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OpenTrials
Completed

NCT Number: NCT05037214

COVID-19 : Stress Within Hospital Workers

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.

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Key information

Conditions

COVID 19 Behavior Behavioral Symptoms Burnout Burnout, Psychological COVID-19 Coronaviridae Infections Coronavirus Infections Depression Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress, Psychological Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Anxiety symptoms

    Time frame: 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

    Time frame: day 1

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

  3. Sleep

    Time frame: day 1

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

Secondary outcomes

  1. Post traumatic stress disorder

    Time frame: 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

    Time frame: day 1

    physical pain assessed with a likert scale

  3. Burnout symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Measure of Stress After the First Wave of Covid 19 Within Hospital Workers

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 8, 2021
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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