<?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>IRCT20111122008170N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-02</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of consuling with EXPLISSIT approach on sexual function and marital satisfaction in newly delivered women</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of consuling with EXPLISSIT approach on sexual function and marital satisfaction in newly delivered women: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30478</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The selected individuals will be assigned by random blocking using the RAS software with blocks 4 and 6 with a ratio of 1: 1 to two groups (Consultation recipient and control,  34 people for each group), the type allocation will be written on the paper and placed in the opaque packets numbered down, the pockets will be opened in the order of the individuals entering the study and the type of group will be specified. The allocation sequence will be performed by the person not involved in the sampling and collecting of data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual dysfunction in women newly delivered.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, sexual counseling will be given by the trained midwife during a 60-90 minute or more session in accordance with the EXPLISSIT model and will be based on the concerns and needs of the participants. Intervention 2: Control group: Get routine care.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Robab Gholizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardebil, Ayatollah Moghadas Ardebili St., Shahid Moadi St., Alawi Medical Education Center</address>
        <city>َArdabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5613974156</zip>
        <telephone>+98 45 3324 8888</telephone>
        <email>205rgh@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malakouti.Jamileh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, South Shariati Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66156-15733</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>jamilehmalakouti@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having at least a literacy guide according to the person herself
Score less than 28 from the Female Sexual Function Index questionnaire (FSFI )
Single lactating women
Being between 3 and 6 months after childbirth
Having a call number to follow up
Husband's monogamous</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exposure to a stressful event or any complication of pregnancy during pregnancy and postpartum (for example: death of a family members) according to the person herself
Having a history of depression pre-pregnancy, during pregnancy and postpartum according to the person herself
Having a history of chronic physical and mental illness such as cardiovascular disease, diabetes, severe depression and high blood pressure that consumes the drug according to the person herself
Use of any effective medicines on person's sexual response, (antihypertensive drugs, thiazide diuretics, antidepressants, antihistamines, Barbiturates, narcotics, diazepins, amphetamines and cocaine) according to the person herself
Child with known anomalies or preterm (less than 37 weeks)
Marriage separation (emotional divorce or full divorce)
The death of the baby after delivery for any cause
Addiction to a person or his wife according to the person herself
The history of sexual dysfunction before pregnancy in couples (including disorders of sexual desire or orgasm in women, early and late ejaculation, erectile dysfunction and male orgasm) according to the person herself</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified sexual dysfunction, not caused by organic disorder or disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, sexual counseling will be given by the trained midwife during a 60-90 minute or more session in accordance with the EXPLISSIT model and will be based on the concerns and needs of the participants</i_keyword>
      <i_keyword>Control group: Get routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function score. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Female Sexual Function Index questionnaire.</prim_outcome>
      <prim_outcome>Marital satisfaction score. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Enrich Marital Satisfaction questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of sexual life score. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Female 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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-05</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences Research &amp; Technology, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
