<?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>IRCT2016062228575N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-02</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences, Vice chancellor for research</primary_sponsor>
      <public_title>Sexual counseling in women's postpartum</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sex consultation on sexual function and the quality of sexual life based on “Women's Postpartum Sexual Health Program”</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Sexual counseling in women's postpartum.</hc_freetext>
      <i_freetext>Intervention 1: . It lasts 5-7 weeks, and with 1-3 weeks gap between sessions. The researcher holds the first three sessions, composed of 6-8 person groups. In the last session, each subject and her spouse receive a 60-90 minutes consultation in the presence of a psychologist .&#13;
 The first session is about female sexual response and postpartum period. After one week, the second session is held about biological, psychological and social factors to avoid sexual issue in postpartum period. The third session is held after two weeks with the subject of intimate and effective communication. The aim of fourth session is supporting each subject and her spouse. Sexual function and the quality of sexual life will be measured before and 8 weeks after the intervention, so both groups can be compared. Intervention 2: There was no intervention in the control group.</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>Maryam Zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 915 154 6300</telephone>
        <email>zamanim931@mums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Robab Latifnejad Roodsari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 937 040 0607</telephone>
        <email>latifnejadr@mums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery</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>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Be Iranian and lives in Mashhad; 18 to 35 years old; Literacy; Be in the period of three months to one year after her delivery; Has a healthy full-term baby from a singleton pregnancy; Be married and the only wife of her spouse; Lives with her spouse at the moment; Starts having sex again after her delivery; Has reported at least one sexual dysfunction in the last two months; The scores of DASS-21 are less than 25 in the scale of stress, less than 14 in the scale of anxiety and less than 20 in the scale of depression; The score of Dyadic Adjustment Scale (DAS) is more than 38.&#13;
&#13;
Exclusion criteria: Addiction to drugs or alcohol in any of couple; Takes medications that affect sexual function; Occur stressful event during the last 6 months; Medical history in any of couple; Mental problems in any of couple; Suffers from complication after her last delivery; Has experienced pelvic surgery (repair colporrhaphy) or genital irradiation.&#13;
&#13;
Exclusion criteria during the study: Lack of tendency to continue her cooperation; Pregnancy during the study; Has not sexual relationship during the study;	Occur stressful event during the intervention; Receive sexual training during the study; Attends in less than three sessions.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>sexual dysfunction, not caused by organic disorder or disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>. It lasts 5-7 weeks, and with 1-3 weeks gap between sessions. The researcher holds the first three sessions, composed of 6-8 person groups. In the last session, each subject and her spouse receive a 60-90 minutes consultation in the presence of a psychologist .&#13;
 The first session is about female sexual response and postpartum period. After one week, the second session is held about biological, psychological and social factors to avoid sexual issue in postpartum period. The third session is held after two weeks with the subject of intimate and effective communication. The aim of fourth session is supporting each subject and her spouse. Sexual function and the quality of sexual life will be measured before and 8 weeks after the intervention, so both groups can be compared.</i_keyword>
      <i_keyword>There was no intervention in the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function. Timepoint: Before the intervention and 8 weeks after ending of treatment. Method of measurement: sexual function  questionnaire (FSFI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Women's quality of sexual life. Timepoint: Before the intervention and 8 weeks after ending of treatment. Method of measurement: Sexual Quality of Life-Female (SQOL-F) 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>Mashhad University of Medical Sciences, Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-20</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, Daneshgah St Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
