AzTrials
AzTrials

NurseStudentCovNCT04402229

Psychological Impact of the Covid-19 Pandemic on Student Nurses

An observational study of Nurse and Student, run by Versailles Hospital at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nurse, Student, Post Traumatic Stress Disorder
How many people
2,000 participants
Where
2 sitesFrance
Study dates
12 May 2020to 31 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: All French Student Nurses

Who may be able to join

  • Age>18 years old

Who cannot join

  • Opposition to participate to the questionnaire

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Versailles hospital

    Le Chesnay

  • Toulouse University Hospital

    Toulouse

Other trials in France

About this study

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

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.

Read the 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

Keywords
student nurses, covid-19, post tramatic stress disorder
Medical subject headings
Stress Disorders, Post-Traumatic, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start12 May 2020
  3. Primary completion31 Jul 2020
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04402229
Sponsor's protocol ID
P17/04_StudentCov
Acronym
StudentCov
Status last verified
Nov 2020
First submitted
21 May 2020
Last updated
19 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Nurse and Student, run by Versailles Hospital at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04402229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in