<?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>IRCT20190615043895N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-09</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Survey on the effect of educational intervention using mobile application on breastfeeding self-Efficacy</public_title>
      <acronym></acronym>
      <scientific_title>Survey on the effect of educational intervention using mobile application on breastfeeding self-Efficacy of mothers attending to the Health Center of Rasht</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>198</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40163</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The investigation units: researchers who are studying the units, Will give them a number from 1 to 198. By random allocation software, a table with 50 rows of blocks Will be designed and each block Will be named A and B. Afterwards, the numbers Will Be placed in each house in order, after that , all numbers Will  Be placed in blocks. 50 Quadruple blocks Will Be randomly selected. Random blocks Will be placed in sealed and locked envelopes and Will keep at the Community Health Center No. 4 and no one Will know their sequence. After starting the study, the blocks Are randomly selected daily. Those in house A Are placed in the test group and those in house B  Are placed in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Self-efficacy of mothers breastfeeding.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After filling the questionnaire, the promotion of the breastfeeding booklet published by the Ministry of Health, based on the benefits of breastfeeding for infants, breastfeeding benefits for mother , breastfeeding ingredients, the usage of pacifier, lactation numbers, how to breastfeed, symptoms of satiety and hunger ,The correct stat of hugging the baby during lactation, the types of Breastfeeding, Breastfeeding Diagnosis, breast feeding Methods , how to save breast milk, melting the Frozen Breast milk ,     Common Causes of refusing the breast milk , Nipple fissure ، breast hyperemia ,lightweight and premature babies , capsules and powder to increase milk,  mother's cold , taking  the medicine and lactation at the  same time , baby with diarrhea, how to increase mother's milk and the constancy of breastfeeding and Disadvantage of milk powder and an executable  program will be installed on mother’s smart phone via Bluetooth and one week after the installation of the software , they will be contacted and they will be answered any questions or  problems that mothers have with the  software .Then to remind them of this program , they will be sent a message every week .Also, they will give researcher’s phone number to mothers that if they have any questions about the software , they will ask Then, in the eighth week after delivery, the questionnaire of breastfeeding self-efficacy will be completed by the interviewer over the telephone. Intervention 2: Control group:  the control group does not receive any educational intervention. they receive only routine breastfeeding training, which includes training in hospital and comprehensive health centers by health care providers. Then, Two times, 3-5 days after delivery and eighth week after delivery, the questionnaire of breastfeeding self-efficacy will be completed by the interviewer over the telephone.</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:
Comparing the self-efficacy of mothers breastfeeding with and without using mobile software in the first and eighth week after completing a shortened and psychometric self-efficacy questionnaire for Denis

When:
1 years

To whom:
Faculty Members  of Shahid Beheshti Faculty of Midwifery and Nursing, Rasht

Conditions:
In order to verify the accuracy of the information and with a written and approved request from the research deputy of Shahid Beheshti Faculty of Nursing and Midwifery, Rasht

Where to obtain:
Library of Shahid Beheshti Faculty of Midwifery and Nursing of Rasht as well as a written request from the project implementer

How to obtain:
Permission from the librarian of Shahid Beheshti Faculty of Midwifery and Nursing in Rasht in writing

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zahra Bostani khalesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht-yakhsazi Creator - Student Park- Shahid Beheshti Faculty of Nursing and Midwifery</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4471683835</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>z_bostani@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Bostani Khalesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht - yakhsazy Arena - Student Park- Shahid Beheshti Faculty of Nursing and Midwifery</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4471683835</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>z_bostani@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfaction to participate in the study
Mothers residing in Rasht city
No history of systemic disease, mental disorder
Lack of Addiction to alcohol, cigarettes and drugs (based on self-report)
Breastfeeding in the last 24 hours
Uncomplicated pregnancy
Lack of medical prohibition for breastfeeding
Have a reading and writing literacy
Having an Android smartphone and the skill of using the software</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>history of systemic disease, mental disorder
Feeding with milk powder
multiple pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P92.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal difficulty in feeding at breast</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: After filling the questionnaire, the promotion of the breastfeeding booklet published by the Ministry of Health, based on the benefits of breastfeeding for infants, breastfeeding benefits for mother , breastfeeding ingredients, the usage of pacifier, lactation numbers, how to breastfeed, symptoms of satiety and hunger ,The correct stat of hugging the baby during lactation, the types of Breastfeeding, Breastfeeding Diagnosis, breast feeding Methods , how to save breast milk, melting the Frozen Breast milk ,     Common Causes of refusing the breast milk , Nipple fissure ، breast hyperemia ,lightweight and premature babies , capsules and powder to increase milk,  mother's cold , taking  the medicine and lactation at the  same time , baby with diarrhea, how to increase mother's milk and the constancy of breastfeeding and Disadvantage of milk powder and an executable  program will be installed on mother’s smart phone via Bluetooth and one week after the installation of the software , they will be contacted and they will be answered any questions or  problems that mothers have with the  software .Then to remind them of this program , they will be sent a message every week .Also, they will give researcher’s phone number to mothers that if they have any questions about the software , they will ask Then, in the eighth week after delivery, the questionnaire of breastfeeding self-efficacy will be completed by the interviewer over the telephone.</i_keyword>
      <i_keyword>Control group:  the control group does not receive any educational intervention. they receive only routine breastfeeding training, which includes training in hospital and comprehensive health centers by health care providers. Then, Two times, 3-5 days after delivery and eighth week after delivery, the questionnaire of breastfeeding self-efficacy will be completed by the interviewer over the telephone.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The First Outcome: Mother’s knowledge of breastfeeding. Timepoint: Day 2-5 after delivery. Before intervention. Method of measurement: A shortened and psychometric questionnaire for Denis's lactation self- efficacy.   before the implementation of    the breast feeding training program is completed by the researcher on the second to    fifth day after delivery in both experimental and control groups. Mother's awareness is measured by a breastfeeding self-efficacy questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Secondary Outcome: the Breastfeeding Self-efficacy. Timepoint: 8 weeks after the end of the Intervention. Method of measurement: Short-lived and psychometric inventory of Denis's lactation self-efficacy.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-15</approval_date>
        <contact_name>National Ethics Committee for Biomedical Research</contact_name>
        <contact_address>Tehran, Ghods Town (West), Between South Falamak and Zarafshan, Iran, Iran - Central Headquarters of the Ministry of Health and Medical Education, block A, thirteenth floor Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
