<?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>IRCT20200625047914N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-10</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of empowerment program for mothers of infants with congenital heart disease on their resilience and neonatal growth criteria</public_title>
      <acronym></acronym>
      <scientific_title>The effect of empowerment program for mothers of infants with congenital heart disease on their resilience and neonatal growth criteria</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49797</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>congential heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first meeting, an introduction will be made and explanations will be given about the study and  the baby's illness . The next day, an emotional empowerment session will be held to teach coping techniques and stress management techniques. The third session will teach them about the impact of nutrition and nutrition on improving the condition of patients with congenital heart disease. .The fourth session is about drugs and the importance of their correct and timely use, their side effects and how to control them.On the last day and the fifth session, will be explained to the mothers about the effect of the infection and its symptoms on the baby and how to control and prevent the infection and the necessary care in case of infection of the infant.The duration of the sessions will vary from 45 minutes to one hour and a day, depending on the mother's needs. The teaching method is in the form of lectures, practical demonstrations, questions and answers, showing educational videos through mobile phones and role-playing. During the sessions with the mothers, the given exercises will be reviewed and practiced more. And if needed, mothers' questions will be answered. Intervention 2: Control group: In the control group, routine care is provided for nutrition and medication, and trainings are also given orally by the nurse or giving pamphlet to mothers.</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:
Part of the data, can be shared such as information about the main outcome, ie maternal resilience and infant growth criteria, .

When:
14 monthes

To whom:
Researchers working in academic and scientific institutions

Conditions:
All requests are reviewed for access to data or documentation

Where to obtain:
Refer to the researcher, Dr. Razaghi.
Email: ‌razaghin@mums.ac.ir

How to obtain:
Just send an email. Will be answered within 3 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Naghmeh Razaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne sina Street</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9314733333</zip>
        <telephone>+98 51 3846 5038</telephone>
        <email>razaghin@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr.razaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>chahrah doctora</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>93156465456</zip>
        <telephone>+98 51 3526 2652</telephone>
        <email>joneidir971@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>infant with congenital heart disease
Term or near term (above 35 weeks)
Direct care of the baby by the mother</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>10 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Has not heart surgery
No other chronic disease
No history of birth of a baby with heart disease in family
Not bad state and not under mechanical ventilation.
The mother does not have a known mental disorder or the mother is taking neuroleptics
Not experiencing severe accidents (such as ‌death of loved ones) ‌‌ in 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the first meeting, an introduction will be made and explanations will be given about the study and  the baby's illness . The next day, an emotional empowerment session will be held to teach coping techniques and stress management techniques. The third session will teach them about the impact of nutrition and nutrition on improving the condition of patients with congenital heart disease. .The fourth session is about drugs and the importance of their correct and timely use, their side effects and how to control them.On the last day and the fifth session, will be explained to the mothers about the effect of the infection and its symptoms on the baby and how to control and prevent the infection and the necessary care in case of infection of the infant.The duration of the sessions will vary from 45 minutes to one hour and a day, depending on the mother's needs. The teaching method is in the form of lectures, practical demonstrations, questions and answers, showing educational videos through mobile phones and role-playing. During the sessions with the mothers, the given exercises will be reviewed and practiced more. And if needed, mothers' questions will be answered.</i_keyword>
      <i_keyword>Control group: In the control group, routine care is provided for nutrition and medication, and trainings are also given orally by the nurse or giving pamphlet to mothers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience score in Conner-Davidson Resilience Questionnaire. In this questionnaire, the maximum score is 125 and the minimum score is zero, and the score of each subject is equal to the total score of each of the questions. Timepoint: after the intervention and at one month of age. Method of measurement: For maternal resilience variable: Connor-Davidson resilience questionnaire.</prim_outcome>
      <prim_outcome>Infant growth criteria( weight and head circumference). Timepoint: after the intervention and at one month of age. Method of measurement: Measure the infant's weight and head circumference.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-02</approval_date>
        <contact_name>Ethics committee of mashhad univercity of Medical Sciences</contact_name>
        <contact_address>Ebne sina Street mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
