xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000878</url>
    </required_header>
    <id_info>
      <org_study_id>KMUHIRB-SV(I)-20210025</org_study_id>
      <nct_id>NCT06000878</nct_id>
    </id_info>
    <brief_title>Evaluate the Effectiveness of First Aid E-book Intervention Among New Nurses</brief_title>
    <official_title>Evaluate the Effectiveness of First Aid E-book Intervention on First Aid Knowledge, Self-efficacy, and Skills Among New Nurses</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: First aid skills are clinical performance ability requiring a higher level of&#xD;
        skills for new nurses. At present, the focus of first aid-related teaching materials and&#xD;
        methods remain on books and physical courses. E-books have not yet been applied to first aid&#xD;
        skills training for new nurses despite their advantage of making reading, learning, and&#xD;
        reviewing available at any time.&#xD;
  &#xD;
        Objective: To assess the effect of receiving interactive first aid e-book interventions on&#xD;
        new nurses in a medical center in southern Taiwan in respect of first aid knowledge,&#xD;
        self-efficacy, and first aid skills.&#xD;
  &#xD;
        Methods: A two-group three-time repeated measures experimental design was adopted. 70&#xD;
        qualified new nurses were randomly assigned to the experimental group and the control group,&#xD;
        each composed of 35 nurses. The experimental group received a one-hour e-book course plus one&#xD;
        month of first aid e-book intervention and regular training, whereas the control group only&#xD;
        received one month of regular training. Performance indicators included administering the&#xD;
        objective structured clinical examination (OSCE) on first aid skills, and questionnaires for&#xD;
        knowledge and self-efficacy related to first aid skills. The experimental group received&#xD;
        qualitative interviews and filled out the system usability scale one month after the&#xD;
        intervention. Data were analyzed using the independent samples t-test, chi-squared test,&#xD;
        paired samples t-test, and generalized estimating equations (GEE).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Introduction Paramedics are the first-line medical personnel on the emergency scene and&#xD;
             can help in effectively treating the medical condition in the first few minutes. For&#xD;
             instance, Cardiopulmonary resuscitation (CPR) can improve the chances of survival of&#xD;
             cardiac arrest patients (Partiprajak &amp; Thongpo, 2016 ; P. Y. Hsieh et al., 2021). CPR is&#xD;
             an attempt to restore spontaneous circulation through chest compressions when the&#xD;
             patient is not breathing and the heart is beating (Suseel et al., 2019). Crucially, the&#xD;
             ability to perform effective CPR immediately requires repeated first aid training (Roh &amp;&#xD;
             Issenberg, 2014 ; Moon &amp; Hyun, 2019). However, among clinical skills, new nurses find it&#xD;
             most difficult to perform CPR (Liou et al., 2020). If new recruits lack professional&#xD;
             training or confidence in their abilities, the quality of first aid provided by them may&#xD;
             be affected (Ihunanya et al., 2020). Therefore, it is imperative to implement a&#xD;
             well-designed training program that effectively equips clinical nurses with the&#xD;
             necessary first aid knowledge and skills. (P. Y. Hsieh et al., 2021).&#xD;
  &#xD;
          2. Method 2.1 Design and participants This study used an experimental two-group pre- and&#xD;
             post-test design. Three repeated measures were taken: pre-test (T0), immediate post-test&#xD;
             (T1), and one-month post-test (T2). The one-month post-test was used to detect new&#xD;
             nursing care personnel's retention of first aid knowledge, self-efficacy, and first aid&#xD;
             skills. G power 3.1.9.2 version was used to estimate the number of samples using&#xD;
             repeated measures ANOVA. The effect size was set to 0.3 (Kotrlik &amp; Williams, 2003),&#xD;
             alpha value was set to 0.05, detection power was 0.8, and correlation value was 0.5. The&#xD;
             measurement was repeated thrice. As such, the total number of samples required should be&#xD;
             62 bits. Considering an estimated attrition rate of 10% or 7 people, the total number of&#xD;
             cases accepted was 70. The main investigator explained the purpose and process of the&#xD;
             study to the new nurses in each ward and invited them to participate in the study. Data&#xD;
             was collected between August 2021 and October 2021. The sample inclusion criteria were&#xD;
             that participants were newly recruited nurses within two years with a basic first aid&#xD;
             BLS certificate. Meanwhile, those who were unable to perform CPR due to hand injuries&#xD;
             were excluded. A computer was used to randomly assign the 70 eligible new nurses in the&#xD;
             medical center to the experimental and control groups, with 35 each.&#xD;
  &#xD;
        2.2 Study protocol The experimental group took a one-hour e-book course plus one month of&#xD;
        first aid e-book intervention and routine training, whereas the control group received only&#xD;
        one month of routine training. Effectiveness indicators were measured at pre-test (T0),&#xD;
        immediate post-test (T1), and one-month post-test (T2). In order to assess the effectiveness&#xD;
        of the first aid e-book intervention, the first aid skill Objective Structured Clinical&#xD;
        Examination (OSCE) evaluation form was utilized alongside self-efficacy questionnaires for&#xD;
        first aid knowledge and first aid ability. This comprehensive approach aimed to evaluate the&#xD;
        effectiveness of the intervention.&#xD;
  &#xD;
        2.3 Research tool The research tools included the basic demographic data sheet, first aid&#xD;
        knowledge questionnaire, first aid self-efficacy scale, first aid skills OSCE evaluation&#xD;
        form, and system usability scale (SUS).&#xD;
  &#xD;
        2.3.1 Demographic basic data sheet The demographic basic data sheet was exclusively utilized&#xD;
        during the pre-test (T0) phase. It encompassed details such as gender, age, education level,&#xD;
        clinical experience, previous participation in first aid training courses, and the number of&#xD;
        times the participants had engaged in first aid activities.&#xD;
  &#xD;
        2.3.2 First aid knowledge questionnaire The first aid knowledge questionnaire was based on&#xD;
        the 2020 American Heart Association First Aid Guidelines Update (Cummins &amp; Hazinski, 2020),&#xD;
        and American Heart Association Cardiopulmonary Resuscitation and Cardiovascular Emergency&#xD;
        Guidelines (Craig-Brangan &amp; Day, 2020). The questionnaire included five items with a total of&#xD;
        20 questions to test the new nurses' concept and understanding of first aid: first aid&#xD;
        assessment and initial treatment (four questions), maintenance of airway and circulation&#xD;
        (four questions), interpretation and treatment of abnormal heart rhythm (five questions),&#xD;
        teamwork and abnormal handling (six questions), and communication and coordination with the&#xD;
        patient's family members (one question). Each question is 5 points and measured on a&#xD;
        five-point scale, with the total score being 0 to 100 points for 20 questions. The higher the&#xD;
        score, the better was the awareness of first aid. The self-made first aid knowledge&#xD;
        questionnaire, assessed by three experts, demonstrated a Content Validity Index (CVI) of&#xD;
        0.93, indicating a high level of content validity. The Cronbach's α value of the internal&#xD;
        consistency reliability of the scale was 0.713, indicating an acceptable level of internal&#xD;
        consistency.&#xD;
  &#xD;
        2.3.3 First aid self-efficacy scale This study modified the &quot;Self-efficacy Scale of First Aid&#xD;
        Ability for Nurses&quot; developed by Xie et al. (2014) to measure the self-efficacy of first aid&#xD;
        ability assessed by new nurses themselves (Xie et al., 2014). The self-efficacy scale has six&#xD;
        items with a total of 30 questions: maintenance of the respiratory tract and circulation&#xD;
        (seven questions), teamwork and abnormal handling (twelve questions), communication and&#xD;
        coordination between patients and their families (three questions), and abnormal heart rhythm&#xD;
        interpretation and treatment (three questions), first aid assessment and initial treatment&#xD;
        (four questions), demonstration of nursing first aid role and function (one question). Each&#xD;
        question was answered on a five-point Likert Scale, with a total score ranging between 30-150&#xD;
        points; the higher the score, the higher the confidence level. The modified first aid&#xD;
        self-efficacy scale demonstrated a content-related validity CVI value of 0.94, indicating&#xD;
        strong expert agreement on the content relevance. Furthermore, the internal consistency&#xD;
        reliability of the scale, measured by Cronbach's α value, was 0.964, signifying excellent&#xD;
        internal consistency.&#xD;
  &#xD;
        2.3.4 First aid skills OSCE A modified first aid skill measurement OSCE based on Li Huizhen&#xD;
        et al. (2016) OSCE was used (Li Huizhen et al., 2016). A standardized clinical scenario was&#xD;
        employed, and the examiner provided prompts during the test to assess the participants' first&#xD;
        aid skills. The test was divided into three dimensions, with a total of 30 questions. The&#xD;
        first dimension was pre-emergency assessment, performing cardiac compressions, and first aid&#xD;
        balls (9 questions). The second dimension was the use of electric shock device and electric&#xD;
        shock, and placing the endotracheal tube to confirm the position and fix it (11 questions).&#xD;
        The third dimension was communication and coordination between first aid administration, and&#xD;
        patient's family members (10 questions). The test time was 15 min, and each question was&#xD;
        scored on five points. The total score on this scale ranges from 0 to 150 points. The higher&#xD;
        the score, the better the first aid skill. Here, the CVI value of the OSCE evaluation form&#xD;
        was 0.97 and Cronbach's α value of the internal consistency reliability of the scale was&#xD;
        0.964, indicating strong the expert content-related validity and excellent internal&#xD;
        consistency .&#xD;
  &#xD;
        2.3.5 First aid e-book The interactive first aid e-book was produced by SimMAGIC eBook, an&#xD;
        interactive multimedia e-book editing software developed by Hama Star Technology. The&#xD;
        interactive functions of the e-book included clicking, covering, dragging, scratching,&#xD;
        linking, preset questions, and timely feedback. For each first aid concept, we provided&#xD;
        multimedia learning materials, such as pictures and video explanations. Individuals can click&#xD;
        &quot;Play&quot; and watch videos. The content of the e-book includes basic first aid knowledge and&#xD;
        first aid drug knowledge, basic cardiopulmonary resuscitation first aid skills, assisting&#xD;
        intubation, electric shock device operation video, how to perform team first aid practical&#xD;
        operation teaching video, and interpretation and treatment of fatal arrhythmia. At the end,&#xD;
        we designed some first aid concept knowledge about self-assessment, with interactive&#xD;
        operation questions and answers to increase learning interest and enhance learning&#xD;
        motivation. Then, we uploaded the e-book to the website and linked the URL into a QR code so&#xD;
        that new nursing staff could use mobile phones, tablets, or computers to learn.&#xD;
  &#xD;
        2.3.6 System usability scale (SUS) John Brooke constructed the SUS in 1986. SUS has been used&#xD;
        to measure various products, system interfaces, and services, including websites, mobile&#xD;
        phones, and applications. It has 10 items which are measured on a five-point Likert scale&#xD;
        from 1 = strongly disagree to 5 = strongly agree. Questions 1, 3, 5, 7, and 9 were positive&#xD;
        questions, and questions 2, 4, 6, 8, and 10 were negative questions. The calculation method&#xD;
        was as follows: subtract 1 from the score of the positive question, subtract the score of&#xD;
        each question from 5 for the negative question, add up the scores of all questions, and&#xD;
        multiply by 2.5 to get the average score of system usability (Wang et al., 2020). The SUS&#xD;
        score was divided into six grades to represent the overall usability of the product: 90-100&#xD;
        were labelled A grade, representing super easy to use (best imaginable); 80-89 were labelled&#xD;
        B grade, representing excellent use (excellent); 70-79 were labelled C Grade, representing&#xD;
        good (good), grades 60-69 represent D-grades (ok), and grades 0-59 represent F-grades (poor)&#xD;
        (Bangor, 2009). The CVI value of the expert content-related validity of the modified system&#xD;
        usability scale is 0.90.&#xD;
  &#xD;
        2.3.7 Qualitative interview Finally, interviews were conducted with participants in a&#xD;
        confidential discussion room. The interviews were recorded and the content was kept&#xD;
        confidential to ensure the reliability and authenticity of the data collection. Six new&#xD;
        nurses were interviewed, who had become nurses in the past two years and had just completed&#xD;
        the second post-test of the e-book intervention. The outline of the interview was structured&#xD;
        on the following questions: 1. How helpful do you think the first aid e-book is? 2. What&#xD;
        devices do you use to read e-books? 3. What do you think about the first aid e-book compared&#xD;
        with other BLS courses? Which one do you prefer? Why? This study adopted the data analysis&#xD;
        method of Colaizzi (1978). Specifically, We performed a systematic analysis, induction, and&#xD;
        translation, categorizing the shared characteristics of these meanings into distinct themes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 19, 2021</start_date>
    <completion_date type="Actual">January 21, 2022</completion_date>
    <primary_completion_date type="Actual">January 21, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>First Aid Knowledge Questionnaire</measure>
      <time_frame>pre-test, immediate post-test, and one-month post-test</time_frame>
      <description>The first aid knowledge questionnaire was based on the 2020 American Heart Association First Aid Guidelines Update (Cummins &amp; Hazinski, 2020), and American Heart Association Cardiopulmonary Resuscitation and Cardiovascular Emergency Guidelines (Craig-Brangan &amp; Day, 2020). The questionnaire included five items with a total of 20 questions to test the new nurses' concept and understanding of first aid: first aid assessment and initial treatment (four questions), maintenance of airway and circulation (four questions), interpretation and treatment of abnormal heart rhythm (five questions), teamwork and abnormal handling (six questions), and communication and coordination with the patient's family members (one question). Each question is 5 points and measured on a five-point scale, with the total score being 0 to 100 points for 20 questions. The higher the score, the better was the awareness of first aid.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>First Aid Self-Efficacy Scale</measure>
      <time_frame>pre-test, immediate post-test, and one-month post-test</time_frame>
      <description>This study modified the &quot;Self-efficacy Scale of First Aid Ability for Nurses&quot; developed by Xie et al. (2014) to measure the self-efficacy of first aid ability assessed by new nurses themselves (Xie et al., 2014). The self-efficacy scale has six items with a total of 30 questions: maintenance of the respiratory tract and circulation (seven questions), teamwork and abnormal handling (twelve questions), communication and coordination between patients and their families (three questions), and abnormal heart rhythm interpretation and treatment (three questions), first aid assessment and initial treatment (four questions), demonstration of nursing first aid role and function (one question). Each question was answered on a five-point Likert Scale, with a total score ranging between 30-150 points; the higher the score, the higher the confidence level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>First aid skills OSCE</measure>
      <time_frame>pre-test, immediate post-test, and one-month post-test</time_frame>
      <description>A modified first aid skill measurement OSCE based on Li Huizhen et al. (2016) OSCE was used (Li Huizhen et al., 2016). A standardized clinical scenario was employed, and the examiner provided prompts during the test to assess the participants' first aid skills. The test was divided into three dimensions, with a total of 30 questions. The first dimension was pre-emergency assessment, performing cardiac compressions, and first aid balls (9 questions). The second dimension was the use of electric shock device and electric shock, and placing the endotracheal tube to confirm the position and fix it (11 questions). The third dimension was communication and coordination between first aid administration, and patient's family members (10 questions). The test time was 15 min, and each question was scored on five points. The total score on this scale ranges from 0 to 150 points. The higher the score, the better the first aid skill.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>System usability scale (SUS)</measure>
      <time_frame>one-month post-test</time_frame>
      <description>SUS has been used to measure various products, including websites, mobile phones, and applications (John Brooke, 1986). It has 10 items which are measured on a five-point Likert scale from 1 to 5. Questions 1, 3, 5, 7, and 9 were positive questions, and questions 2, 4, 6, 8, and 10 were negative questions. The calculation method was as follows: subtract 1 from the score of the positive question, subtract the score of each question from 5 for the negative question, add up the scores of all questions, and multiply by 2.5 to get the average score of system usability (Wang et al., 2020). The SUS score was divided into six grades to represent the overall usability of the product: 90-100 were labelled A grade, representing super easy to use (best imaginable); 80-89 were labelled B grade, representing excellent use (excellent); 70-79 were labelled C Grade, representing good (good), grades 60-69 represent D-grades (ok), and grades 0-59 represent F-grades (poor) (Bangor, 2009).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative interview</measure>
      <time_frame>one-month post-test</time_frame>
      <description>1. How helpful do you think the first aid e-book is? 2. What devices do you use to read e-books? 3. What do you think about the first aid e-book compared with other BLS courses? Which one do you prefer? Why?</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">70</enrollment>
    <condition>First Aid</condition>
    <condition>Knowledge</condition>
    <condition>Self-efficacy</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group received a one-hour e-book course plus one month of first aid e-book intervention and regular training</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group only received one month of regular training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>first aid e-book</intervention_name>
      <description>interactive first aid e-book interventions</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  In medicine within 2 years after graduation New nurses working in the center who have&#xD;
               passed the probationary period and have a basic first aid BLS certificate.&#xD;
  &#xD;
            -  Willing to participate with this researcher.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Injured hands and unable to perform CPR&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>CHIA-KUEI HU</last_name>
      <role>Study Director</role>
      <affiliation>Kaohsiung Medical University Hospital, Kaohsiung Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kaohsiung Medical University Hospital, Kaohsiung Medical University</name>
        <address>
          <city>Kaohsiung</city>
          <state>No.100, Tzyou 1st Rd., Sanmin District</state>
          <zip>80708</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>January 2022</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>e-book</keyword>
    <keyword>first aid knowledge</keyword>
    <keyword>self-efficacy</keyword>
    <keyword>first aid skills</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000878
  org study id: KMUHIRB-SV(I)-20210025
  nct id: NCT06000878
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Background: First aid skills are clinical performance ability requiring a higher level of
        skills for new nurses. At present, the focus of first aid-related teaching materials and
        methods remain on books and physical courses. E-books have not yet been applied to first aid
        skills training for new nurses despite their advantage of making reading, learning, and
        reviewing available at any time.
  
        Objective: To assess the effect of receiving interactive first aid e-book interventions on
        new nurses in a medical center in southern Taiwan in respect of first aid knowledge,
        self-efficacy, and first aid skills.
  
        Methods: A two-group three-time repeated measures experimental design was adopted. 70
        qualified new nurses were randomly assigned to the experimental group and the control group,
        each composed of 35 nurses. The experimental group received a one-hour e-book course plus one
        month of first aid e-book intervention and regular training, whereas the control group only
        received one month of regular training. Performance indicators included administering the
        objective structured clinical examination (OSCE) on first aid skills, and questionnaires for
        knowledge and self-efficacy related to first aid skills. The experimental group received
        qualitative interviews and filled out the system usability scale one month after the
        intervention. Data were analyzed using the independent samples t-test, chi-squared test,
        paired samples t-test, and generalized estimating equations (GEE).
  1. Introduction Paramedics are the first-line medical personnel on the emergency scene and
             can help in effectively treating the medical condition in the first few minutes. For
             instance, Cardiopulmonary resuscitation (CPR) can improve the chances of survival of
             cardiac arrest patients (Partiprajak & Thongpo, 2016 ; P. Y. Hsieh et al., 2021). CPR is
             an attempt to restore spontaneous circulation through chest compressions when the
             patient is not breathing and the heart is beating (Suseel et al., 2019). Crucially, the
             ability to perform effective CPR immediately requires repeated first aid training (Roh &
             Issenberg, 2014 ; Moon & Hyun, 2019). However, among clinical skills, new nurses find it
             most difficult to perform CPR (Liou et al., 2020). If new recruits lack professional
             training or confidence in their abilities, the quality of first aid provided by them may
             be affected (Ihunanya et al., 2020). Therefore, it is imperative to implement a
             well-designed training program that effectively equips clinical nurses with the
             necessary first aid knowledge and skills. (P. Y. Hsieh et al., 2021).
  
          2. Method 2.1 Design and participants This study used an experimental two-group pre- and
             post-test design. Three repeated measures were taken: pre-test (T0), immediate post-test
             (T1), and one-month post-test (T2). The one-month post-test was used to detect new
             nursing care personnel's retention of first aid knowledge, self-efficacy, and first aid
             skills. G power 3.1.9.2 version was used to estimate the number of samples using
             repeated measures ANOVA. The effect size was set to 0.3 (Kotrlik & Williams, 2003),
             alpha value was set to 0.05, detection power was 0.8, and correlation value was 0.5. The
             measurement was repeated thrice. As such, the total number of samples required should be
             62 bits. Considering an estimated attrition rate of 10% or 7 people, the total number of
             cases accepted was 70. The main investigator explained the purpose and process of the
             study to the new nurses in each ward and invited them to participate in the study. Data
             was collected between August 2021 and October 2021. The sample inclusion criteria were
             that participants were newly recruited nurses within two years with a basic first aid
             BLS certificate. Meanwhile, those who were unable to perform CPR due to hand injuries
             were excluded. A computer was used to randomly assign the 70 eligible new nurses in the
             medical center to the experimental and control groups, with 35 each.
  
        2.2 Study protocol The experimental group took a one-hour e-book course plus one month of
        first aid e-book intervention and routine training, whereas the control group received only
        one month of routine training. Effectiveness indicators were measured at pre-test (T0),
        immediate post-test (T1), and one-month post-test (T2). In order to assess the effectiveness
        of the first aid e-book intervention, the first aid skill Objective Structured Clinical
        Examination (OSCE) evaluation form was utilized alongside self-efficacy questionnaires for
        first aid knowledge and first aid ability. This comprehensive approach aimed to evaluate the
        effectiveness of the intervention.
  
        2.3 Research tool The research tools included the basic demographic data sheet, first aid
        knowledge questionnaire, first aid self-efficacy scale, first aid skills OSCE evaluation
        form, and system usability scale (SUS).
  
        2.3.1 Demographic basic data sheet The demographic basic data sheet was exclusively utilized
        during the pre-test (T0) phase. It encompassed details such as gender, age, education level,
        clinical experience, previous participation in first aid training courses, and the number of
        times the participants had engaged in first aid activities.
  
        2.3.2 First aid knowledge questionnaire The first aid knowledge questionnaire was based on
        the 2020 American Heart Association First Aid Guidelines Update (Cummins & Hazinski, 2020),
        and American Heart Association Cardiopulmonary Resuscitation and Cardiovascular Emergency
        Guidelines (Craig-Brangan & Day, 2020). The questionnaire included five items with a total of
        20 questions to test the new nurses' concept and understanding of first aid: first aid
        assessment and initial treatment (four questions), maintenance of airway and circulation
        (four questions), interpretation and treatment of abnormal heart rhythm (five questions),
        teamwork and abnormal handling (six questions), and communication and coordination with the
        patient's family members (one question). Each question is 5 points and measured on a
        five-point scale, with the total score being 0 to 100 points for 20 questions. The higher the
        score, the better was the awareness of first aid. The self-made first aid knowledge
        questionnaire, assessed by three experts, demonstrated a Content Validity Index (CVI) of
        0.93, indicating a high level of content validity. The Cronbach's α value of the internal
        consistency reliability of the scale was 0.713, indicating an acceptable level of internal
        consistency.
  
        2.3.3 First aid self-efficacy scale This study modified the "Self-efficacy Scale of First Aid
        Ability for Nurses" developed by Xie et al. (2014) to measure the self-efficacy of first aid
        ability assessed by new nurses themselves (Xie et al., 2014). The self-efficacy scale has six
        items with a total of 30 questions: maintenance of the respiratory tract and circulation
        (seven questions), teamwork and abnormal handling (twelve questions), communication and
        coordination between patients and their families (three questions), and abnormal heart rhythm
        interpretation and treatment (three questions), first aid assessment and initial treatment
        (four questions), demonstration of nursing first aid role and function (one question). Each
        question was answered on a five-point Likert Scale, with a total score ranging between 30-150
        points; the higher the score, the higher the confidence level. The modified first aid
        self-efficacy scale demonstrated a content-related validity CVI value of 0.94, indicating
        strong expert agreement on the content relevance. Furthermore, the internal consistency
        reliability of the scale, measured by Cronbach's α value, was 0.964, signifying excellent
        internal consistency.
  
        2.3.4 First aid skills OSCE A modified first aid skill measurement OSCE based on Li Huizhen
        et al. (2016) OSCE was used (Li Huizhen et al., 2016). A standardized clinical scenario was
        employed, and the examiner provided prompts during the test to assess the participants' first
        aid skills. The test was divided into three dimensions, with a total of 30 questions. The
        first dimension was pre-emergency assessment, performing cardiac compressions, and first aid
        balls (9 questions). The second dimension was the use of electric shock device and electric
        shock, and placing the endotracheal tube to confirm the position and fix it (11 questions).
        The third dimension was communication and coordination between first aid administration, and
        patient's family members (10 questions). The test time was 15 min, and each question was
        scored on five points. The total score on this scale ranges from 0 to 150 points. The higher
        the score, the better the first aid skill. Here, the CVI value of the OSCE evaluation form
        was 0.97 and Cronbach's α value of the internal consistency reliability of the scale was
        0.964, indicating strong the expert content-related validity and excellent internal
        consistency .
  
        2.3.5 First aid e-book The interactive first aid e-book was produced by SimMAGIC eBook, an
        interactive multimedia e-book editing software developed by Hama Star Technology. The
        interactive functions of the e-book included clicking, covering, dragging, scratching,
        linking, preset questions, and timely feedback. For each first aid concept, we provided
        multimedia learning materials, such as pictures and video explanations. Individuals can click
        "Play" and watch videos. The content of the e-book includes basic first aid knowledge and
        first aid drug knowledge, basic cardiopulmonary resuscitation first aid skills, assisting
        intubation, electric shock device operation video, how to perform team first aid practical
        operation teaching video, and interpretation and treatment of fatal arrhythmia. At the end,
        we designed some first aid concept knowledge about self-assessment, with interactive
        operation questions and answers to increase learning interest and enhance learning
        motivation. Then, we uploaded the e-book to the website and linked the URL into a QR code so
        that new nursing staff could use mobile phones, tablets, or computers to learn.
  
        2.3.6 System usability scale (SUS) John Brooke constructed the SUS in 1986. SUS has been used
        to measure various products, system interfaces, and services, including websites, mobile
        phones, and applications. It has 10 items which are measured on a five-point Likert scale
        from 1 = strongly disagree to 5 = strongly agree. Questions 1, 3, 5, 7, and 9 were positive
        questions, and questions 2, 4, 6, 8, and 10 were negative questions. The calculation method
        was as follows: subtract 1 from the score of the positive question, subtract the score of
        each question from 5 for the negative question, add up the scores of all questions, and
        multiply by 2.5 to get the average score of system usability (Wang et al., 2020). The SUS
        score was divided into six grades to represent the overall usability of the product: 90-100
        were labelled A grade, representing super easy to use (best imaginable); 80-89 were labelled
        B grade, representing excellent use (excellent); 70-79 were labelled C Grade, representing
        good (good), grades 60-69 represent D-grades (ok), and grades 0-59 represent F-grades (poor)
        (Bangor, 2009). The CVI value of the expert content-related validity of the modified system
        usability scale is 0.90.
  
        2.3.7 Qualitative interview Finally, interviews were conducted with participants in a
        confidential discussion room. The interviews were recorded and the content was kept
        confidential to ensure the reliability and authenticity of the data collection. Six new
        nurses were interviewed, who had become nurses in the past two years and had just completed
        the second post-test of the e-book intervention. The outline of the interview was structured
        on the following questions: 1. How helpful do you think the first aid e-book is? 2. What
        devices do you use to read e-books? 3. What do you think about the first aid e-book compared
        with other BLS courses? Which one do you prefer? Why? This study adopted the data analysis
        method of Colaizzi (1978). Specifically, We performed a systematic analysis, induction, and
        translation, categorizing the shared characteristics of these meanings into distinct themes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: First Aid Knowledge Questionnaire
  time frame: pre-test, immediate post-test, and one-month post-test
  description: The first aid knowledge questionnaire was based on the 2020 American Heart Association First Aid Guidelines Update (Cummins & Hazinski, 2020), and American Heart Association Cardiopulmonary Resuscitation and Cardiovascular Emergency Guidelines (Craig-Brangan & Day, 2020). The questionnaire included five items with a total of 20 questions to test the new nurses' concept and understanding of first aid: first aid assessment and initial treatment (four questions), maintenance of airway and circulation (four questions), interpretation and treatment of abnormal heart rhythm (five questions), teamwork and abnormal handling (six questions), and communication and coordination with the patient's family members (one question). Each question is 5 points and measured on a five-point scale, with the total score being 0 to 100 points for 20 questions. The higher the score, the better was the awareness of first aid.
  measure: First Aid Self-Efficacy Scale
  time frame: pre-test, immediate post-test, and one-month post-test
  description: This study modified the "Self-efficacy Scale of First Aid Ability for Nurses" developed by Xie et al. (2014) to measure the self-efficacy of first aid ability assessed by new nurses themselves (Xie et al., 2014). The self-efficacy scale has six items with a total of 30 questions: maintenance of the respiratory tract and circulation (seven questions), teamwork and abnormal handling (twelve questions), communication and coordination between patients and their families (three questions), and abnormal heart rhythm interpretation and treatment (three questions), first aid assessment and initial treatment (four questions), demonstration of nursing first aid role and function (one question). Each question was answered on a five-point Likert Scale, with a total score ranging between 30-150 points; the higher the score, the higher the confidence level.
  measure: First aid skills OSCE
  time frame: pre-test, immediate post-test, and one-month post-test
  description: A modified first aid skill measurement OSCE based on Li Huizhen et al. (2016) OSCE was used (Li Huizhen et al., 2016). A standardized clinical scenario was employed, and the examiner provided prompts during the test to assess the participants' first aid skills. The test was divided into three dimensions, with a total of 30 questions. The first dimension was pre-emergency assessment, performing cardiac compressions, and first aid balls (9 questions). The second dimension was the use of electric shock device and electric shock, and placing the endotracheal tube to confirm the position and fix it (11 questions). The third dimension was communication and coordination between first aid administration, and patient's family members (10 questions). The test time was 15 min, and each question was scored on five points. The total score on this scale ranges from 0 to 150 points. The higher the score, the better the first aid skill.
  measure: System usability scale (SUS)
  time frame: one-month post-test
  description: SUS has been used to measure various products, including websites, mobile phones, and applications (John Brooke, 1986). It has 10 items which are measured on a five-point Likert scale from 1 to 5. Questions 1, 3, 5, 7, and 9 were positive questions, and questions 2, 4, 6, 8, and 10 were negative questions. The calculation method was as follows: subtract 1 from the score of the positive question, subtract the score of each question from 5 for the negative question, add up the scores of all questions, and multiply by 2.5 to get the average score of system usability (Wang et al., 2020). The SUS score was divided into six grades to represent the overall usability of the product: 90-100 were labelled A grade, representing super easy to use (best imaginable); 80-89 were labelled B grade, representing excellent use (excellent); 70-79 were labelled C Grade, representing good (good), grades 60-69 represent D-grades (ok), and grades 0-59 represent F-grades (poor) (Bangor, 2009).
  measure: Qualitative interview
  time frame: one-month post-test
  description: 1. How helpful do you think the first aid e-book is? 2. What devices do you use to read e-books? 3. What do you think about the first aid e-book compared with other BLS courses? Which one do you prefer? Why?
  arm group label: experimental group
  arm group type: Experimental
  description: The experimental group received a one-hour e-book course plus one month of first aid e-book intervention and regular training
  arm group label: control group
  arm group type: No Intervention
  description: The control group only received one month of regular training.
  intervention type: Other
  intervention name: first aid e-book
  description: interactive first aid e-book interventions
  arm group label: experimental group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: CHIA-KUEI HU
  role: Study Director
  affiliation: Kaohsiung Medical University Hospital, Kaohsiung Medical University
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  sharing ipd: No