<?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>IRCT20220509054795N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-10</date_registration>
      <primary_sponsor>Çanakkale 18 Mart University</primary_sponsor>
      <public_title>The effect of education on breastfeeding self-efficacy and success</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Breastfeeding Education Given by Teach-Back Method on Breastfeeding Self-Efficacy and Breastfeeding Success: A Randomized Controlled Experimental Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66558</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 88 puerperant women who gave birth in Tekirdağ Çorlu State Hospital Gynecology Service between March 2022 and November 2022 and fulfilling the research criteria were included in the study. The research was conducted as an open-label, blinded, randomized and controlled experimental study. A simple computer-assisted randomization method was used to distribute the groups homogeneously. For this purpose, 88 sets were created by using the functions on the internet address "https://www.random.org/integer-sets" and each of these sets included 8 participants, 4 participants from each study group. As the next process, 88 sets were shown with 1 number each, and 11 numbers between 1 and 88 were generated using the "RANDOMLY SEARCH" function in Excel, and 11 sets to be used in randomization were randomly determined. Thus, in order to reduce selection bias and control the variables that may affect the outcome parameters, 44 of the participants were randomly assigned to the experimental and 44 to the control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of breastfeeding education given by teach-back method on breastfeeding self-efficacy and breastfeeding success.</hc_freetext>
      <i_freetext>Intervention 1: The first interview with the women in the intervention group was made within the first 24 hours after delivery in their own room in the obstetrics ward. During the interview, the pre-training personal information that form, the Breastfeeding Diagnostic Tool LATCH, and the Postpartum Breastfeeding Self-Efficacy Scale were applied to the women. In accordance with the content of the Breastfeeding Training Guide, the women in the intervention group were provided with training and consultancy services on the subjects they needed about breastfeeding with the Teach-Back Method. While the intervention group was being trained, the researcher's application of the method was evaluated by a healthcare professional using the Teach-Back Observation Tool. After the training, the Breastfeeding Diagnostic Tool LATCH and the Postpartum Breastfeeding Self-Efficacy Scale were re-applied to the women before the training. The scales were repeated in the 1st month postpartum so that the permanence of the information learned in the previous interview was evaluated. Intervention 2: The first interview with the women in the control group was made in the women's room in the obstetrics ward within the first 24 hours after delivery. During the interview, the pre-training personal information that form, the Breastfeeding Diagnostic Tool LATCH, and the Postpartum Breastfeeding Self-Efficacy Scale were applied to the women. Women were given standard training and consultancy services on breastfeeding by gynecology and obstetrics nurses. At the end of the trainings, the Breastfeeding Diagnostic Tool LATCH and the Postpartum Breastfeeding Self-Efficacy Scale were reapplied. The Breastfeeding Diagnostic Tool LATCH and the Postpartum Breastfeeding Self-Efficacy Scale, which were administered to the women before the training in the 1st month postpartum, were re-applied and the permanence of the information learned in the previous interview was evaluated.</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 It is not yet known if there will be any plans to roll this out.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elif Ocaktan Çetindemir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Çanakkale 18 Mart University Terzioğlu Campus Graduate Education Institute</address>
        <city>Çanakkale</city>
        <country1>Turkey</country1>
        <zip>17000</zip>
        <telephone>+90 286 218 05 25</telephone>
        <email>elf.ocktn.1996@gmail.com</email>
        <affiliation>Çanakkale 18 Mart University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elif Ocaktan Çetindemir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Çanakkale 18 Mart University Terzioglu Campus Graduate Education Institute</address>
        <city>Çanakkale</city>
        <country1>Turkey</country1>
        <zip>17000</zip>
        <telephone>+90 286 218 05 25</telephone>
        <email>elf.ocktn.1996@gmail.com</email>
        <affiliation>Çanakkale 18 Mart University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Turkey</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Living in Çorlu district of Tekirdağ province
Being 18 years or older
Ability to read and write
Giving a term and healthy birth
Having a healthy newborn
Absence of anomaly that will prevent breastfeeding in the baby</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a condition that prevents breastfeeding (mastitis, drug use, psychological disorders, etc.)
Not knowing Turkish
Hearing or speech impairment</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>The first interview with the women in the intervention group was made within the first 24 hours after delivery in their own room in the obstetrics ward. During the interview, the pre-training personal information that form, the Breastfeeding Diagnostic Tool LATCH, and the Postpartum Breastfeeding Self-Efficacy Scale were applied to the women. In accordance with the content of the Breastfeeding Training Guide, the women in the intervention group were provided with training and consultancy services on the subjects they needed about breastfeeding with the Teach-Back Method. While the intervention group was being trained, the researcher's application of the method was evaluated by a healthcare professional using the Teach-Back Observation Tool. After the training, the Breastfeeding Diagnostic Tool LATCH and the Postpartum Breastfeeding Self-Efficacy Scale were re-applied to the women before the training. The scales were repeated in the 1st month postpartum so that the permanence of the information learned in the previous interview was evaluated.</i_keyword>
      <i_keyword>The first interview with the women in the control group was made in the women's room in the obstetrics ward within the first 24 hours after delivery. During the interview, the pre-training personal information that form, the Breastfeeding Diagnostic Tool LATCH, and the Postpartum Breastfeeding Self-Efficacy Scale were applied to the women. Women were given standard training and consultancy services on breastfeeding by gynecology and obstetrics nurses. At the end of the trainings, the Breastfeeding Diagnostic Tool LATCH and the Postpartum Breastfeeding Self-Efficacy Scale were reapplied. The Breastfeeding Diagnostic Tool LATCH and the Postpartum Breastfeeding Self-Efficacy Scale, which were administered to the women before the training in the 1st month postpartum, were re-applied and the permanence of the information learned in the previous interview was evaluated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy  of the puerperant about breastfeeding. Timepoint: Pretest and posttest, after 1 month. Method of measurement: Postpartum breastfeeding self-efficacy scale (short form).</prim_outcome>
      <prim_outcome>Evaluation of breastfeeding education given by teaching method. Timepoint: During education. Method of measurement: Teach-Back monitoring tool.</prim_outcome>
      <prim_outcome>Puerperant’ s success in breastfeeding. Timepoint: Pretest and posttest, after 1 month. Method of measurement: Breastfeeding Diagnostic Tool LATCH.</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>Çanakkale 18 Mart University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-10</approval_date>
        <contact_name>Çanakkale Onsekiz Mart University Graduate Education Institute Scientific Research Ethics Committee</contact_name>
        <contact_address>Çanakkale 18 Mart University Terzioğlu Campus Graduate Education Institute Çanakkale Çanakkale Turkey</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
