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/NCT06004518</url>
    </required_header>
    <id_info>
      <org_study_id>2023/870</org_study_id>
      <nct_id>NCT06004518</nct_id>
    </id_info>
    <brief_title>The Effect of Sexual Counseling With the PLISSIT Model on Sexual Function and Sexual Quality of Life in Women With Multiple Sclerosis: A Randomized Controlled Study</brief_title>
    <official_title>The Effect of Sexual Counseling With the PLISSIT Model on Sexual Function and Sexual Quality of Life in Women With Multiple Sclerosis: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul 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>
        Multiple Sclerosis (MS) is a chronic neuroinflammatory disease of the central nervous system&#xD;
        that is common in young ages and women. Plaques formed in MS can develop at any point in the&#xD;
        brain and spinal cord, causing various symptoms and adversely affecting the patient's quality&#xD;
        of life. Although not counted among the affected neurological systems, one of the most&#xD;
        important symptoms experienced by MS patients is sexual dysfunction. Sexual dysfunction in MS&#xD;
        may occur due to symptoms of MS such as spasticity, fatigue, and bladder problems, due to the&#xD;
        presence of lesions affecting the neural pathways. The most common method used in the&#xD;
        treatment of sexual dysfunction in women with MS is sexual counseling. The PLISSIT model is&#xD;
        one of the most frequently used models by health professionals in sexual counseling and&#xD;
        evaluation. PLISSIT stands for Permission, limited Information, Specific Suggestion and&#xD;
        Intensive Therapy.&#xD;
  &#xD;
        In this randomized controlled study, the long-term effect of sexual counseling given to&#xD;
        female MS patients with the PLISSIT model on sexual function and sexual quality of life will&#xD;
        be evaluated. The study is planned to be carried out between July 2023 and December 2024 in&#xD;
        the MS and Demyenizing Diseases Unit of Istanbul University Istanbul Medical Faculty&#xD;
        Hospital, Department of Neurology. The sample size was calculated as 86, 43 in the sexual&#xD;
        counseling group and 43 in the control group, in the G*Power (v3.1.9.7) program using the&#xD;
        power analysis method. The data of the study will be collected with the &quot;Descriptive&#xD;
        Information Form&quot;, &quot;Multiple Sclerosis Intimacy and Sexuality Questionnaire-15&quot;, &quot;Sexual&#xD;
        Quality of Life Questionnaire for Women&quot;, &quot;Patient Health Questionnaire-4&quot; and &quot;Fatigue&#xD;
        Severity Scale&quot; developed by the researchers.&#xD;
  &#xD;
        The data will be analyzed in SPPS 28 package program. Number, percentage, mean, standard&#xD;
        deviation, median and minimum-maximum values will be given in descriptive statistics. The&#xD;
        t-test for independent samples/Mann-Whitney U test will be used to compare the mean score of&#xD;
        the dependent variables of the two groups. Paired groups t-test/Wilcoxon test will be used in&#xD;
        the comparison of each group within the group.&#xD;
  &#xD;
        As a result of the research, it is possible to develop an alternative solution approach to&#xD;
        the treatment of sexual problems of women with MS by comprehensively evaluating women with MS&#xD;
        with sexual problems in line with the PLISSIT model, suggesting solutions, examining the&#xD;
        long-term effectiveness of sexual counseling and evaluating the results with concrete, valid&#xD;
        and reliable tools. will be provided.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multiple sclerosis (MS) is a chronic autoimmune, inflammatory, demyelinating and/or&#xD;
        neurodegenerative disease of the central nervous system. Plaques seen in patients with MS can&#xD;
        lead to various symptoms (1). Sexual dysfunction, one of these symptoms, is common in MS&#xD;
        patients and negatively affects their quality of life. Sexual dysfunction in MS can be&#xD;
        classified as primary, secondary and tertiary. Primary sexual dysfunction is due to the&#xD;
        effects of demyelinating lesions on the spinal cord or brain. Secondary dysfunction is due to&#xD;
        the physical disorders associated with MS and the side effects of drugs. They indirectly&#xD;
        affect the sexual response. Fatigue, loss of attention and concentration, difficulties with&#xD;
        movement, coordination disorders, muscle stiffness, bladder and bowel dysfunction, muscle&#xD;
        weakness, lower extremity weakness, tremor, pain and drug side effects can be counted as&#xD;
        examples of these side effects. Tertiary sexual disorder is the cultural, social and&#xD;
        psychological effects of MS. Although sexual dysfunction is a common problem in MS, it is&#xD;
        difficult to diagnose and treat because it is not mentioned or questioned. There is no&#xD;
        reliable specific treatment for sexual dysfunction for women with MS, but a multidisciplinary&#xD;
        approach involving physicians, nurses, sexual therapists, and psychologists is one of the&#xD;
        most important components of care for MS patients. It is necessary to provide enough&#xD;
        information to the patients about sexual dysfunctions and to enable them to learn the effect&#xD;
        of MS on sexuality and current practices in a clear and easy way (3,4).&#xD;
  &#xD;
        It is recommended that health professionals use models in order to comprehensively evaluate&#xD;
        sexuality and focus on solving sexual problems (5,6). The use of models in the evaluation of&#xD;
        sexuality guides health professionals in facilitating the history-taking process and&#xD;
        determining sexual problems. The P-LISS-IT model, one of the recommended models for sexual&#xD;
        counseling, provides four levels of approach to each problem of the individual: P&#xD;
        (Permission): Allowing, Ll (Limited Information): Giving limited information, SS (Specific&#xD;
        Suggestions): Giving specific suggestions, IT (Intensive Therapy) is expressed as Intensive&#xD;
        Therapy (6). Although there are a limited number of studies showing that sexual counseling&#xD;
        based on the PLISSIT model is effective in solving sexual problems in patients with MS,&#xD;
        uncertainty about the long-term effects of sexual counseling continues (7-10). In this study,&#xD;
        an alternative to the treatment of sexual problems of women with MS was investigated by&#xD;
        comprehensively evaluating women with MS with sexual problems in a randomized controlled&#xD;
        design in line with the PLISSIT model, examining the long-term effectiveness of sexual&#xD;
        counseling by comparing it with the control group, and evaluating the results with concrete,&#xD;
        valid and reliable tools. an opportunity to develop a solution approach will be provided. In&#xD;
        addition, due to the limited number of studies, it is thought that it will make an important&#xD;
        contribution to the literature.&#xD;
  &#xD;
        In this study, the following hypotheses will be tested;&#xD;
  &#xD;
          1. Sexual functions of women with MS given sexual counseling based on the PLISSIT model are&#xD;
             better than women in the control group.&#xD;
  &#xD;
          2. Sexual life quality of women with MS who received sexual counseling based on the PLISSIT&#xD;
             model is better than women in the control group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>Crossover Assignment</intervention_model>
      <intervention_model_description>It was planned in a randomized controlled type.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>sexual function</measure>
      <time_frame>1 year</time_frame>
      <description>Multiple Sclerosis Intimacy and Sexuality Questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>sexual quality of life</measure>
      <time_frame>1 year</time_frame>
      <description>Sexual Quality of Life Questionnaire-Female</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">86</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Female Sexual Dysfunction</condition>
    <arm_group>
      <arm_group_label>sexual counselling group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women with MS who are given sexual counseling along with the training booklet will form the sexual counseling group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Women with MS who are not given sexual counseling will form the control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>sexual counselling with PLISSIT model</intervention_name>
      <description>sexual counselling with PLISSIT model</description>
      <arm_group_label>sexual counselling group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Women between the ages of 18-45,&#xD;
  &#xD;
                 -  MS diagnosis is finalized,&#xD;
  &#xD;
                 -  Able to communicate (speak and understand Turkish, no speech disorder),&#xD;
  &#xD;
                 -  Have not had an attack for at least a month,&#xD;
  &#xD;
                 -  Expanded Disability Status Scale (EDSS) score of 5.5 or less&#xD;
  &#xD;
                 -  Those who score 3 or more on each item of the Multiple Sclerosis Intimacy and&#xD;
                    Sexuality Scale-15&#xD;
  &#xD;
                 -  Depression and anxiety scores of 3 and below according to the Patient Health&#xD;
                    Questionnaire-4&#xD;
  &#xD;
                 -  Those who have a Fatigue Severity Scale score of 8 and below&#xD;
  &#xD;
                 -  Does not have any additional chronic disease&#xD;
  &#xD;
                 -  Having a sexual partner and&#xD;
  &#xD;
                 -  Patients willing to participate in the study will be included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women with urinary and stool incontinence problems, menopausal or premenopausal&#xD;
               symptoms, a major psychiatric problem and using antidepressant medication, an&#xD;
               inflammatory disease such as ankylosing spondylitis or rheumatoid arthritis, substance&#xD;
               abuse and those who do not volunteer to participate in the study will not be included.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>female</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Merve TUNCER</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University</investigator_affiliation>
      <investigator_full_name>Merve Tuncer</investigator_full_name>
      <investigator_title>Assist. Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>undecided</ipd_description>
    </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/NCT06004518
  org study id: 2023/870
  nct id: NCT06004518
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Multiple Sclerosis (MS) is a chronic neuroinflammatory disease of the central nervous system
        that is common in young ages and women. Plaques formed in MS can develop at any point in the
        brain and spinal cord, causing various symptoms and adversely affecting the patient's quality
        of life. Although not counted among the affected neurological systems, one of the most
        important symptoms experienced by MS patients is sexual dysfunction. Sexual dysfunction in MS
        may occur due to symptoms of MS such as spasticity, fatigue, and bladder problems, due to the
        presence of lesions affecting the neural pathways. The most common method used in the
        treatment of sexual dysfunction in women with MS is sexual counseling. The PLISSIT model is
        one of the most frequently used models by health professionals in sexual counseling and
        evaluation. PLISSIT stands for Permission, limited Information, Specific Suggestion and
        Intensive Therapy.
  
        In this randomized controlled study, the long-term effect of sexual counseling given to
        female MS patients with the PLISSIT model on sexual function and sexual quality of life will
        be evaluated. The study is planned to be carried out between July 2023 and December 2024 in
        the MS and Demyenizing Diseases Unit of Istanbul University Istanbul Medical Faculty
        Hospital, Department of Neurology. The sample size was calculated as 86, 43 in the sexual
        counseling group and 43 in the control group, in the G*Power (v3.1.9.7) program using the
        power analysis method. The data of the study will be collected with the "Descriptive
        Information Form", "Multiple Sclerosis Intimacy and Sexuality Questionnaire-15", "Sexual
        Quality of Life Questionnaire for Women", "Patient Health Questionnaire-4" and "Fatigue
        Severity Scale" developed by the researchers.
  
        The data will be analyzed in SPPS 28 package program. Number, percentage, mean, standard
        deviation, median and minimum-maximum values will be given in descriptive statistics. The
        t-test for independent samples/Mann-Whitney U test will be used to compare the mean score of
        the dependent variables of the two groups. Paired groups t-test/Wilcoxon test will be used in
        the comparison of each group within the group.
  
        As a result of the research, it is possible to develop an alternative solution approach to
        the treatment of sexual problems of women with MS by comprehensively evaluating women with MS
        with sexual problems in line with the PLISSIT model, suggesting solutions, examining the
        long-term effectiveness of sexual counseling and evaluating the results with concrete, valid
        and reliable tools. will be provided.
  Multiple sclerosis (MS) is a chronic autoimmune, inflammatory, demyelinating and/or
        neurodegenerative disease of the central nervous system. Plaques seen in patients with MS can
        lead to various symptoms (1). Sexual dysfunction, one of these symptoms, is common in MS
        patients and negatively affects their quality of life. Sexual dysfunction in MS can be
        classified as primary, secondary and tertiary. Primary sexual dysfunction is due to the
        effects of demyelinating lesions on the spinal cord or brain. Secondary dysfunction is due to
        the physical disorders associated with MS and the side effects of drugs. They indirectly
        affect the sexual response. Fatigue, loss of attention and concentration, difficulties with
        movement, coordination disorders, muscle stiffness, bladder and bowel dysfunction, muscle
        weakness, lower extremity weakness, tremor, pain and drug side effects can be counted as
        examples of these side effects. Tertiary sexual disorder is the cultural, social and
        psychological effects of MS. Although sexual dysfunction is a common problem in MS, it is
        difficult to diagnose and treat because it is not mentioned or questioned. There is no
        reliable specific treatment for sexual dysfunction for women with MS, but a multidisciplinary
        approach involving physicians, nurses, sexual therapists, and psychologists is one of the
        most important components of care for MS patients. It is necessary to provide enough
        information to the patients about sexual dysfunctions and to enable them to learn the effect
        of MS on sexuality and current practices in a clear and easy way (3,4).
  
        It is recommended that health professionals use models in order to comprehensively evaluate
        sexuality and focus on solving sexual problems (5,6). The use of models in the evaluation of
        sexuality guides health professionals in facilitating the history-taking process and
        determining sexual problems. The P-LISS-IT model, one of the recommended models for sexual
        counseling, provides four levels of approach to each problem of the individual: P
        (Permission): Allowing, Ll (Limited Information): Giving limited information, SS (Specific
        Suggestions): Giving specific suggestions, IT (Intensive Therapy) is expressed as Intensive
        Therapy (6). Although there are a limited number of studies showing that sexual counseling
        based on the PLISSIT model is effective in solving sexual problems in patients with MS,
        uncertainty about the long-term effects of sexual counseling continues (7-10). In this study,
        an alternative to the treatment of sexual problems of women with MS was investigated by
        comprehensively evaluating women with MS with sexual problems in a randomized controlled
        design in line with the PLISSIT model, examining the long-term effectiveness of sexual
        counseling by comparing it with the control group, and evaluating the results with concrete,
        valid and reliable tools. an opportunity to develop a solution approach will be provided. In
        addition, due to the limited number of studies, it is thought that it will make an important
        contribution to the literature.
  
        In this study, the following hypotheses will be tested;
  
          1. Sexual functions of women with MS given sexual counseling based on the PLISSIT model are
             better than women in the control group.
  
          2. Sexual life quality of women with MS who received sexual counseling based on the PLISSIT
             model is better than women in the control group.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: It was planned in a randomized controlled type.
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: sexual function
  time frame: 1 year
  description: Multiple Sclerosis Intimacy and Sexuality Questionnaire
  measure: sexual quality of life
  time frame: 1 year
  description: Sexual Quality of Life Questionnaire-Female
  arm group label: sexual counselling group
  arm group type: Experimental
  description: Women with MS who are given sexual counseling along with the training booklet will form the sexual counseling group.
  arm group label: control group
  arm group type: No Intervention
  description: Women with MS who are not given sexual counseling will form the control group.
  intervention type: Other
  intervention name: sexual counselling with PLISSIT model
  description: sexual counselling with PLISSIT model
  arm group label: sexual counselling group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University
  investigator full name: Merve Tuncer
  investigator title: Assist. Prof.
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis
  sharing ipd: Undecided
  ipd description: undecided