<?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>IRCT20190703044082N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-20</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of kangaroo mother care by role-playing method on resilience and breastfeeding self-efficacy in mothers of premature neonates, Fatemieh hospitalized in neonatal intensive care unit, Hamadan, 202</public_title>
      <acronym></acronym>
      <scientific_title>The effect of kangaroo mother care by role-playing method on resilience and breastfeeding self-efficacy in mothers of premature neonates, Fatemieh hospitalized in neonatal intensive care unit, Hamadan, 2021</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55045</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, two neonatal intensive care units are available to researchers. For random allocation of samples in the control and intervention groups, 6 types of 4 blocks will be used as random block allocation by alternative method. Thus, the letter A will be considered for the intervention group and the letter B for the control group. On the pieces of paper, write the following blocks and put them in an envelope and we will randomly place them. Next, according to the possible order, sampling will start as AABB, BBAA, ABBA, BAAB, ABAB, BABA. According to the order of the letters in the blocks, the mothers of the babies will be assigned to the intervention or control group. The next blocks will then be selected in the same way, Blinding description: The person analyzing the data will be blinded to the assignment of individuals in groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Resilience and self-efficacy of breastfeeding mothers admitted to neonatal intensive care units.</hc_freetext>
      <i_freetext>Intervention 1: To perform the intervention, the mothers of the experimental group, each mother individually attends two sessions of 30 minutes in the conference room and is taught how to perform cuddle care using the baby model.  For this purpose, the researcher first teaches the mothers and helps them to embrace the baby's model and place it between her breast. while the mother's hand is around the baby's model and holds baby's model between her breasts with kindness and look at baby's model and caress baby's model head with the other hand. The mother practices the procedure under the supervision of a researcher to feel ready to perform kangaroo care for her baby.  then researcher helps them wear a special blouse designed according to the kangaroo care standard and protocol. These blouses are loose, have sleeves, short buttons with a distance from the front of the dress that can be easily opened and closed. The mother then sits in a comfortable chair in a sitting or half-sitting position that feels comfortable. The researcher then places the baby, who has only a hat and diaper, vertically between the mother's two breasts. The bottom buttons of the mother's blouse will closed, this way the baby will be completely in the mother's breast and in the fabric fence, reducing the possibility of falls and hypothermia. The researcher then stands next to the mother and asks her to try to make eye contact with the model while smiling and caressing and talking to her.  Mothers in the intervention group will perform kangaroo mother care for their babies three times a day and each time 30 minutes . Intervention 2: Control group: Mothers in the control group will receive a routine kangaroo mother care training (pamphlet).</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 No information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3334 5634</telephone>
        <email>F-mohammadi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fateme mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3334 5634</telephone>
        <email>F-mohammadi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Premature infants weighing 1,800 grams or less
Have a minimum APGAR score of 5 minutes for births 7 and above
Do not undergo photo therapy
The baby is 30 weeks old
older Single twin babies
The baby has not had surgery
the infant should have the conditions to leave the incubator and warmer according to the opinion of a specialist doctor
The baby has the ability to suck on the mother's breast
Non-use of psychiatric drugs and tobacco by the mother
Mothers age 18 years and older
Mothers have the ability to read and write
Second childbirth onwards
The first infant admitted to the intensive care unit
Mothers' desire to participate in the study
Healthy babies without severe physical disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>psychiatric problems in mothers (depression, bipolar, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R09.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asphyxia and hypoxemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>To perform the intervention, the mothers of the experimental group, each mother individually attends two sessions of 30 minutes in the conference room and is taught how to perform cuddle care using the baby model.  For this purpose, the researcher first teaches the mothers and helps them to embrace the baby's model and place it between her breast. while the mother's hand is around the baby's model and holds baby's model between her breasts with kindness and look at baby's model and caress baby's model head with the other hand. The mother practices the procedure under the supervision of a researcher to feel ready to perform kangaroo care for her baby.  then researcher helps them wear a special blouse designed according to the kangaroo care standard and protocol. These blouses are loose, have sleeves, short buttons with a distance from the front of the dress that can be easily opened and closed. The mother then sits in a comfortable chair in a sitting or half-sitting position that feels comfortable. The researcher then places the baby, who has only a hat and diaper, vertically between the mother's two breasts. The bottom buttons of the mother's blouse will closed, this way the baby will be completely in the mother's breast and in the fabric fence, reducing the possibility of falls and hypothermia. The researcher then stands next to the mother and asks her to try to make eye contact with the model while smiling and caressing and talking to her.  Mothers in the intervention group will perform kangaroo mother care for their babies three times a day and each time 30 minutes .</i_keyword>
      <i_keyword>Control group: Mothers in the control group will receive a routine kangaroo mother care training (pamphlet)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: Before training, at the time of discharge and one week after discharge. Method of measurement: Conner- Davidson Resilience Scale.</prim_outcome>
      <prim_outcome>Breastfeeding self-efficacy. Timepoint: Before training, at the time of discharge and one week after discharge. Method of measurement: Dennis breastfeeding self-efficacy.</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>Hamedan University of Medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-27</approval_date>
        <contact_name>Research Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Begining of khajeh rashid Boulvard Hamedan University of Medical sciences Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
