- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350151
National French Survey on Psychological Distress at Work of Anesthesia and Intensive Care Residents (PSY-DESAR)
April 15, 2020 updated by: François JAULIN, Facteurs Humains en Santé
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
519
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ile De France
-
Paris, Ile De France, France, 75011
- Facteurs Humains en Santé
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
French resident of intensive care and anesthesia
Description
Inclusion Criteria:
- resident of intensive care or anesthesia, french
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: baseline
|
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)
Time Frame: baseline
|
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
Time Frame: baseline
|
Investigation of the stress at work
|
baseline
|
Perceived Stress Scale (PSS)
Time Frame: baseline
|
Investigation of the stress with 10 questions
|
baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Workload
Time Frame: baseline
|
number of work-hours per week
|
baseline
|
Gender
Time Frame: baseline
|
Male, female
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 2, 2019
Primary Completion (ACTUAL)
May 1, 2019
Study Completion (ACTUAL)
May 1, 2019
Study Registration Dates
First Submitted
March 16, 2020
First Submitted That Met QC Criteria
April 15, 2020
First Posted (ACTUAL)
April 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 16, 2020
Last Update Submitted That Met QC Criteria
April 15, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200316
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
At the end of the survey
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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