National French Survey on Psychological Distress at Work... | NCT04350151

Studies
National French Survey on Psychological Distress at Work of Anesthesia and Intensive Care Residents

NCT04350151

Sponsor

Facteurs Humains en Santé

Status

Completed

Last Update Posted

Apr 16, 2020Actual

Enrollment

519Actual

Phase

Not provided

Conditions

Burnout, Professional
Intensive Care
Anesthesia
Depression, Anxiety
Stress, Psychological
Fatigue
Work Load

Interventions

no intervention

Countries

France

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

Apr 2020

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

Feb 2, 2019Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

May 1, 2019Actual

First Submitted Date

Mar 16, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 16, 2020Actual

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

Apr 15, 2020

Last Update Posted Date

Apr 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

François JAULIN, Principal Investigator, Facteurs Humains en SantéPrincipal Investigator

Lead Sponsor

Facteurs Humains en SantéOTHER

Collaborators

Name	Class
Dominique FLETCHER MD-PhD	UNKNOWN
François Marty MD	UNKNOWN
Dinh Phong Nguyen MD	UNKNOWN
Loic Druette MD

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Psychological distress is a significant problem for healthcare professionals and students in training. The investigator question the prevalence of this problem in French residents in anaesthesia and intensive care training.

Detailed Description

The investigator performed an observational study on the national population of anaesthesia residents. A questionnaire was sent to all residents composed with validated questionnaires analyzing psychological distress (Hospital Anxiety and Depression Scale (HADS), Copenhagen Burnout Inventory (CBI), Perceived Stress Scale (PSS), Karasek's questionnaire; work-related questions (work hours per week, night shift per month, application of safety rest after night shift, average time to start and end work, break time and time for food per day; two semi-open work-related questions (main stressor during internship, professional orientation); a free verbatim.

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

No data available

No data is available for this block.

Enrollment

519Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Behavioral	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital Anxiety and Depression Scale (HADS)	Investigation of the anxiety and depression with 14 questions, the cut-off score is more than 11 for anxiety or depression	baseline
Copenhagen Burnout Inventory (CBI)	Investigation of the burnout on 3 axes: personal, professional and relational with 19 questions, the cut-off score is 50 to identify a burnout	baseline
Karacek's questionnaire	Investigation of the stress at work	baseline
Perceived Stress Scale (PSS)	Investigation of the stress with 10 questions	baseline

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Workload	number of work-hours per week	baseline
Gender	Male, female	baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

resident of intensive care or anesthesia, french

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

French resident of intensive care and anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Facteurs Humains en Santé		Paris	Île-de-France Region	75011	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

At the end of the survey

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002055	Burnout, Professional
D003863	Depression
D001008	Anxiety Disorders
D013315	Stress, Psychological
D005221	Fatigue

Ancestor Terms

ID	Term
D000073397	Occupational Stress
D009784	Occupational Diseases
D000077062	Burnout, Psychological
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided