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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04350151
Other study ID # 20200316
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2019
Est. completion date May 1, 2019

Study information

Verified date April 2020
Source Facteurs Humains en Santé
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 519
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- resident of intensive care or anesthesia, french

Exclusion Criteria:

- none

Study Design


Intervention

Behavioral:
no intervention
no intervention

Locations

Country Name City State
France Facteurs Humains en Santé Paris Ile De France

Sponsors (7)

Lead Sponsor Collaborator
Facteurs Humains en Santé Benoit Plaud MD-PhD, Clément Duret MD, Dinh Phong Nguyen MD, Dominique FLETCHER MD-PhD, François Marty MD, Loic Druette MD

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Workload number of work-hours per week baseline
Other Gender Male, female baseline
Primary 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
Primary 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
Primary Karacek's questionnaire Investigation of the stress at work baseline
Primary Perceived Stress Scale (PSS) Investigation of the stress with 10 questions baseline
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