<?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>IRCT20260226068953N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-17</date_registration>
      <primary_sponsor>Islamic Azad University, Yazd Branch</primary_sponsor>
      <public_title>Designing and evaluating the impact of the "Simplified Tracheostomy Care Package" on the self-efficacy and performance of nurses working in intensive care units</public_title>
      <acronym></acronym>
      <scientific_title>Designing and evaluating the impact of the "Simplified Tracheostomy Care Package" on the self-efficacy and performance of nurses working in intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: First, all eligible nurses in the intensive care units of Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd are listed by census method.
From among the listed individuals, 70 individuals are selected by simple random method (using a table of random numbers or lottery).
Then, these 70 individuals are divided into two groups: test (intervention) and control
by random assignment method, Blinding description: Blinding will be done in a three-way blind manner. In this way, the participants, researcher, and data analyst will not be aware of the coding and banner division of the control and experimental groups. This means that the nurses will not be aware of the allocation to the control and experimental groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tracheostomy care.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Control group: The intervention is implemented only for the experimental group and includes the following multifaceted strategy:• a) Face-to-face training: Holding small workshops for 45 to 60 minutes in the ward conference room or nursing station. The workshop content includes a brief review of theoretical principles followed by practical exercises on a model or educational equipment based on the "5 Golden Steps of the Care Package".• b) Providing reminder tools:1. Pocket card: Distributing laminated cards in pocket size on which the 5 main actions of the package are printed.2. Wall poster: Installing a graphic and colored poster of the simplified care package algorithm above the heads of tracheostomy patients and in the dirty/clean workroom. C) Immediate feedback: In the first week after training, the researcher will be present in the ward, answer any possible questions, and provide corrective feedback. Intervention 2: Control group: During this period, the control group only received routine ward care and did not receive any educational intervention.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data will be published publicly and confidentially to help advance education.

When:
After completing data analysis

To whom:
Researchers, investigators, and individuals involved in the clinical care of tracheostomy patients.

Conditions:
In order to protect patient privacy and advance scientific insights

Where to obtain:
To the journal that will publish the study results.

How to obtain:
The requester can access the data by obtaining permission from the researcher, protecting patient privacy, and by referring to journals.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir farsiou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 21، 16 Meter Street، 18 Meter Street، Sari Land</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165947663</zip>
        <telephone>+98 41 3545 0897</telephone>
        <email>1490414241@iau.ir</email>
        <affiliation>Islamic Azad University, Yazd Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir farsiou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 21، 16 Meter Street، 18 Meter Street، Sari Land</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165947663</zip>
        <telephone>+98 41 3545 0897</telephone>
        <email>149041241@iau.ir</email>
        <affiliation>Islamic Azad University, Yazd Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In the first stage (closed design): Textual sources and documents that directly address tracheostomy care in adults in special wards are included in the study.
They should be clinical guidelines, standard protocols, or original articles/systematic reviews with a high level of evidence.
Published in Persian or English within the last 5 years (2020 to 2025).
Their full text is available.
Expert Panel: Specialists who: have a PhD or Master's degree in nursing (specialization) or specialization in anesthesia or critical care will be included in the study.
Be a member of the university faculty or have a relevant clinical or educational position.
Have at least 5 years of useful work experience in intensive care and tracheostomy departments.
Willingness to participate and sufficient time to review and rate items.
In the second stage (clinical intervention): Nurses who work in the intensive care units of Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd will be included in the study.
Have a bachelor's degree in nursing or higher.
Have at least 6 months of clinical work experience in the intensive care unit.
Have written informed consent to participate in the research.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Nurses who are on leave.
Nurses who are unwilling 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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Control group: The intervention is implemented only for the experimental group and includes the following multifaceted strategy:• a) Face-to-face training: Holding small workshops for 45 to 60 minutes in the ward conference room or nursing station. The workshop content includes a brief review of theoretical principles followed by practical exercises on a model or educational equipment based on the "5 Golden Steps of the Care Package".• b) Providing reminder tools:1. Pocket card: Distributing laminated cards in pocket size on which the 5 main actions of the package are printed.2. Wall poster: Installing a graphic and colored poster of the simplified care package algorithm above the heads of tracheostomy patients and in the dirty/clean workroom. C) Immediate feedback: In the first week after training, the researcher will be present in the ward, answer any possible questions, and provide corrective feedback.</i_keyword>
      <i_keyword>Control group: During this period, the control group only received routine ward care and did not receive any educational intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy of nurses. Timepoint: Beginning of the study, two weeks after the end of the intervention. Method of measurement: The self-efficacy scale will be the confidence level questionnaire that was used in the study of Onovah's PhD and in the study of Fatema Abdoltaeb.</prim_outcome>
      <prim_outcome>Performance of nurses. Timepoint: Beginning of the study, two weeks after the end of the intervention. Method of measurement: Tracheostomy Care Questionnaire: To assess the performance of nurses, the Tracheostomy Care Questionnaire will be used. This questionnaire was designed by Kashaninia et al. (8) and was derived from the study by Moussazadeh et al. (28).</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>Islamic Azad University, Yazd Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-04-12</approval_date>
        <contact_name>research Ethics committees of islamic azad University - isfahan (khorasgan) branch</contact_name>
        <contact_address>Islamic Azad University of Isfahan Branch (Khorasgan)، Daneshgah Blvd، Arghavanieh، East Jay St. ، Isfahan Khorasgan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
