Psychology, SocialNCT04436861
the Health Crisis at the Healthcare Professionals, Careers and Non-careers, a Month After the Containment Period
An observational study of Psychology, Social, run by Clinique Medipole Garonne.
Trial summary
The investigator wish to study, at a distance from the lifting of confinement (1 month), whether the psychological impact on professionals in nursing and non-nursing care establishments is associated with their living context (professional and personal situation) during confinement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychology, Social
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2020to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We are not basing the study size on statistical arguments for this observational study. The study will be offered to all healthcare professionals in order to limit bias. However, we expect a minimum of 200 responses
Who may be able to join
- Nursing and non-nursing care professionals
Who cannot join
- Refusal to participate
- Subject included in an interventional study
About this study
Official title: Demonstration of the Level of Anxiety / Depression of Healthcare Professionals and Non-healthcare Professionals One Month After the Confinement Period
The investigator wish to study, at a distance from the lifting of confinement (1 month), whether the psychological impact on professionals in nursing and non-nursing care establishments is associated with their living context (professional and personal situation) during confinement.
Read the detailed description
The context of confinement and of the global pandemic is a major source of stress for the entire population: separation of loved ones, loss of freedom, uncertainty about the infectious status, boredom. All of these factors can cause negative mental health consequences. Having little social contact was one of the factors increasing the negative psychological impact of confinement.
People suffering from psychological disorders are particularly vulnerable during quarantine periods. On March 17, 2020, the French government implemented national containment measures due to the Covid-19 epidemic.
Although the effects of containment have been studied for fragile populations, no study to date has focused on the specific population of healthcare facility staff. These caregivers have for the most part continued their professional activity, but they have been confronted with the fear of contracting or causing patients to contract Covid-19.
At a distance from the lifting of confinement (1 month), the investigator wish to study whether the highlighting of anxiety or depression in these healthcare professionals is associated with their context of life (professional and personal situation) during confinement
- Conditions
- Psychology, Social
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of the level of anxiety / depression of healthcare professionals and non-healthcare professionals one month after the confinement period
Anxiety-depression will be assessed by the hospital anxiety and depression scalequestionnaire. The context of life during confinement will be assessed by a self-questionnaire collecting data relating to lifestyle and work.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start28 Jun 2020
- Primary completion28 Jun 2020
- Study completion1 Jul 2020
Why it stopped: the sponsor decided to stop the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychology, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Medipole Garonne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436861
- Sponsor's protocol ID
- Decovid
- Status last verified
- Apr 2022
- First submitted
- 11 Jun 2020
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the Level of Anxiety / Depression of Healthcare Professionals and Non-healthcare Professionals One Month After the Confinement Period
- ClinicalTrials.gov ID
- NCT04436861
- Acronym / sponsor ID
- Decovid
- Conditions
- Psychology, Social
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: the sponsor decided to stop the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clinique Medipole GaronneUniversity, hospital or other
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 28 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator wish to study, at a distance from the lifting of confinement (1 month), whether the psychological impact on professionals in nursing and non-nursing care establishments is associated with their living context (professional and personal situation) during confinement.
Detailed description
The context of confinement and of the global pandemic is a major source of stress for the entire population: separation of loved ones, loss of freedom, uncertainty about the infectious status, boredom. All of these factors can cause negative mental health consequences. Having little social contact was one of the factors increasing the negative psychological impact of confinement.
People suffering from psychological disorders are particularly vulnerable during quarantine periods. On March 17, 2020, the French government implemented national containment measures due to the Covid-19 epidemic.
Although the effects of containment have been studied for fragile populations, no study to date has focused on the specific population of healthcare facility staff. These caregivers have for the most part continued their professional activity, but they have been confronted with the fear of contracting or causing patients to contract Covid-19.
At a distance from the lifting of confinement (1 month), the investigator wish to study whether the highlighting of anxiety or depression in these healthcare professionals is associated with their context of life (professional and personal situation) during confinement
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We are not basing the study size on statistical arguments for this observational study. The study will be offered to all healthcare professionals in order to limit bias. However, we expect a minimum of 200 responses
Key inclusion criteria (1 listed)
- Nursing and non-nursing care professionals
Key exclusion criteria (2 listed)
- Refusal to participate
- Subject included in an interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demonstration of the level of anxiety / depression of healthcare professionals and non-healthcare professionals one month after the confinement period
Time frame: 1 month
Anxiety-depression will be assessed by the hospital anxiety and depression scalequestionnaire. The context of life during confinement will be assessed by a self-questionnaire collecting data relating to lifestyle and work.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychology, Social, run by Clinique Medipole Garonne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of the level of anxiety / depression of healthcare professionals and non-healthcare professionals one month after the confinement period (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.