<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/NCT04490473</url>
  </required_header>
  <id_info>
    <org_study_id>DSAYIK2</org_study_id>
    <secondary_id>Ayfer AÇIKGÖZ</secondary_id>
    <secondary_id>ERTUĞRUL ÇOLAK</secondary_id>
    <secondary_id>DENİZ YİĞİT</secondary_id>
    <secondary_id>ÖZLEM MUMCU</secondary_id>
    <nct_id>NCT04490473</nct_id>
  </id_info>
  <brief_title>Turkish of the SARS-CoV-2 Anxiety Scale</brief_title>
  <official_title>Turkish Validity And Reliability of the SARS-CoV-2 Anxiety Scale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DILEK SAYIK</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eskisehir Osmangazi University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The coronavirus outbreak has adversely affected individuals in the community, as in the rest&#xD;
      of the world. However, in order to carry out this epidemic period in a healthy and conscious&#xD;
      manner, determining the anxiety levels of individuals in the society and supporting them&#xD;
      psychologically is of great importance. In order to achieve this, healthcare professionals&#xD;
      working clinically or academically have important duties. This study was planned to test its&#xD;
      validity and reliability in order to adapt the Coronavirus Anxiety Scale to Turkish.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronaviruses can be seen in animals and humans as infections that can be mild and severe in&#xD;
      society. The SARS-CoV-2 virus, a type of coronavirus, started in China in December 2019 and&#xD;
      has spread worldwide as of January 2020. The absence of vaccine and treatment for SARS-CoV-2&#xD;
      disease threatens health worldwide and significantly affects people's daily routine. In&#xD;
      China, where the pandemic started, shopping malls and schools were closed for a while, and&#xD;
      city entrances and exits were stopped for a while. Although there are similar practices in&#xD;
      excellence, as in many countries, measures such as curfew, nursery and school closure&#xD;
      continue to be taken for under-20s and over-65s. . The coronavirus epidemic that affects our&#xD;
      entire life is not fully known about the disease process, WHO is defined as the pandemic of&#xD;
      the epidemic, the nearest contact is the greatest risk of transmission, and the loss of many&#xD;
      lives during this process affects all individuals in the society negatively and increases the&#xD;
      level of anxiety .&#xD;
&#xD;
      It is a psychological reaction involving many emotions such as anxiety, stress, or anxiety,&#xD;
      fear and distress that arise in a situation that threatens the safety of the individual.&#xD;
      Conditions such as uncertainty, various diseases (cancer, epidemic, etc.) and losing a&#xD;
      relative can cause anxiety. Outbreaks that occur suddenly and are at risk of death are among&#xD;
      these reasons.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 24, 2020</start_date>
  <completion_date type="Anticipated">April 24, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 24, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This research will be conducted in a methodological manner in order to conduct the validity and reliability studies of the Coronary Virus Anxiety Scale in Turkish.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety in SARS-CoV-2</measure>
    <time_frame>4 weeks</time_frame>
    <description>anxiety increase in SARS-CoV-2 in humans.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of SARS-CoV-2 anxiety scale to beck anxiety scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>The ratio of SARS-CoV-2 anxiety scale to beck anxiety scale is similar.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Anxiety</condition>
  <condition>SARS-CoV Infection</condition>
  <arm_group>
    <arm_group_label>volunteer group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Only volunteer participants will be included in the research. Survey forms will be sent to individuals online. Individuals who agree to participate in the study will fill in the questionnaire and send it back online.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>survey work</intervention_name>
    <description>Survey forms will be sent to individuals online. Information about the study will be given to individuals with the informative text at the beginning of the questionnaire form. Individuals who agree to participate in the study will fill in the questionnaire and send it back online.</description>
    <arm_group_label>volunteer group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria;&#xD;
&#xD;
          -  individuals agree to participate in the study&#xD;
&#xD;
          -  18 years old,&#xD;
&#xD;
          -  Lack of visual obstacle,&#xD;
&#xD;
          -  Knowing how to speak, read and write in Turkish.&#xD;
&#xD;
        Exclusion criteria;&#xD;
&#xD;
          -  individuals refuse to participate in the study&#xD;
&#xD;
          -  18 years old,&#xD;
&#xD;
          -  Visually impaired,&#xD;
&#xD;
          -  Does not know how to speak, read and write in Turkish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>DILEK SAYIK</last_name>
    <role>Principal Investigator</role>
    <affiliation>ESKISEHIR OSMANGAZI UNIVERSTY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>DILEK SAYIK</last_name>
    <phone>5065416642</phone>
    <email>dileksayik@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>DENIZ YIGIT</last_name>
    <phone>05428092848</phone>
    <email>yigitdenizyigit@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Eskisehir Osmangazi University</name>
      <address>
        <city>Eskisehir</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>AYFER AÇIKGÖZ</last_name>
      <phone>05352919374</phone>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Benli, S. S., &amp; Yıldırım, A. (2017). Hemşirelerde yaşam doyumu ve ölüme karşı tutum arasındaki ilişki. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, 6(4), 167-179</citation>
  </reference>
  <reference>
    <citation>Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.</citation>
    <PMID>3204199</PMID>
  </reference>
  <reference>
    <citation>Chen P, Mao L, Nassis GP, Harmer P, Ainsworth BE, Li F. Coronavirus disease (COVID-19): The need to maintain regular physical activity while taking precautions. J Sport Health Sci. 2020 Mar;9(2):103-104. doi: 10.1016/j.jshs.2020.02.001. Epub 2020 Feb 4. No abstract available.</citation>
    <PMID>32099716</PMID>
  </reference>
  <reference>
    <citation>Chen Y, Liu Q, Guo D. Emerging coronaviruses: Genome structure, replication, and pathogenesis. J Med Virol. 2020 Apr;92(4):418-423. doi: 10.1002/jmv.25681. Epub 2020 Feb 7. Erratum In: J Med Virol. 2020 Oct;92(10):2249.</citation>
    <PMID>31967327</PMID>
  </reference>
  <reference>
    <citation>Faraji A, Karimi M, Azizi SM, Janatolmakan M, Khatony A. Occupational stress and its related demographic factors among Iranian CCU nurses: a cross-sectional study. BMC Res Notes. 2019 Sep 27;12(1):634. doi: 10.1186/s13104-019-4674-5.</citation>
    <PMID>31558161</PMID>
  </reference>
  <reference>
    <citation>Lee SA. Coronavirus Anxiety Scale: A brief mental health screener for COVID-19 related anxiety. Death Stud. 2020;44(7):393-401. doi: 10.1080/07481187.2020.1748481. Epub 2020 Apr 16.</citation>
    <PMID>32299304</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>December 22, 2020</last_update_submitted>
  <last_update_submitted_qc>December 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Eskisehir Osmangazi University</investigator_affiliation>
    <investigator_full_name>DILEK SAYIK</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Coronavirus Anxiety Scale</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>It is planned to be published in the journal after the study is completed. The study will be shared with other researchers after it is published in the journal.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>will be shared after the work is finished.</ipd_time_frame>
    <ipd_access_criteria>It will be shared with researchers who want to use the anxiety scale.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>March 30, 2022</submitted>
    <returned>April 1, 2022</returned>
  </pending_results>
  <!-- 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/NCT04490473
org study id: DSAYIK2
secondary id: Ayfer AÇIKGÖZ
secondary id: ERTUĞRUL ÇOLAK
secondary id: DENİZ YİĞİT
secondary id: ÖZLEM MUMCU
nct id: NCT04490473
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The coronavirus outbreak has adversely affected individuals in the community, as in the rest
      of the world. However, in order to carry out this epidemic period in a healthy and conscious
      manner, determining the anxiety levels of individuals in the society and supporting them
      psychologically is of great importance. In order to achieve this, healthcare professionals
      working clinically or academically have important duties. This study was planned to test its
      validity and reliability in order to adapt the Coronavirus Anxiety Scale to Turkish.
Coronaviruses can be seen in animals and humans as infections that can be mild and severe in
      society. The SARS-CoV-2 virus, a type of coronavirus, started in China in December 2019 and
      has spread worldwide as of January 2020. The absence of vaccine and treatment for SARS-CoV-2
      disease threatens health worldwide and significantly affects people's daily routine. In
      China, where the pandemic started, shopping malls and schools were closed for a while, and
      city entrances and exits were stopped for a while. Although there are similar practices in
      excellence, as in many countries, measures such as curfew, nursery and school closure
      continue to be taken for under-20s and over-65s. . The coronavirus epidemic that affects our
      entire life is not fully known about the disease process, WHO is defined as the pandemic of
      the epidemic, the nearest contact is the greatest risk of transmission, and the loss of many
      lives during this process affects all individuals in the society negatively and increases the
      level of anxiety .

      It is a psychological reaction involving many emotions such as anxiety, stress, or anxiety,
      fear and distress that arise in a situation that threatens the safety of the individual.
      Conditions such as uncertainty, various diseases (cancer, epidemic, etc.) and losing a
      relative can cause anxiety. Outbreaks that occur suddenly and are at risk of death are among
      these reasons.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This research will be conducted in a methodological manner in order to conduct the validity and reliability studies of the Coronary Virus Anxiety Scale in Turkish.
primary purpose: Other
masking: None (Open Label)
measure: Anxiety in SARS-CoV-2
time frame: 4 weeks
description: anxiety increase in SARS-CoV-2 in humans.
measure: Ratio of SARS-CoV-2 anxiety scale to beck anxiety scale
time frame: 4 weeks
description: The ratio of SARS-CoV-2 anxiety scale to beck anxiety scale is similar.
arm group label: volunteer group
arm group type: Other
description: Only volunteer participants will be included in the research. Survey forms will be sent to individuals online. Individuals who agree to participate in the study will fill in the questionnaire and send it back online.
intervention type: Other
intervention name: survey work
description: Survey forms will be sent to individuals online. Information about the study will be given to individuals with the informative text at the beginning of the questionnaire form. Individuals who agree to participate in the study will fill in the questionnaire and send it back online.
arm group label: volunteer group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: DILEK SAYIK
role: Principal Investigator
affiliation: ESKISEHIR OSMANGAZI UNIVERSTY
last name: DILEK SAYIK
phone: 5065416642
email: dileksayik@hotmail.com
last name: DENIZ YIGIT
phone: 05428092848
email: yigitdenizyigit@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
citation: Benli, S. S., & Yıldırım, A. (2017). Hemşirelerde yaşam doyumu ve ölüme karşı tutum arasındaki ilişki. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, 6(4), 167-179
citation: Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PMID: 3204199
citation: Chen P, Mao L, Nassis GP, Harmer P, Ainsworth BE, Li F. Coronavirus disease (COVID-19): The need to maintain regular physical activity while taking precautions. J Sport Health Sci. 2020 Mar;9(2):103-104. doi: 10.1016/j.jshs.2020.02.001. Epub 2020 Feb 4. No abstract available.
PMID: 32099716
citation: Chen Y, Liu Q, Guo D. Emerging coronaviruses: Genome structure, replication, and pathogenesis. J Med Virol. 2020 Apr;92(4):418-423. doi: 10.1002/jmv.25681. Epub 2020 Feb 7. Erratum In: J Med Virol. 2020 Oct;92(10):2249.
PMID: 31967327
citation: Faraji A, Karimi M, Azizi SM, Janatolmakan M, Khatony A. Occupational stress and its related demographic factors among Iranian CCU nurses: a cross-sectional study. BMC Res Notes. 2019 Sep 27;12(1):634. doi: 10.1186/s13104-019-4674-5.
PMID: 31558161
citation: Lee SA. Coronavirus Anxiety Scale: A brief mental health screener for COVID-19 related anxiety. Death Stud. 2020;44(7):393-401. doi: 10.1080/07481187.2020.1748481. Epub 2020 Apr 16.
PMID: 32299304
responsible party type: Sponsor-Investigator
investigator affiliation: Eskisehir Osmangazi University
investigator full name: DILEK SAYIK
investigator title: Principal Investigator
mesh term: Severe Acute Respiratory Syndrome
mesh term: Anxiety Disorders
sharing ipd: Yes
ipd description: It is planned to be published in the journal after the study is completed. The study will be shared with other researchers after it is published in the journal.
ipd info type: Study Protocol
ipd time frame: will be shared after the work is finished.
ipd access criteria: It will be shared with researchers who want to use the anxiety scale.
submitted: March 30, 2022
returned: April 1, 2022