<?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>IRCT20150128020854N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-02</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigate the effect of sex life enrichment training program on attitude, function, and sexual quality of life in postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>Investigate the effect of sex life enrichment training program on attitude, function, and sexual quality of life in postmenopausal women based on a solution-focused approach</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63043</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method is that first Qazvin city is divided into 4 regions according to socio-economic conditions. Then, two comprehensive health centers with the highest number of clients will be assigned to each region. To prevent the possibility of exchanging information between individuals in the intervention and control groups, the selected centers in each region are randomly assigned to the intervention or control group using a table of random numbers.  Therefore, in each area, we will have two centers, one for the intervention group and one for the control group. Then, postmenopausal women under the auspices of the above centers who are eligible to enter the study will be invited to participate in the study and after providing a full explanation and obtaining informed consent will enter the study. Therefore, sampling in each center will be available based on inclusion criteria and this sampling will continue until the number of samples in each center reaches 18 people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual life of postmenopausal women.</hc_freetext>
      <i_freetext>Intervention 1: We will divide 72 people in the intervention group into four groups, each group will be 18 people, and sex life enrichment training sessions with a solution-oriented approach will be held in groups in comprehensive health service centers. In 4 sessions of 90-60 minutes, the training program will be held by the researcher (Ph.D. student in reproductive and sexual health) who has passed the course related to problem-solving and has succeeded in obtaining the certificate of completion of the course. The goals of the above training sessions are as follows, the first session: introduce people, and start to set goals (goals in a positive, clear, and achievable way in marital and sexual dimensions). Session 2: Helping group members to realize positive abilities and capabilities in previous encounters with marital and sexual life challenges. Session 3: Helping to discover the exceptions to life in the marital identity and sexual life of members (disrupting thought, behavioral and emotional patterns that disrupt life). Session 4: Helping to adopt different mental, behavioral and emotional ways of facing challenges. In all sex life enrichment training sessions, the researcher will answer the participants' questions. Attitudes, practices, and quality of sex life will be measured and compared before and after the intervention (immediately and one month after the sessions). Intervention 2: Control group: 72 people in the control group will not receive any intervention. Before, immediately and one month after the training sessions, attitude, performance and quality of sexual life will be evaluated and compared. After the end of this research, life enrichment will be implemented for the educational groups in order to observe the ethical principles.</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>Elnaz Haji Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 33, Keramat Alley, Modares Boulevard, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413816341</zip>
        <telephone>+98 28 3333 4574</telephone>
        <email>Elnazhajirafiei@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>School of Nursing &amp; Midwifery,   Vali Asr Ave., Niayesh Cross Road,  Niayesh Complex,  Tehran, Iran</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>
    </countries>
    <criteria>
      <inclusion_criteria>Be Iranian
Have at least a literacy education
Be married
Be sexually active
Be in the first ten years of menopause
Do not face a stressful event in the last six months (such as an accident, serious illness, or loss of loved ones)
Women and their husbands do not have a known mental illness (according to the woman)
Women and their husbands do not have severe physical illnesses (such as uncontrolled diabetes, limited mobility) (according to the woman)
They are not on hormone therapy
Have no history of hysterectomy or mastectomy
Women and their husbands should not use drugs that are effective in sexual activity (such as Sildenafil) (according to the woman)
Women and their husbands should not smoke, drink alcohol, or use drugs (according to the woman)
Have not had a serious marital conflict (such as a divorce / the thought of divorce) in the last six months (according to the woman)
No sexual dysfunction in the spouse such as erectile dysfunction and ejaculation (according to the woman)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>We will divide 72 people in the intervention group into four groups, each group will be 18 people, and sex life enrichment training sessions with a solution-oriented approach will be held in groups in comprehensive health service centers. In 4 sessions of 90-60 minutes, the training program will be held by the researcher (Ph.D. student in reproductive and sexual health) who has passed the course related to problem-solving and has succeeded in obtaining the certificate of completion of the course. The goals of the above training sessions are as follows, the first session: introduce people, and start to set goals (goals in a positive, clear, and achievable way in marital and sexual dimensions). Session 2: Helping group members to realize positive abilities and capabilities in previous encounters with marital and sexual life challenges. Session 3: Helping to discover the exceptions to life in the marital identity and sexual life of members (disrupting thought, behavioral and emotional patterns that disrupt life). Session 4: Helping to adopt different mental, behavioral and emotional ways of facing challenges. In all sex life enrichment training sessions, the researcher will answer the participants' questions. Attitudes, practices, and quality of sex life will be measured and compared before and after the intervention (immediately and one month after the sessions).</i_keyword>
      <i_keyword>Control group: 72 people in the control group will not receive any intervention. Before, immediately and one month after the training sessions, attitude, performance and quality of sexual life will be evaluated and compared. After the end of this research, life enrichment will be implemented for the educational groups in order to observe the ethical principles.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual Attitude Score in Sexual Attitude Assessment Questionnaire. Timepoint: Measurement of sexual attitude at the beginning of the study (before the intervention), immediately and 1 month after the intervention. Method of measurement: Sexual Attitude Assessment Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual function score in the Sexual Function Questionnaire. Timepoint: Measurement of sexual function at the beginning of the study (before the intervention), immediately and 1 month after the intervention. Method of measurement: Sexual Function Questionnaire.</sec_outcome>
      <sec_outcome>Sexual quality of life score in Sexual quality of life Questionnaire. Timepoint: Measurement of sexual quality of life at the beginning of the study (before the intervention), immediately and 1 month after the intervention. Method of measurement: Sexual Quality of Life Questionnaire.</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>2022-02-22</approval_date>
        <contact_name>Ethics committee of  Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>St Velenjak, Shahid Chamran Highway, Shahid Beheshti University Of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
