<?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>IRCT20231028059885N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-27</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mental relaxation technique on self –efficacy, breastfeeding sufficiency and performance of primiparous women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mental relaxation technique on self –efficacy, breastfeeding sufficiency and performance of primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73545</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: The participants do not know which group they belong to and this study is a blind strain.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Self-efficacy, adequacy and performance of breastfeeding.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In the first session, the researcher holds a training session and teaches them about the definition, importance and types of Aramaic body through lectures and film screenings. The researcher teaches mental relaxation technique  technique practically for women. Then the second session is held on another day and the women are asked to implement the training techniques for the researcher. The maximum duration of each training session is 60 minutes. Until the day of delivery, women perform mental relaxation techniques at home twice a day (in the morning and evening) and each time for 20 minutes. The mental relaxation technique continues until 60 days after delivery, and during this period, mothers follow up They can feed their baby exclusively with their own milk for 60 days after giving birth. After completing the intervention, women refer to the research environment on days 3, 10 and 30 after giving birth. In these sessions, the infant's weight, head circumference and chest circumference are measured. Intervention 2: Control group: The participants in the control group will only receive the usual breastfeeding training from the instructors of childbirth preparation classes that are taught to both groups during the seventh and eighth sessions, and no additional training will be provided by the researcher.</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 Due to confidentiality of information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sepideh Hajian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti School of Midwifery Nursing, Valiasr Ave., Niayesh Intersection, Opposite Shahid Rajaei Heart Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8856 5366</telephone>
        <email>s.hajian@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sepideh Hajian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti School of Midwifery Nursing, Valiasr Ave., Niayesh Intersection, Opposite Shahid Rajaei Heart Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8856 5366</telephone>
        <email>s.hajian@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being Iranian and resident of Talesh city
Having a pregnancy record in one of the comprehensive health centers or urban health centers covered by the health and treatment center of Talash city
Elementary school
Gestational age 30-32 weeks
Nulliparous
singleton pregnancy
No abuse of drugs, tobacco and alcohol
Not having diseases or any disorders that prohibit breastfeeding such as HIV/AIDS,Active Genital Herpes, Active untreated tuberculosis in the mother, or Breast abscess, Extensive breast burn or any abnormality that makes it difficult to breastfeed.
Low-risk pregnancy and the mother's absence of chronic physical or mental debilitating diseases requiring medical treatment according to the doctor's opinion.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mother's strong unwillingness to breastfeed after delivery
Occurrence of mental or physical disorders diagnosed by the doctor during the implementation of the study, which requires referral and necessary medical/surgical interventions that disrupt or prohibit the continuation of the breastfeeding process.
Unwillingness to continue participating in the study or her simultaneous participation in another research with similar educational interventions
Performing relaxation exercises and mental imagery for less than 60 days
Simultaneous and daily use of milk-enhancing drugs
Delivery before the 37th week of pregnancy (in this case, it is reported as perinatal outcomes)
Admission of the baby to the NICU
Any abnormality of the baby's jaw and face that interferes with the baby's natural breastfeeding
Preterm birthday
Absence or development of gagging and sucking reflexes up to 3-5 days</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>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In the first session, the researcher holds a training session and teaches them about the definition, importance and types of Aramaic body through lectures and film screenings. The researcher teaches mental relaxation technique  technique practically for women. Then the second session is held on another day and the women are asked to implement the training techniques for the researcher. The maximum duration of each training session is 60 minutes. Until the day of delivery, women perform mental relaxation techniques at home twice a day (in the morning and evening) and each time for 20 minutes. The mental relaxation technique continues until 60 days after delivery, and during this period, mothers follow up They can feed their baby exclusively with their own milk for 60 days after giving birth. After completing the intervention, women refer to the research environment on days 3, 10 and 30 after giving birth. In these sessions, the infant's weight, head circumference and chest circumference are measured.</i_keyword>
      <i_keyword>Control group: The participants in the control group will only receive the usual breastfeeding training from the instructors of childbirth preparation classes that are taught to both groups during the seventh and eighth sessions, and no additional training will be provided by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breastfeeding self-efficacy. Timepoint: The beginning of the study, the third, 15th and 60th day after delivery. Method of measurement: Abbreviated Breastfeeding Self-Efficacy Questionnaire.</prim_outcome>
      <prim_outcome>Lactation performance. Timepoint: The beginning of the study, the third, 15th and 60th day after delivery. Method of measurement: Breastfeeding performance checklist.</prim_outcome>
      <prim_outcome>Adequacy of breastfeeding. Timepoint: The beginning of the study, the third, 15th and 60th day after delivery. Method of measurement: Breastfeeding adequacy questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Infant weight. Timepoint: 3rd day, 10th day and 30th day after birth. Method of measurement: scales.</sec_outcome>
      <sec_outcome>Around the infant's head. Timepoint: 3rd day, 10th day and 30th day after birth. Method of measurement: tape measure.</sec_outcome>
      <sec_outcome>Around the infant's chest. Timepoint: 3rd day, 10th day and 30th day after birth. Method of measurement: meter reading.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-05</approval_date>
        <contact_name>Ethics commite of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery Faculties of Shahid Beheshti University of Medical Sciences, In front of Shahid Rajaei Heart Hospital, Hashemi Rafsanjani Blv., Valiasr Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
