<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04402229</url>
  </required_header>
  <id_info>
    <org_study_id>P17/04_StudentCov</org_study_id>
    <nct_id>NCT04402229</nct_id>
  </id_info>
  <brief_title>Psychological Impact of the Covid-19 Pandemic on Student Nurses</brief_title>
  <acronym>StudentCov</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Versailles Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Versailles Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The World Health Organization (WHO) declared in early 2020 the emergence of a new highly&#xD;
      contagious SARS-CoV-2 coronavirus responsible for a global public health emergency. In&#xD;
      France, the first cases of contamination have been reported since the end of January 2020,&#xD;
      and the first death in mid-February 2020. Then, data published by Public Healh France&#xD;
      reported an increasing and rapidly exponential number of contaminations. First cases have&#xD;
      been identified on a cluster mode, then rapidly spreading in some French departments and&#xD;
      regions, indicating rapid kinetics of virus spread. Given the magnitude of the situation both&#xD;
      French territory and neighboring European territories (mainly Italy), the government&#xD;
      mobilized the entire health system to critically manage this epidemic. This exceptional and&#xD;
      unprecedented pandemic deeply impacted the health structures, disrupting healthcare&#xD;
      organizations. All caregivers, including all student nurses, actively participated in the&#xD;
      mobilization and strengthening of care teams. The health crisis exposed the population of&#xD;
      caregivers to potentially traumatic events which can have major repercussions on their health&#xD;
      state. The description and identification of the risk factors of the occurrence of post&#xD;
      traumatic stress disorders in student nurses during the health crisis would allow to provide&#xD;
      avenues for improving training devices and to facilitate health workers access to specific&#xD;
      psychological care particularly dedicated to the student nurses population needs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Describe the prevalence of post-traumatic stress disorder among student nurses 1 month after&#xD;
      the end of the French epidemic Covid-19 peak&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2020</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of PTSD-related symptoms assessed by the IES-R</measure>
    <time_frame>1 month after the end of the French epidemic Covid-19 peak</time_frame>
    <description>Proportion of students with IES-R&gt; 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PTSD-related symptoms assessed by the IES-R in the total population of students nurses</measure>
    <time_frame>1 month after the end of the French epidemic Covid-19 peak</time_frame>
    <description>IES-R&gt; 22 PTSD-related symptoms in the total population of students nurses( 3 years training)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD-related symptoms assessed by the IES-R according to student's years of school</measure>
    <time_frame>1 month after the end of the French epidemic Covid-19 peak</time_frame>
    <description>IES-R&gt; 22 PTSD-related symptoms in each population of students nurses of first-, second-, and third-year.</description>
  </secondary_outcome>
  <enrollment type="Actual">2000</enrollment>
  <condition>Nurse</condition>
  <condition>Student</condition>
  <condition>Post Traumatic Stress Disorder</condition>
  <condition>COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All French Student Nurses&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Opposition to participate to the questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Gwenaelle Jacq, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH Versailles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Versailles hospital</name>
      <address>
        <city>Le Chesnay</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toulouse University Hospital</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Versailles Hospital</investigator_affiliation>
    <investigator_full_name>Jacq Gwenaelle</investigator_full_name>
    <investigator_title>Investigator Coodinator</investigator_title>
  </responsible_party>
  <keyword>student nurses</keyword>
  <keyword>covid-19</keyword>
  <keyword>post tramatic stress disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04402229
org study id: P17/04_StudentCov
nct id: NCT04402229
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Describe the prevalence of post-traumatic stress disorder among student nurses 1 month after
      the end of the French epidemic Covid-19 peak
observational model: Other
time perspective: Prospective
measure: Prevalence of PTSD-related symptoms assessed by the IES-R
time frame: 1 month after the end of the French epidemic Covid-19 peak
description: 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.
measure: PTSD-related symptoms assessed by the IES-R in the total population of students nurses
time frame: 1 month after the end of the French epidemic Covid-19 peak
description: IES-R> 22 PTSD-related symptoms in the total population of students nurses( 3 years training)
measure: PTSD-related symptoms assessed by the IES-R according to student's years of school
time frame: 1 month after the end of the French epidemic Covid-19 peak
description: IES-R> 22 PTSD-related symptoms in each population of students nurses of first-, second-, and third-year.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Gwenaelle Jacq, RN
role: Principal Investigator
affiliation: CH Versailles
facility: 
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Versailles Hospital
investigator full name: Jacq Gwenaelle
investigator title: Investigator Coodinator
mesh term: COVID-19
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No