<?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>IRCT20230124057204N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-25</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison Of The Effect Of Face To Face Training And Training Package On The Attitude And Willingness Of Mothers With Premature Babies To Feed With Milk Donated From The Milk Bank</public_title>
      <acronym></acronym>
      <scientific_title>Comparison Of The Effect Of Face To Face Training And Training Package On The Attitude And Willingness Of Mothers With Premature Babies To Feed With Milk Donated From The Milk Bank</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68243</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples were randomly assigned to two groups of face-to-face training and training package in such a way that during the first 4 to 6 sessions, all samples were sampled by the available method and face-to-face training, and the next 4 to 6 sessions were sampled by The available method and training is the use of a training package.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attitude and willingness of mothers with premature babies to donate milk.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Direct face-to-face training will take place in the first group. Before the intervention, demographic information is obtained by completing a demographic questionnaire. The interventions include an educational program that is implemented to educate mothers with premature babies in the hospital who are unable to breastfeed. A 2-hour training session is arranged with the agreement of the mothers and in coordination with the departments, and it is implemented by the researcher after completing the milk bank workshop in the milk room located in the department. The training is face-to-face, which includes: the existence of milk banks, the benefits of using donated milk, the comparison of donated milk and formula in terms of ingredients, the disadvantages of powdered milk, prevention of infections and diseases, helping to improve physical and mental development and Encouraging mothers to use donated milk from the milk bank. After completing the training, the mother will be asked to raise any questions or doubts about feeding with donated milk, and the researcher will answer her questions. Intervention 2: Intervention group: In the second group, the training content will be the same as the face-to-face group, with the difference that the training content includes video files that can be used on tablets, smart phones, and televisions, and educational booklets approved by professors will be presented to mothers. If the mothers wish, the educational video file will be sent to the authorized messenger, and to ensure that they have read the educational package before completing the questionnaires after the educational interventions, the mothers will be asked about this.</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:
All participant data can be shared after being unidentified

When:
Start the access period after 6 months printing the results

To whom:
Public

Conditions:
For use in studies allowed.

Where to obtain:
s.shahidi@stu.ssu.ac.ir

How to obtain:
The application will be sent to the project implementer by email and within one week will receive the necessary items.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Shahidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>s.shahidi@stu.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mostafa Javadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>javadinurse@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Wliilngness to participate in the study
Mothers with premature babies hospitalized in the neonatal intensive care unit who are unable to feed with breast milk
Having the ability to take care of a baby and be literate
Not to have a confirmed physical and mental problem and have the necessary training and cooperation in participating in training sessions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of using donated milk in the previous babies of the mother or first and second degree relatives
Any reason that prevents you from receiving donated milk, such as religious barriers
Any medical problem, including the baby's digestive problems or other problems and diseases that prevent milk intake.
Abnormal appearance and other problems of premature babies that affect the mother.</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: Direct face-to-face training will take place in the first group. Before the intervention, demographic information is obtained by completing a demographic questionnaire. The interventions include an educational program that is implemented to educate mothers with premature babies in the hospital who are unable to breastfeed. A 2-hour training session is arranged with the agreement of the mothers and in coordination with the departments, and it is implemented by the researcher after completing the milk bank workshop in the milk room located in the department. The training is face-to-face, which includes: the existence of milk banks, the benefits of using donated milk, the comparison of donated milk and formula in terms of ingredients, the disadvantages of powdered milk, prevention of infections and diseases, helping to improve physical and mental development and Encouraging mothers to use donated milk from the milk bank. After completing the training, the mother will be asked to raise any questions or doubts about feeding with donated milk, and the researcher will answer her questions.</i_keyword>
      <i_keyword>Intervention group: In the second group, the training content will be the same as the face-to-face group, with the difference that the training content includes video files that can be used on tablets, smart phones, and televisions, and educational booklets approved by professors will be presented to mothers. If the mothers wish, the educational video file will be sent to the authorized messenger, and to ensure that they have read the educational package before completing the questionnaires after the educational interventions, the mothers will be asked about this.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The attitude of mothers with premature babies towards feeding from the milk bank. Timepoint: Before the beginning of the educational intervention and after its completion. Method of measurement: A three-part researcher-made questionnaire.</prim_outcome>
      <prim_outcome>The willingness of mothers with premature babies towards feeding from the milk bank. Timepoint: Before the beginning of the educational intervention and after its completion. Method of measurement: Visual Analogue Scale.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-16</approval_date>
        <contact_name>Ethics Committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Bahonar Square, The Central Building Of Yazd University of Medical Sciences Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
