<?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>IRCT20241225064172N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-28</date_registration>
      <primary_sponsor>Maragheh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of telenursing on self-efficacy, social support, and exclusive breastfeeding experience of primiparous mothers</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of telenursing on self-efficacy, social support, and exclusive breastfeeding experience of primiparous mothers: A clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>280</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83137</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants were individually allocated to the intervention or control group using block randomization with a block size of four and a 1:1 allocation ratio. Six possible allocation sequences were formed, with each block containing two intervention and two control allocations in different sequences. Seventy blocks were randomly selected with replacement to generate the allocation sequence for the 280 participants. Participants were subsequently allocated sequentially to the intervention or control group according to the resulting randomization sequence. No stratified randomization was used. The randomization sequence was generated before participant allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breastfeeding Education for Mothers via Tele-Nursing.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: An educational channel and educational group will be established in nationally authorized settings, and the intervention will be carried out in four stages, according to the GATHER counseling principles and the Ministry of Health breastfeeding protocol. (Each of the stages will be carried out for one week, two days a week, on Saturdays and Mondays at 7 p.m.) We will explain to the mothers that they should view the educational content with a sponsor (mother or spouse or...). The questionnaires of the present study will be completed by the participants before the start of the intervention, one week, one month, and six months after the end of the intervention. Intervention 2: Control group: Mothers in the control group will receive only standard care, including routine breastfeeding education and pamphlets about breastfeeding.</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:
The study results will be published in the groups and channels created for participants, without mentioning any personal names

When:
Access period begins 6 months after results publication

To whom:
Mothers of infants

Conditions:
For training purposes at the hospital

Where to obtain:
laila30968@gmail.com

How to obtain:
Sending an email

Comments:
Please ensure the registered data becomes visible after article publication.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Hajitaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 113, North Saba Alley, Azadegan Street, Maragheh</address>
        <city>Maragheh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5517858600</zip>
        <telephone>+98 914 907 6020</telephone>
        <email>laila30968@gmail.com</email>
        <affiliation>Maragheh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>leila Hajitaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 113, North Saba Alley, Azadegan Street, Maragheh</address>
        <city>Maragheh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5517858600</zip>
        <telephone>+98 914 907 6020</telephone>
        <email>laila30968@gmail.com</email>
        <affiliation>Maragheh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous mothers
Informed parental consent to participate in the study
Exclusive breastfeeding at the time of discharge
Ability to read and write in Persian (Parents)
Family support for the mother from her mother, spouse, etc
Owning a mobile phone compatible with the Ita app
Gestational age of 37–42 weeks at the birth of term infants</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Medical contraindication for breastfeeding for either mother or infant
Employed in a hospital-related profession
Congenital anomalies or abnormalities in the infant</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>Other</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: An educational channel and educational group will be established in nationally authorized settings, and the intervention will be carried out in four stages, according to the GATHER counseling principles and the Ministry of Health breastfeeding protocol. (Each of the stages will be carried out for one week, two days a week, on Saturdays and Mondays at 7 p.m.) We will explain to the mothers that they should view the educational content with a sponsor (mother or spouse or...). The questionnaires of the present study will be completed by the participants before the start of the intervention, one week, one month, and six months after the end of the intervention.</i_keyword>
      <i_keyword>Control group: Mothers in the control group will receive only standard care, including routine breastfeeding education and pamphlets about breastfeeding.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy score of primiparous mothers. Timepoint: Before the intervention, and at one week, one month, and six months after the intervention. Method of measurement: Dennis Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF).</prim_outcome>
      <prim_outcome>Maternal Breastfeeding Social Support. Timepoint: Before the intervention, and at one week, one month, and six months after the intervention. Method of measurement: Exclusive Breastfeeding Social Support Scale.</prim_outcome>
      <prim_outcome>Mothers' Experience of Exclusive Breastfeeding. Timepoint: Before the intervention, and at one week, one month, and six months after the intervention. Method of measurement: Breastfeeding Experience Scale (BES).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Maragheh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-16</approval_date>
        <contact_name>The Research Ethics Committee of Maragheh University of Medical Sciences</contact_name>
        <contact_address>No. 113, North Saba Alley, Azadegan Street, Maragheh Maragheh East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
