<?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>IRCT20201108049304N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-17</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Oketani massage on breastfeeding</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Oketani massage on volume milk and breastfeeding behavior in premature infants admitted to neonatal intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52896</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Blinding description: In this study, data analysts and sample allocators to groups are not aware of the allocation of samples in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fetus and newborn affected by other maternal noxious substances.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Oketani massage will be performed in three days after delivery, 6 hours after delivery (for 20 minutes in each session in the morning and evening) in the mothers' rest room. Oketani massage for the intervention group includes breast massage which includes a total of 8 hand techniques. Stage 1-7 is called a course of treatment, this step is done in 1 minute and repeated for 15-20 minutes. Step 1 Pressing and lifting the breast by the third finger of the right hand and the little finger of the left hand to the left shoulder, Step 2 Pressing and lifting the central part by the third finger of both hands to the armpit, Step 3 Pressing and lifting the breast by the third finger and sixty hands Right and third finger of the left hand and placing the thumb above the second joint of the thumb of the right hand, here pressing and pulling parallel to the opposite breast, these steps 1, 2 and 3 are to separate the firm part of the breast from the pectoralis major muscle, step 4 pressing the whole breast towards Umbilical cord, step 5 pulling the breast down to the right, step 6 pulling the breast down to the left, step 7 Turn the breast gently clockwise and pay attention to the elasticity of the breast base, step 8 milking the breast in four directions upwards. Intervention 2: Control group: There is no intervention in this group.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahere Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad University of Medical Sciences, Daneshgah St., Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91778-99191</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>sadeghit@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahere Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad University of Medical Sciences, Daneshgah St., Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91778-99191</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>sadeghit@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of the mother is between at least 20 and at most 35 years
Be literate and be able to understand writing and verbal instructions
The mother tends to breastfeed</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The mother has a history of serious and chronic illness such as cardiovascular disease or mental illness (postpartum depression, schizophrenia) according to the mother.
The mother is addicted to drugs, especially cocaine and derivatives, according to the mother.
The mother take medications that are contraindicated during breastfeeding, such as doxepin tricyclic antidepressants, iodine compounds, gold salts, salicylates, and anticonvulsants during the intervention.
The mother has a history of breast surgery and no history of injuries or wounds at the massage site and no breast problems (breast fissures, congestion, mastitis and breast abscess).
The mother take lactation-enhancing drugs, including metoclopramide.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P04.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Newborn (suspected to be) affected by other maternal noxious substances</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: Oketani massage will be performed in three days after delivery, 6 hours after delivery (for 20 minutes in each session in the morning and evening) in the mothers' rest room. Oketani massage for the intervention group includes breast massage which includes a total of 8 hand techniques. Stage 1-7 is called a course of treatment, this step is done in 1 minute and repeated for 15-20 minutes. Step 1 Pressing and lifting the breast by the third finger of the right hand and the little finger of the left hand to the left shoulder, Step 2 Pressing and lifting the central part by the third finger of both hands to the armpit, Step 3 Pressing and lifting the breast by the third finger and sixty hands Right and third finger of the left hand and placing the thumb above the second joint of the thumb of the right hand, here pressing and pulling parallel to the opposite breast, these steps 1, 2 and 3 are to separate the firm part of the breast from the pectoralis major muscle, step 4 pressing the whole breast towards Umbilical cord, step 5 pulling the breast down to the right, step 6 pulling the breast down to the left, step 7 Turn the breast gently clockwise and pay attention to the elasticity of the breast base, step 8 milking the breast in four directions upwards.</i_keyword>
      <i_keyword>Control group: There is no intervention in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The volume of mothers' breast milk. Timepoint: In the first to third days after delivery, half an hour before and after the intervention in the morning and evening. Method of measurement: Electric milking machine.</prim_outcome>
      <prim_outcome>Breastfeeding behavior. Timepoint: Once in the first three days and once on the day of discharge and once at the end of the neonatal period (28 days) at the time of the mother's visit to examine the newborn. Method of measurement: PIBBS Breastfeeding Behavior Questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-17</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>The central building of Mashhad University of Medical Sciences, Daneshgah St., Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
