<?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>IRCT2014080518691N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-09</date_registration>
      <primary_sponsor>Breastfeeding Research Center, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of communication skills training for nurses and midwives in increasing rates of effective breastfeeding in infants</public_title>
      <acronym>Evaluation of the effect of communication skills training  in breastfeeding</acronym>
      <scientific_title>Evaluation of the effect of communication skills training for nurses and midwives in increasing rates of effective breastfeeding in infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16875</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>breastfeeding.</hc_freetext>
      <i_freetext>This is a before-after study and one intervention is done on one group. Intervention consists of a 4- hour workshop which will be held  2 to 3 times for maximum participation . In the beginning of these workshops a video clip of incorrect communication between a health care professional and a mother will be shown . The content has been confirmed by The Society for Promoting breastfeeding.The participants will be asked to work in groups to fill an assessment Check List. Then the clip is reviewed once again based on sub- skills including: starting consultation, encouraging mother to expression of feelings and concerns , listening skills , asking open questions , giving information and feedback , and closing the consultation . Each of these skills are then practiced in form of small exercise scenarios and short training . ،The emphasis is on skills in which the greatest weakness has been observed in the evaluation before the 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>Nikoo Niknafs</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bagherkhan Avanue, Valiasr Hospital, Second floor,  Neonatal Intensive Care Unit</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2407</telephone>
        <email>nikoo.niknafs@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences, valiasr hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nikoo Niknafs</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bagherkhan avanue, Valiasr Hospital, Second floor</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2407</telephone>
        <email>nikoo.niknafs@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences, Valiasr hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria :  nurses and midwives at the maternity ward of Vali-Asr hospital and the mothers who have at least a bachelor's degree; have passed their obligatory duties; Mothers who have been with their newborns for at least the past 12 hours; the baby is born maximum 48 hours ago; there is no contraindication to breastfeeding .</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>p 92.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal difficulty in feeding at breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This is a before-after study and one intervention is done on one group. Intervention consists of a 4- hour workshop which will be held  2 to 3 times for maximum participation . In the beginning of these workshops a video clip of incorrect communication between a health care professional and a mother will be shown . The content has been confirmed by The Society for Promoting breastfeeding.The participants will be asked to work in groups to fill an assessment Check List. Then the clip is reviewed once again based on sub- skills including: starting consultation, encouraging mother to expression of feelings and concerns , listening skills , asking open questions , giving information and feedback , and closing the consultation . Each of these skills are then practiced in form of small exercise scenarios and short training . ،The emphasis is on skills in which the greatest weakness has been observed in the evaluation before the intervention .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effective sucking. Timepoint: before , immidiately after , 3 and 6 months after intervention. Method of measurement: checklist direct observation.</prim_outcome>
      <prim_outcome>Latch on. Timepoint: before , immidiately after , 3 and 6 months after intervention. Method of measurement: checklist direct observation.</prim_outcome>
      <prim_outcome>Breast appearance. Timepoint: before , immidiately after , 3 and 6 months after intervention. Method of measurement: direct observation.</prim_outcome>
      <prim_outcome>Carrying the baby. Timepoint: before , immidiately after , 3 and 6 months after intervention. Method of measurement: direct observation.</prim_outcome>
      <prim_outcome>Infants general condition. Timepoint: before , immidiately after , 3 and 6 months after intervention. Method of measurement: checklist direct observation.</prim_outcome>
      <prim_outcome>Mothers general condition. Timepoint: before , immidiately after , 3 and 6 months after intervention. Method of measurement: checklist direct observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Listening  skills. Timepoint: before , immidiately after , 3 and 6 months after intervention. Method of measurement: check list , OSCE.</sec_outcome>
      <sec_outcome>Non varbal communication skills. Timepoint: before , immidiately after , 3 and 6 months after intervention. Method of measurement: check list , OSCE.</sec_outcome>
      <sec_outcome>Self confidence encouraging skills. Timepoint: before , immidiately after , 3 and 6 months after intervention. Method of measurement: check list , OSCE.</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>Breastfeeding Research Center, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-25</approval_date>
        <contact_name>Ethics in Research Committee - Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz boulevard,  Ghods avenue, 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>
