<?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>IRCT20210913052457N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-09</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of infant care training and sharing the experiences of peer groups on infants' growth status, breastfeeding self-efficacy and quality of life of mothers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of infant care training and sharing the experiences of peer groups on infants' growth status, breastfeeding self-efficacy and quality of life of mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59093</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the lottery method, mothers who will enter the study be asked to choose a card. These cards will be in the envelope, with the words control or test on them. Thus, based on the mother's choice, she will be placed in the control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>self-efficacy of breastfeeding mothers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: All mothers in the experimental group become members of the WhatsApp virtual group, which is managed by researcher with a master's degree in pediatric nursing, PhD in health education. In addition, other members of this group in cyberspace are a midwife and a family doctor in order to answer mothers' specialized questions. Therefore, mothers will have quick access to the nurse, doctor and midwife regarding their questions. In this group, two days a week for two months, an educational program will be conducted by the researcher in the form of sending educational packages related to breastfeeding, growth and development, vaccination, health and nutrition and other care for children under two years old (educational content - Table 1). ). These packages will be sent to mothers based on the latest references in pediatric nursing books approved by the Ministry of Health and approved by the family doctor. Two days after sending the educational materials in the group for mothers, the researcher (babysitter) will teach the necessary additional explanations about the educational content for the mothers for 40 minutes and the mothers will ask their questions, to ensure the promotion of awareness and learning. Research units are evaluated at the end of the first month of mothers by answering questions designed from the educational content taught by the researcher. In addition, mothers in this group are able to share their experiences related to the growth and development of their children over a period of three months. Share each other in cyberspace. Intervention 2: Control group: The control group receives routine care in health centers.</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 The release schedule is not yet known</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Forogh Okhovat Ghahfarokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.,18, Alley10, Khayyam2 Ave. West Mirabad</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8817936363</zip>
        <telephone>+98 38 3338 2219</telephone>
        <email>foroghokhovat92@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Forogh Okhovat Ghahfarokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.18, Alley10, Khayyam Ave, West Mirabad</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8817936363</zip>
        <telephone>+98 38 3338 2219</telephone>
        <email>foroghokhovat92@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in the study
Primiparous mothers
having a minimum literacy
having a baby under two years old
the child's physical health and no underlying disease,
access to mobile phones or other tools to be present in cyberspace
the ability to use social media</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>A history of mothers' anxiety disorders 
Taking anti-anxiety and anti-depressant medications</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: All mothers in the experimental group become members of the WhatsApp virtual group, which is managed by researcher with a master's degree in pediatric nursing, PhD in health education. In addition, other members of this group in cyberspace are a midwife and a family doctor in order to answer mothers' specialized questions. Therefore, mothers will have quick access to the nurse, doctor and midwife regarding their questions. In this group, two days a week for two months, an educational program will be conducted by the researcher in the form of sending educational packages related to breastfeeding, growth and development, vaccination, health and nutrition and other care for children under two years old (educational content - Table 1). ). These packages will be sent to mothers based on the latest references in pediatric nursing books approved by the Ministry of Health and approved by the family doctor. Two days after sending the educational materials in the group for mothers, the researcher (babysitter) will teach the necessary additional explanations about the educational content for the mothers for 40 minutes and the mothers will ask their questions, to ensure the promotion of awareness and learning. Research units are evaluated at the end of the first month of mothers by answering questions designed from the educational content taught by the researcher. In addition, mothers in this group are able to share their experiences related to the growth and development of their children over a period of three months. Share each other in cyberspace</i_keyword>
      <i_keyword>Control group: The control group receives routine care in health centers</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score in the quality of life questionnaire 36 questions in two groups of control and intervention. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: 36-Question Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Breastfeeding self-efficacy score in the Dennis Breastfeeding Self-efficacy Questionnaire In two groups of control and intervention. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Dennis Breastfeeding Self-efficacy Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anthropometric indices of infants in control and intervention groups. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Meters and scales.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-02</approval_date>
        <contact_name>Faculty of Health - Shahid Sadoughi University of Medical Sciences, Yazd (Research Ethics Committee)</contact_name>
        <contact_address>Alam Square, Anonymous Martyrs Boulevard, Medical Sciences Campus, Faculty of Health Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
