<?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>IRCT20170809035592N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-10</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The efficacy of sexual health counseling (group and telephone counseling) on sexual satisfaction and function in lactating women</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of sexual health counseling (group and telephone counseling) on sexual satisfaction and function in lactating women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26848</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: Using a random number table, simple randomization was done individually.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual satisfaction                                                                                                                    sexual function.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group 1:" Five weekly counseling sessions. Intervention 2: "Intervention group 2:" Five weekly phone calls. Intervention 3: "Control group:" without 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
We will show all of the data.

When:
Get started 9 months after printing results

To whom:
All people are allowed.

Conditions:
The data will be available for scientific research with reference to the research. In order to access the data, they can reply to the person's email address.

Where to obtain:
Samira Hajimaghsoudy
samira_hajimaghsoudy@yahoo.com
00989132738876

How to obtain:
Applicants can respond to the email of the respondent and receive a response within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Haji Maghsoudy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi University of Medical Sciences, Alem Sq, Safaieh, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8991768547</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>samira_hajimaghsoudy@yahoo.com</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Bokaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi University of Medical Sciences, Alem Sq., Safaieh Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8991768547</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>mah_bokaie@yahoo.com</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women who are nulliparous 18 years of age
Married Iranian Muslims whose first marriage is the sole wife of a person living side by side
Child is healthy, monogamous, terminated, is the result of natural birth and has exclusive breastfeeding
At least reading and writing skills
Have phones</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Rebirth
Unwanted pregnancy in the present delivery
Instrumental vaginal delivery
Grade 4 rupture during labor
Macrosomal neonate
Infant death, abnormalities and postpartum health problems
Presence of signs of postpartum depression
All diseases and Or drugs that affect the sexual function of couples
Drug addiction to each spouse
Their growth in a single parent
A history of any abnormal functioning and sexual abuse during pre-pregnancy
Genital surgery, hormonal dysfunction
Using hormonal contraceptive methods
Severe family disagreement Lady is lactating.</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group 1:" Five weekly counseling sessions</i_keyword>
      <i_keyword>"Intervention group 2:" Five weekly phone calls</i_keyword>
      <i_keyword>"Control group:" without intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual satisfaction. Timepoint: Before the intervention, immediately and one month after the end of the intervention. Method of measurement: Larsson Sexual Satisfaction Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual function. Timepoint: Before the intervention, immediately and one month after the end of the intervention. Method of measurement: Sexual Function Questionnaire (FSFI).</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-02</approval_date>
        <contact_name>Ethics committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Shahid Sadoughi University of Medical Sciences, Alem Sq., Safaieh Yazd Yazd Iran, Islamic Republic Of Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
