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/NCT05967104</url>
    </required_header>
    <id_info>
      <org_study_id>03072023</org_study_id>
      <nct_id>NCT05967104</nct_id>
    </id_info>
    <brief_title>Sexual Education in Women Based On The Plissit Model On Awareness And Attitude in Midwifery Students</brief_title>
    <official_title>The Effect of Sexual Education in Women With Gynecological Cancer Based On The Plissit Model On Awareness And Attitude in Midwifery Students: A Randomised Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sakarya University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sakarya University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, it was aimed to determine the awareness levels and attitudes of the students&#xD;
        with the sexual counseling training conducted in line with the PLISSIT model. This&#xD;
        experimental (randomized-controlled) study was conducted with midwifery students who agreed&#xD;
        to participate in the study and met the inclusion criteria at a state university in western&#xD;
        Turkey. As a result of the randomization, there were 38 students in the intervention group&#xD;
        and 36 students in the control group. While training based on the PLISSIT framework was given&#xD;
        to the intervention group, no training was given to the control group. Data were collected&#xD;
        through the Introductory Information Form, the Gynecological Cancer Awareness Scale (GCPS),&#xD;
        and the Sexual Attitudes and Beliefs Scale (CTİÖ) before the training and after the&#xD;
        completion of the 3 trainings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Intervention In order to improve the educational content, researchers conducted a literature&#xD;
        review on gynecological cancers, sexual problems in gynecological cancer, sexual counseling.&#xD;
        The training content was created after the literature review.&#xD;
  &#xD;
        Gynecological cancers are malignant diseases of the ovaries, cervix, endometrium, vulva,&#xD;
        vagina and fallopian tubes that make up the female reproductive system. GLOBACAN (Global&#xD;
        Cancer Observatory) 2020 data show that gynecological cancers rank fourth among the most&#xD;
        common types of cancer among women in the world. Gynecological cancers are responsible for&#xD;
        more than 100,000 incidences and 32,000 deaths per year. Significant changes are taking&#xD;
        place, especially in the area of sexuality. It is known that sexually active gynecological&#xD;
        cancer cases often complain of dyspareunia, vaginal dryness, postcoital bleeding,&#xD;
        deterioration in sexual arousal, lack of sexual desire, genitopelvic pain. In addition,&#xD;
        changes in the female genital organs, such as vaginal stenosis, vaginal dryness, scar&#xD;
        formation in the vagina and vaginal atrophy, can lead to sexual dysfunction. Sexual&#xD;
        dysfunction is one of the most common and troubling qualities of life issues faced by women&#xD;
        with gynecological cancer, but it is rarely discussed among cancer patients, survivors, and&#xD;
        health professionals. Therefore, a comprehensive assessment of sexual health from the first&#xD;
        visit of patients should be carried out as a routine part of each examination. In this&#xD;
        regard, health professionals need to apply resources that will encourage effective,&#xD;
        sensitive, communication with patients about sexual health problems. One of the most widely&#xD;
        used interventions in the field of assessing and managing sexual problems is the PLISSIT&#xD;
        model. The PLISSIT model provides a safe, tolerant and therapeutic environment for the&#xD;
        discussion of sexual concerns, encouraging referral to an appropriate specialist as needed.&#xD;
        The model consists of four steps to address sexual concerns: Consent, Limited Information,&#xD;
        Specific Recommendations, and Intensive Therapy. The first stage of this model is to allow&#xD;
        patients to share their thoughts and concerns about their sex life. In the second stage,&#xD;
        individuals are informed about their thoughts and concerns about their sex life. In the third&#xD;
        stage, patients are given &quot;special recommendations&quot;. Specific recommendations should be&#xD;
        appropriate to each person's individual needs. At this point, health professionals need to&#xD;
        know more about sexuality in order to give patient-specific information. The fourth stage&#xD;
        involves the referral of the patient to the relevant specialist. This model enables&#xD;
        healthcare professionals to develop effective strategies for addressing sexual concerns. In&#xD;
        order for the model to be applied effectively, it is essential that the relevant health&#xD;
        professionals are informed about the subject. In this context, it is very important to show&#xD;
        health professionals and students studying in the field of health that sexuality is very&#xD;
        important in women with gynecological cancer, to raise their awareness in the field and to&#xD;
        ensure that their positive attitudes towards sexuality are formed. For this reason, in this&#xD;
        study, 3rd-year students of the midwifery department were trained on &quot;sexuality education for&#xD;
        women with gynecological cancer&quot; prepared based on the PLISSIT model, and it was examined how&#xD;
        the gynecological cancer awareness and sexual attitudes and beliefs of the students were&#xD;
        affected.&#xD;
  &#xD;
        In this study, it is aimed to determine the effect of sexuality education in line with the&#xD;
        PLISSIT model on the gynecological cancer awareness levels of the students and their sexual&#xD;
        attitudes and beliefs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2022</start_date>
    <completion_date type="Actual">February 27, 2023</completion_date>
    <primary_completion_date type="Actual">July 20, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gynecological cancer awareness scale change</measure>
      <time_frame>pre-intervention, 1 month after intervention</time_frame>
      <description>Scale; It consists of four sub-dimensions: routine control and awareness of serious disease perception in gynecological cancers, awareness of gynecological cancer risks, awareness of prevention from gynecological cancers and early diagnosis and information awareness in gynecological cancers.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sexual Attitudes and Beliefs Scale Change</measure>
      <time_frame>pre-intervention, 1 month after intervention</time_frame>
      <description>high scores from scale items and grand total; It shows that negative beliefs and attitudes towards evaluating the patient's sexuality/providing sexual counseling increase and there are more obstacles in evaluating sexual problems and providing counseling.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">76</enrollment>
    <condition>Cancer</condition>
    <condition>Educational Problems</condition>
    <condition>Sex Behavior</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Training to the intervention group was carried out in 3 sessions of 45 minutes each week, organized by the first author (AD). In each session, training was organized based on the PLISSIT framework.&#xD;
  Questionnaires (Introductory individual form, Gynecological cancer awareness scale and Sexual Attitudes and Beliefs Scale) were completed by students included in the intervention and control groups at the beginning and one month after the completion of the 3 training sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The students in the control group were not given any training within the scope of the study, and they only had knowledge about gynecological cancers and sexuality, which are included in the course content of gynecological diseases. However, in order to comply with ethical principles, training information was provided online to the control group after the study data collection process was completed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Education based on the PLISSIT model</intervention_name>
      <description>Training to the intervention group was carried out in 3 sessions of 45 minutes each week, organized by the first author (AD). In each session, training was organized based on the PLISSIT framework.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being a midwifery 3rd year student,&#xD;
  &#xD;
            -  Agree to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -Having failed or not taken the &quot;Gynecology&quot; course even though it is a third year.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahsen DEMİRHAN KAYACIK</last_name>
      <role>Study Chair</role>
      <affiliation>Sakarya University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Sakarya University</name>
        <address>
          <city>Sakarya</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sakarya University</investigator_affiliation>
      <investigator_full_name>yasemin hamlacı başkaya</investigator_full_name>
      <investigator_title>Head of Midwifery Depatment</investigator_title>
    </responsible_party>
    <keyword>PLISSIT</keyword>
    <keyword>sexual education</keyword>
    <keyword>gynecological cancer</keyword>
    <keyword>sexual attitudes and beliefs</keyword>
    <patient_data>
      <sharing_ipd>No</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/NCT05967104
  org study id: 03072023
  nct id: NCT05967104
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In this study, it was aimed to determine the awareness levels and attitudes of the students
        with the sexual counseling training conducted in line with the PLISSIT model. This
        experimental (randomized-controlled) study was conducted with midwifery students who agreed
        to participate in the study and met the inclusion criteria at a state university in western
        Turkey. As a result of the randomization, there were 38 students in the intervention group
        and 36 students in the control group. While training based on the PLISSIT framework was given
        to the intervention group, no training was given to the control group. Data were collected
        through the Introductory Information Form, the Gynecological Cancer Awareness Scale (GCPS),
        and the Sexual Attitudes and Beliefs Scale (CTİÖ) before the training and after the
        completion of the 3 trainings.
  Intervention In order to improve the educational content, researchers conducted a literature
        review on gynecological cancers, sexual problems in gynecological cancer, sexual counseling.
        The training content was created after the literature review.
  
        Gynecological cancers are malignant diseases of the ovaries, cervix, endometrium, vulva,
        vagina and fallopian tubes that make up the female reproductive system. GLOBACAN (Global
        Cancer Observatory) 2020 data show that gynecological cancers rank fourth among the most
        common types of cancer among women in the world. Gynecological cancers are responsible for
        more than 100,000 incidences and 32,000 deaths per year. Significant changes are taking
        place, especially in the area of sexuality. It is known that sexually active gynecological
        cancer cases often complain of dyspareunia, vaginal dryness, postcoital bleeding,
        deterioration in sexual arousal, lack of sexual desire, genitopelvic pain. In addition,
        changes in the female genital organs, such as vaginal stenosis, vaginal dryness, scar
        formation in the vagina and vaginal atrophy, can lead to sexual dysfunction. Sexual
        dysfunction is one of the most common and troubling qualities of life issues faced by women
        with gynecological cancer, but it is rarely discussed among cancer patients, survivors, and
        health professionals. Therefore, a comprehensive assessment of sexual health from the first
        visit of patients should be carried out as a routine part of each examination. In this
        regard, health professionals need to apply resources that will encourage effective,
        sensitive, communication with patients about sexual health problems. One of the most widely
        used interventions in the field of assessing and managing sexual problems is the PLISSIT
        model. The PLISSIT model provides a safe, tolerant and therapeutic environment for the
        discussion of sexual concerns, encouraging referral to an appropriate specialist as needed.
        The model consists of four steps to address sexual concerns: Consent, Limited Information,
        Specific Recommendations, and Intensive Therapy. The first stage of this model is to allow
        patients to share their thoughts and concerns about their sex life. In the second stage,
        individuals are informed about their thoughts and concerns about their sex life. In the third
        stage, patients are given "special recommendations". Specific recommendations should be
        appropriate to each person's individual needs. At this point, health professionals need to
        know more about sexuality in order to give patient-specific information. The fourth stage
        involves the referral of the patient to the relevant specialist. This model enables
        healthcare professionals to develop effective strategies for addressing sexual concerns. In
        order for the model to be applied effectively, it is essential that the relevant health
        professionals are informed about the subject. In this context, it is very important to show
        health professionals and students studying in the field of health that sexuality is very
        important in women with gynecological cancer, to raise their awareness in the field and to
        ensure that their positive attitudes towards sexuality are formed. For this reason, in this
        study, 3rd-year students of the midwifery department were trained on "sexuality education for
        women with gynecological cancer" prepared based on the PLISSIT model, and it was examined how
        the gynecological cancer awareness and sexual attitudes and beliefs of the students were
        affected.
  
        In this study, it is aimed to determine the effect of sexuality education in line with the
        PLISSIT model on the gynecological cancer awareness levels of the students and their sexual
        attitudes and beliefs.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Gynecological cancer awareness scale change
  time frame: pre-intervention, 1 month after intervention
  description: Scale; It consists of four sub-dimensions: routine control and awareness of serious disease perception in gynecological cancers, awareness of gynecological cancer risks, awareness of prevention from gynecological cancers and early diagnosis and information awareness in gynecological cancers.
  measure: Sexual Attitudes and Beliefs Scale Change
  time frame: pre-intervention, 1 month after intervention
  description: high scores from scale items and grand total; It shows that negative beliefs and attitudes towards evaluating the patient's sexuality/providing sexual counseling increase and there are more obstacles in evaluating sexual problems and providing counseling.
  arm group label: Experimental group
  arm group type: Experimental
  description: Training to the intervention group was carried out in 3 sessions of 45 minutes each week, organized by the first author (AD). In each session, training was organized based on the PLISSIT framework.
  Questionnaires (Introductory individual form, Gynecological cancer awareness scale and Sexual Attitudes and Beliefs Scale) were completed by students included in the intervention and control groups at the beginning and one month after the completion of the 3 training sessions.
  arm group label: Control group
  arm group type: No Intervention
  description: The students in the control group were not given any training within the scope of the study, and they only had knowledge about gynecological cancers and sexuality, which are included in the course content of gynecological diseases. However, in order to comply with ethical principles, training information was provided online to the control group after the study data collection process was completed.
  intervention type: Other
  intervention name: Education based on the PLISSIT model
  description: Training to the intervention group was carried out in 3 sessions of 45 minutes each week, organized by the first author (AD). In each session, training was organized based on the PLISSIT framework.
  arm group label: Experimental group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahsen DEMİRHAN KAYACIK
  role: Study Chair
  affiliation: Sakarya University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Sakarya University
  investigator full name: yasemin hamlacı başkaya
  investigator title: Head of Midwifery Depatment
  sharing ipd: No