<?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>IRCT20150128020854N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-12</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of sexual counseling based on the BETTER model on sexual function and sexual dysfunctional beliefs in postmenopausal women referred to comprehensive health services affiliated to Shahid Beheshti University of Medical Sciences</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sexual counseling based on the BETTER model on sexual function and sexual dysfunctional beliefs in postmenopausal women referred to comprehensive health services affiliated to Shahid Beheshti University of Medical Sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71128</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, two centers will be randomly selected from the comprehensive health service centers affiliated to Shahid Beheshti University of Medical Sciences. Then randomly one center will be assigned to the intervention group, and one center will be assigned to the control group by lottery. Then, from the medical record numbers of the women who meet the inclusion criteria, 53 people will be selected in each center by lottery. Based on the lottery in the control center, those whose last digit of their file number is odd and in the intervention center those whose last digit of their file number is even will enter the study after the lottery.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual counselling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the women of the intervention group will have two individual counseling sessions of 60 to 90 minutes, one week apart. The content of the sessions is based on the sexual problems raised by women, which will be implemented according to the BETTER model. The first session: The purpose of this session is to create a sense of security and peace in the client and to normalize sexual discourse and reduce the client's sense of shame. The counselor simply talks about sexual issues with the client and tells them that he can talk quite easily. In fact, normalization of the problem is done in this step (first step, Bring up). Then the consultant talks to the client about the importance and impact of sexual issues, especially after menopause, on the quality of life, and gives brief explanations about the function of the sexual organs after menopause and common problems during this period, and about the fact that not treating sexual problems is possible. has effects on married life, gives explanations and it will be said that the client is completely free to talk about this. Then, by asking a few open questions about the client's sexual problem and concern, he will be asked if he has ever discussed this with his wife, thus encouraging the client to talk (second step, explain). Then solutions are given according to their main problem and the counselor assures the client that he will provide all the necessary information to solve his problem (third stage, tell). At the end of the session, the client is asked to discuss his sexual concerns with his wife and list his sexual problems again. At the same time, apply the provided solutions. The second session: The purpose of this session is to increase the client's sense of confidence in the availability of the counselor and to increase the ability to manage sexual problems by herself, as well as to correct misconceptions related to sexual issues after menopause. First, it is requested to express the result of the action regarding the solutions presented in the previous session, especially the conversation with her husband, and express her sexual problems again, and then according to the prioritization of the problems, the duration of the consultation is based on the preference and readiness of the client. It is determined and since the restoration of sexual relationship is an ongoing process, the counselor will be available to address the concerns and answer the client's questions. For this purpose, the researcher will answer their questions by providing them with a contact number at specific hours (fourth step, time). In this meeting, which is held according to the client's preparation and request, the consultant first asks the client's opinion about the previous meeting and the effect of the proposed solutions to be recorded in his file. The counselor is informed by the client's knowledge about how to deal with sexual problems after menopause, so he is asked which of the strategies he used to solve the problem was effective and in order to correct the misconceptions about intimacy after menopause. Menopause is attempted (stage 5, education). Then the counselor provides more complete training about the client's sexual problem. (Continuation of the training of the first session). In the sixth stage of the BETTER model,(stage 6, Record), evaluations, interventions and treatment outcomes of the client are recorded. Women's sexual function questionnaires (FSFI) and sexual dysfunctional beliefs were made by the researcher before the intervention and 4 weeks after the end of the intervention by the company. will be completed. Intervention 2: Control group: for the control group, no intervention with the BETTER model will be carried out during the research, and only the usual interventions and the presentation of pamphlets prepared by the research team will be carried out, but after the end of the research, they will be invited to receive advice based on the above model.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is If there is a logical reason, it will be provided to the journal for publication of the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negin Bahri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali-e-Asr St- Niayesh Intersection- In front of Shahid Rajaei Heart Hospital- School of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>negin.bahri1376@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hedyeh Riazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali-e-Asr St - Niayesh Intersection- In front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>h.riazi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- At least one year has passed since the last menstruation. 2- Being in the first ten years of menopause. 3- Have sexual activity. 4- Do not use hormone replacement therapy. 5- Have not undergone hysterectomy, oophorectomy, cystocele, rectocele, and mastectomy. 6- Their spouses do not suffer from sexual problems. 7- Do not use chemical or herbal drugs effective on sexual function. 8- Premature menopause has not happened. 9- Do not suffer from depression, anxiety, and stress (according to the results of the DASS questionnaire).</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1_ Unwillingness to continue participating in the study. 2_ Interruption of sexual activity during the study for any reason (such as illness, death of spouse).</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the women of the intervention group will have two individual counseling sessions of 60 to 90 minutes, one week apart. The content of the sessions is based on the sexual problems raised by women, which will be implemented according to the BETTER model. The first session: The purpose of this session is to create a sense of security and peace in the client and to normalize sexual discourse and reduce the client's sense of shame. The counselor simply talks about sexual issues with the client and tells them that he can talk quite easily. In fact, normalization of the problem is done in this step (first step, Bring up). Then the consultant talks to the client about the importance and impact of sexual issues, especially after menopause, on the quality of life, and gives brief explanations about the function of the sexual organs after menopause and common problems during this period, and about the fact that not treating sexual problems is possible. has effects on married life, gives explanations and it will be said that the client is completely free to talk about this. Then, by asking a few open questions about the client's sexual problem and concern, he will be asked if he has ever discussed this with his wife, thus encouraging the client to talk (second step, explain). Then solutions are given according to their main problem and the counselor assures the client that he will provide all the necessary information to solve his problem (third stage, tell). At the end of the session, the client is asked to discuss his sexual concerns with his wife and list his sexual problems again. At the same time, apply the provided solutions. The second session: The purpose of this session is to increase the client's sense of confidence in the availability of the counselor and to increase the ability to manage sexual problems by herself, as well as to correct misconceptions related to sexual issues after menopause. First, it is requested to express the result of the action regarding the solutions presented in the previous session, especially the conversation with her husband, and express her sexual problems again, and then according to the prioritization of the problems, the duration of the consultation is based on the preference and readiness of the client. It is determined and since the restoration of sexual relationship is an ongoing process, the counselor will be available to address the concerns and answer the client's questions. For this purpose, the researcher will answer their questions by providing them with a contact number at specific hours (fourth step, time). In this meeting, which is held according to the client's preparation and request, the consultant first asks the client's opinion about the previous meeting and the effect of the proposed solutions to be recorded in his file. The counselor is informed by the client's knowledge about how to deal with sexual problems after menopause, so he is asked which of the strategies he used to solve the problem was effective and in order to correct the misconceptions about intimacy after menopause. Menopause is attempted (stage 5, education). Then the counselor provides more complete training about the client's sexual problem. (Continuation of the training of the first session). In the sixth stage of the BETTER model,(stage 6, Record), evaluations, interventions and treatment outcomes of the client are recorded. Women's sexual function questionnaires (FSFI) and sexual dysfunctional beliefs were made by the researcher before the intervention and 4 weeks after the end of the intervention by the company. will be completed.</i_keyword>
      <i_keyword>Control group: for the control group, no intervention with the BETTER model will be carried out during the research, and only the usual interventions and the presentation of pamphlets prepared by the research team will be carried out, but after the end of the research, they will be invited to receive advice based on the above model.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function. Timepoint: Before the intervention, 4 week after intervention. Method of measurement: Female sexual function index.</prim_outcome>
      <prim_outcome>Dysfunctional sexual beliefs. Timepoint: Before the intervention, 4 week after intervention. Method of measurement: A self-designed questionnaire for dysfunctional sexual beliefs.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-01</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery</contact_name>
        <contact_address>Vali-e-Asr St - Niayesh Intersection- In front of Shshid Rajaei Heart Hospital- School of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
