<?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>IRCT20170430033718N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-01</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of acupressure, OKETANI massage and lactation training</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of acupressure, OKETANI massage and lactation training  on the breastfeeding self-efficacy, quality of breastfeeding, breast milk sufficiency and exclusive breast feeding in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53958</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation was done by the The steps of using the software listed were as follows: ETCETERA, Randomization (Random allocation) . Eligible patients are registered by the first author. Envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and will be placed inside the envelope. The envelopes will be closed and its contents are not visible from the outside. Then, the purpose of the study is explained to the person who follows the conditions, and the person, if desired, signs the informed consent form and removes an envelope, then opens it and, based on the contents of the envelope, enters into the  groups. In this study, individuals will be randomly divided into four groups A (intervention 1), group B (intervention 2), group C (intervention 3) and group D (control) using randomized 8 blocks, Blinding description: In the pre-intervention stage, the questionnaire will be completed by someone other than the Care provider. To blind the methodologist, the group of people will also be hidden from them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast feeding.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Recipient of acupressure. The points used in this group are three points GB21 (at the top of the sternocleidomastoid muscle), point CV17, 4 fingers above the sternum, approximately in the center of the chest) and point CO18 (at the bottom of the indentation) is. Mothers are taught to do these points three times a day for 2 to 5 minutes each time for a total of 14 days. Intervention 2: Intervention group2: Recipients of OKETANI massage for 30 minutes once a day for 14 days (the first day is done by the researcher and the next days by the mother after the necessary training was given to the mother) in both right and left breasts. In total, it includes 8 hand techniques. Intervention 3: Intervention group 3: Breastfeeding counseling and training group that receives breastfeeding-related training as soon as possible after delivery and communicating with the baby, as well as for 14 days after delivery by phone or in person if necessary. Intervention 4: Control group: They only receive routine postpartum care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Rabiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrood University of Medical Sciences</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717419582</zip>
        <telephone>+98 23 3235 0513</telephone>
        <email>karimifr941@mums.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niloofar Rabiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrood University of Medical Sciences</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717419582</zip>
        <telephone>+98 21 3235 0513</telephone>
        <email>karimifr941@mums.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 t0 35 years
primipar
Ability to speak Persian and be literate
No history of breast surgery
Exclusive breastfeeding intention
Giving birth to a full-term (2500 to 4000 g) healthy baby who is not prohibited from breastfeeding (such as cleft palate, lips and prematurity)
Do not take any medication that secondarily disrupts milk production and flow</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Infant hospitalization if breastfeeding is delayed
Use fluids other than breast milk to feed the baby
The mother's unwillingness to continue participating in the study</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Recipient of acupressure. The points used in this group are three points GB21 (at the top of the sternocleidomastoid muscle), point CV17, 4 fingers above the sternum, approximately in the center of the chest) and point CO18 (at the bottom of the indentation) is. Mothers are taught to do these points three times a day for 2 to 5 minutes each time for a total of 14 days.</i_keyword>
      <i_keyword>Intervention group2: Recipients of OKETANI massage for 30 minutes once a day for 14 days (the first day is done by the researcher and the next days by the mother after the necessary training was given to the mother) in both right and left breasts. In total, it includes 8 hand techniques.</i_keyword>
      <i_keyword>Intervention group 3: Breastfeeding counseling and training group that receives breastfeeding-related training as soon as possible after delivery and communicating with the baby, as well as for 14 days after delivery by phone or in person if necessary.</i_keyword>
      <i_keyword>Control group: They only receive routine postpartum care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breast feeding. Timepoint: Before the intervention Two weeks after the intervention and one month after the intervention. Method of measurement: Breastfeeding self-efficacy questionnaires, evaluation of infant breastfeeding quality, continuation of exclusive breastfeeding.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-05</approval_date>
        <contact_name>Ethics committee of shahrood University of Medical Sciences</contact_name>
        <contact_address>Shahrood University of Medical Sciences Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
