Systems
November 8, 2018 updated by: University Hospital Inselspital, Berne
Hormonal and Physiological Stress Response of Medical Doctors Working in Rescue Helicopter or Van
Stress reactions in emergency physicians will be measures using cortol-awakening-reaction, heart-rate-variability and standardised stress questionnaires
Study Overview
Status
Completed
Detailed 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.
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bern, Switzerland, 3011
- Bern University Hospital and University of Bern
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Medical Doctor working in rescue helicopter or van
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortisol-awakening-response (CAR)
Time Frame: 30 min each day, six days
|
Differences on the CAR on rescue services, clinical services and on days off.
|
30 min each day, six days
|
|
Heart rate variability
Time Frame: six days
|
Continuous measurement
|
six days
|
|
Stress questionnaire
Time Frame: first day
|
Subjective perceived strain with questionnaires with validated scores of stress
|
first day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Possible factors that may affect the measured parameter
Time Frame: six days
|
Monitoring the health status and workload: BMI kg/m2 Heartrate bpm Bloodpressure mmHg Body-Temperature °C Time working h |
six days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lorenz Theiler, PD Dr. med, attending anaesthesiologist
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2017
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
May 15, 2017
First Submitted That Met QC Criteria
January 30, 2018
First Posted (Actual)
February 6, 2018
Study Record Updates
Last Update Posted (Actual)
November 9, 2018
Last Update Submitted That Met QC Criteria
November 8, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-00561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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