<?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>IRCT20180805040710N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-02</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education based on the theory of planned behavior to continue exclusive breastfeeding</public_title>
      <acronym></acronym>
      <scientific_title>The effect of education based on the theory of planned behavior on the continuation of exclusive breastfeeding in drug dependent mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35502</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization (permutation blocks)
Permutational blocks are a random allocation method for the groups under study. In this method, if we have two groups, we have two blocks AB and BA. In the size of the sample size in each block, random numbers are chosen between 1 and 2, based on the selective numbers People are assigned to study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The Continuation of Exclusive Feeding in Mothers Consuming Drugs.</hc_freetext>
      <i_freetext>Intervention 1: For the mothers of the intervention group whose infant is admitted to the neonatal intensive care unit, 4 individual training sessions are held in the hospital within 4 days and the contents of the educational materials are presented based on the correlation of the planned behavior theory with the intention of exclusive nutrition. Intervention 2: Control group: They will receive routine hospital training on breastfeeding.</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:
Main outcome information

When:
6 months after printing results

To whom:
Scientific and academic researchers

Conditions:
To cite in the papers of the researchers

Where to obtain:
zarifnejadgh@mums.ac.ir
ramezanimn@mums.ac.ir
Sadeghif951@mums.ac.ir

How to obtain:
Email to the authors

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshte Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,St. Ibn Sinai ,intersection, PhD,University Avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 338591511051</telephone>
        <email>sadeghif951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Monir Ramezani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,St. Ibn Sinai ,intersection, PhD,University Avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>ramezanimn@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>Conscious Consent to Participate in Intervention
Drug addiction (raw opium, opium sap, methadone, buprenorphine , tramadol)
Ability to communicate
Spoken in Persian
Have at least reading and writing skills
Gestational age 35 to 42 weeks
Not having a disease that can interfere with breastfeeding
The presence of any illness or drug use as directed by a doctor who interferes with breastfeeding
The lack of mental disorders and the use of psychoactive drugs
Lack of infant congenital anomalies where breastfeeding is prohibited by the mother.
Being at least 18 years of age and up to 40 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not wanting to continue working mother
Having any illness or taking medication according to your doctor's prescription that interferes with breastfeeding.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P92.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Underfeeding of newborn</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For the mothers of the intervention group whose infant is admitted to the neonatal intensive care unit, 4 individual training sessions are held in the hospital within 4 days and the contents of the educational materials are presented based on the correlation of the planned behavior theory with the intention of exclusive nutrition.</i_keyword>
      <i_keyword>Control group: They will receive routine hospital training on breastfeeding.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of exclusive breastfeeding. Timepoint: Investigating the continuation of exclusive breastfeeding 2 and 4 months after intervention. Method of measurement: Theory of planned behavior questionnaire,Breastfeeding Checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The performance of the studied units in the continuation of exclusive breastfeeding. Timepoint: 2 and 4 months after childbirth. Method of measurement: Lactation checklist.</sec_outcome>
      <sec_outcome>Average knowledge of the studied units. Timepoint: Immediately after the intervention, 2 and 4 months after childbirth. Method of measurement: Theory of planned behavior questionnaire.</sec_outcome>
      <sec_outcome>Immediately after the intervention, 2 and 4 months after childbirth. Timepoint: Immediately after the intervention, 2 and 4 months after childbirth. Method of measurement: Theory of planned behavior questionnaire.</sec_outcome>
      <sec_outcome>The mean of abstract norms of the studied units. Timepoint: Immediately after the intervention, 2 and 4 months after childbirth. Method of measurement: Theory of planned behavior questionnaire.</sec_outcome>
      <sec_outcome>Average perceived behavioral control of the units under study. Timepoint: Immediately after the intervention, 2 and 4 months after childbirth. Method of measurement: Theory of planned behavior questionnaire.</sec_outcome>
      <sec_outcome>Average behavioral intention of the units under study. Timepoint: Immediately after the intervention, 2 and 4 months after childbirth. Method of measurement: Theory of planned behavior questionnaire.</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>2018-07-16</approval_date>
        <contact_name>Ethic commite of Mashhad University of medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery,St. Ibn Sinai ,intersection, PhD,University Avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
