<?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>IRCT201605131788N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-15</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Parental Education on the Stress of Parents with an Infant Admitted to Neonatal Intensive Care Units</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Parental Education Emphasizing the Parental Role on the Stress of Parents with an Infant Admitted to Neonatal Intensive Care Units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1375</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In the research training of parents as dedicated to each family. Group training is not considered. For training needs analysis in the first fathers of FSS tool has been used.</study_design>
      <phase>3</phase>
      <hc_freetext>Stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: from the beginning of July eligible for inclusion in the study 36  parents were selected to participate in the intervention group The full explanation of the study was to parents, then their written consent to participate in the project was completed. On the third day of hospitalization of children in the questionnaire (PSS: NICU) was completed by both parents. The distance between the third and tenth days of hospitalization in infants in the two sessions of face to face training class was held for two hours. This class includes training parents in cases where the stress was more on them. The issues that parents need to know to keep your baby  . Finally, a practical class meeting was held with the replica or the baby to bug fixed. The distance between the third and tenth days of hospitalization in infants in a special section for parents by telephone, telegram and email were in contact with the researche. Intervention 2: Control group : 36 parents for a month and a half has Inclusion criteria were selected for the control group. Authorities first full explanation of the study parents were simple language. After written consent was signed by parents participating in the study, On the third day in the intensive care unit NICU parents were enrolled. In these days of stress questionnaire ( PSS: NICU) was completed by them.Then, without intervention and only doing routine infant hospitalized again on the tenth day of this questionnaire (PSS: NICU) was 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>Dr. Leili Borimnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sidet to the martyr Motahhari Hospital  St. martyr Yassami , Vali Asr Ave. City *</address>
        <city>Thehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997713883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>l.borimnejad@gmail.com</email>
        <affiliation>School of Nursing and Midwifery , Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr , Naima  Seyedfatemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sidet to the martyr Motahhari Hospital  St. martyr Yassami , Vali Asr Ave. City *</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>nseyedfatemi@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery , Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria of the study are as follows: Literacy; having no stressful experience, such as divorce, death of relatives, and so forth in the previous three months; having no history of admitting the infant to NICU; having no history of using psychiatric medications; . &#13;
Exclusion criteria: infants who died from any cause " babies who were discharged earlier than ten day؛ infants whose parents do not demonstrate a willingness to continue to cooperate with the investigator.</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>34 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>f43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Arises as a delayed or protracted response to a stressful event or situation (of either brief or long duration) of an exceptionally threatening or catastrophic nature, which is likely to cause pervasive distress in almost anyone. Predisposing factors, suc</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: from the beginning of July eligible for inclusion in the study 36  parents were selected to participate in the intervention group The full explanation of the study was to parents, then their written consent to participate in the project was completed. On the third day of hospitalization of children in the questionnaire (PSS: NICU) was completed by both parents. The distance between the third and tenth days of hospitalization in infants in the two sessions of face to face training class was held for two hours. This class includes training parents in cases where the stress was more on them. The issues that parents need to know to keep your baby  . Finally, a practical class meeting was held with the replica or the baby to bug fixed. The distance between the third and tenth days of hospitalization in infants in a special section for parents by telephone, telegram and email were in contact with the researche.</i_keyword>
      <i_keyword>Control group : 36 parents for a month and a half has Inclusion criteria were selected for the control group. Authorities first full explanation of the study parents were simple language. After written consent was signed by parents participating in the study, On the third day in the intensive care unit NICU parents were enrolled. In these days of stress questionnaire ( PSS: NICU) was completed by them.Then, without intervention and only doing routine infant hospitalized again on the tenth day of this questionnaire (PSS: NICU) was completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: The first baby dresses for measuring parental stress is the third day of the second measure is the tenth day hospital stay. Method of measurement: Pss standard tools to help measure the amount of stress that it is done is done validity reliability .</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 and Technology, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-06</approval_date>
        <contact_name>Ethics committee, Iran University of Medical Sciences</contact_name>
        <contact_address>Sidet to the martyr Motahhari Hospital  St. martyr Yassami , Vali Asr Ave. City * Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
