<?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>IRCT20251117068027N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-26</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of theory-based education versus video-based education on breastfeeding</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of education based on the theory of planned behavior and video based education on the knowledge, attitude, and breastfeeding performance of mothers of  premature  infants hospitalized in the neonatal intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-03-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87828</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Blinding description: Assessor blinding: This is the most important form of blinding feasible in this design. The person who collects the questionnaires after the intervention and the person who enters and analyzes the data in SPSS software must not know which group (test or control) each participant was in. This prevents biased interpretation of the results.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breastfeeding in premature neonates.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mothers of preterm infants hospitalized in the NICU who received breastfeeding education based on the Theory of Planned Behavior. The educational intervention will consist of 4 training sessions, each lasting 60 to 90 minutes. These sessions will be conducted over 4 days during the week (Saturday to Tuesday). The sessions will be held in small groups, with 4 or 5 mothers participating together with the instructor. Intervention 2: Control group: Video-based training on breastfeeding will be delivered to them.</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 raw data files of the demographic information, Theory of Planned Behavior, knowledge, and breastfeeding practice scale are shareable.

When:
Access period begins in 2025.

To whom:
Researchers affiliated with academic and scientific institutions.

Conditions:
The use of the scales in research projects is permitted.

Where to obtain:
To receive the scales, please send a message to the email address: 
sh.bolandian@yahoo.com

How to obtain:
To receive the scales, please send a message to the email address: 
sh.bolandian@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahnaz Bolandian Bafghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Bouali Street, Yazd.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۶۹۷۸۴۷۷</zip>
        <telephone>+98 917 258 9636</telephone>
        <email>sh.bolandian@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnaz Bolandian Bafghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Bouali Street, Yazd.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۶۹۷۸۴۷۷</zip>
        <telephone>+98 917 258 9636</telephone>
        <email>sh.bolandian@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers of premature infants hospitalized in the NICU.
Iranian nationality.
Having at least basic literacy (reading and writing).
No maternal addiction to alcohol or cigarettes.
Medically stable and able to attend the sessions.
Premature infants hospitalized in the NICU, possessing the ability to suck and not requiring gavage feeding.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Mothers with contraindications for breastfeeding, such as having AIDS/HIV or active tuberculosis.
Mothers who use medications that are prohibited during breastfeeding.
Mothers who are simultaneously participating in another study related to breastfeeding while enrolled in our study
Infants who are unable to receive breast milk due to medical conditions or anomalies such as cleft palate
Infants with cardiac anomalies and various syndromes.</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mothers of preterm infants hospitalized in the NICU who received breastfeeding education based on the Theory of Planned Behavior. The educational intervention will consist of 4 training sessions, each lasting 60 to 90 minutes. These sessions will be conducted over 4 days during the week (Saturday to Tuesday). The sessions will be held in small groups, with 4 or 5 mothers participating together with the instructor.</i_keyword>
      <i_keyword>Control group: Video-based training on breastfeeding will be delivered to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breastfeeding  knowledge score. Timepoint: before the intervention and two weeks after the intervention. Method of measurement: Breastfeeding Knowledge scale.</prim_outcome>
      <prim_outcome>Breastfeeding attitude score. Timepoint: before the intervention and two weeks after the intervention. Method of measurement: Theory of Planned Behavior scale.</prim_outcome>
      <prim_outcome>Breastfeeding Performance score. Timepoint: before the intervention and two weeks after the intervention. Method of measurement: Breastfeeding Performance scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Perceived Behavioral Control Score. Timepoint: before the intervention and two weeks after the intervention. Method of measurement: Theory of Planned Behavior scale.</sec_outcome>
      <sec_outcome>Subjective Norms Score. Timepoint: before the intervention and two weeks after the intervention. Method of measurement: Theory of Planned Behavior scale.</sec_outcome>
      <sec_outcome>Behavioral Intention Score. Timepoint: before the intervention and two weeks after the intervention. Method of measurement: Theory of Planned Behavior scale.</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>2025-11-11</approval_date>
        <contact_name>Ethics committee of Nursing and Midwifery School, Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Bouali Street, Yazd, Iran. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
