<?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>IRCT2017052034040N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-06</date_registration>
      <primary_sponsor>Vice for research, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Telenursing on Maternal-Infant Attachment and Stress on Premature Infant’s Mothers.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Telenursing on Maternal-Infant Attachment and Stress among Premature Infant’s Mothers who Hospitalized in Neonatal Intensive Care Unit of the Shahid Beheshti Hospital 2017.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26131</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: stress. Condition 2: attachment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group receive Telenursing. Telenursing consist of two parts (offline and online). Off line system have 10 codes with recorded information about NICU, characterization of premature newborns, changes of weight, length and head circumstances in premature newborns, therapeutic procedures in premature newborns, equipment in NICU, relaxing premature newborns, different methods of feeding in premature newborns, breast milk storage and handling, ways of increasing milk expression, listening to relaxation voice messages) and the offline system will be always available by phone during 24 hours. In online part mothers can contact to the researcher and ask their questions. Telenursing starts with in a week after newborn hospitalization until a week after discharge. Intervention 2: Control groups received only routine interventions. Before discharge all samples receive pamphlet about Kangaroo Mother Care (KMC).</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>Zahra Alsadat Jafarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezarjereeb street, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81969-38511</zip>
        <telephone>+98 31 3688 0048</telephone>
        <email>zahraalsadatjafarzadeh@gmail.comzs.jafarzadeh@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Alsadat Jafarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezarjereeb street, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3688 0048</telephone>
        <email>zs.jafarzadeh@nm.mui.ac.ir zahraalsadatjafarzadeh@gmail.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Mother’s consent to participate the study؛ Mothers who able to read and write؛ Parents who are non-employed in medical and paramedical jobs ؛No evidence of maternal physical or psychological condition that effect maternal supportive care role like postpartum depression, anxiety, addiction؛ No evidence of major stress like divorce, impersonate of husband or death of family member during last year; Gestational Age 33-37 weeks; Newborns who have taken Kangaroo Mother Care(KMC); No evidence of neonatal extreme condition like grades third or fourth Internal Ventricular Hemorrhage (IVH) or physical or congenital problem; Mothers who are not participating in any other research.&#13;
Exclusion criteria:&#13;
Intention of mothers to leave the study; Evidence of any maternal physical or psychological problem during the study that prevent her to do supportive care role for her neonate; Less than two contacts from the mothers; Discharge of newborns before the end of the study; Deterioration of the disease, or death of the neonates;</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R45.7</hc_code>
      <hc_code>F93</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>State of emotional shock and stress</hc_keyword>
      <hc_keyword>Emotional disorders with onset specific to childhood</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 receive Telenursing. Telenursing consist of two parts (offline and online). Off line system have 10 codes with recorded information about NICU, characterization of premature newborns, changes of weight, length and head circumstances in premature newborns, therapeutic procedures in premature newborns, equipment in NICU, relaxing premature newborns, different methods of feeding in premature newborns, breast milk storage and handling, ways of increasing milk expression, listening to relaxation voice messages) and the offline system will be always available by phone during 24 hours. In online part mothers can contact to the researcher and ask their questions. Telenursing starts with in a week after newborn hospitalization until a week after discharge.</i_keyword>
      <i_keyword>Control groups received only routine interventions. Before discharge all samples receive pamphlet about Kangaroo Mother Care (KMC).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: During seven days after birth, The day of dischare. Method of measurement: Stress with Parental Stress Scale: Neonatal Intensive Care Unit (PSS:NICU).</prim_outcome>
      <prim_outcome>Attachment. Timepoint: During seven days after birth,  One week after discharge. Method of measurement: Maternal Postnatal Attachment (MPA).</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>Vice for research, Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-19</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Ethics committee of Isfahan University of Medical Science, Nursing Midwifery School, Isfahan University of Medical Science, Hezarjereeb Street, Isfahan, Iran Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
