Sars-CoV2NCT04604119
Anxiety and Burnout in Anesthetists and Intensive Care Unit Nurses During Covid-19 Pandemic
An observational study of Sars-CoV2 and Anxiety, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim is to measure anxiety level and burnout frequency of healthcare workers including attending physicians, residents and nurses working at intensive care unit during COVID-19 pandemic. The study protocol had consisted of three parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 1 Jun 2020
- How long will I take part?
- 10 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Attending physicians, resident doctors, nurses working tertiary intensive care units of our institution
Who may be able to join
- Healthcare workers in our institute's intensive care units
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Education and Training Hospital
Istanbul, 34771
About this study
The aim is to measure anxiety level and burnout frequency of healthcare workers including attending physicians, residents and nurses working at intensive care unit during COVID-19 pandemic.
The study protocol had consisted of three parts. The first part was related to demographic details including age, sex, marital status, working position, past medical history.
The second part of the survey was validated Turkish form of Beck anxiety inventory (BAI) It has 21 questions. Every question is a somatic symptom of anxiety. Participants scored them regarding how this symptom bothered them past week. Items have four possible answers: not at all (0 point), mildly (1 point), moderate (2 point), severe (3 point). Total anxiety score can be between 0 and 63. Participants were categorized as no or mild anxiety if the total beck anxiety score was between 0-16, and moderate to severe anxiety if it was more than 16 The last part of the survey was validated Turkish form of Maslach Burnout Inventory (MBI) to evaluate components of BOS
Read the detailed description
Our institution's ICU has served 31 beds for COVID-19 and 21 beds for other patients during pandemic with 27 attending physicians and 35 residents. Number of night shifts for attending physicians and residents were 3 and 8 per month, respectively. The aim of the study was to evaluate the by measuring anxiety level and burnout frequency of HCWs including attending physicians, residents and nurses in our institution's ICU.
- Keywords
- anxiety, burnout, covid 19
- Medical subject headings
- Anxiety Disorders, Burnout, Psychological, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Measured by Beck anxiety inventory. Total anxiety score can be between 0 and 63. Participants were categorized as no or mild anxiety if the total beck anxiety score was between 0-16, and moderate to severe anxiety if it was more than 16
Measured: 10-25 may
Secondary outcomes (1)
Burnout
Measured by Maslach Burnout Inventory. MBI has 7-point 22 Likerd type questions and subdivided into three parts to measure emotional exhaustion (EE) (9 items), depersonalization (DP) (5 items), personal accomplishment (PA) (8 items). High scores on EE and DP subscales and low score on PA subscale imply higher level of burnout
Measured: 10-25 may
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 May 2020
- Primary completion30 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Acar Sevinç, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604119
- Sponsor's protocol ID
- 1577
- Status last verified
- Oct 2020
- First submitted
- 25 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Burnout in Anesthetists and Intensive Care Unit Nurses During Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04604119
- Acronym / sponsor ID
- 1577
- Keywords
- anxiety, burnout, covid 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 27 Oct 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 aim is to measure anxiety level and burnout frequency of healthcare workers including attending physicians, residents and nurses working at intensive care unit during COVID-19 pandemic.
The study protocol had consisted of three parts. The first part was related to demographic details including age, sex, marital status, working position, past medical history.
The second part of the survey was validated Turkish form of Beck anxiety inventory (BAI) It has 21 questions. Every question is a somatic symptom of anxiety. Participants scored them regarding how this symptom bothered them past week. Items have four possible answers: not at all (0 point), mildly (1 point), moderate (2 point), severe (3 point). Total anxiety score can be between 0 and 63. Participants were categorized as no or mild anxiety if the total beck anxiety score was between 0-16, and moderate to severe anxiety if it was more than 16 The last part of the survey was validated Turkish form of Maslach Burnout Inventory (MBI) to evaluate components of BOS
Detailed description
Our institution's ICU has served 31 beds for COVID-19 and 21 beds for other patients during pandemic with 27 attending physicians and 35 residents. Number of night shifts for attending physicians and residents were 3 and 8 per month, respectively. The aim of the study was to evaluate the by measuring anxiety level and burnout frequency of HCWs including attending physicians, residents and nurses in our institution's ICU.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Attending physicians, resident doctors, nurses working tertiary intensive care units of our institution
Key inclusion criteria (1 listed)
- Healthcare workers in our institute's intensive care units
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety
Time frame: 10-25 may
Measured by Beck anxiety inventory. Total anxiety score can be between 0 and 63. Participants were categorized as no or mild anxiety if the total beck anxiety score was between 0-16, and moderate to severe anxiety if it was more than 16
1 secondary outcome
Burnout
Time frame: 10-25 may
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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 Sars-CoV2 and Anxiety, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 28 Oct 2020. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety (time frame: 10-25 may). 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 28 Oct 2020.