<?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>IRCT20101113005163N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-03</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Assessing the Effects of Implementation of Comfort Caring Model on Distress, Pain, and Hemodynamic Parameters of  Children with Congenital Heart Disease Following the Cardiac Surgery</public_title>
      <acronym>-</acronym>
      <scientific_title>Assessing the Effects of Implementation of Comfort Caring Model on Distress, Pain, and Hemodynamic Parameters of  Children with Congenital Heart Disease Following the Cardiac Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5513</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: -, Randomization description: In this research, random blocking sampling method is used. The researcher selects his samples from eligible children at a specified time interval. Assignment of samples is done in two experimental and control groups by random method and the completion of the samples is continued.
 Block random sampling is a randomized method that ensures that at each point in a research, roughly equal numbers of participants are assigned to all the comparison groups. To randomly assign samples to test groups and Random blocking control is the best method and it is possible to achieve the same number of samples in groups in sequential or sequential sampling at any time point of the study. The number of blocks based on the sample size determined according to the pilot study .</study_design>
      <phase>N/A</phase>
      <hc_freetext>Check distress, pain and hemodynamic parameters in children with congenital heart defects after open heart surgery.</hc_freetext>
      <i_freetext>Intervention 1: 1) Intervention group: The intervention in this group is the implementation of a nursing care program based on the nursing theory of comfort. Nurses carry out three levels of interventions for the care of children in the intervention group after surgery based on comfort theory. These three levels include  relief, ease and transcendence in four aspects of physical, psycho spiritual, socio-cultural and environmental care. Interventions in the physical aspect include the establishment and maintenance of homeostasis in the body, maintaining water and electrolyte balance, oxygenation, temperature adjustment, heart rhythm monitoring, gastrointestinal stability, nervous system, respiratory system, circulation system Blood and disfiguring system. Another aspect of care is the psycho spiritual dimension, nursing care is touching, encouraging words, special appointments, and self-esteem strategies. The third dimension  is the socio-cultural dimension, which includes support, attention to cultural sensitivities, the use of body language in the proper manner, and the care that is being taken to achieve it, including providing appropriate information about procedures, family presence And donations, respect for cultural traditions. The last one is the environmental dimension including silence, order, security, light and ambient control, ambient temperature control, avoidance of falling sleep rhythm and awakening and control of odor. Intervention 2: Control group: The control group will usual receive post-operative care. Regular care will be performed based on internal policies and care protocols related to nursing care after surgery for pediatric cardiopulmonary abnormalities.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no program for publishing participant data file.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akramsadat Sadat Hosieni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Nosrat St,Tohid Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4423</telephone>
        <email>ashoseini@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akramsadat Sadat Hosieni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ّFaculty of Nursing and Midwifery, Noshahr St, Tohid Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4423</telephone>
        <email>ashoseini@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>child with cardiac abnormalities Parental satisfaction for participate in the study after undergo open heart surgery
Lack of chromosomal abnormalities and mental retardation
Non-treatment with neuromuscular blockers drugs
Age of the child: from 28 days until the end of two years
having no history of previous hospitalization and performing surgery for the first time
having a CV line
Connection to the mechanical ventilation device at the time of admission and separation within the first 24 hours after surgery</inclusion_criteria>
      <agemin>28 days</agemin>
      <agemax>2 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Death of a child
Dissatisfied parents to continue implementing a care method based on the comfort theory
Incidence of unpredictable effects after surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acyanotic and cyanotic congenital heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1) Intervention group: The intervention in this group is the implementation of a nursing care program based on the nursing theory of comfort. Nurses carry out three levels of interventions for the care of children in the intervention group after surgery based on comfort theory. These three levels include  relief, ease and transcendence in four aspects of physical, psycho spiritual, socio-cultural and environmental care. Interventions in the physical aspect include the establishment and maintenance of homeostasis in the body, maintaining water and electrolyte balance, oxygenation, temperature adjustment, heart rhythm monitoring, gastrointestinal stability, nervous system, respiratory system, circulation system Blood and disfiguring system. Another aspect of care is the psycho spiritual dimension, nursing care is touching, encouraging words, special appointments, and self-esteem strategies. The third dimension  is the socio-cultural dimension, which includes support, attention to cultural sensitivities, the use of body language in the proper manner, and the care that is being taken to achieve it, including providing appropriate information about procedures, family presence And donations, respect for cultural traditions. The last one is the environmental dimension including silence, order, security, light and ambient control, ambient temperature control, avoidance of falling sleep rhythm and awakening and control of odor.</i_keyword>
      <i_keyword>Control group: The control group will usual receive post-operative care. Regular care will be performed based on internal policies and care protocols related to nursing care after surgery for pediatric cardiopulmonary abnormalities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Distress. Timepoint: On arrival, 24, 48, 72 hours after surgery and entering  to PICU. Method of measurement: comfort behavior scale.</prim_outcome>
      <prim_outcome>Pain. Timepoint: On arrival, 24, 48, 72 hours after surgery and entering  to PICU. Method of measurement: comfort behavior scale.</prim_outcome>
      <prim_outcome>Hemodynamic parameters. Timepoint: On arrival, 24, 48, 72 hours after surgery and entering  to PICU. Method of measurement: comfort behavior 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-04</approval_date>
        <contact_name>The Ethics Committee of the Research Committee of Midwifery Faculty, Tehran University of Medical Sc</contact_name>
        <contact_address>Nosrat St,Tohid Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
