<?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>IRCT20240212060983N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-23</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of multiple nursing interventions on ischemic stroke-related pneumonia</public_title>
      <acronym>SAP</acronym>
      <scientific_title>The Effect of Multiple Nursing Interventions on the Incidence of Stroke Associated Pneumonia in Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76536</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: In this study, patients are divided into two control and intervention groups based on the random assignment of quadruple blocks; Regarding the equal placement of the samples in the two control and intervention groups, a limited randomization method called blocking was used. This method helps this study so that in cases where intermediate analyzes are needed during the sampling process, the number of samples allocated to each of the studied groups is equal. In this study, the size of all blocks is equal. In this study, online randomization was used to generate random sequences. The decision to accept or reject participation in the study is made first and the informed consent form is completed, and then the participants are randomly assigned to each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ischemic stroke.</hc_freetext>
      <i_freetext>Intervention 1: In order to collect the necessary data for the study, three tools and a checklist will be used; With the help of these tools and checklist, patients' conditions are accurately evaluated and then based on the results, appropriate nursing care is provided for each patient's condition. Tool number one (GUSS) consists of two tests; The test starts with swallowing saliva and then continues with swallowing semi-solid, liquid and solid tissues respectively. Instrument number two (IDDSI) consists of two components: food and beverage component; The nutritional strategy will be chosen by the nurse based on the severity of dysphagia, for example, in moderate dysphagia, feeding will be through a nasogastric tube and the use of pureed food, and in severe dysphagia, the patient will be given fasting and supplements through a nasogastric tube. will be. Oral care will be done using a ten-step checklist. In this study, nursing interventions to affect the occurrence of pneumonia related to ischemic stroke will include the examination of the severity of dysphagia, strategies related to diet and oral care methods in this group of patients after a detailed evaluation of the parameters of the tools and the above checklist. After the implementation of the mentioned care package, in this study, in order to evaluate stroke-related pneumonia, the developed symptoms include the presence or absence of fever, cough and white blood cells equal to and greater than 10x109 per liter or white blood cells equal to and smaller than 4 x 109 per liter and the final diagnosis of the neurologist will be examined by the stroke-related pneumonia tool and finally the occurrence of SAP will be announced by him. Intervention 2: Control group: will receive routine ward care for four consecutive days.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asma Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Mazari 19, Mazari Mazari Boulevard</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817747843</zip>
        <telephone>+98 54 3344 0566</telephone>
        <email>nrsasma1155@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Esmaeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Mirkhani Ave. (East Nosrat), Tohid Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>mesmaeilie77@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Detecting confirmation of ischemic stroke by a specialist physician
Moderate or intense dysphagia (in accordance with the GUSS tool score 0-14)
Age older than 18
24 hours after the onset of ischemic stroke symptoms
NIHSS score above 3
Direct acceptance of the patient from the emergency department or the patient's direct referral to the doctor's office and then referred to the department</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of pneumonia before hospitalization
Patients with liver and kidney failure
Infectious patients
Patients in need of specialized oral care and evaluation
Allergy to chlorhexidine
Oral surgery
Gum diseases
Infectious diseases of the mouth
Patients with immunosuppression
Having any malignancy
Lack of consent to participate in the study</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>In order to collect the necessary data for the study, three tools and a checklist will be used; With the help of these tools and checklist, patients' conditions are accurately evaluated and then based on the results, appropriate nursing care is provided for each patient's condition. Tool number one (GUSS) consists of two tests; The test starts with swallowing saliva and then continues with swallowing semi-solid, liquid and solid tissues respectively. Instrument number two (IDDSI) consists of two components: food and beverage component; The nutritional strategy will be chosen by the nurse based on the severity of dysphagia, for example, in moderate dysphagia, feeding will be through a nasogastric tube and the use of pureed food, and in severe dysphagia, the patient will be given fasting and supplements through a nasogastric tube. will be. Oral care will be done using a ten-step checklist. In this study, nursing interventions to affect the occurrence of pneumonia related to ischemic stroke will include the examination of the severity of dysphagia, strategies related to diet and oral care methods in this group of patients after a detailed evaluation of the parameters of the tools and the above checklist. After the implementation of the mentioned care package, in this study, in order to evaluate stroke-related pneumonia, the developed symptoms include the presence or absence of fever, cough and white blood cells equal to and greater than 10x109 per liter or white blood cells equal to and smaller than 4 x 109 per liter and the final diagnosis of the neurologist will be examined by the stroke-related pneumonia tool and finally the occurrence of SAP will be announced by him.</i_keyword>
      <i_keyword>Control group: will receive routine ward care for four consecutive days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stroke-related pneumonia. Timepoint: Before the implementation of the intervention and then 4 days after the end of the intervention. Method of measurement: Ischemic stroke-related pneumonia instrument.</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>2024-01-30</approval_date>
        <contact_name>Joint Organizational Ethics Committee of Nursing and Midwifery Faculty and Rehabilitation Faculty of</contact_name>
        <contact_address>No.4, Mazari 19, Mazari Boulevard Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
