<?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>IRCT2015080613691N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-27</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>“Effect of educational- supportive intervention for fathers of premature newborn on mother-newborn attachment and parents anxiety”</public_title>
      <acronym></acronym>
      <scientific_title>“Effect of educational- supportive intervention for fathers of premature newborn on mother-newborn attachment and parents anxiety”</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13479</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: maternal-infant attachment. Condition 2: anexity.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will support educational interventions. The intervention will be done 2 days after admission to the intensive care unit for newborns. &#13;
Two meetings of a group that includes45-minute face-to-face with the parents of premature infants in the environment, equipment, personnel intensive care unit and medical care such as IV therapy, oxygen therapy, etc., and information on premature babies (behaviors and physical symptoms), the role of parents in protecting and caring for the baby and the mother, physical and emotional changes made to the mother after delivery, will be presented by the researcher using Power Point.And questions and answers between the researcher and fathers topics will be presented.At the end of the first session of the color manual and CD training 40 minutes, with educational content developed by researchers and confirmed by the teachers, the parents and the parents will be taught how to use them.And at the end of the first session, parents to see the facilities and meet the staff, and training in the sector will be&#13;
&#13;
&#13;
&#13;
&#13;
&#13;
The intervention group will support educational interventions.&#13;
The intervention 2 days after admission to the intensive care unit for newborns at will&#13;
Two meetings of a group that includes 60-minute face-to-face with the parents of premature infants in the environment, equipment, personnel intensive care unit and medical care such as IV therapy, oxygen therapy, etc., and information on premature babies (behaviors and physical symptoms), the role of parents in protecting and caring for the baby and the mother, physical and emotional changes made to the mother after delivery, will be presented by the researcher using Power Point. Intervention 2: In the control group، Fathers  will be visit their infants as ward routine and  will be have no accessibility to rsearch team during hospitalization.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arshadi Bostanabad Mohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Sharyati Ave. Nursing and Midwifery Faculty</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>arshadi@tbzmed.ac.irarshadi-m@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>(Baby Inclusion criteria : premature babies between 37-34 weeks of pregnancy;   Apgar score of more than 7 minutes;  lack of major congenital anormalies;  two days after the adoption of childr;  enLack of intubation ;  One roll of;  Having at least one meeting;  the first time؛ Do not use aids fertility;  Minimum weight 2000 gr;  having oral feeding;   wanted pregnancy)&#13;
 ( Parents Inclusion criteria:  sign the consent and willingness to participate in the study ;  there is no known mental problems ;  having at least primary education ;  living with his wife in Tabriz ;  lack of medical staff)&#13;
(  Exclusion criteria: The occurrence of adverse events during treatment (infant death) ; The reluctance of parents to continue reading ;Consumption of  anti-anxiety drugs)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>2 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z00.6</hc_code>
      <hc_code>f41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Examination for normal comparison and control in clinical research programme</hc_keyword>
      <hc_keyword>generalized anexiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will support educational interventions. The intervention will be done 2 days after admission to the intensive care unit for newborns. &#13;
Two meetings of a group that includes45-minute face-to-face with the parents of premature infants in the environment, equipment, personnel intensive care unit and medical care such as IV therapy, oxygen therapy, etc., and information on premature babies (behaviors and physical symptoms), the role of parents in protecting and caring for the baby and the mother, physical and emotional changes made to the mother after delivery, will be presented by the researcher using Power Point.And questions and answers between the researcher and fathers topics will be presented.At the end of the first session of the color manual and CD training 40 minutes, with educational content developed by researchers and confirmed by the teachers, the parents and the parents will be taught how to use them.And at the end of the first session, parents to see the facilities and meet the staff, and training in the sector will be&#13;
&#13;
&#13;
&#13;
&#13;
&#13;
The intervention group will support educational interventions.&#13;
The intervention 2 days after admission to the intensive care unit for newborns at will&#13;
Two meetings of a group that includes 60-minute face-to-face with the parents of premature infants in the environment, equipment, personnel intensive care unit and medical care such as IV therapy, oxygen therapy, etc., and information on premature babies (behaviors and physical symptoms), the role of parents in protecting and caring for the baby and the mother, physical and emotional changes made to the mother after delivery, will be presented by the researcher using Power Point</i_keyword>
      <i_keyword>In the control group، Fathers  will be visit their infants as ward routine and  will be have no accessibility to rsearch team during hospitalization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anexity. Timepoint: before Intervention،  post Intervention. Method of measurement: Spielberger questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mother-newborn attachment. Timepoint: before Intervention،  post Intervention. Method of measurement: Inventory observation Avant.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-25</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave. Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
