<?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>IRCT2013123010746N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-04</date_registration>
      <primary_sponsor>Research Council of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of acknowledgement and self-awareness on breastfeeding</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of acknowledgement and self-awareness on breastfeeding</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11162</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: anxiety and depression. Condition 2: Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, including training of health care workers (nurses or midwife delivery) to communicate proper of mothers who have given birth to their baby recently. The psychologist will be made at least two group sessions. The training consisted of four 10 skills are life skills. Listed four skills associated with effective communication, stress management and anger is. With this training, it is expected that staff communicate better and more responsive with mothers. In addition they attend their mothers’ demands to encourage breastfeeding. Also in relation to mothers' parenting awareness training package will be provided and it is necessary will be held individual psychological counseling sessions. In relationship self-Efficacy, mothers will reach with breastfeeding education and counseling psychology. Intervention 2: In the control group, only if required to contact mothers with telephone when they have problems and we do not abandon ethically.</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>Nasrin Abedinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asr Hospital, Imam Khomeini Hospital Maternal Fetal and Neonatal Research Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 21 6119 2357</telephone>
        <email>Nasrin.Abedinia@yahoo.com</email>
        <affiliation>Research Center of Maternal-Fetal and Neonatal</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Abedinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asr Hospital, Imam Khomeini Hospital Maternal Fetal and Neonatal Research Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 21 6119 2357</telephone>
        <email>Nasrin.Abedinia@yahoo.com</email>
        <affiliation>Maternal Fetal and Neonatal Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:nulliparous pregnant women at least 18 years of age who have decided to breastfeed. None of the samples was not affected by systemic diseases during pregnancy.There is not history of postpartum psychosis and before they have not trianed breastfeeding. Not having any disease or defects in newborns and mothers having any disease that affects her ability to breastfeed. These cases will be excluded.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.9</hc_code>
      <hc_code>F41.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Depressive episode, unspecified</hc_keyword>
      <hc_keyword>Mixed anxiety and depressive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, including training of health care workers (nurses or midwife delivery) to communicate proper of mothers who have given birth to their baby recently. The psychologist will be made at least two group sessions. The training consisted of four 10 skills are life skills. Listed four skills associated with effective communication, stress management and anger is. With this training, it is expected that staff communicate better and more responsive with mothers. In addition they attend their mothers’ demands to encourage breastfeeding. Also in relation to mothers' parenting awareness training package will be provided and it is necessary will be held individual psychological counseling sessions. In relationship self-Efficacy, mothers will reach with breastfeeding education and counseling psychology.</i_keyword>
      <i_keyword>In the control group, only if required to contact mothers with telephone when they have problems and we do not abandon ethically.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Increase breastfeeding. Timepoint: Baseline and at 6, 12, 18 and 24 months from delivery. Method of measurement: Breastfeeding self-efficacy questionnaire; Edinburgh Test; Test Spielberger Trait anxiety and trait STAI -.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Increased efficacy. Timepoint: Baseline and at 6, 12, 18 and 24 months from delivery. Method of measurement: Efficacy 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>Research Council of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-23</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Research Qods St., Keshavarz Blvd Tehran University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
