Stress Response in Emergency Among Physicians in Helicopt... | NCT03422952

Studies
Stress Response in Emergency Among Physicians in Helicopter and Ambulance Based Emergency Medical Systems

NCT03422952

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Nov 9, 2018Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Hormone Disturbance
Stress Reaction
Stress Related Disorder

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2017Actual

Primary Completion Date

Nov 1, 2018Actual

Completion Date

Nov 1, 2018Actual

First Submitted Date

May 15, 2017

First Submission Date that Met QC Criteria

Jan 30, 2018

First Posted Date

Feb 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2018

Last Update Posted Date

Nov 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Medical Doctor working in rescue helicopter or van

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lorenz Theiler, PD Dr. med	attending anaesthesiologist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bern University Hospital and University of Bern		Bern		3011	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004700	Endocrine System Diseases
D015775	Fractures, Stress

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

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Browse Branches

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