StudentCov: Psychological Impact of the Covid-19 Pandemic on Student Nurses

Sponsor
Versailles Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04402229
Collaborator
(none)
2,000
Enrollment
2
Locations
2.6
Actual Duration (Months)
1000
Patients Per Site
380.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Psychological Impact of the Covid-19 Pandemic on Student Nurses :Prevalence and Risk Factors of Acute Post-traumatic Stress Symptoms 1 Month After the Epidemic Peak
    Actual Study Start Date :
    May 12, 2020
    Actual Primary Completion Date :
    Jul 31, 2020
    Actual Study Completion Date :
    Jul 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of PTSD-related symptoms assessed by the IES-R [1 month after the end of the French epidemic Covid-19 peak]

      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.

    Secondary Outcome Measures

    1. 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]

      IES-R> 22 PTSD-related symptoms in the total population of students nurses( 3 years training)

    2. 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]

      IES-R> 22 PTSD-related symptoms in each population of students nurses of first-, second-, and third-year.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Age>18 years old
    Exclusion Criteria:
    • Opposition to participate to the questionnaire

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Versailles hospitalLe ChesnayFrance
    2Toulouse University HospitalToulouseFrance

    Sponsors and Collaborators

    • Versailles Hospital

    Investigators

    • Principal Investigator: Gwenaelle Jacq, RN, CH Versailles

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jacq Gwenaelle, Investigator Coodinator, Versailles Hospital
    ClinicalTrials.gov Identifier:
    NCT04402229
    Other Study ID Numbers:
    • P17/04_StudentCov
    First Posted:
    May 26, 2020
    Last Update Posted:
    Nov 19, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jacq Gwenaelle, Investigator Coodinator, Versailles Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2020