<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/NCT03837028</url>
  </required_header>
  <id_info>
    <org_study_id>BakirkoyDr.SadiKonuk</org_study_id>
    <nct_id>NCT03837028</nct_id>
  </id_info>
  <brief_title>The Human Papilloma Virus Effect on Sexual Life</brief_title>
  <acronym>HPVandFSFI</acronym>
  <official_title>The Effect of Human Papilloma Virus Genotype on Women's Sexual Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training 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>
      Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases&#xD;
      and its link with malignancies is well established, especially with anogenital tract cancers&#xD;
      (cervical, vaginal, vulvar, anal cancers). HPV 16 and 18 are the most commonly isolated HPV&#xD;
      types in cervical cancer, however not all infections with HPV 16 or 18 progress to cancer.&#xD;
      After the HPV test has been used in cervical cancer screening, there have been concerns about&#xD;
      whether women carry this virus. Although HPV testing may cause negative emotional responses,&#xD;
      adverse emotional responses are related to HPV infection rather than testing. In this&#xD;
      respect, there were several studies which evaluated the quality of life and psychological&#xD;
      responses of women with positive HPV test results and it is known that positive HPV test&#xD;
      results cause additional anxiety, distress and negative emotional responses in women. We&#xD;
      hypothesized that the awareness of having a sexually transmitted infection in women with HPV&#xD;
      and, therefore, a close follow-up and the need for further investigation such as colposcopy&#xD;
      can affect their sexual life. In this study, we aimed to observe the changes in sexual&#xD;
      function and anxiety of the HPV positive women with validated objective tools after being&#xD;
      informed about their co-test results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present prospective, observational study was undertaken among women who were attended to&#xD;
      our gynecology outpatient clinic due to HPV positivity according to the cervical cancer&#xD;
      screening programme. After the ethics approval was obtained from our hospital's local ethics&#xD;
      committee, women aged between 30 and 50 years, sexually active, and who were first diagnosed&#xD;
      with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82)&#xD;
      were included in the study. Women with HPV positive were given standard information about HPV&#xD;
      and HPV testing (co-test) developed by a clinical expert. This information includes; sexually&#xD;
      transmitted nature of HPV, its high prevalence in sexually active women, usually transient&#xD;
      nature of HPV, the association between high risk and low- risk HPV types and cervical&#xD;
      intraepithelial neoplasia (CIN) and cervical cancer, the importance of HPV 16/18 positivity&#xD;
      for cervical premalignant and malign lesions. After given the standard information, the&#xD;
      patients were informed about their co-test results including HPV genotype, cytology results.&#xD;
      The demographic data of the patients such as gravidity, parity,Body Mass Index (BMI),&#xD;
      educational status, and marital status were recorded at the time of admission. The routine&#xD;
      gynecologic examination was performed to all participants. The BMI was calculated as weight&#xD;
      (kg) divided by the square of the height (m2). The patients were divided into four groups&#xD;
      according to their HPV genotype and cytology results. The patients were divided into four&#xD;
      groups according to their HPV genotype and cytology results. Group 1: HPV 16/18 (+), cytology&#xD;
      normal, Group 2: HPV 16/18 (+), cytology abnormal, Group 3: non-16/18 HPV (+), cytology&#xD;
      abnormal, Group 4: non-16/18 HPV (+), cytology normal. In our clinic, we manage the patients&#xD;
      with abnormal co-test results according to the American Society for Colposcopy and Cervical&#xD;
      Pathology guidelines. The patients in group 1, 2, and 3 were referred to colposcopy according&#xD;
      to American Society for Colposcopy and Cervical Pathology (ASCCP) guideline and the patients&#xD;
      in group 4 were referred to colposcopy according to their symptoms and vaginal examination&#xD;
      results such as suspicious cervical observation for cervical intraepithelial neoplasia,&#xD;
      postcoital bleeding and all of the participants were informed about the colposcopy procedure.&#xD;
      All of the patients called for a follow-up visit two months later and were performed a&#xD;
      colposcopy. Sexual function of the patients was assessed at the time of admission and two&#xD;
      months later via the self-administered Female Sexual Function Index (FSFI) questionnaire. The&#xD;
      anxiety status of the patients has assessed via the Beck Anxiety Inventory (BAI)&#xD;
      questionnaire at the time of admission and 2 months later.&#xD;
&#xD;
      Cervical Cancer Screening and management of the results:&#xD;
&#xD;
      According to the national cervical cancer screening program in our country, screening is&#xD;
      initiating at the age of 21 and women age &lt;30 are screening with Papanicolaou test alone at&#xD;
      intervals of every three years. Women ≥ 30 years have been screening with co-testing (HPV&#xD;
      testing and Pap test) every five years. When HPV positivity is detected in the co-test, the&#xD;
      HPV genotype is determined and the pap test is evaluated cytologically. While the patients&#xD;
      with HPV 16/18 positive (cytology normal or abnormal) and non-HPV 16/18 positive and cytology&#xD;
      abnormal referred to a specialist gynecologist for colposcopy, it is recommended that&#xD;
      patients who have a non-HPV 16/18 positive and cytology normal should have a co-test after 1&#xD;
      year.&#xD;
&#xD;
      Beck Anxiety Inventory The Beck Anxiety Inventor (BAI) is a brief measure of anxiety with a&#xD;
      focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating&#xD;
      between anxiety and depression. The BAI is administered via self-report and includes&#xD;
      assessment of symptoms such as nervousness, dizziness, inability to relax, etc. The BAI has a&#xD;
      total of 21 items. Respondents indicate how much they have been bothered by each symptom over&#xD;
      the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to&#xD;
      3 (severely). The BAI is used in efforts to obtain a purer measure of anxiety that is&#xD;
      relatively independent of depression. The total score is calculated by finding the sum of the&#xD;
      21 items. It is defined as; Score of 0-21 = low anxiety Score of 22-35 = moderate anxiety&#xD;
      Score of 36 and above = potentially concerning levels of anxiety Female Sexual Function Index&#xD;
      Sexual dysfunction was assessed via the self-administered FSFI which was adapted to the&#xD;
      Turkish population. This is a 19-item questionnaire that covers six domains: desire (two&#xD;
      questions); arousal and lubrication (four questions each); and orgasm, satisfaction, and pain&#xD;
      (three questions each). The possible scores are 0-5 for the arousal, lubrication, orgasm, and&#xD;
      pain domains; 1-5 for the satisfaction domain; and 1-5 for the desire domain. Domain scores&#xD;
      were obtained by summing the scores of the individual items comprising the domain and then&#xD;
      multiplying by the following domain factors: 0.6 for desire, 0.3 for arousal and lubrication,&#xD;
      and 0.4 for orgasm, satisfaction, and pain. Regarding the individual domains, a score of less&#xD;
      than 65% of the maximum achievable score was considered to indicate dysfunction in that&#xD;
      domain. Thus, a score of less than 3.9 in each domain was considered to indicate Female&#xD;
      sexual disorder (FSD). The full score is obtained by adding the six domain scores. FSFI&#xD;
      scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The&#xD;
      total FSFI score was calculated and categorized as a dichotomous variable using 26.55 as a&#xD;
      cutoff for overall Female sexual disorder. Sexual function was further categorized into four&#xD;
      groups, as described previously: normal sexual function (total FSFI score ≥26.55), mild&#xD;
      Female sexual disorder (total FSFI score 18-26.55), moderate Female sexual disorder (total&#xD;
      FSFI score 11-17), and severe Female sexual disorder (total FSFI score ≤10).&#xD;
&#xD;
      We compared the FSFI and BAI scores between the groups and between the time of admission and&#xD;
      2 months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Female Sexual Function Index (FSFI) Score</measure>
    <time_frame>change from initial overall FSFI score at second months.</time_frame>
    <description>This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and six domain scores are our first primer outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI) Score</measure>
    <time_frame>change from initial BAI score at second months.</time_frame>
    <description>The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score is calculated by finding the sum of the 21 items. The BAI scores range from 0 to 63 and higher scores are associated with high anxiety levels.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Human Papillomavirus Infection</condition>
  <arm_group>
    <arm_group_label>HPV 16/18 (+), cytology normal</arm_group_label>
    <description>Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.&#xD;
The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPV 16/18 (+), cytology abnormal</arm_group_label>
    <description>Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-16/18 HPV (+), cytology abnormal</arm_group_label>
    <description>Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-16/18 HPV (+), cytology normal</arm_group_label>
    <description>Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FSFI</intervention_name>
    <description>Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
    <arm_group_label>HPV 16/18 (+), cytology abnormal</arm_group_label>
    <arm_group_label>HPV 16/18 (+), cytology normal</arm_group_label>
    <arm_group_label>non-16/18 HPV (+), cytology abnormal</arm_group_label>
    <arm_group_label>non-16/18 HPV (+), cytology normal</arm_group_label>
    <other_name>Female Sexual Function Index Questionnaire</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who were attended to our gynecology outpatient clinic due to HPV positivity according&#xD;
        to the cervical cancer screening programme were recruited in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women aged between 30 and 50 years&#xD;
&#xD;
          -  sexually active women&#xD;
&#xD;
          -  women who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35,&#xD;
             39, 45, 51, 52, 56, 58, 59, 68, 69, 82)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  postmenopausal women (defined as those with at least 12 consecutive months of&#xD;
             amenorrhea with no other medical cause and a follicle- stimulating hormone (FSH) level&#xD;
             of 40)&#xD;
&#xD;
          -  women with chronic disease&#xD;
&#xD;
          -  patients with antidepressant usage or patients with psychiatric disorders&#xD;
&#xD;
          -  women who did not agree to participate in the study after reading the informed consent&#xD;
             form&#xD;
&#xD;
          -  women who admitted for follow up due to prior HPV infection&#xD;
&#xD;
          -  women with only low-risk HPV (HPV 6, 11) positivity&#xD;
&#xD;
          -  women with a sexual abuse history&#xD;
&#xD;
          -  women with sexual penetration disorder&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismail Alay</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Of Health Sciences Bakirkoy Sadi Konuk Training And Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bakirkoy Dr. Sadi Konuk Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34147</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <results_first_submitted>July 12, 2020</results_first_submitted>
  <results_first_submitted_qc>August 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2020</results_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</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>Papillomavirus Infections</mesh_term>
    <mesh_term>Papilloma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The researchers in the study have not yet taken a decision on individual participant data (IPD) sharing.</ipd_description>
  </patient_data>
  <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>January 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03837028/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Human Papillomavirus (HPV) 16/18 (+), Cytology Normal</title>
          <description>Women who have Human papillomavirus (HPV) (16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.&#xD;
The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="P2">
          <title>Human Papillomavirus (HPV)16/18 (+), Cytology Abnormal</title>
          <description>Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="P3">
          <title>Non-16/18 Human Papillomavirus (HPV) (+), Cytology Abnormal</title>
          <description>Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="P4">
          <title>Non-16/18 Human Papillomavirus (HPV) (+), Cytology Normal</title>
          <description>Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>HPV 16/18 (+), Cytology Normal</title>
          <description>Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.&#xD;
The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="B2">
          <title>HPV 16/18 (+), Cytology Abnormal</title>
          <description>Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="B3">
          <title>Non-16/18 HPV (+), Cytology Abnormal</title>
          <description>Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="B4">
          <title>Non-16/18 HPV (+), Cytology Normal</title>
          <description>Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="18"/>
            <count group_id="B5" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="23"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="18"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.2" spread="5.6"/>
                    <measurement group_id="B2" value="37.7" spread="4.9"/>
                    <measurement group_id="B3" value="36.6" spread="4.8"/>
                    <measurement group_id="B4" value="40.1" spread="4.5"/>
                    <measurement group_id="B5" value="38.1" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="23"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="18"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Overall Female Sexual Function Index Score</title>
          <description>Female sexual function index (FSFI) covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The overall FSFI score is obtained by summing the six domain scores and ranges between 2.0 and 36.0, with higher scores indicating better sexual functioning. We presented the baseline overall FSFI score of the study groups in this section.</description>
          <units>scores on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="23"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="18"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.2" lower_limit="19.8" upper_limit="30.2"/>
                    <measurement group_id="B2" value="27.1" lower_limit="16.6" upper_limit="35.6"/>
                    <measurement group_id="B3" value="23.8" lower_limit="17.4" upper_limit="31.6"/>
                    <measurement group_id="B4" value="23" lower_limit="15.3" upper_limit="34"/>
                    <measurement group_id="B5" value="25.1" lower_limit="16.6" upper_limit="35.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Female Sexual Function Index (FSFI) Score</title>
        <description>This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and six domain scores are our first primer outcomes.</description>
        <time_frame>change from initial overall FSFI score at second months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HPV 16/18 (+), Cytology Normal</title>
            <description>Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.&#xD;
The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
          </group>
          <group group_id="O2">
            <title>HPV 16/18 (+), Cytology Abnormal</title>
            <description>Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
          </group>
          <group group_id="O3">
            <title>Non-16/18 HPV (+), Cytology Abnormal</title>
            <description>Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
          </group>
          <group group_id="O4">
            <title>Non-16/18 HPV (+), Cytology Normal</title>
            <description>Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
          </group>
        </group_list>
        <measure>
          <title>Female Sexual Function Index (FSFI) Score</title>
          <description>This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and six domain scores are our first primer outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.5"/>
                    <measurement group_id="O2" value="1.2" spread="0.9"/>
                    <measurement group_id="O3" value="0.9" spread="0.9"/>
                    <measurement group_id="O4" value="0.7" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Anxiety Inventory (BAI) Score</title>
        <description>The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score is calculated by finding the sum of the 21 items. The BAI scores range from 0 to 63 and higher scores are associated with high anxiety levels.</description>
        <time_frame>change from initial BAI score at second months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HPV 16/18 (+), Cytology Normal</title>
            <description>Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.&#xD;
The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
          </group>
          <group group_id="O2">
            <title>HPV 16/18 (+), Cytology Abnormal</title>
            <description>Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
          </group>
          <group group_id="O3">
            <title>Non-16/18 HPV (+), Cytology Abnormal</title>
            <description>Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
          </group>
          <group group_id="O4">
            <title>Non-16/18 HPV (+), Cytology Normal</title>
            <description>Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory (BAI) Score</title>
          <description>The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score is calculated by finding the sum of the 21 items. The BAI scores range from 0 to 63 and higher scores are associated with high anxiety levels.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="3.0"/>
                    <measurement group_id="O2" value="4.8" spread="2.3"/>
                    <measurement group_id="O3" value="4.1" spread="2.1"/>
                    <measurement group_id="O4" value="2.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>HPV 16/18 (+), Cytology Normal</title>
          <description>Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.&#xD;
The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="E2">
          <title>HPV 16/18 (+), Cytology Abnormal</title>
          <description>Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="E3">
          <title>Non-16/18 HPV (+), Cytology Abnormal</title>
          <description>Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
        <group group_id="E4">
          <title>Non-16/18 HPV (+), Cytology Normal</title>
          <description>Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.&#xD;
FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ismail Alay</name_or_title>
      <organization>bakirkoy dr sadi konuk training and research hospital</organization>
      <phone>+905462375638</phone>
      <email>dr_ismailalay@hotmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03837028
org study id: BakirkoyDr.SadiKonuk
nct id: NCT03837028
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases
      and its link with malignancies is well established, especially with anogenital tract cancers
      (cervical, vaginal, vulvar, anal cancers). HPV 16 and 18 are the most commonly isolated HPV
      types in cervical cancer, however not all infections with HPV 16 or 18 progress to cancer.
      After the HPV test has been used in cervical cancer screening, there have been concerns about
      whether women carry this virus. Although HPV testing may cause negative emotional responses,
      adverse emotional responses are related to HPV infection rather than testing. In this
      respect, there were several studies which evaluated the quality of life and psychological
      responses of women with positive HPV test results and it is known that positive HPV test
      results cause additional anxiety, distress and negative emotional responses in women. We
      hypothesized that the awareness of having a sexually transmitted infection in women with HPV
      and, therefore, a close follow-up and the need for further investigation such as colposcopy
      can affect their sexual life. In this study, we aimed to observe the changes in sexual
      function and anxiety of the HPV positive women with validated objective tools after being
      informed about their co-test results.
The present prospective, observational study was undertaken among women who were attended to
      our gynecology outpatient clinic due to HPV positivity according to the cervical cancer
      screening programme. After the ethics approval was obtained from our hospital's local ethics
      committee, women aged between 30 and 50 years, sexually active, and who were first diagnosed
      with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82)
      were included in the study. Women with HPV positive were given standard information about HPV
      and HPV testing (co-test) developed by a clinical expert. This information includes; sexually
      transmitted nature of HPV, its high prevalence in sexually active women, usually transient
      nature of HPV, the association between high risk and low- risk HPV types and cervical
      intraepithelial neoplasia (CIN) and cervical cancer, the importance of HPV 16/18 positivity
      for cervical premalignant and malign lesions. After given the standard information, the
      patients were informed about their co-test results including HPV genotype, cytology results.
      The demographic data of the patients such as gravidity, parity,Body Mass Index (BMI),
      educational status, and marital status were recorded at the time of admission. The routine
      gynecologic examination was performed to all participants. The BMI was calculated as weight
      (kg) divided by the square of the height (m2). The patients were divided into four groups
      according to their HPV genotype and cytology results. The patients were divided into four
      groups according to their HPV genotype and cytology results. Group 1: HPV 16/18 (+), cytology
      normal, Group 2: HPV 16/18 (+), cytology abnormal, Group 3: non-16/18 HPV (+), cytology
      abnormal, Group 4: non-16/18 HPV (+), cytology normal. In our clinic, we manage the patients
      with abnormal co-test results according to the American Society for Colposcopy and Cervical
      Pathology guidelines. The patients in group 1, 2, and 3 were referred to colposcopy according
      to American Society for Colposcopy and Cervical Pathology (ASCCP) guideline and the patients
      in group 4 were referred to colposcopy according to their symptoms and vaginal examination
      results such as suspicious cervical observation for cervical intraepithelial neoplasia,
      postcoital bleeding and all of the participants were informed about the colposcopy procedure.
      All of the patients called for a follow-up visit two months later and were performed a
      colposcopy. Sexual function of the patients was assessed at the time of admission and two
      months later via the self-administered Female Sexual Function Index (FSFI) questionnaire. The
      anxiety status of the patients has assessed via the Beck Anxiety Inventory (BAI)
      questionnaire at the time of admission and 2 months later.

      Cervical Cancer Screening and management of the results:

      According to the national cervical cancer screening program in our country, screening is
      initiating at the age of 21 and women age <30 are screening with Papanicolaou test alone at
      intervals of every three years. Women ≥ 30 years have been screening with co-testing (HPV
      testing and Pap test) every five years. When HPV positivity is detected in the co-test, the
      HPV genotype is determined and the pap test is evaluated cytologically. While the patients
      with HPV 16/18 positive (cytology normal or abnormal) and non-HPV 16/18 positive and cytology
      abnormal referred to a specialist gynecologist for colposcopy, it is recommended that
      patients who have a non-HPV 16/18 positive and cytology normal should have a co-test after 1
      year.

      Beck Anxiety Inventory The Beck Anxiety Inventor (BAI) is a brief measure of anxiety with a
      focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating
      between anxiety and depression. The BAI is administered via self-report and includes
      assessment of symptoms such as nervousness, dizziness, inability to relax, etc. The BAI has a
      total of 21 items. Respondents indicate how much they have been bothered by each symptom over
      the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to
      3 (severely). The BAI is used in efforts to obtain a purer measure of anxiety that is
      relatively independent of depression. The total score is calculated by finding the sum of the
      21 items. It is defined as; Score of 0-21 = low anxiety Score of 22-35 = moderate anxiety
      Score of 36 and above = potentially concerning levels of anxiety Female Sexual Function Index
      Sexual dysfunction was assessed via the self-administered FSFI which was adapted to the
      Turkish population. This is a 19-item questionnaire that covers six domains: desire (two
      questions); arousal and lubrication (four questions each); and orgasm, satisfaction, and pain
      (three questions each). The possible scores are 0-5 for the arousal, lubrication, orgasm, and
      pain domains; 1-5 for the satisfaction domain; and 1-5 for the desire domain. Domain scores
      were obtained by summing the scores of the individual items comprising the domain and then
      multiplying by the following domain factors: 0.6 for desire, 0.3 for arousal and lubrication,
      and 0.4 for orgasm, satisfaction, and pain. Regarding the individual domains, a score of less
      than 65% of the maximum achievable score was considered to indicate dysfunction in that
      domain. Thus, a score of less than 3.9 in each domain was considered to indicate Female
      sexual disorder (FSD). The full score is obtained by adding the six domain scores. FSFI
      scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The
      total FSFI score was calculated and categorized as a dichotomous variable using 26.55 as a
      cutoff for overall Female sexual disorder. Sexual function was further categorized into four
      groups, as described previously: normal sexual function (total FSFI score ≥26.55), mild
      Female sexual disorder (total FSFI score 18-26.55), moderate Female sexual disorder (total
      FSFI score 11-17), and severe Female sexual disorder (total FSFI score ≤10).

      We compared the FSFI and BAI scores between the groups and between the time of admission and
      2 months later.
observational model: Cohort
time perspective: Prospective
measure: Female Sexual Function Index (FSFI) Score
time frame: change from initial overall FSFI score at second months.
description: This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and six domain scores are our first primer outcomes.
measure: Beck Anxiety Inventory (BAI) Score
time frame: change from initial BAI score at second months.
description: The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score is calculated by finding the sum of the 21 items. The BAI scores range from 0 to 63 and higher scores are associated with high anxiety levels.
arm group label: HPV 16/18 (+), cytology normal
description: Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.
The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
arm group label: HPV 16/18 (+), cytology abnormal
description: Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
arm group label: non-16/18 HPV (+), cytology abnormal
description: Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
arm group label: non-16/18 HPV (+), cytology normal
description: Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
intervention type: Other
intervention name: FSFI
description: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
arm group label: HPV 16/18 (+), cytology abnormal
arm group label: HPV 16/18 (+), cytology normal
arm group label: non-16/18 HPV (+), cytology abnormal
arm group label: non-16/18 HPV (+), cytology normal
other name: Female Sexual Function Index Questionnaire
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ismail Alay
role: Principal Investigator
affiliation: University Of Health Sciences Bakirkoy Sadi Konuk Training And Research Hospital
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Papillomavirus Infections
mesh term: Papilloma
sharing ipd: No
ipd description: The researchers in the study have not yet taken a decision on individual participant data (IPD) sharing.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 