NCT04371302

Brief Summary

The investigators plan to perform an observational study to evaluate the prevalence of burnout, depression and medical errors in a designated exclusive Covid-19 patients hospital in Malaysia, during the Covid-19 pandemic. In addition, the relationship between burnout and depression with medical errors will be assessed. The population studied will be the nurses working in the Intensive Care Unit, who are at higher risk due to the nature of their work at the frontlines of the pandemic.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

April 29, 2020

Last Update Submit

September 30, 2021

Conditions

Keywords

BurnoutDepressionMedical errorsIntensive Care Unit nursesCovid-19

Outcome Measures

Primary Outcomes (4)

  • Prevalence of burnout among ICU nurses during Covid-19

    Prevalence of burnout risk

    2 months

  • Prevalence of depression among ICU nurses during Covid-19

    Prevalence of depression risk

    2 months

  • Prevalence of self-perceived medical errors among ICU nurses during Covid-19

    Prevalence of self perceived medical errors

    2 months

  • Association of burnout, depression and medical errors among anaesthesiology clinicians during Covid-19

    To find out if there exists a relationship between burnout, depression and medical errors

    2 months

Study Arms (1)

Intensive Care Unit nurses

Nurses working in the Intensive care Unit of an exclusive Covid-19 hospital in Malaysia, during the Covid-19 pandemic

Diagnostic Test: Questionnaire

Interventions

QuestionnaireDIAGNOSTIC_TEST

Assessment of demographics, burnout, depression and self-perceived medical errors

Intensive Care Unit nurses

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All ICU nurses serving in Sungai Buloh Hospital, a nationally designated exclusive Covid-19 hospital in Malaysia during the Covid-19 pandemic.

You may qualify if:

  • \. All nurses currently serving in the ICU, Sungai Buloh Hospital

You may not qualify if:

  • Subjects who refuse to participate
  • Subjects working in ICU, Sungai Buloh Hospital, for less than 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sungai Buloh Hospital

Kuala Lumpur, 59000, Malaysia

Location

MeSH Terms

Conditions

Burnout, ProfessionalDepressionBurnout, PsychologicalCOVID-19

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 1, 2020

Study Start

May 1, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations