<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04500652</url>
  </required_header>
  <id_info>
    <org_study_id>PMRMentalcovid</org_study_id>
    <nct_id>NCT04500652</nct_id>
  </id_info>
  <brief_title>Mental Health Status and Related Factors Among Physical Medicine &amp; Rehabilitation Physicians in the Covid-19 Pandemic</brief_title>
  <official_title>Evaluation of Mental Health Status and Related Factors Among Physical Medicine &amp; Rehabilitation Physicians During the Covid-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dokuz Eylul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dokuz Eylul University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2)&#xD;
      emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared&#xD;
      COVID-19 a pandemic. Facing this critical situation, health care workers on the front line&#xD;
      are at risk of developing psychological distress and other mental health symptoms. Physical&#xD;
      medicine and rehabilitation (PM&amp;R) physicians works both in specialty outpateint/inpatient&#xD;
      clinic and pandemic outpatient/inpatient clinics during the outbreak. Accordingly, PM&amp;R&#xD;
      physicians are expected to be mentally affected by COVID-19 pandemic. In this study we aimed&#xD;
      to evaluate mental health status of PM&amp;R physicians and related factors during COVID-19&#xD;
      pandemic. This study is a cross-sectional survey which is conducted on an online platform.&#xD;
      Demographic data, working conditions of PM&amp;R physicians and factors that may be related to&#xD;
      mental health status is questioned in the survey. The Depression, Anxiety and Stress Scale -&#xD;
      21 (DASS-21) is used to measure the emotional states of depression, anxiety and stress.The&#xD;
      Insomnia Severity Index (ISI) is used to assess the severity of both nighttime and daytime&#xD;
      components of insomnia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 27, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Depression, Anxiety and Stress Scales 21 Score</measure>
    <time_frame>5 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insomnia severity index score</measure>
    <time_frame>5 months</time_frame>
    <description>The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.</description>
  </primary_outcome>
  <enrollment type="Anticipated">310</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Insomnia</condition>
  <condition>Covid19</condition>
  <condition>Coronavirus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Physical medicine and rehabilitation physicians in Turkey who worked during COVID-19&#xD;
        pandemic in specialty outpatient/inpatient clinic or pandemic outpatient/inpatient clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being a physical medicine and rehabilitation physician&#xD;
&#xD;
          -  Worked during COVID-19 pandemic in specialty outpatient/inpatient clinic or pandemic&#xD;
             outpatient/inpatient clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being a specialist in a branch other than physical medicine and rehabilitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Banu Dilek</last_name>
    <phone>+905052248340</phone>
    <email>banu.dilek@deu.edu.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dokuz Eylul University</name>
      <address>
        <city>Izmir</city>
        <zip>35000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Banu Dilek</last_name>
      <phone>+905052248340</phone>
      <email>banu.dilek@deu.edu.tr</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
    <investigator_full_name>Banu Dilek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <keyword>insomnia</keyword>
  <keyword>Covid-19</keyword>
  <keyword>coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04500652
org study id: PMRMentalcovid
nct id: NCT04500652
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Cross-Sectional
measure: Depression, Anxiety and Stress Scales 21 Score
time frame: 5 months
description: 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.
measure: Insomnia severity index score
time frame: 5 months
description: The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 24 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Banu Dilek
phone: +905052248340
email: banu.dilek@deu.edu.tr
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dokuz Eylul University
investigator full name: Banu Dilek
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Depression
sharing ipd: No