xml: <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/NCT06038773</url>
    </required_header>
    <id_info>
      <org_study_id>Yeditepeu3</org_study_id>
      <nct_id>NCT06038773</nct_id>
    </id_info>
    <brief_title>Social and Clinical Aspects of Pelvic Pain in Turkey</brief_title>
    <official_title>Social and Clinical Aspects of Pelvic Pain in Turkey</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yeditepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yeditepe University</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>
        Chronic Pelvic Pain (CPP) is a common medical condition with a complex treatment due to&#xD;
        different variables that influence its clinical course.There is a growing literature which&#xD;
        discussing the effect of ethnicity and culture on pain. It was aimed to invesitigate whether&#xD;
        there is a considerable difference in the presentation and experience of pelvic pain in women&#xD;
        from a different societies and cultures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic Pelvic Pain (CPP) is a common medical condition with a complex treatment due to&#xD;
        different variables that influence its clinical course.There is a growing literature which&#xD;
        discussing the effect of ethnicity and culture on pain. It was aimed to invesitigate whether&#xD;
        there is a considerable difference in the presentation and experience of pelvic pain in women&#xD;
        from a different societies and cultures.&#xD;
  &#xD;
        The study includes randomly selected 45 females who completed a comprehensive set of&#xD;
        questions derived from International Pelvic Pain Society (IPPS), pelvic pain assesment form.&#xD;
        Character and intensity of pain, sexual abuse and harresment, coping with pain, physical&#xD;
        activites (exercising) and comorbidities were evaluated. The McGill pain questionnaire short&#xD;
        form was used to evaluate pain. Sexual Abuse Items in the Questionnaire (modified) to assess&#xD;
        patients' sexual abuse status.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 10, 2023</start_date>
    <completion_date type="Actual">July 22, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>McGill pain scale</measure>
      <time_frame>1 month</time_frame>
      <description>&quot;.Pain intensity was evaluated with the McGill pain questionnaire short form. At the same time, the patients drew the areas where they felt the most pain with the pain maps scale.</description>
    </primary_outcome>
    <enrollment type="Actual">45</enrollment>
    <condition>Chronic Pelvic Pain Syndrome</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Diagnosis</intervention_name>
      <description>Baseline data were presented with descriptive statistics. Sociodemographic information, pregnancy status, surgical history, exercise habits, gynecologic, obstetric, urologic and gastrointestinal history of the patients were evaluated with the &quot;Patient Information Form&quot;.Pain intensity was evaluated with the McGill pain questionnaire short form. At the same time, the patients drew the areas where they felt the most pain with the pain maps scale. Pain intensity during sexual intercourse was evaluated with the Visual Analog Scale (VAS).Sexual Abuse Items on the Questionnaire (Modified from Badgley).</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study included 45 women with pelvic pain. Women aged 18-65 years with pelvic pain ≥6&#xD;
          months were eligible. The study was conducted at Yeditepe University Hospital on female&#xD;
          patients diagnosed with chronic pelvic pain syndrome due to pelvic floor muscle problems by&#xD;
          a gynecologist.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women aged 18-65 years with pelvic pain ≥6 months were eligible.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient who have had pelvic surgery&#xD;
  &#xD;
            -  Gynecological female patients with problems other than pelvic pain&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>nilüfer cerbezer, Msc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yeditepe Üniversitesi</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Nilüfer Cerbezer</name>
        <address>
          <city>İstanbul</city>
          <zip>34758</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pelvic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038773
  org study id: Yeditepeu3
  nct id: NCT06038773
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic Pelvic Pain (CPP) is a common medical condition with a complex treatment due to
        different variables that influence its clinical course.There is a growing literature which
        discussing the effect of ethnicity and culture on pain. It was aimed to invesitigate whether
        there is a considerable difference in the presentation and experience of pelvic pain in women
        from a different societies and cultures.
  Chronic Pelvic Pain (CPP) is a common medical condition with a complex treatment due to
        different variables that influence its clinical course.There is a growing literature which
        discussing the effect of ethnicity and culture on pain. It was aimed to invesitigate whether
        there is a considerable difference in the presentation and experience of pelvic pain in women
        from a different societies and cultures.
  
        The study includes randomly selected 45 females who completed a comprehensive set of
        questions derived from International Pelvic Pain Society (IPPS), pelvic pain assesment form.
        Character and intensity of pain, sexual abuse and harresment, coping with pain, physical
        activites (exercising) and comorbidities were evaluated. The McGill pain questionnaire short
        form was used to evaluate pain. Sexual Abuse Items in the Questionnaire (modified) to assess
        patients' sexual abuse status.
  observational model: Cohort
  time perspective: Retrospective
  measure: McGill pain scale
  time frame: 1 month
  description: ".Pain intensity was evaluated with the McGill pain questionnaire short form. At the same time, the patients drew the areas where they felt the most pain with the pain maps scale.
  intervention type: Diagnostic Test
  intervention name: Diagnosis
  description: Baseline data were presented with descriptive statistics. Sociodemographic information, pregnancy status, surgical history, exercise habits, gynecologic, obstetric, urologic and gastrointestinal history of the patients were evaluated with the "Patient Information Form".Pain intensity was evaluated with the McGill pain questionnaire short form. At the same time, the patients drew the areas where they felt the most pain with the pain maps scale. Pain intensity during sexual intercourse was evaluated with the Visual Analog Scale (VAS).Sexual Abuse Items on the Questionnaire (Modified from Badgley).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: nilüfer cerbezer, Msc
  role: Principal Investigator
  affiliation: Yeditepe Üniversitesi
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Pelvic Pain
  sharing ipd: Undecided