<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/NCT04413058</url>
  </required_header>
  <id_info>
    <org_study_id>HNEAH KAEK 2020/KK/</org_study_id>
    <secondary_id>Ministry of Health</secondary_id>
    <nct_id>NCT04413058</nct_id>
  </id_info>
  <brief_title>Menstrual Cycle Characteristics of Healthcare Professionals</brief_title>
  <official_title>Menstrual Cycle Characteristics of Healthcare Professionals at Covid 19 Pandemic Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haydarpasa Numune Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haydarpasa Numune Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</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 Covid-19 pandemic has impacted healthcare workers physically and psychologically. The aim&#xD;
      of this study is to examine whether there is a change in menstrual cycle characteristics&#xD;
      during pandemia. The aim of this study is to investigate whether there is an association&#xD;
      between covid infection and menstrual cycle changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Covid-19 pandemic has impacted healthcare workers physically and psychologically.&#xD;
      Healthcare workers have ben required to work under stressful conditions and take difficult&#xD;
      decisions involving ethical implications. Increasing work demands on healthcare professionals&#xD;
      conflict with their duties to family and friends, which causes psychological stress. All of&#xD;
      these factors may negatively affect their menstrual cycle.&#xD;
&#xD;
      The aim of this study is to examine whether there is a change in menstrual cycle&#xD;
      characteristics during pandemia. Second aim is to investigate whether there is an association&#xD;
      between Covid 19 infection and menstrual cycle changes.&#xD;
&#xD;
      This cross-sectional study is conducted with healthy female participants who are working at&#xD;
      Haydarpasa Numune Research and Training Hospital in Turkey. The researcher investigates the&#xD;
      characteristics of menstrual cycle in female healthy workers employed in Covid 19 pandemic&#xD;
      inpatient and outpatient clinics. The participants who are sure about their pertinent&#xD;
      information are enrolled in the study. The exclusion criteria includes pregnancy, history of&#xD;
      hysterectomy, oophorectomy, diseases like Asherman's syndrome and also history of endocrine&#xD;
      disorders (progesterone deficiency, thyroid disorders and diabetes mellitus), oral&#xD;
      contraceptive use, malignancy, primary amenorrhea, menopause and lactation.&#xD;
&#xD;
      After informed consent, detailed information is collected using structured questionnaires&#xD;
      about their reproductive factors and menstrual cycles by direct interviews. The questionnaire&#xD;
      contains questions about age, work experience, marital status, height, weight, working hours,&#xD;
      use of medication, menstrual cycle characteristics (including cycle duration, duration and&#xD;
      amount of bleeding, bleeding during the cycle, regular or irregular menstrual cycles) and&#xD;
      dysmenorrhea. Also, the difference in menstrual cycle characteristics between covid positive&#xD;
      and negative healthcare professionals is investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2020</start_date>
  <completion_date type="Actual">September 10, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of irregular menstrual cycle</measure>
    <time_frame>1 month after starting to work at pandemic clinic</time_frame>
    <description>Irregular menstrual cycle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of cycle</measure>
    <time_frame>1 month after starting to work at pandemic clinic</time_frame>
    <description>Length of cycle (day)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of prolonged bleeding</measure>
    <time_frame>1 month after starting to work at pandemic clinic</time_frame>
    <description>Duration of bleeding (day)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of flow</measure>
    <time_frame>1 month after starting to work at pandemic clinic</time_frame>
    <description>Number of used tampons during bleeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of dysmenorrhea</measure>
    <time_frame>1 month after starting to work at pandemic clinic</time_frame>
    <description>Dysmenorrhea status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of difference in menstrual cycle length</measure>
    <time_frame>Up to 1 month after covid infection</time_frame>
    <description>Menstrual cycle difference between covid positive and negative healthcare workers (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of difference in bleeding days</measure>
    <time_frame>Up to 1 month after covid infection</time_frame>
    <description>Duration of bleeding difference between covid positive and negative healthcare workers (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of difference in amount of flow</measure>
    <time_frame>Up to 1 month after covid infection</time_frame>
    <description>Amount of flow difference between covid positive and negative healthcare workers (tampons)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">260</enrollment>
  <condition>Menstrual Irregularity</condition>
  <condition>Covid 19</condition>
  <arm_group>
    <arm_group_label>Female healthcare workers</arm_group_label>
    <description>Healthy female healthcare workers at Covid 19 clinic in Istanbul, Turkey</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy female healthcare workers at Covid 19 pandemic hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Working at Covid 19 Pandemic Hospital&#xD;
&#xD;
          -  Being at between 18 and 47 years old&#xD;
&#xD;
          -  Having menstruation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oral contraceptive users&#xD;
&#xD;
          -  Pregnants&#xD;
&#xD;
          -  Having malignancy&#xD;
&#xD;
          -  Having primary amenorrhea&#xD;
&#xD;
          -  Being at menopause&#xD;
&#xD;
          -  Lactation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>47 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Health Sciences Turkey</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Attarchi M, Darkhi H, Khodarahmian M, Dolati M, Kashanian M, Ghaffari M, Mirzamohammadi E, Mohammadi S. Characteristics of menstrual cycle in shift workers. Glob J Health Sci. 2013 Feb 28;5(3):163-72. doi: 10.5539/gjhs.v5n3p163.</citation>
    <PMID>23618486</PMID>
  </reference>
  <reference>
    <citation>Moen BE, Baste V, Morken T, Alsaker K, Pallesen S, Bjorvatn B. Menstrual characteristics and night work among nurses. Ind Health. 2015;53(4):354-60. doi: 10.2486/indhealth.2014-0214. Epub 2015 Apr 24.</citation>
    <PMID>25914071</PMID>
  </reference>
  <reference>
    <citation>Ok G, Ahn J, Lee W. Association between irregular menstrual cycles and occupational characteristics among female workers in Korea. Maturitas. 2019 Nov;129:62-67. doi: 10.1016/j.maturitas.2019.07.019. Epub 2019 Aug 2.</citation>
    <PMID>31547916</PMID>
  </reference>
  <reference>
    <citation>Wan GH, Chung FF. Working conditions associated with ovarian cycle in a medical center nurses: a Taiwan study. Jpn J Nurs Sci. 2012 Jun;9(1):112-8. doi: 10.1111/j.1742-7924.2011.00191.x. Epub 2011 Sep 16.</citation>
    <PMID>22583945</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
    <investigator_full_name>Sevcan Arzu Arinkan</investigator_full_name>
    <investigator_title>Medical Doctor, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>health care professionals</keyword>
  <keyword>menstrual cycle</keyword>
  <keyword>Covid 19</keyword>
  <keyword>Pandemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Menstruation Disturbances</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT04413058/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04413058
org study id: HNEAH KAEK 2020/KK/
secondary id: Ministry of Health
nct id: NCT04413058
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Covid-19 pandemic has impacted healthcare workers physically and psychologically. The aim
      of this study is to examine whether there is a change in menstrual cycle characteristics
      during pandemia. The aim of this study is to investigate whether there is an association
      between covid infection and menstrual cycle changes.
The Covid-19 pandemic has impacted healthcare workers physically and psychologically.
      Healthcare workers have ben required to work under stressful conditions and take difficult
      decisions involving ethical implications. Increasing work demands on healthcare professionals
      conflict with their duties to family and friends, which causes psychological stress. All of
      these factors may negatively affect their menstrual cycle.

      The aim of this study is to examine whether there is a change in menstrual cycle
      characteristics during pandemia. Second aim is to investigate whether there is an association
      between Covid 19 infection and menstrual cycle changes.

      This cross-sectional study is conducted with healthy female participants who are working at
      Haydarpasa Numune Research and Training Hospital in Turkey. The researcher investigates the
      characteristics of menstrual cycle in female healthy workers employed in Covid 19 pandemic
      inpatient and outpatient clinics. The participants who are sure about their pertinent
      information are enrolled in the study. The exclusion criteria includes pregnancy, history of
      hysterectomy, oophorectomy, diseases like Asherman's syndrome and also history of endocrine
      disorders (progesterone deficiency, thyroid disorders and diabetes mellitus), oral
      contraceptive use, malignancy, primary amenorrhea, menopause and lactation.

      After informed consent, detailed information is collected using structured questionnaires
      about their reproductive factors and menstrual cycles by direct interviews. The questionnaire
      contains questions about age, work experience, marital status, height, weight, working hours,
      use of medication, menstrual cycle characteristics (including cycle duration, duration and
      amount of bleeding, bleeding during the cycle, regular or irregular menstrual cycles) and
      dysmenorrhea. Also, the difference in menstrual cycle characteristics between covid positive
      and negative healthcare professionals is investigated.
observational model: Case-Crossover
time perspective: Prospective
measure: Rate of irregular menstrual cycle
time frame: 1 month after starting to work at pandemic clinic
description: Irregular menstrual cycle
measure: Length of cycle
time frame: 1 month after starting to work at pandemic clinic
description: Length of cycle (day)
measure: Rate of prolonged bleeding
time frame: 1 month after starting to work at pandemic clinic
description: Duration of bleeding (day)
measure: Amount of flow
time frame: 1 month after starting to work at pandemic clinic
description: Number of used tampons during bleeding
measure: Rate of dysmenorrhea
time frame: 1 month after starting to work at pandemic clinic
description: Dysmenorrhea status
measure: The number of difference in menstrual cycle length
time frame: Up to 1 month after covid infection
description: Menstrual cycle difference between covid positive and negative healthcare workers (days)
measure: The number of difference in bleeding days
time frame: Up to 1 month after covid infection
description: Duration of bleeding difference between covid positive and negative healthcare workers (days)
measure: The number of difference in amount of flow
time frame: Up to 1 month after covid infection
description: Amount of flow difference between covid positive and negative healthcare workers (tampons)
arm group label: Female healthcare workers
description: Healthy female healthcare workers at Covid 19 clinic in Istanbul, Turkey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 47 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
citation: Attarchi M, Darkhi H, Khodarahmian M, Dolati M, Kashanian M, Ghaffari M, Mirzamohammadi E, Mohammadi S. Characteristics of menstrual cycle in shift workers. Glob J Health Sci. 2013 Feb 28;5(3):163-72. doi: 10.5539/gjhs.v5n3p163.
PMID: 23618486
citation: Moen BE, Baste V, Morken T, Alsaker K, Pallesen S, Bjorvatn B. Menstrual characteristics and night work among nurses. Ind Health. 2015;53(4):354-60. doi: 10.2486/indhealth.2014-0214. Epub 2015 Apr 24.
PMID: 25914071
citation: Ok G, Ahn J, Lee W. Association between irregular menstrual cycles and occupational characteristics among female workers in Korea. Maturitas. 2019 Nov;129:62-67. doi: 10.1016/j.maturitas.2019.07.019. Epub 2019 Aug 2.
PMID: 31547916
citation: Wan GH, Chung FF. Working conditions associated with ovarian cycle in a medical center nurses: a Taiwan study. Jpn J Nurs Sci. 2012 Jun;9(1):112-8. doi: 10.1111/j.1742-7924.2011.00191.x. Epub 2011 Sep 16.
PMID: 22583945
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi
investigator full name: Sevcan Arzu Arinkan
investigator title: Medical Doctor, Principal Investigator
mesh term: COVID-19
mesh term: Menstruation Disturbances
provided document: 