<?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>IRCT20170512033932N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>An Empowerment Program on Parents with Preterm Infants</public_title>
      <acronym></acronym>
      <scientific_title>Impact of empowerment program on participation and attachment of parents with premature infants admitted to neonatal intensive care unit of Sayyad Shirazi Hospital in Gorgan in 1397</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33957</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A simple randomization is done with sealed envelope tools in such a way that the envelopes are written in letters A and B, and the mothers are asked to select an envelope that the group A of the intervention group and the B group will be tested.</study_design>
      <phase>N/A</phase>
      <hc_freetext>In this study, the effect of parents empowerment on their participation in care and their attachment level is studied.</hc_freetext>
      <i_freetext>Intervention 1: ntervention group: Includes 25 parents with premature infants. After receiving the pre-test, the demographic characteristics, attachment and participation of the parents in the 2-4 days after the admission and 4-4 days after the first stage receive the necessary training for the newborns, and 2 days before the post-discharge post-attachment test And participate. Intervention 2: Control group:  Twenty-five parents with premature infants admitted to the neonatal intensive care unit, on the second day of admission, pre-test, demographic characteristics, attachment and participation were taken without intervention. Two days before the discharge, the post-test was also taken.</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:
Results and results of the study will be shared

When:
Post-print information will be publicly available

To whom:
All students and researchers can apply for information.

Conditions:
Use of questionnaires and titles for further studies and studies is allowed.

Where to obtain:
Email haniehsajadi74@gmail.com Message to be sent.

How to obtain:
Email request or contact

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hanieh ُSajadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golshahr Square, Golshahr Street 32</address>
        <city>Gorgon</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234</zip>
        <telephone>+98 17 3323 3131</telephone>
        <email>H_hojjati@aliabadiau.ac.ir</email>
        <affiliation>Islamic Azad University of Ali Abad Katoul</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hanieh Sajadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golshahr Square, Golshahr Street 32</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234</zip>
        <telephone>+98 17 3323 3131</telephone>
        <email>H_hojjati@aliabadiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Get informed consent from the company in this study..
Reading and writing materials are over 18 years old
. It is the direct responsibility of caring for the patient.
Waldin is not physically and mentally handicapped
Premature infants admitted at age 26 to 34 weeks and birth weight less than 2500 grams.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If they do not want to continue their collaboration, they will be excluded from the study
Two absentee sessions eliminate parents from studying</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ICD-10 Cha</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>عوامل مؤثر بر سلامت و تماس با خدمات بهداشتی و درمانی</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>ntervention group: Includes 25 parents with premature infants. After receiving the pre-test, the demographic characteristics, attachment and participation of the parents in the 2-4 days after the admission and 4-4 days after the first stage receive the necessary training for the newborns, and 2 days before the post-discharge post-attachment test And participate.</i_keyword>
      <i_keyword>Control group:  Twenty-five parents with premature infants admitted to the neonatal intensive care unit, on the second day of admission, pre-test, demographic characteristics, attachment and participation were taken without intervention. Two days before the discharge, the post-test was also taken</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Parents have premature infants. Timepoint: Before intervention, 4.8 days after intervention and 2 days before discharge. Method of measurement: Avant Attachment Questionnaire and Participation Questionnaire for Parents with Premature Infants.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-27</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Gorgan, Golshahr Square, Golshahr 32, Gorgan Gorgon Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
