NCT04402229

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

May 12, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

May 21, 2020

Last Update Submit

November 18, 2020

Conditions

Keywords

student nursescovid-19post tramatic stress disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • PTSD-related symptoms assessed by the IES-R in the total population of students nurses

    1 month after the end of the French epidemic Covid-19 peak

  • PTSD-related symptoms assessed by the IES-R according to student's years of school

    1 month after the end of the French epidemic Covid-19 peak

Eligibility Criteria

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

All French Student Nurses

You may qualify if:

  • Age\>18 years old

You may not qualify if:

  • Opposition to participate to the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Versailles hospital

Le Chesnay, France

Location

Toulouse University Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticCOVID-19

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gwenaelle Jacq, RN

    CH Versailles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator Coodinator

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 26, 2020

Study Start

May 12, 2020

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations