<?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>IRCT2016112631117N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-16</date_registration>
      <primary_sponsor>Vice chancellor for research, Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Investigate the effectiveness of performing educational package based on consultant midwife on sexual function in postmenopausal women and sexual satisfaction of middle-aged couples</public_title>
      <acronym></acronym>
      <scientific_title>Investigate the effectiveness of performing educational package based on consultant midwife on sexual function in postmenopausal women and sexual satisfaction of middle-aged couples</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24542</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Menopause.</hc_freetext>
      <i_freetext>Intervention 1: Control group: This group during the study will not be any intervention, but to consider the ethical aspects, after doing research, training manual containing the contents of the meetings will be presented to them. Intervention 2: Intervention group: Sessions will be established to a single couple. Educational – consultative sessions will be established four sixty-minute sessions once a week. The contents of the meeting include, training in the field of menopause, sexual function and dysfunction, stimulus control, sensate focus, real confrontation and conflict intervention.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Khani Soghra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ُSexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 8918</telephone>
        <email>s.khani@mazums.ac.ir   khanisog343@gmail.com</email>
        <affiliation>Mazandaran University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Khani Soghra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ُSexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 8918</telephone>
        <email>s.khani@mazums.ac.ir   khanisog343@gmail.com</email>
        <affiliation>Mazandaran University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: A written consent to participate in the study; Their husbands alive and living with his wife; One year from the last menstrual period of the past; They have a natural menopause; Obtaining a score less than 26/5 of the scale of sexual function; Having basic literacy; Having age between 44 to 55 years; Having sexual dysfunction, at least in the last 4 weeks; Lack of drug addiction; No diagnosis of severe physical or mental disease in postmenopausal women, according to GHQ questionnaire.&#13;
&#13;
Exclusion criteria: The receipt of any psychological or additional treatment such as hormone therapy for menopause before or during the study; Chronic diseases such as advanced physical and mental diabetes, multiple sclerosis, heart disease and psychosis; The occurrence of any event or crisis in their life such special events as the death of relatives, incurable disease in family members in the last month; receive any formal education about sex before or during the study; The absence of the wife of training sessions and Consultancy; Diagnosis of impotence in the IIEF questionnaire wife.</inclusion_criteria>
      <agemin>44 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary ovarian failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: This group during the study will not be any intervention, but to consider the ethical aspects, after doing research, training manual containing the contents of the meetings will be presented to them.</i_keyword>
      <i_keyword>Intervention group: Sessions will be established to a single couple. Educational – consultative sessions will be established four sixty-minute sessions once a week. The contents of the meeting include, training in the field of menopause, sexual function and dysfunction, stimulus control, sensate focus, real confrontation and conflict intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function in postmenopausal women. Timepoint: A week before, two weeks after the last sessions, two months after the last sessions. Method of measurement: Female Sexual Function Questionnaire Rosen.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual satisfaction of middle-aged couples. Timepoint: A week before, two weeks after the last sessions, two months after the last sessions. Method of measurement: International sexual satisfaction questionnaire Larson.</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>Vice chancellor for research, Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-06</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical sciences</contact_name>
        <contact_address>Vice chancellor for research, Mazandaran University of Medical Sciences, Moalem square,  Moalem street Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
