NCT04375644

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,565

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

May 4, 2020

Last Update Submit

December 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stress state score, during the confinement period

    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)

Interventions

Assessement of evolution of the psychological quality of life of health professionals during the confinement period linked to the COVID-19 pandemic by two questionnaires (one during the confinement period and the second one month after the end of the confinement period)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Gynécologie-Obstétrique CHU de Angers

Angers, France

Location

Gynécologie-Obstétrique Hôpital Pellegrin

Bordeaux, France

Location

Gynécologie-Obstétrique CHRU de Brest

Brest, France

Location

Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Bron, 69677, France

Location

Gynécologie-Obstétrique Hôpital Antoine Béclère (APHP)

Clamart, France

Location

Gynécologie-Obstétrique CHU Grenoble-Alpes, Hôpital Couple Enfant

La Tronche, France

Location

Gynécologie-Obstétrique Hôpital BICETRE (APHP)

Le Kremlin-Bicêtre, France

Location

Gynécologie-Obstétrique Hôpital Jeanne de Flandre - CHRU Lille

Lille, France

Location

Gynécologie-Obstétrique Hôpital de la Mère et de l'Enfant

Limoges, France

Location

Gynécologie-Obstétrique Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Gynécologie-Obstétrique Hôpital La Conception

Marseille, France

Location

Gynécologie-Obstétrique Hôpital de la Pitié Salpêtrière (APHP)

Paris, France

Location

Gynécologie-Obstétrique Maternité Port-Royal, Groupe Hospitalier Cochin-Broca- Hotel Dieu (APHP)

Paris, France

Location

Gynécologie-Obstétrique CHU de Poitiers

Poitiers, France

Location

Gynécologie-Obstétrique CHU Reims - Institut Mère Enfant Alix de Champagne

Reims, France

Location

Gynécologie-Obstétrique CHU de Rennes

Rennes, France

Location

Gynécologie-Obstétrique CHU de Saint Etienne

Saint-Etienne, France

Location

Gynécologie-Obstétrique Hôpital de Hautepierre

Strasbourg, France

Location

Related Publications (1)

  • Chene G, Nohuz E, Cerruto E, Moret S, Atallah A, Saoud M; French Covid-Pro-Impact Consortium. Psychological impact on healthcare workers in obstetrics and gynecology in France in 18 French University Hospitals during the first Covid-19 lockdown: a prospective observational study. J Psychosom Obstet Gynaecol. 2022 Dec;43(4):433-440. doi: 10.1080/0167482X.2021.2014812. Epub 2021 Dec 16.

MeSH Terms

Conditions

COVID-19Stress, Psychological

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 5, 2020

Study Start

May 7, 2020

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations