AnxietyNCT04500652
Mental Health Status and Related Factors Among Physical Medicine & Rehabilitation Physicians in the Covid-19 Pandemic
An observational study of Anxiety and Depression, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Read more about this study
- Who is it for?
- Ages 24 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Insomnia
- How many people
- 310 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jun 2020to 1 Oct 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 24 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physical medicine and rehabilitation physicians in Turkey who worked during COVID-19 pandemic in specialty outpatient/inpatient clinic or pandemic outpatient/inpatient clinic.
Who may be able to join
- Being a physical medicine and rehabilitation physician
- Worked during COVID-19 pandemic in specialty outpatient/inpatient clinic or pandemic outpatient/inpatient clinic.
Who cannot join
- Being a specialist in a branch other than physical medicine and rehabilitation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University
Izmir, 35000
Banu Dilek, +905052248340, banu.dilek@deu.edu.tr
About this study
Official title: Evaluation of Mental Health Status and Related Factors Among Physical Medicine & Rehabilitation Physicians During the Covid-19 Pandemic
In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Facing this critical situation, health care workers on the front line are at risk of developing psychological distress and other mental health symptoms. Physical medicine and rehabilitation (PM\&R) physicians works both in specialty outpateint/inpatient clinic and pandemic outpatient/inpatient clinics during the outbreak. Accordingly, PM\&R physicians are expected to be mentally affected by COVID-19 pandemic. In this study we aimed to evaluate mental health status of PM\&R physicians and related factors during COVID-19 pandemic. This study is a cross-sectional survey which is conducted on an online platform. Demographic data, working conditions of PM\&R physicians and factors that may be related to mental health status is questioned in the survey. The Depression, Anxiety and Stress Scale - 21 (DASS-21) is used to measure the emotional states of depression, anxiety and stress.The Insomnia Severity Index (ISI) is used to assess the severity of both nighttime and daytime components of insomnia.
- Conditions
- Anxiety, Depression, Insomnia, Covid19, Coronavirus
- Keywords
- depression, anxiety, insomnia, Covid-19, coronavirus
- Medical subject headings
- Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders, COVID-19, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety and Stress Scales 21 Score
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Measured: 5 months
Insomnia severity index score
The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start27 Jun 2020
- Primary completion30 Aug 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Dilek, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500652
- Sponsor's protocol ID
- PMRMentalcovid
- Status last verified
- Aug 2020
- First submitted
- 24 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mental Health Status and Related Factors Among Physical Medicine & Rehabilitation Physicians During the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04500652
- Acronym / sponsor ID
- PMRMentalcovid
- Conditions
- Anxiety, Depression, Insomnia, Covid19, Coronavirus
- Keywords
- depression, anxiety, insomnia, Covid-19, coronavirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 27 Jun 2020 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 5 Aug 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.
In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Facing this critical situation, health care workers on the front line are at risk of developing psychological distress and other mental health symptoms. Physical medicine and rehabilitation (PM\&R) physicians works both in specialty outpateint/inpatient clinic and pandemic outpatient/inpatient clinics during the outbreak. Accordingly, PM\&R physicians are expected to be mentally affected by COVID-19 pandemic. In this study we aimed to evaluate mental health status of PM\&R physicians and related factors during COVID-19 pandemic. This study is a cross-sectional survey which is conducted on an online platform. Demographic data, working conditions of PM\&R physicians and factors that may be related to mental health status is questioned in the survey. The Depression, Anxiety and Stress Scale - 21 (DASS-21) is used to measure the emotional states of depression, anxiety and stress.The Insomnia Severity Index (ISI) is used to assess the severity of both nighttime and daytime components of insomnia.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 24 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physical medicine and rehabilitation physicians in Turkey who worked during COVID-19 pandemic in specialty outpatient/inpatient clinic or pandemic outpatient/inpatient clinic.
Key inclusion criteria (2 listed)
- Being a physical medicine and rehabilitation physician
- Worked during COVID-19 pandemic in specialty outpatient/inpatient clinic or pandemic outpatient/inpatient clinic.
Key exclusion criteria (1 listed)
- Being a specialist in a branch other than physical medicine and rehabilitation
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
Depression, Anxiety and Stress Scales 21 Score
Time frame: 5 months
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Insomnia severity index score
Time frame: 5 months
The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- 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.
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 Anxiety and Depression, run by Dokuz Eylul University 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 2 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: status not confirmed, as of the sponsor's last update on 5 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Banu Dilek (+905052248340, banu.dilek@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety and Stress Scales 21 Score (time frame: 5 months). The study lists 2 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 5 Aug 2020.