<?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>IRCT20210907052403N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-29</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of electronic breastfeeding counseling on indicators related to breastfeeding in nulliparous women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of electronic breastfeeding counseling on indicators related to breastfeeding in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59051</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, a researcher-made questionnaire of demographic and lactation characteristics - Breastfeeding Self-Efficacy Questionnaire (BSES) - BBAT breastfeeding technique assessment checklist and mothers' perceived milk insufficiency questionnaire will be used, Randomization description: The research samples will be selected by the available method and then divided into two groups of intervention and control by random allocation method. The samples will be divided into 2 intervention and control groups by random allocation method. Based on the calculated sample size, 62 people will be in the intervention group and 62 people in the control group. A quadruple block will be used to allocate individuals in the control and intervention groups. Thus, all possible states are considered for placing the letters A and B in the four blocks, which include a total of 6 states. These 6 modes were numbered from 1 to 6 and the number of required 4 blocks was determined based on the number of samples studied. Then, according to the computer table, random numbers are randomly assigned to the required number of blocks. Then, based on the order of the numbers extracted from the table, the blocks related to each number are listed in order. Finally, when the samples are included in the study, each person will take a specific letter in the order obtained. And 4 random blocks are made with a 1: 1 allocation ratio. In the first stage, women in the first abdomen referred to Tehran Health Sciences Health Centers, who have successfully started breastfeeding in the first week after delivery, are included in the study after examining the inclusion criteria.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breastfeeding problems.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention in this study is in the form of providing educational materials based on the working method of similar texts and available scientific resources in relation to breastfeeding interventions under the title of professional intervention. Sessions are generally from 15 to 45 minutes and usually take more than 1 time. In this study, 5 consultation visits of at least 15 minutes with the mother were performed in the intervention group and in each breastfeeding visit, both groups will be observed. Each visit includes an educational and counseling component and psychological support. The content of the training includes the following headings: correct method of breastfeeding, frequency and duration of breastfeeding, correct way of hugging the infant, correct method of breastfeeding, effective sucking sign, diagnosis of breastfeeding adequacy in infants up to 6 months only with They are breastfed. Intervention 2: Control group: Half of the samples that met the inclusion criteria were randomly assigned to the control group and during the study of routine care such as fixed activities (counseling in case of breastfeeding problems, counseling about breast problems in breastfeeding and ..) which is currently implemented in health centers, will benefit.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Pending</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shirin Shahbaziseghalde</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid St. School of Nursing and Midwifery, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3441653362</zip>
        <telephone>+98 21 4291 1000</telephone>
        <email>shahbazishirin@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shirin Shahbaziseghalde</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid St. School of Nursing and Midwifery, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3441653362</zip>
        <telephone>+98 21 4291 1000</telephone>
        <email>shahbazishirin@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mother's access to the Internet and knowing how to use it
mother's literacy
mother's decision to continue breastfeeding,
no fetal abnormalities
birth weight 2500 to 4000 grams
Singleton
Nulliparous
the absence of chronic maternal and childhood diseases,
the absence of simultaneous or combined breastfeeding or formula
the absence of drugs that affect milk that have contraindications to breastfeeding
term gestational age</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Hospitalization of the child for any reason
breastfeeding jaundice
absence of more than one session in online counseling sessions
radiotherapy and maternal cancer
any contraindications to breastfeeding
Diagnosis of phenylketonuria</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention in this study is in the form of providing educational materials based on the working method of similar texts and available scientific resources in relation to breastfeeding interventions under the title of professional intervention. Sessions are generally from 15 to 45 minutes and usually take more than 1 time. In this study, 5 consultation visits of at least 15 minutes with the mother were performed in the intervention group and in each breastfeeding visit, both groups will be observed. Each visit includes an educational and counseling component and psychological support. The content of the training includes the following headings: correct method of breastfeeding, frequency and duration of breastfeeding, correct way of hugging the infant, correct method of breastfeeding, effective sucking sign, diagnosis of breastfeeding adequacy in infants up to 6 months only with They are breastfed.</i_keyword>
      <i_keyword>Control group: Half of the samples that met the inclusion criteria were randomly assigned to the control group and during the study of routine care such as fixed activities (counseling in case of breastfeeding problems, counseling about breast problems in breastfeeding and ..) which is currently implemented in health centers, will benefit.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal perception of milk insufficiency. Timepoint: Before the intervention and one week after the study. Method of measurement: Questionnaire of perceived milk insufficiency by mothers.</prim_outcome>
      <prim_outcome>Breastfeeding self efficacy. Timepoint: Before the intervention and one week after the study. Method of measurement: Breastfeeding Self efficacy Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The correct breastfeeding technique. Timepoint: Before the intervention and one week after the study. Method of measurement: Bristol Breastfeeding Technique Assessment Checklist.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-04</approval_date>
        <contact_name>Ethics committee of tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences - Central Building - Fifth Floor - Organization Development Management and Human CapitalKeshavarz Blvd, Tehran. tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
