Hormone DisturbanceNCT03422952
Stress Response in Emergency Among Physicians in Helicopter and Ambulance Based Emergency Medical Systems
An observational study of Hormone Disturbance and Stress Reaction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Stress reactions in emergency physicians will be measures using cortol-awakening-reaction, heart-rate-variability and standardised stress questionnaires Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hormone Disturbance, Stress Reaction, Stress Related Disorder
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2017to 1 Nov 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical Doctor working in rescue helicopter or van
Who may be able to join
- Medical Doctor working in rescue helicopter or van
Who cannot join
- Metabolic disease
- Autoimmune disease
- Heart disease
- Blood disease
- Mental disease
- Endocrinologic disease
Show all 9Show fewer
- BMI>30
- >10 cigarettes/day
- Taking cortisone medication
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bern University Hospital and University of Bern
Bern, 3011
About this study
Official title: 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
Read the 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.
- Medical subject headings
- Endocrine System Diseases, Fractures, Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol-awakening-response (CAR)
Differences on the CAR on rescue services, clinical services and on days off.
Measured: 30 min each day, six days
Heart rate variability
Continuous measurement
Measured: six days
Stress questionnaire
Subjective perceived strain with questionnaires with validated scores of stress
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start30 Apr 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone DisturbanceStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenz Theiler, PD Dr. med, Principal investigator, attending anaesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422952
- Sponsor's protocol ID
- 2017-00561
- Other IDs
- 2017
- Status last verified
- Nov 2018
- First submitted
- 15 May 2017
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal and Physiological Stress Response of Medical Doctors Working in Rescue Helicopter or Van
- ClinicalTrials.gov ID
- NCT03422952
- Acronym / sponsor ID
- 2017-00561
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 6 Feb 2018 (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.
Stress reactions in emergency physicians will be measures using cortol-awakening-reaction, heart-rate-variability and standardised stress questionnaires
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical Doctor working in rescue helicopter or van
Key inclusion criteria (1 listed)
- Medical Doctor working in rescue helicopter or van
Key exclusion criteria (9 listed)
- Metabolic disease
- Autoimmune disease
- Heart disease
- Blood disease
- Mental disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Heart rate variability
Time frame: six days
Continuous measurement
Stress questionnaire
Time frame: first day
Subjective perceived strain with questionnaires with validated scores of stress
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 9 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Lorenz Theiler, PD Dr. med principal investigator
attending anaesthesiologist
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 Hormone Disturbance and Stress Reaction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 9 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 9 Nov 2018. 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 Switzerland. 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-awakening-response (CAR) (time frame: 30 min each day, six days). The study lists 3 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 9 Nov 2018.