<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20160709028847N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-09</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Sexual Counseling with Cognitive-Behavioral Therapy approach on Sexual Function of Menopausal women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Sexual Counseling with Cognitive-Behavioral Therapy approach on Sexual Function of Menopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35637</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The sampling method in this research is multi-stage. The first step is selected in a cluster of three areas of the city of Kashan, six centers (from each district of two centers) by lot, and in the next stage, between the two centers, based on the drawing of one The center will be the control group as the intervention group and the other center. In the next step, the researcher will attend the centers from the first to the weekend from 8 am to 12 noon, and will be sampling in the appropriate manner among eligible postmenopausal women who are willing to participate in the research. The questionnaire will then be completed by the clients and screening for sexual function will be performed and those who score less than 28 will enter the research plan. Sampling will continue as long as the prescribed sample size reaches the quid pro quo.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The Impact of Sexual Counseling on the Cognitive-Behavioral Approach of Postmenopausal Women.</hc_freetext>
      <i_freetext>Intervention group: The sample size is 60. The members of the two intervention and control groups complete the pre-test in the first session. Then, the intervention team participates in interventional sessions based on a cognitive-behavioral approach that includes 8 sessions. The control group does not receive intervention. At the end of the sessions, both groups respond to the post-test. Also, in the follow up phase immediately after the intervention, one month and two months later, the two groups will again respond to the questionnaire questions..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Sexual function and its components will be calculated in both groups at the time of entering the research and after the intervention. Using descriptive statistics methods, the two-dimensional frequency distribution tables are set and the quantitative indices of the quantitative variables are also divided into two Calculate the group and then homogeneity tests, homogeneity of the two groups of evaluators. Then, using the t test, we will compare the variables of the two groups. Meanwhile, the pairwise exits will be used to compare before and after quantitative variables. Covariance analysis will be used to control covetails and will be used in the SPSS16 software version.

When:
18 months

To whom:
Dr. Zahra Zanjani - Dr Hamid Haqani

Conditions:
To analyze

Where to obtain:
Dr. Zahra Zanjani - Dr Hamid Haghani - Dr. Leila Neissani

How to obtain:
1/5 years

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Neissani Samani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 86701</telephone>
        <email>neisanisamani.l@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>leila Neisani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 86701</telephone>
        <email>neisanisamani.l@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality
Marital status
Being Muslim
Not being in the profession of psychology and psychiatry
No addiction in couples
Not having couples to have diabetes
Not having sensory and motor disturbances in couples
Have reading and writing skills
Do not use sedative medications
Menopause
The age of a woman is 45 to 60 years old
In the first 5 years after menopause
Amenorrhea for more than a year
Monogamy
Missing menopause at age 40
Not having acute heart disease and any acute mental illness in couples
Lack of stressful experiences in the last three months
The normal nature of the spouse's sexual power, according to one's own words
Not taking herbal remedies containing phytoestrogens or sexual enhancers in any form.غيبت بيش از دو جلسه در جلسات CBT.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Missing more than two sessions at CBT sessions
The occurrence of stressful events during the study
Wife's death or separation from her during study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The sample size is 60. The members of the two intervention and control groups complete the pre-test in the first session. Then, the intervention team participates in interventional sessions based on a cognitive-behavioral approach that includes 8 sessions. The control group does not receive intervention. At the end of the sessions, both groups respond to the post-test. Also, in the follow up phase immediately after the intervention, one month and two months later, the two groups will again respond to the questionnaire questions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive behavioral counseling. Timepoint: Immediately after intervention, 1 month and two months after intervention. Method of measurement: Sexual Function of Women's Sexual Function Index (FSFI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual function. Timepoint: Immediately after intervention, 1 month and two months after intervention. Method of measurement: Questionnaire 19 questions (FSFI).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-26</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
