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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04357418
Other study ID # 10477M-ICOS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source Centre hospitalier de Ville-Evrard, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population.


Recruitment information / eligibility

Status Completed
Enrollment 187
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- For hospital staff: Adult members of the Ville Evrard Hospital staff (trainees or employees) willing to participate to at least one survey during the COVID lockdown.

- For close relatives: Adult relatives of the Ville Evrard Hospital staff members, living or not with them.

Exclusion Criteria:

- NONE

Study Design


Intervention

Other:
it is a survey
this interview can be carried out face to face or remotely.

Locations

Country Name City State
France URC Ville Evrard Neuilly-sur-Marne

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary State Anxiety assessed by the State-Trait Anxiety Inventory (STAI) The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group. Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
Primary State Anxiety assessed by the State-Trait Anxiety Inventory (STAI) The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group. Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
Secondary Visual numeric scales assessing anger and stress the ongoing week. 1 to 7 Likert scales. Anger scale going from "No anger, at no time" to "strong and sustained anger". Stress scale going from "No stress, at no time" to "strong and sustained stress". Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
Secondary Visual numeric scales assessing anger and stress the ongoing week. 1 to 7 Likert scales. Anger scale going from "No anger, at no time" to "strong and sustained anger". Stress scale going from "No stress, at no time" to "strong and sustained stress". Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
Secondary Beck Depression Inventory The tool provides a quantitative estimate of the intensity of depressive feelings. Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
Secondary Beck Depression Inventory The tool provides a quantitative estimate of the intensity of depressive feelings. Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
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