<?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>IRCT20250421065433N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-13</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of two methods: smartphone-based software and role-playing for teaching neonatal resuscitation program on self-efficacy, knowledge, and clinical skills of undergraduate nursing students</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of two methods of smartphone-based software and role-playing for teaching neonatal resuscitation program on self-efficacy, knowledge and clinical skills of undergraduate nursing students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83157</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Eligible samples will be placed into intervention and control groups using cluster randomization, Blinding description: In this study, participants, as well as data collectors and data analysts, will be kept blind to the study groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Undergraduate Nursing Students.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Smartphone-based software                                         for the test group Smartphone-based software, training in the neonatal resuscitation program under Android, will be installed. This software will be available to the test group for one month and will be locked after one month. The educational software will be installed on the students' phones in a one-hour session and they will be trained on how to use it. Web programmer engineers and graphic designers will be used to design the background and icons to prepare the educational software. The content of the educational program will be created based on the 2021 American Heart Association guidelines, which will consist of 4 main sections: introducing the software, listing, introducing educational resources, and exiting the program. In order to prevent information contamination and the lack of access to the software by the role-playing and control intervention groups and other students until the end of the study, it will be foreseen for the software password that each virtual user who has a defined password for himself can use to log in and install the software. A management software will also be used to track the number of times the software is logged in, which will display the usage of each user. For the scientific validity of the software, the opinions of 3 faculty members who are experts in the fields of neonatal intensive care, neonatal resuscitation program, and smartphone-based software design will be used. After collecting expert opinions, the necessary corrections will be made. Intervention 2: Intervention Group Role-Playing Intervention: After receiving the usual training using PowerPoint and film, the students in the role-playing intervention group will be presented with a resuscitation scenario. Based on the scenario, each student will be assigned a specific role in the resuscitation team, such as team leader, massage therapist, airway management, or medication administration. The students will then form groups of four and, under the supervision of a project partner (with a master's degree in neonatology and 12 years of experience in working and teaching in the field of neonatology), will actively participate in performing a real resuscitation scene and apply their knowledge and skills in a simulated real world. Intervention 3: Control group: Students in the control group will only receive the standard neonatal resuscitation program training, which is delivered through lectures using PowerPoint and video presentations.</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 No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Eshghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Entrance to Namazi Hospital, Namazi Square,  Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹ - ۷۱۹۳۶</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>eshghifateme@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Eshghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Entrance to Namazi Hospital, Namazi Square,Shiraz,</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹ - ۷۱۹۳۶</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>eshghifateme@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having an Android phone
Willingness to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participate in another neonatal resuscitation program educational study during the duration of this research.</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>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Smartphone-based software                                         for the test group Smartphone-based software, training in the neonatal resuscitation program under Android, will be installed. This software will be available to the test group for one month and will be locked after one month. The educational software will be installed on the students' phones in a one-hour session and they will be trained on how to use it. Web programmer engineers and graphic designers will be used to design the background and icons to prepare the educational software. The content of the educational program will be created based on the 2021 American Heart Association guidelines, which will consist of 4 main sections: introducing the software, listing, introducing educational resources, and exiting the program. In order to prevent information contamination and the lack of access to the software by the role-playing and control intervention groups and other students until the end of the study, it will be foreseen for the software password that each virtual user who has a defined password for himself can use to log in and install the software. A management software will also be used to track the number of times the software is logged in, which will display the usage of each user. For the scientific validity of the software, the opinions of 3 faculty members who are experts in the fields of neonatal intensive care, neonatal resuscitation program, and smartphone-based software design will be used. After collecting expert opinions, the necessary corrections will be made.</i_keyword>
      <i_keyword>Intervention Group Role-Playing Intervention: After receiving the usual training using PowerPoint and film, the students in the role-playing intervention group will be presented with a resuscitation scenario. Based on the scenario, each student will be assigned a specific role in the resuscitation team, such as team leader, massage therapist, airway management, or medication administration. The students will then form groups of four and, under the supervision of a project partner (with a master's degree in neonatology and 12 years of experience in working and teaching in the field of neonatology), will actively participate in performing a real resuscitation scene and apply their knowledge and skills in a simulated real world.</i_keyword>
      <i_keyword>Control group: Students in the control group will only receive the standard neonatal resuscitation program training, which is delivered through lectures using PowerPoint and video presentations.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy score. Timepoint: Before the intervention, after the intervention and one month later. Method of measurement: The Resuscitation Self-efficacy Scale will be used.</prim_outcome>
      <prim_outcome>Knowledge score. Timepoint: Before the intervention, after the intervention and one month later. Method of measurement: It will consist of 30 multiple choice questions (MCQs) based on the steps of the neonatal resuscitation program that will assess knowledge of neonatal resuscitation.</prim_outcome>
      <prim_outcome>Clinical skill score. Timepoint: Before the intervention, after the intervention and one month later. Method of measurement: The OSCE Neonatal Resuscitation Checklist and Neonatal Resuscitation Scenario will be used to assess clinical skills.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-05</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Opposite Palestine Street, Zand Street, Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
