<?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>IRCT20230126057239N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-11</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The Effect Of Using Evidence-Based Care Package in brain trauma</public_title>
      <acronym></acronym>
      <scientific_title>Comparing The Effectiveness of Using Evidence-Based Care Packages By Emergency Nurses On on The Hemodynamic Status of Brain Trauma Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68277</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: First, the demographic information questionnaire is completed by the nurses of both groups in the first meeting, and then the quality of the emergency nurse's usual care of patients with moderate to severe brain trauma and the hemodynamic status of these patients, through the management checklist of patients with moderate to severe head trauma. It is completed by the researcher and the researcher's colleague through monitoring the hemodynamic status of the patients and also reviewing the documentation of their files, during the work shifts of these nurses for 3 patients with moderate to severe head trauma.After completing the checklist in the first stage, these nurses will be trained in the management of moderate to severe brain trauma patients based on the evidence-based care package, through 4 2-hour training workshops (during 2 weeks); After the end of the intervention, for each nurse to implement the instructions on 3 patients by monitoring the patient's hemodynamic status for a period of eight weeks, it is again evaluated by the same initial checklist and the average of the patient's hemodynamic status is determined. Finally, the hemodynamic status of the patients before and after the intervention will be compared and analyzed, Randomization description: In order to carry out this research, multi-stage sampling will be done. First, the selection of trauma centers is done by random cluster method, in this way, Tehran is divided into four parts (clusters) North, South, East and West, and one hospital with a trauma center is selected from each region. And then in these centers, 60 nurses will be selected by quota sampling method, in such a way that the selection is improbable and among the people in the available units, but it will be proportional to the number of nurses working in the selected hospitals. Then the allocation of nurse samples to groups will be done randomly and based on lottery. To select patients with moderate to severe trauma, through available sampling during 8 weeks during the work shifts of these nurses, 3 patients who meet the criteria for entering the research are selected and included in the study. To prevent leakage of information between the two groups, first the control group and then the intervention group are examined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Brain Trauma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:60 nurses are randomly selected and placed in two control and intervention groups. In the intervention group, firstly, the effect of the performance of 30 nurses on the hemodynamic status of brain trauma patients is investigated using the brain trauma patients management checklist for a period of 8 weeks. 3 patients are evaluated for each nurse; Then they are trained in the management of brain trauma patients based on the evidence-based care package, through 4 two-hour training workshops; And within eight weeks after the end of the sessions, their performance in the field of caring for these patients will be evaluated again by the same checklist. The results of two tests of the control group and the results of two tests of the intervention group are also compared. Also, the results of the control and intervention groups will be compared. Intervention 2: Control group: There was no intervention in the control group, and the effect of the performance of 30 nurses in the control group on the hemodynamic status of brain trauma patients was investigated using the brain trauma patients management checklist. 3 patients are evaluated for each nurse. Again, 8 weeks later, the effect of the performance of 30 nurses in the control group on the hemodynamic status of brain trauma patients will be evaluated by the same checklist.</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 The publication program is the publication of the article extracted from the thesis.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>shiva yousefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 33, Panzdeh East Alley, Shahid Sadoqi Street, Yas Blvd., Tehran, Sar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1388973586</zip>
        <telephone>+98 21 4454 7203</telephone>
        <email>shivayousefi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyedeh Narjes Mousavizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 33, Panzdeh East Alley, Shahid Sadoqi Street, Yas Blvd., Tehran, Sar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1388973586</zip>
        <telephone>+98 21 4454 7203</telephone>
        <email>n.mousavi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>For nurses, having at least a bachelor's degree and at least 6 months of continuous clinical work experience in the emergency department of the hospital
For patients, the presence of moderate to severe head trauma based on the GCS criterion and the diagnosis of the attending physician</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>for nurses, participating in research or similar training courses, simultaneously with the present study; transfer to another department, transfer to other medical centers, sick leave, immigration; Absence in more than 2 training sessions and not being able to make up for the sessions
For patients, death or transfer to departments other than trauma emergency before completion of checklists</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:60 nurses are randomly selected and placed in two control and intervention groups. In the intervention group, firstly, the effect of the performance of 30 nurses on the hemodynamic status of brain trauma patients is investigated using the brain trauma patients management checklist for a period of 8 weeks. 3 patients are evaluated for each nurse; Then they are trained in the management of brain trauma patients based on the evidence-based care package, through 4 two-hour training workshops; And within eight weeks after the end of the sessions, their performance in the field of caring for these patients will be evaluated again by the same checklist. The results of two tests of the control group and the results of two tests of the intervention group are also compared. Also, the results of the control and intervention groups will be compared.</i_keyword>
      <i_keyword>Control group: There was no intervention in the control group, and the effect of the performance of 30 nurses in the control group on the hemodynamic status of brain trauma patients was investigated using the brain trauma patients management checklist. 3 patients are evaluated for each nurse. Again, 8 weeks later, the effect of the performance of 30 nurses in the control group on the hemodynamic status of brain trauma patients will be evaluated by the same checklist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemodynamic Status of Brain Trauma Patients. Timepoint: 8 weeks. Method of measurement: Care management checklist for brain trauma patients.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-15</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti School of Midwifery Nursing</contact_name>
        <contact_address>No. 33, Panzdeh East Alley, Shahid Sadoqi Street, Yas Blvd., Tehran, Sar Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
