<?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>IRCT2014101519545N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-11-23</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effectiveness of Creating Opportunities for Parent Empowerment (COPE) program on  coping mechanism and mother–preterm infants bonding</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effectiveness of Creating Opportunities for Parent Empowerment (COPE) program on  coping mechanism and mother–preterm infants bonding hospitalized in NICUs.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17468</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Parental Empowerment Program (COPE)  a educational-behavioural intervention based on the theory of self-regulation and Control is designed by Melyk, in 2001 for parents parents of premature infants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>preterm infant.</hc_freetext>
      <i_freetext>Intervention 1: Treatment included four stages:&#13;
Stage 1: 2 to 4 days after infant hospitalization&#13;
 Stage2: 2 to 4 days after the first stage&#13;
Stage3: 1 to 3 days before discharging&#13;
 Stage 4: 1 week after discharging&#13;
In every stage, in the absence of the researcher, the mother listened to an audio file containing information regarding that stage, for 15 minutes. At the same time this information was provided for the mother in the form of a booklet to use during the time of listening. Also, there was a workbook related to that stage at the end of every booklet and mother was required to complete. The completed version was provided for the research. Intervention 2: In the control group, the intervention not be;  2_4 day after admitted after infant   brife cope questionnaire completed by the mother ;  then  baby's mother attachment 1 day before discharge by;  researchers help blind study assessed ;  coping strategies questionnaire was also being used by mother completed.</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>AZAM Momenizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Doctora Crossroads, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>iran</zip>
        <telephone>+98 51 5224 7033</telephone>
        <email>momeniza911@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Karbandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Doctora Crossroads, Mashhad   Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>iran</zip>
        <telephone>+98 518591511</telephone>
        <email>KarbandiS@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All mothers older than 18 years of age and who could read and speak Persian; who had not had another infant admitted to the NICU; who According to information obtained from the medical records had not had any; physical illness disrupts daily activities and specific medical problems associated with delivery of as well as mental illness;  neurological problems that lead to drug use is clearly. and whose infants met the following criteria were eligible for participation: gestational age of under 37 weeks inclusive;  birth weight of less than 2500 grams; no problem is life threatening ; anticipated survival; and There is no physical abnormalities ; Exclusion criteria, mothers whose infants discharged from hospital before the program ends  and mothers whose neonate died and. Mother's unwillingness to cooperation</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>37 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other preterm infants</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Treatment included four stages:&#13;
Stage 1: 2 to 4 days after infant hospitalization&#13;
 Stage2: 2 to 4 days after the first stage&#13;
Stage3: 1 to 3 days before discharging&#13;
 Stage 4: 1 week after discharging&#13;
In every stage, in the absence of the researcher, the mother listened to an audio file containing information regarding that stage, for 15 minutes. At the same time this information was provided for the mother in the form of a booklet to use during the time of listening. Also, there was a workbook related to that stage at the end of every booklet and mother was required to complete. The completed version was provided for the research.</i_keyword>
      <i_keyword>In the control group, the intervention not be;  2_4 day after admitted after infant   brife cope questionnaire completed by the mother ;  then  baby's mother attachment 1 day before discharge by;  researchers help blind study assessed ;  coping strategies questionnaire was also being used by mother completed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coping Strategies with Stress. Timepoint: 2 to 4 day after infant hospitalization and 1 days before discharging Stage. Method of measurement: Brief COPE Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lenght of stay. Timepoint: The wole of hospitalization from admission day until discharge. Method of measurement: The wole of hospitalization from admission day until discharge.</sec_outcome>
      <sec_outcome>Rate of readmission. Timepoint: One mounth after discharge from haspital. Method of measurement: Call contact after discharge from haspital.</sec_outcome>
      <sec_outcome>Mother–infant bonding. Timepoint: 1 days before discharging. Method of measurement: Questionnaire 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>Vice Chancellor for Research, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-04-29</approval_date>
        <contact_name>Vice Chancellor for Research, Mashhad University of Medical Sciences</contact_name>
        <contact_address>Resarch Assistance, Building Qureshi, Daneshgah Street, Doctora Crossroads, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
