- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04402229
Psychological Impact of the Covid-19 Pandemic on Student Nurses (StudentCov)
November 18, 2020 updated by: Jacq Gwenaelle, Versailles Hospital
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
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Le Chesnay, France
- Versailles Hospital
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Toulouse, France
- Toulouse University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All French Student Nurses
Description
Inclusion Criteria:
- Age>18 years old
Exclusion Criteria:
- Opposition to participate to the questionnaire
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of PTSD-related symptoms assessed by the IES-R
Time Frame: 1 month after the end of the French epidemic Covid-19 peak
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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.
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1 month after the end of the French epidemic Covid-19 peak
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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IES-R> 22 PTSD-related symptoms in the total population of students nurses( 3 years training)
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1 month after the end of the French epidemic Covid-19 peak
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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
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IES-R> 22 PTSD-related symptoms in each population of students nurses of first-, second-, and third-year.
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1 month after the end of the French epidemic Covid-19 peak
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 12, 2020
Primary Completion (ACTUAL)
July 31, 2020
Study Completion (ACTUAL)
July 31, 2020
Study Registration Dates
First Submitted
May 21, 2020
First Submitted That Met QC Criteria
May 22, 2020
First Posted (ACTUAL)
May 26, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 19, 2020
Last Update Submitted That Met QC Criteria
November 18, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Trauma and Stressor Related Disorders
- COVID-19
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
Other Study ID Numbers
- P17/04_StudentCov
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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