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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04402229
Other study ID # P17/04_StudentCov
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 12, 2020
Est. completion date July 31, 2020

Study information

Verified date November 2020
Source Versailles Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The World Health Organization (WHO) declared in early 2020 the emergence of a new highly contagious SARS-CoV-2 coronavirus responsible for a global public health emergency. In France, the first cases of contamination have been reported since the end of January 2020, and the first death in mid-February 2020. Then, data published by Public Healh France reported an increasing and rapidly exponential number of contaminations. First cases have been identified on a cluster mode, then rapidly spreading in some French departments and regions, indicating rapid kinetics of virus spread. Given the magnitude of the situation both French territory and neighboring European territories (mainly Italy), the government mobilized the entire health system to critically manage this epidemic. This exceptional and unprecedented pandemic deeply impacted the health structures, disrupting healthcare organizations. All caregivers, including all student nurses, actively participated in the mobilization and strengthening of care teams. The health crisis exposed the population of caregivers to potentially traumatic events which can have major repercussions on their health state. The description and identification of the risk factors of the occurrence of post traumatic stress disorders in student nurses during the health crisis would allow to provide avenues for improving training devices and to facilitate health workers access to specific psychological care particularly dedicated to the student nurses population needs.


Description:

Describe the prevalence of post-traumatic stress disorder among student nurses 1 month after the end of the French epidemic Covid-19 peak


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date July 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age>18 years old Exclusion Criteria: - Opposition to participate to the questionnaire

Study Design


Locations

Country Name City State
France Versailles hospital Le Chesnay
France Toulouse University Hospital Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of PTSD-related symptoms assessed by the IES-R Proportion of students with IES-R> 22 PTSD-related symptoms. Impact of Event Scale - Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events. ... The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales. 1 month after the end of the French epidemic Covid-19 peak
Secondary PTSD-related symptoms assessed by the IES-R in the total population of students nurses IES-R> 22 PTSD-related symptoms in the total population of students nurses( 3 years training) 1 month after the end of the French epidemic Covid-19 peak
Secondary PTSD-related symptoms assessed by the IES-R according to student's years of school IES-R> 22 PTSD-related symptoms in each population of students nurses of first-, second-, and third-year. 1 month after the end of the French epidemic Covid-19 peak
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