- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04371302
Nursing Perspective on Burnout and Medical Errors in the Intensive Care Unit During Covid-19 Pandemic
September 30, 2021 updated by: Samuel E H Tsan, MD, BMedSc, University of Malaya
Nursing Perspective on Burnout and Medical Errors in the Intensive Care Unit of an Exclusively Covid-19 Hospital: the Malaysian Experience
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
During this unprecedented Covid-19 pandemic crisis in the whole world, Malaysia is also affected, with more than 5000 patients infected in the whole country as of 20th April, 2020.
Many Intensive Care Unit nurses, who are at the frontlines of managing Covid-19 patients, face increased workload, in addition to psychological stress from managing these patients, with stress also coming from being exposed to the risk of cross infection.
Hence, they are possibly at high risk of burnout and depression.
In such a time of increased stress, the investigators also seek to find out the prevalence of medical errors made by Intensive Care Unit nurses during this pandemic, and whether the medical errors are associated with burnout.
Factors associated with burnout, depression and medical errors will also be evaluated.
Study Type
Observational
Enrollment (Actual)
145
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
-
-
-
Kuala Lumpur, Malaysia, 59000
- Sungai Buloh Hospital
-
-
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 ICU nurses serving in Sungai Buloh Hospital, a nationally designated exclusive Covid-19 hospital in Malaysia during the Covid-19 pandemic.
Description
Inclusion criteria
1. All nurses currently serving in the ICU, Sungai Buloh Hospital
Exclusion criteria
- Subjects who refuse to participate
- Subjects working in ICU, Sungai Buloh Hospital, for less than 1 month
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intensive Care Unit nurses
Nurses working in the Intensive care Unit of an exclusive Covid-19 hospital in Malaysia, during the Covid-19 pandemic
|
Assessment of demographics, burnout, depression and self-perceived medical errors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of burnout among ICU nurses during Covid-19
Time Frame: 2 months
|
Prevalence of burnout risk
|
2 months
|
Prevalence of depression among ICU nurses during Covid-19
Time Frame: 2 months
|
Prevalence of depression risk
|
2 months
|
Prevalence of self-perceived medical errors among ICU nurses during Covid-19
Time Frame: 2 months
|
Prevalence of self perceived medical errors
|
2 months
|
Association of burnout, depression and medical errors among anaesthesiology clinicians during Covid-19
Time Frame: 2 months
|
To find out if there exists a relationship between burnout, depression and medical errors
|
2 months
|
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 1, 2020
Primary Completion (ACTUAL)
June 30, 2020
Study Completion (ACTUAL)
June 30, 2020
Study Registration Dates
First Submitted
April 29, 2020
First Submitted That Met QC Criteria
April 29, 2020
First Posted (ACTUAL)
May 1, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2021
Last Update Submitted That Met QC Criteria
September 30, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Stress, Psychological
- Occupational Stress
- Occupational Diseases
- Depression
- COVID-19
- Burnout, Professional
- Burnout, Psychological
Other Study ID Numbers
- 54843
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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