Impact of the COVID-19 Pandemic on the Quality of Psychological Life (COVID-PRO-IMPACT) (COVIDPROIMPACT)

December 17, 2020 updated by: Hospices Civils de Lyon

Impact of the COVID-19 Pandemic on the Quality of Psychological Life of Healthcare Professionals

The COVID-19 pandemic is profoundly changing the way people live and work. After the health impact, it is the mental and psychological impact that reaches varying degrees in the entire world population. The previous Asian epidemics have had a lasting impact on the health professionals concerned.

In France, no study has yet assessed the psychological impact of this health crisis on the level of health professionals. Investigators propose to study prospectively the evolution of the state of stress and anxiety of all the professionals practicing within the gynecology-obstetrics departments of 18 French hospitals.

Investigators also hypothesize that the mental repercussions in terms of stress and anxiety within the same service could be different depending on the professional status and the place of exercise (the French regions being impacted in different ways).

In addition to the epidemiological interest, the results of this study may help us to target regions and professionals who will need psychological support during and after this serious health crisis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1565

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

  • France
      • Angers, France
        • Gynécologie-Obstétrique CHU de Angers
      • Bordeaux, France
        • Gynécologie-Obstétrique Hôpital Pellegrin
      • Brest, France
        • Gynécologie-Obstétrique CHRU de Brest
      • Bron, France, 69677
        • Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
      • Clamart, France
        • Gynécologie-Obstétrique Hôpital Antoine Béclère (APHP)
      • La Tronche, France
        • Gynécologie-Obstétrique CHU Grenoble-Alpes, Hôpital Couple Enfant
      • Le Kremlin-Bicêtre, France
        • Gynécologie-Obstétrique Hôpital BICETRE (APHP)
      • Lille, France
        • Gynécologie-Obstétrique Hôpital Jeanne de Flandre - CHRU Lille
      • Limoges, France
        • Gynécologie-Obstétrique Hôpital de la Mère et de l'Enfant
      • Lyon, France, 69317
        • Gynécologie-Obstétrique Hôpital de la Croix Rousse
      • Marseille, France
        • Gynécologie-Obstétrique Hôpital La Conception
      • Paris, France
        • Gynécologie-Obstétrique Hôpital de la Pitié Salpêtrière (APHP)
      • Paris, France
        • Gynécologie-Obstétrique Maternité Port-Royal, Groupe Hospitalier Cochin-Broca- Hotel Dieu (APHP)
      • Poitiers, France
        • Gynécologie-Obstétrique CHU de Poitiers
      • Reims, France
        • Gynécologie-Obstétrique CHU Reims - Institut Mère Enfant Alix de Champagne
      • Rennes, France
        • Gynécologie-Obstétrique CHU de Rennes
      • Saint-Étienne, France
        • Gynécologie-Obstétrique CHU de Saint Etienne
      • Strasbourg, France
        • Gynécologie-Obstétrique Hôpital de Hautepierre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Person over 18 years of age practicing a health profession in the participating gynecology and obstetrics departments

Description

Inclusion Criteria:

  • person over 18
  • person exercising a profession in the health field
  • person having expressed his non-opposition

Exclusion Criteria:

  • inability to understand the information given and the questionnaire
  • person deprived of liberty, person under guardianship.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stress state score, during the confinement period
Time Frame: About 10 minutes ( Questionnaire filling time)
Stress state score, during the confinement period, established by a comparison VAS (visual analogue scale) compared to a period outside COVID-19 (from -5: considerable degradation to +5: considerable improvement, with 0: no change)
About 10 minutes ( Questionnaire filling time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL20_0413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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