<?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>IRCT2013121515810N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-07-05</date_registration>
      <primary_sponsor>Vice chancellor for research, shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the educational program on Iranian premature infants' parental stress in neonatal intensive care unit: A double-blind randomized controlled trial.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the educational program on Iranian premature infants' parental stress in neonatal intensive care unit: A double-blind randomized controlled trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14969</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parental Stress Parameters.</hc_freetext>
      <i_freetext>Intervention 1: intervention group:  Parents in the intervention group during four 45-minute sessions of face to face training in a hospital conference room and the baby's bedside are trained by the researcher. Intervention 2: control group: Parents in the control group did not receive any training of researcher and only in times of stress test similar to the intervention group evaluate their stress.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://ijcbnm.sums.ac.ir/index.php/ijcbnm/article/view/145</results_url_link>
      <results_summary>Background: Hospitalization in neonatal intensive care unit (NICU) leads to a lot of stress and shock to the parents. Nurses, as the primary sources of information, could play an important role in reducing their stress. The aim of this study was to determine the effect of educational program on the premature infants’ parental stress in NICU.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Methods: This double-blind randomized controlled trial study with a pre-and post-test and follow up design was conducted from February 2013 to March 2014. Sixty parents in Hazrat Zainab hospital affiliated to Shiraz University of Medical Sciences were randomly allocated into the intervention (received educational program) and control groups (received routine care). The valid and reliable ”Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)“ was used to measure the parental stress. In the intervention group, information about general condition of the baby, the equipment and unit’s environment, spouse support, and problem solving strategies were given. The data were collected the second day after admission, fifth day after admission, and a week after the intervention. The data were analyzed in SPSS (Version 14), using t-test and repeated measures analysis of variance.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Results: In the second day after admission, the mean score of stress in premature infants’ mothers and fathers in the intervention group were 94.79±14.28 and 76.77±16.39, respectively. In the control group, it was 94.48±20.03 and 92.30±21.95 for mothers and fathers. After the intervention in the fifth day of admission, a significant difference was observed between the two groups concerning the premature infants’ maternal (t=-5. 23, P</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>Seyedeh Marzieh Baharlu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrate Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1647 4257</telephone>
        <email>Baharlu_m@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences,  Hazrate Fatemeh Nursing and Midwifery Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nooshin Beheshtipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrate Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1647 4257</telephone>
        <email>Beheshti64@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences , Hazrate Fatemeh Nursing and Midwifery Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1) age greater than 18 years, 2) mastered in the Persian language and reading and writing ability, 3) a minimum of 1 times to meet the baby and had seen the NICU, 4) during the past year they didn’t have the previous experience stressors, 5) they didn’t have the previous precedent of a child had been hospitalized in the neonatal intensive care unit, 6) according to their own statements they were not being treated with certain medications such as tranquilizers, anti-anxiety, 7) according to their own statements they didn’t have physical or mental problems which interfere the participation in the study and completion the questionnaire used in the study, 8) during participation in curriculum they were not participate in another program or intervention, 9) they were not one of the medical staff, 10) they were willing to participate in the study in addition they completed a consent form.&#13;
Exclusion criteria: 1) The parents want to leave the study, 2) The parents did not participate all of the educational meeting, 3) The parents had another stressor factors moreover than inclusion criteria.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z00,Z01,Z0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>عوامل مؤثر بر اوضاع سلامتی و مرتبط با خدمات سلامت</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group:  Parents in the intervention group during four 45-minute sessions of face to face training in a hospital conference room and the baby's bedside are trained by the researcher</i_keyword>
      <i_keyword>control group: Parents in the control group did not receive any training of researcher and only in times of stress test similar to the intervention group evaluate their stress.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: 2days after admition,after intervention,1week after intervention. Method of measurement: Parental Stress Scale.</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 chancellor for research, shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-08</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand Street, Shiraz Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
