Covid 19COVIDPROIMPACTNCT04375644
Impact of the COVID-19 Pandemic on the Quality of Psychological Life (COVID-PRO-IMPACT)
An observational study of Covid 19 and Stress, Psychological, run by Hospices Civils de Lyon at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid 19, Stress, Psychological
- What is being tested?
- Questionnaires on psychological quality of life
- How many people
- 1,565 participants
- Where
- 18 sitesFrance
- Study dates
- 7 May 2020to 15 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Person over 18 years of age practicing a health profession in the participating gynecology and obstetrics departments
Who may be able to join
- person over 18
- person exercising a profession in the health field
- person having expressed his non-opposition
Who cannot join
- inability to understand the information given and the questionnaire
- person deprived of liberty, person under guardianship.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Gynécologie-Obstétrique CHU de Angers
Angers
Gynécologie-Obstétrique Hôpital Pellegrin
Bordeaux
Gynécologie-Obstétrique CHRU de Brest
Brest
Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, 69677
Gynécologie-Obstétrique Hôpital Antoine Béclère (APHP)
Clamart
Gynécologie-Obstétrique CHU Grenoble-Alpes, Hôpital Couple Enfant
La Tronche
Gynécologie-Obstétrique Hôpital BICETRE (APHP)
Le Kremlin-Bicêtre
Gynécologie-Obstétrique Hôpital Jeanne de Flandre - CHRU Lille
Lille
Gynécologie-Obstétrique Hôpital de la Mère et de l'Enfant
Limoges
Gynécologie-Obstétrique Hôpital de la Croix Rousse
Lyon, 69317
Gynécologie-Obstétrique Hôpital La Conception
Marseille
Gynécologie-Obstétrique Hôpital de la Pitié Salpêtrière (APHP)
Paris
Gynécologie-Obstétrique Maternité Port-Royal, Groupe Hospitalier Cochin-Broca- Hotel Dieu (APHP)
Paris
Gynécologie-Obstétrique CHU de Poitiers
Poitiers
Gynécologie-Obstétrique CHU Reims - Institut Mère Enfant Alix de Champagne
Reims
Gynécologie-Obstétrique CHU de Rennes
Rennes
Gynécologie-Obstétrique CHU de Saint Etienne
Saint-Etienne
Gynécologie-Obstétrique Hôpital de Hautepierre
Strasbourg
About this study
Official title: 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.
Read more
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.
- Conditions
- Covid 19, Stress, Psychological
- Being tested
- Questionnaires on psychological quality of life
- Medical subject headings
- COVID-19, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires on psychological quality of lifeOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: About 10 minutes ( Questionnaire filling time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start7 May 2020
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid 19Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375644
- Sponsor's protocol ID
- 69HCL20_0413
- Acronym
- COVIDPROIMPACT
- Status last verified
- Dec 2020
- First submitted
- 4 May 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34915826
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the COVID-19 Pandemic on the Quality of Psychological Life of Healthcare Professionals
- ClinicalTrials.gov ID
- NCT04375644
- Acronym / sponsor ID
- COVIDPROIMPACT / 69HCL20_0413
- Conditions
- Covid 19, Stress, Psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,565 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 5 May 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Person over 18 years of age practicing a health profession in the participating gynecology and obstetrics departments
Key inclusion criteria (3 listed)
- person over 18
- person exercising a profession in the health field
- person having expressed his non-opposition
Key exclusion criteria (2 listed)
- inability to understand the information given and the questionnaire
- person deprived of liberty, person under guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires on psychological quality of lifeAssessement 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) | Other | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Derived from this study: PubMed 34915826Chene 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.
- 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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid 19 and Stress, Psychological, run by Hospices Civils de Lyon at 18 sites in France.
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 3 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: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stress state score, during the confinement period (time frame: About 10 minutes ( Questionnaire filling time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375644, which also lists 1 linked publication.
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 21 Dec 2020.