<?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>IRCT20180127038529N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-30</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of NIDCAP program on mother's anxiety and stress</public_title>
      <acronym></acronym>
      <scientific_title>The effect of home care follow-up program on premature newborns who receive NIDCAP, on mother's anxiety and stress and neonate's Physical growth parameters</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29560</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be done in an accessible manner with simple random assignment, Blinding description: The intervention and control groups of mothers with preterm infants aged 32-26 who are blind to the purpose of the intervention. Data analysis is also conducted by the unacquainted person in the intervention and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>mother’s anxiety and stress  and  neonate’s Physical growth parameters.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: includes the implementation the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) in accordance to the standards of this care program is done by the researcher on the first day of the baby's birth, and then every week and after the sustained condition of the newborn, every two weeks until the discharge is done.Its feedback is prepared by a person with an international certificate of NIDCAP and will be provided to the mothers. After one week after the discharge of the baby, the amount of anxiety and stress of the mother and growth parameters of the baby will be assessed and recorded.Re-assessment of NIDCAP will be done at home by a physician and a nurse and its developmental feedback will be provided to the mother. Then, after one week, assessment of NIDCAP will be done at home by a nurse and necessary trainings will be provided to the mother. Intervention 2: Control group: In the control group received routine care.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Malihe KHoshahang</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Om-o-lbanin Hospital, Behjat 16th , Behjat St., Kamyab Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9144734767</zip>
        <telephone>+98 51 3223 1065</telephone>
        <email>khoshahangm1@mums.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>DR SHahla KHosravan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, Imam Khomeini St., Gonabad</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9144734767</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>khosravan@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mother consented to join to the program
Lack of known mental disorders in mothers
Mother is living in Mashhad
Mother is not addicted to drugs based on self-declaration
Mother do not have any important or serious problem
Mother did not have any twin or multiparty delivery
Mother did not experience any preterm infant birth
The baby's age is between 26-32 weeks</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>8 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Usage of anti-anxiety drug by mother
Diagnosis of abnormalities in the baby</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified</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: includes the implementation the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) in accordance to the standards of this care program is done by the researcher on the first day of the baby's birth, and then every week and after the sustained condition of the newborn, every two weeks until the discharge is done.Its feedback is prepared by a person with an international certificate of NIDCAP and will be provided to the mothers. After one week after the discharge of the baby, the amount of anxiety and stress of the mother and growth parameters of the baby will be assessed and recorded.Re-assessment of NIDCAP will be done at home by a physician and a nurse and its developmental feedback will be provided to the mother. Then, after one week, assessment of NIDCAP will be done at home by a nurse and necessary trainings will be provided to the mother.</i_keyword>
      <i_keyword>Control group: In the control group received routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety in mothers of premature infants. Timepoint: Determine mother's anxiety at beginning of study and after execution of the NIDCAP (the day of discharge of baby, before home care and at the end of 2-month period after discharge). Method of measurement: Spielberger scale.</prim_outcome>
      <prim_outcome>Stress in mothers of premature infants. Timepoint: Determine mother's stress at beginning of study and after execution of the NIDCAP (the day of discharge of baby, before home care and at the end of 2-month period after discharge). Method of measurement: Cohen Perceived Stress Scale.</prim_outcome>
      <prim_outcome>Neonant's Physical growth parameters (such as weight, height, Head circumference, Chest circumference). Timepoint: Determine neonant's Physical growth parameters at beginning of study and after execution of the NIDCAP (the day of discharge of baby, before home care and at the end of 2-month period after discharge). Method of measurement: Meters and Weight Scales.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-10</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad University of Medical Sciences, Imam Khomeini St., Gonabad Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
