COVID-19 : Stress Within Hospital Workers

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT05037214
Collaborator
(none)
779
1
12.9
60.2

Study Details

Study Description

Brief Summary

As of December 2019, the global pandemic of COVID-19 has spread rapidly throughout the world, putting healthcare staff at the frontline.

In this context, several factors leading to the appearance of psychiatric symptoms have emerged : work overload, fear of being infected or of infecting, exhaustion… (The Lancet, 2020)

Indeed, post-traumatic stress disorder (PTSD), depressive symptoms, anxiety symptoms, insomnia and increased stress have been reported (Rossi et al., 2020).

Furthermore, the increased anxiety and depression symptoms and stress associated with the COVID-19 pandemic may increase the risk of suicide in this already high-risk population. For example, suicidal ideation has been reported in up to 5% of healthcare workers in the United States (Young et al., 2021).

It is therefore essential to evaluate the incidence of psychiatric disorders (e.g. PTSD, depression, suicide) and their associated risk factors among the hospital staff.

To do so, Montpellier University Hospital healthcare staff was asked their mental state during the first wave of COVID-19.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    779 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Measure of Stress After the First Wave of Covid 19 Within Hospital Workers
    Actual Study Start Date :
    Jun 1, 2020
    Actual Primary Completion Date :
    Jun 30, 2021
    Actual Study Completion Date :
    Jun 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety symptoms [day 1]

      anxiety level assessed with the Generalized Anxiety Disorder questionnaire (GAD-7) : higher score indicates higher anxiety (min : 0; max : 21)

    2. Depression symptoms [day 1]

      depression symptomatoloy assessed with the Patient Health Questionnaire (PHQ-9) : higher score indicates higher depression level (min : 0; max : 27)

    3. Sleep [day 1]

      sleep quality assessed with the Insomnia Severity Index (ISI) : higher score indicates higher insomnia level (min : 0; max : 28)

    Secondary Outcome Measures

    1. Post traumatic stress disorder [day 1]

      post traumatic stress disorder symptomatology assessed with the Posttraumatic stress disorder Checklist Scale (PCL-S) : higher score indicates more sever post traumatic stress disorder symptoms

    2. Physical pain [day 1]

      physical pain assessed with a likert scale

    3. Burnout symptoms [day 1]

      burnout symptomatology assessed with the Maslach Burnout Inventory (MBI) : higher scores on the emotional exhaustion scale and the depersonalization scale and lower score on the professional accomplishment scale indicate higher burnout level.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:
    • Healthcare staff working at Montpellier University Hospital during the first wave of COVID-19

    • Having responded to the online survey sent to all healthcare staff

    Exclusion criteria:
    • Refusal to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Bénédicte NOBILE, PharmD, PhD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05037214
    Other Study ID Numbers:
    • RECHMPL21_0548
    First Posted:
    Sep 8, 2021
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 8, 2021