NCT03422952

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

May 15, 2017

Last Update Submit

November 8, 2018

Conditions

Hormone DisturbanceStress ReactionStress Related Disorder

Outcome Measures

Primary Outcomes (3)

  • Cortisol-awakening-response (CAR)

    Differences on the CAR on rescue services, clinical services and on days off.

    30 min each day, six days

  • Heart rate variability

    Continuous measurement

    six days

  • Stress questionnaire

    Subjective perceived strain with questionnaires with validated scores of stress

    first day

Other Outcomes (1)

  • Possible factors that may affect the measured parameter

    six days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical Doctor working in rescue helicopter or van

You may qualify if:

  • Medical Doctor working in rescue helicopter or van

You may not qualify if:

  • Metabolic disease
  • Autoimmune disease
  • Heart disease
  • Blood disease
  • Mental disease
  • Endocrinologic disease
  • BMI\>30
  • \>10 cigarettes/day
  • Taking cortisone medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University Hospital and University of Bern

Bern, 3011, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cortisol

MeSH Terms

Conditions

Endocrine System DiseasesFractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Lorenz Theiler, PD Dr. med

    attending anaesthesiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

February 6, 2018

Study Start

April 30, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 9, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)