<?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>IRCT20191225045890N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-19</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the Intensive care unit  liaison nurse's role on patient's outcomes following transition from cardiovascular surgery intensive care unit (ICU - CVS)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the Intensive care unit  liaison nurse's role on patient's outcomes following transition from cardiovascular surgery intensive care unit (ICU - CVS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49383</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>role liaison nurse.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, an explanatory study will be conducted to explain and formulate the role of the liaison nurse in the intensive care unit. To perform intensive care both in the intensive care unit and appropriately and as needed for patients in the internal medicine and surgery wards, ability to communicate with the patient and having educational skills, familiar with the goals of the project and how to perform the role and the importance of the role) Transfer of the patient from the intensive care unit to the general ward will begin and continue until the end of the discharge from the ward. Intervention 2: Control group: The control group receives routine care and training.</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 The data is kept completely confidential by the research team</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>fatemeh keyvanlou shahrestanaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>nirou havaei 8/26 Street . No. 7</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1749663837</zip>
        <telephone>+98 21 7740 7679</telephone>
        <email>fkeyvanlou@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fatemeh keyvanlou shahrestanki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>nirou havaei 8/26 Street . No. 7</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1749663837</zip>
        <telephone>+98 21 7740 7679</telephone>
        <email>fkeyvanlou@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to understand and speak Persian
Transfer to the ward according to the routine section
Over 18 years of age
Lack of disease or disability
Be aware of place and time and person.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of cooperation in the study
Transfer from the intensive care unit to cardiac surgery to other intensive care units
The occurrence of any unforeseen events that lead to the patient's return, such as (َdis Rhythmi or hemodynamic abnormalities)</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, an explanatory study will be conducted to explain and formulate the role of the liaison nurse in the intensive care unit. To perform intensive care both in the intensive care unit and appropriately and as needed for patients in the internal medicine and surgery wards, ability to communicate with the patient and having educational skills, familiar with the goals of the project and how to perform the role and the importance of the role) Transfer of the patient from the intensive care unit to the general ward will begin and continue until the end of the discharge from the ward</i_keyword>
      <i_keyword>Control group: The control group receives routine care and training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hospital Anxiety and Depression. Timepoint: When transferring a patient from the intensive care unit and when discharging from the hospital. Method of measurement: Use of Hospital Anxiety Depression scale Questionnaire.</prim_outcome>
      <prim_outcome>Patient satisfaction. Timepoint: When transferring the patient from the intensive care unit to the general ward and when discharging the patient from the hospital. Method of measurement: Using a standard questionnaire of patient satisfaction  Instrument.</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: From the initial hospitalization of the patient in the intensive care unit until the end of discharge from the hospital. Method of measurement: the number of days of hospitalization.</prim_outcome>
      <prim_outcome>Readmission. Timepoint: Within 14 days after discharge from the hospital. Method of measurement: Telephone contact with the patient and hospital admission.</prim_outcome>
      <prim_outcome>Blood retention syndrome (pericardial and pleural effusion). Timepoint: Before transferring the patient from the intensive care unit to the general ward and the day before the patient is discharged. Method of measurement: With chest x-ray and echocardiography.</prim_outcome>
      <prim_outcome>Atelectasis. Timepoint: Before transferring the patient from the intensive care unit to the general ward and the day before the patient is discharged. Method of measurement: With chest x-ray and echocardiography.</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>School of Nursing, Baqiyatallah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-16</approval_date>
        <contact_name>Ethics committee of Baqiyatallah University  of medical sciences</contact_name>
        <contact_address>No. 7/Nirou havaei St.8/26 tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
