<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/NCT04452227</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH108-REC3-052</org_study_id>
    <nct_id>NCT04452227</nct_id>
  </id_info>
  <brief_title>A Two-stage Translation of the Chinese Version Menstrual Distress Questionnaire</brief_title>
  <official_title>A Two-stage Translation of the Chinese Version Menstrual Distress Questionnaire: a Physical, Psychological, and Behavior Study in Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University 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>
      This study attempted to do the two-stage design of the translation of the MDQC (Menstrual&#xD;
      Distress Questionnaire Form C-Cycle) Chinese version, and to do the validity and reliability&#xD;
      test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Premenstrual syndrome is defined as recurrent moderate physical, psychological, behavior&#xD;
      symptoms that occur during the luteal phase of menses and resolve with menstruation. It&#xD;
      affects 20 to 32 percent of premenopausal women.&#xD;
&#xD;
      A diagnosis of PMS consists of determining the timing of the symptoms in relation to menses,&#xD;
      meaningful change between post- and premenstrual symptom severity, and a clinically&#xD;
      significant severity of the symptoms. The ICD-10 requires only one distressing symptom for a&#xD;
      diagnosis of PMS. The American College of Obstetricians and Gynecologists (ACOG) diagnosis is&#xD;
      that it occurs 5 days before menses and remit within 4 days of onset of menses no recurrence&#xD;
      at least until day 13 of the cycle. A differential diagnosis to distinguish PMS from other&#xD;
      medical and psychiatric conditions is important for appropriate treatment. No hormone or&#xD;
      laboratory test indicates a PMS diagnosis. The current diagnostic standard requires&#xD;
      confirmation of subjective symptom reports by prospective daily diaries. The Menstrual&#xD;
      Distress Questionnaire (MDQ) is a method for measuring perimenstrual symptoms. It is a&#xD;
      46-item self-report inventory for use in the assessment of physical or psychological symptoms&#xD;
      that occur in the premenstrual, menstrual, or intermenstrual phases. There are two forms of&#xD;
      the MDQ: form C (Cycle) and form T (Today). Form C of the MDQ is designed for screening.&#xD;
      Women use this form to describe their symptoms and reactions during each of the three phases&#xD;
      of their most recent menstrual cycle. It may be administered at any time during the cycle.&#xD;
      Form T is designed for treatment evaluation, and research application.&#xD;
&#xD;
      This study attempted to do the two-stage design of the translation of the MDQ (Form C-Cycle).&#xD;
      Previous studies have translated only 14 items of the MDQ (Form C - Cycle) and only done the&#xD;
      internal reliability test. This study is expected to do a two-stage translation of the MDQ&#xD;
      (Form C - Cycle) Chinese version, and to do the reliability and validity test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2019</start_date>
  <completion_date type="Actual">December 24, 2019</completion_date>
  <primary_completion_date type="Actual">June 22, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>questionnaire data</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Statistical analyses were conducted using IBM SPSS Statistics 24 for Windows (IBM Inc., Armonk, NY, USA)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">219</enrollment>
  <condition>Non-disease State</condition>
  <arm_group>
    <arm_group_label>eumenorrheic healthy women</arm_group_label>
    <description>women with a regular menstrual cycle for three months, predictable, and a period between 24-38 days that lasts less than 8 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>Filling the menstrual distress questionnaire, short-form McGill pain questionnaire, present pain index, visual analog scale</description>
    <arm_group_label>eumenorrheic healthy women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy females aged 20-40 years with regular and predictable menstrual cycles, fluent in&#xD;
        speaking, reading, and writing Chinese in Taiwan&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A eumenorrheic healthy woman with a regular menstrual cycle for three months,&#xD;
             predictable, and a period between 24-38 days that lasts less than 8 days.&#xD;
&#xD;
          2. No hormonal contraceptives have been used in the past six months.&#xD;
&#xD;
          3. No history of smoking, drinking or drug abuse.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women with systemic diseases, cardiovascular diseases, liver diseases, kidney&#xD;
             diseases, diabetes or thyroid diseases.&#xD;
&#xD;
          2. Taking any medicine due to chronic disease&#xD;
&#xD;
          3. Women with mental illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Su Shan-Yu, M.D. Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CMUH</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Menstrual Distress Questionnaire, Two-Stage Translation</keyword>
  <!-- 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/NCT04452227
org study id: CMUH108-REC3-052
nct id: NCT04452227
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study attempted to do the two-stage design of the translation of the MDQC (Menstrual
      Distress Questionnaire Form C-Cycle) Chinese version, and to do the validity and reliability
      test.
Premenstrual syndrome is defined as recurrent moderate physical, psychological, behavior
      symptoms that occur during the luteal phase of menses and resolve with menstruation. It
      affects 20 to 32 percent of premenopausal women.

      A diagnosis of PMS consists of determining the timing of the symptoms in relation to menses,
      meaningful change between post- and premenstrual symptom severity, and a clinically
      significant severity of the symptoms. The ICD-10 requires only one distressing symptom for a
      diagnosis of PMS. The American College of Obstetricians and Gynecologists (ACOG) diagnosis is
      that it occurs 5 days before menses and remit within 4 days of onset of menses no recurrence
      at least until day 13 of the cycle. A differential diagnosis to distinguish PMS from other
      medical and psychiatric conditions is important for appropriate treatment. No hormone or
      laboratory test indicates a PMS diagnosis. The current diagnostic standard requires
      confirmation of subjective symptom reports by prospective daily diaries. The Menstrual
      Distress Questionnaire (MDQ) is a method for measuring perimenstrual symptoms. It is a
      46-item self-report inventory for use in the assessment of physical or psychological symptoms
      that occur in the premenstrual, menstrual, or intermenstrual phases. There are two forms of
      the MDQ: form C (Cycle) and form T (Today). Form C of the MDQ is designed for screening.
      Women use this form to describe their symptoms and reactions during each of the three phases
      of their most recent menstrual cycle. It may be administered at any time during the cycle.
      Form T is designed for treatment evaluation, and research application.

      This study attempted to do the two-stage design of the translation of the MDQ (Form C-Cycle).
      Previous studies have translated only 14 items of the MDQ (Form C - Cycle) and only done the
      internal reliability test. This study is expected to do a two-stage translation of the MDQ
      (Form C - Cycle) Chinese version, and to do the reliability and validity test.
observational model: Case-Only
time perspective: Cross-Sectional
measure: questionnaire data
time frame: up to 8 weeks
description: Statistical analyses were conducted using IBM SPSS Statistics 24 for Windows (IBM Inc., Armonk, NY, USA)
arm group label: eumenorrheic healthy women
description: women with a regular menstrual cycle for three months, predictable, and a period between 24-38 days that lasts less than 8 days.
intervention type: Other
intervention name: questionnaire
description: Filling the menstrual distress questionnaire, short-form McGill pain questionnaire, present pain index, visual analog scale
arm group label: eumenorrheic healthy women
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Su Shan-Yu, M.D. Ph.D.
role: Principal Investigator
affiliation: China Medical University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor