<?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>IRCT20171010036690N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Assesing the effect of fathers involvement in the care of premature newborns based on developmental care principels on their bonding and self efficacy</public_title>
      <acronym></acronym>
      <scientific_title>Assesing the effect of fathers involvement in the care of premature newborns based on developmental care principels on their bonding and self efficacy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28575</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: For preventing  the information contamination between control and intervention group father will enter the study in succession of 10 people. The random sequence of the control and intervention group is determined by dropping coin. After ending sampling for 10 person and after discharging the last baby 10 father entered to study by the sequence identified.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Assessing bonding and self- efficacy of fathers who have premature baby.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Fathers have a premature newborn that  They are treated in accordance with the routine. Intervention 2: Intervention group: Fathers have a newborn in the department that will participate in 4 sessions of evolutionary care education, including positioning, moving, feeding, nursing, bathing with a swaddling baby, changing diapers, touching the baby, understanding the behavior of the baby according to the nature of each infant. . After holding fathers' meetings with the help of the researcher, they performed the lessons learned on the baby's side as needed. During the first meeting with the infant's care department, the characteristics of the premature baby and its needs are taught to parents. During the second session, the philosophy of evolutionary care and how to care for the baby will be provided on the basis of the principles of evolutionary care on the replicate. During the third and fourth session, the care of the infant's bedside and in the presence of the researcher will be done by the fathers in practice.</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:
The results will be sent as an article to be printed in internal or external journals

When:
Start access after printing the article

To whom:
All people

Conditions:
If copyright is observed, mention the available resource

Where to obtain:
fatemehmorovati@yahoo.com
ظAn article in the journal has been published

How to obtain:
Within a week, an email request will be answered

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh morovati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no 19, alireza sadegh nia alley, shohaday zia abad ave. barande seyfi blvd</address>
        <city>Eslsmshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3315688456</zip>
        <telephone>+98 21 5613 6589</telephone>
        <email>fatemehmorovati@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Morovati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No19, Alireza Sadegh nia alley, Shohadaye zia abad ave. Barande seyfi Blvd</address>
        <city>Eslamshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3315688456</zip>
        <telephone>+98 21 5613 6589</telephone>
        <email>fatemehmorovati@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fathers who have premature baby (gestational age less than 37) in neonatal intensive care unit, the ability to undrestand and read in Persian,  no addiction, not having a premature baby before</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Exclusion criteria: The infant gets serious illness during the study (Lung hemorrhage, intra ventricular hemorrhage...), mother with post par tum depression (the effect of mother depression on father bonding), hospitalization for more than 4 weeks (the effect of long hospitalization on fathers bonding and self- efficacy), discharge  earlier than 1 week</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>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Fathers have a premature newborn that  They are treated in accordance with the routine</i_keyword>
      <i_keyword>Intervention group: Fathers have a newborn in the department that will participate in 4 sessions of evolutionary care education, including positioning, moving, feeding, nursing, bathing with a swaddling baby, changing diapers, touching the baby, understanding the behavior of the baby according to the nature of each infant. . After holding fathers' meetings with the help of the researcher, they performed the lessons learned on the baby's side as needed. During the first meeting with the infant's care department, the characteristics of the premature baby and its needs are taught to parents. During the second session, the philosophy of evolutionary care and how to care for the baby will be provided on the basis of the principles of evolutionary care on the replicate. During the third and fourth session, the care of the infant's bedside and in the presence of the researcher will be done by the fathers in practice.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bonding: The score obtained from the Mother to infant bonding  questionnaire. Timepoint: After 3 days, 4 weeks later. Method of measurement: The questionnaire of Mother to infant bonding scale.</prim_outcome>
      <prim_outcome>Self efficacy :   The score obtained from the Perceived Parental self- Efficacy questionnaire. Timepoint: After 3 days, 4 weeks later. Method of measurement: Perceived Parental self- Efficacy questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-06</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Enghelab ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
