<?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>IRCT20180501039489N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-24</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of discharge plan on  knowledge  and quality of life in mothers of children with congenital heart diseases</public_title>
      <acronym></acronym>
      <scientific_title>The effect of discharge plan  implementation on  knowledge of care and quality of life in mothers of children with congenital heart diseases undergoing surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35962</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Congenital malformations of cardiac chambers and connections. Condition 2: Congenital malformations of cardiac septa. Condition 3: Congenital malformations of pulmonary and tricuspid valves. Condition 4: Congenital malformations of aortic and mitral valves.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group at first, Demographic questionnaire, knowlege of care and quality of life questionnaire were completed before the intervention by mothers. Then, in the first stage of intervention, the education includes 6 sessions of 30 minutes at admission, hospitalized days and discharge time individually and small groups using a booklet for mothers. The educational content includes: explanations of the natural and abnormal heart structure, surgical treatment, physical activity, child   nutrition post-surgery, baby bathing, infection prevention, surgical scar treatment, medication usage, benefits and side effects of medications and Treatment of fever and diarrhea. The second stage of the intervention involves post discharge follow-up.At this stage, the researcher will call with the mothers, one week, two weeks, one month, and two months after the discharge , asking for the child's condition and, if necessary, giving them the necessary education. Intervention 2: Control group: this group completes the relevant questionnaires and receives  only the usual care and training of the hospital.</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 It will be decided after collecting data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahime Sabeti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and midwifery School.Rashidyasemi St, Valiasr St,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 214365</telephone>
        <email>sabetifa@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahime Sabeti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery,Rashid Yasemi St.,Valiasr St.,IRAN Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 214365</telephone>
        <email>sabetifa@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mother's understanding and mastery of Persian language
Mother's education  is at reading and writing
The mother has not physical, psychological and cognitive disease
The child has undergone cardiac surgery for the first time
The length of the child's admission is more than 3 days.</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Mother's education is in the medical field
The presence of another child with chronic illness in the family</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q20</hc_code>
      <hc_code>Q21</hc_code>
      <hc_code>Q22</hc_code>
      <hc_code>Q23</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congenital malformations of cardiac chambers and connections</hc_keyword>
      <hc_keyword>Congenital malformations of cardiac septa</hc_keyword>
      <hc_keyword>Congenital malformations of pulmonary and tricuspid valves</hc_keyword>
      <hc_keyword>Congenital malformations of aortic and mitral valves</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group at first, Demographic questionnaire, knowlege of care and quality of life questionnaire were completed before the intervention by mothers. Then, in the first stage of intervention, the education includes 6 sessions of 30 minutes at admission, hospitalized days and discharge time individually and small groups using a booklet for mothers. The educational content includes: explanations of the natural and abnormal heart structure, surgical treatment, physical activity, child   nutrition post-surgery, baby bathing, infection prevention, surgical scar treatment, medication usage, benefits and side effects of medications and Treatment of fever and diarrhea. The second stage of the intervention involves post discharge follow-up.At this stage, the researcher will call with the mothers, one week, two weeks, one month, and two months after the discharge , asking for the child's condition and, if necessary, giving them the necessary education.</i_keyword>
      <i_keyword>Control group: this group completes the relevant questionnaires and receives  only the usual care and training of the hospital.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge of care. Timepoint: Before intervention, Discharge time, 2 month after intervention. Method of measurement: Knowledge of care questionnair.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention ,2 month after intervention. Method of measurement: Quality of life questionnair.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-07</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran1449614535, IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
