Burnout, ProfessionalNCT04371302
Nursing Perspective on Burnout and Medical Errors in the Intensive Care Unit During Covid-19 Pandemic
An observational study of Burnout, Professional and Medical Errors, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Professional, Medical Errors, Depression
- What is being tested?
- Questionnaire
- How many people
- 145 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2020to 30 Jun 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 ICU nurses serving in Sungai Buloh Hospital, a nationally designated exclusive Covid-19 hospital in Malaysia during the Covid-19 pandemic.
Who may be able to join
- 1. All nurses currently serving in the ICU, Sungai Buloh Hospital
Who cannot join
- Subjects who refuse to participate
- Subjects working in ICU, Sungai Buloh Hospital, for less than 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Burnout, Professional, Medical Errors, Depression
- Being tested
- Questionnaire
- Keywords
- Burnout, Depression, Medical errors, Intensive Care Unit nurses, Covid-19
- Medical subject headings
- Burnout, Professional, Depression, Burnout, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireDiagnostic test
Assessment of demographics, burnout, depression and self-perceived medical errors
| Study group | Role | What they receive |
|---|---|---|
| Intensive Care Unit nurses | Nurses working in the Intensive care Unit of an exclusive Covid-19 hospital in Malaysia, during the Covid-19 pandemic Receives: Diagnostic Test: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of burnout among ICU nurses during Covid-19
Prevalence of burnout risk
Measured: 2 months
Prevalence of depression among ICU nurses during Covid-19
Prevalence of depression risk
Measured: 2 months
Prevalence of self-perceived medical errors among ICU nurses during Covid-19
Prevalence of self perceived medical errors
Measured: 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 May 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Logistical problems, administrative issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel E H Tsan, MD, BMedSc, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371302
- Sponsor's protocol ID
- 54843
- Status last verified
- Sep 2021
- First submitted
- 29 Apr 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Perspective on Burnout and Medical Errors in the Intensive Care Unit of an Exclusively Covid-19 Hospital: the Malaysian Experience
- ClinicalTrials.gov ID
- NCT04371302
- Acronym / sponsor ID
- 54843
- Conditions
- Burnout, Professional, Medical Errors, Depression
- Keywords
- Burnout, Depression, Medical errors, Intensive Care Unit nurses, Covid-19
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Logistical problems, administrative issues
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Care Unit nurses | – | Diagnostic Test: QuestionnaireNurses working in the Intensive care Unit of an exclusive Covid-19 hospital in Malaysia, during the Covid-19 pandemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All ICU nurses serving in Sungai Buloh Hospital, a nationally designated exclusive Covid-19 hospital in Malaysia during the Covid-19 pandemic.
Key inclusion criteria (1 listed)
- 1. All nurses currently serving in the ICU, Sungai Buloh Hospital
Key exclusion criteria (2 listed)
- Subjects who refuse to participate
- Subjects working in ICU, Sungai Buloh Hospital, for less than 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAssessment of demographics, burnout, depression and self-perceived medical errors | Diagnostic test | Intensive Care Unit nurses |
Primary outcome
Prevalence of burnout among ICU nurses during Covid-19
Time frame: 2 months
Prevalence of burnout risk
Prevalence of depression among ICU nurses during Covid-19
Time frame: 2 months
Prevalence of depression risk
Prevalence of self-perceived medical errors among ICU nurses during Covid-19
Time frame: 2 months
Prevalence of self perceived medical errors
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
Results and safety
The study was stopped early (reason given: Logistical problems, administrative issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout, Professional and Medical Errors, run by University of Malaya at 1 site in Malaysia.
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 2 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: stopped early, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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 was stopped early (reason given: Logistical problems, administrative issues). Results are not available in the source record.
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 burnout among ICU nurses during Covid-19 (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2021.