Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04402229
Recruitment Status : Completed
First Posted : May 26, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jacq Gwenaelle, Versailles Hospital

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 disease
Nurse Student Post Traumatic Stress Disorder COVID-19

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

Layout table for study information
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 : July 31, 2020
Actual Study Completion Date : July 31, 2020



Primary Outcome Measures :
  1. Prevalence of PTSD-related symptoms assessed by the IES-R [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All French Student Nurses
Criteria

Inclusion Criteria:

  • Age>18 years old

Exclusion Criteria:

  • Opposition to participate to the questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402229


Locations
Layout table for location information
France
Versailles hospital
Le Chesnay, France
Toulouse University Hospital
Toulouse, France
Sponsors and Collaborators
Versailles Hospital
Investigators
Layout table for investigator information
Principal Investigator: Gwenaelle Jacq, RN CH Versailles
Layout table for additonal information
Responsible Party: Jacq Gwenaelle, Investigator Coodinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT04402229    
Other Study ID Numbers: P17/04_StudentCov
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacq Gwenaelle, Versailles Hospital:
student nurses
covid-19
post tramatic stress disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders