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/NCT06001879</url>
    </required_header>
    <id_info>
      <org_study_id>JEPeM Code :USM/JEPeM/22110681</org_study_id>
      <nct_id>NCT06001879</nct_id>
    </id_info>
    <brief_title>The Study Focuses on Training Newly Employed Nurses With Two Groups Interventional (Simulation Training) &amp; Control (Brochure) Group Using BLS -AHA 2020 Using Simulation, the Test Includes Pre-test &amp; 2 Post-test Surveys to Assess Knowledge, Practice &amp; Confidence Level.</brief_title>
    <acronym>BLS-NEN-HCP</acronym>
    <official_title>Protocol Title : Development, Validation, and Evaluation of the Effectiveness of Simulation in Basic Life Support Training (SBLST) on Newly Employed Nurses in Governmental Jordanian Hospitals.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>yousef Shukry Mohammad Abu-Wardeh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universiti Sains Malaysia</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>
        The general objective of this study is to develop, validate and evaluate the effectiveness of&#xD;
        simulation in basic life support training (SBLST) among newly employed nurses in Jordanian&#xD;
        governmental hospitals; the study design is a basic experimental study design, randomized&#xD;
        control trial (RCT) design, the dependant variables measure in this study; knowledge,&#xD;
        practice and confidence by using a pre-test and two follow up tests, two groups are&#xD;
        participating in this study; experimental and control group. The control group treatment is&#xD;
        the standard intervention (brochure), and the experimental group intervention is a simulation&#xD;
        in basic life support training (SBLST). The study process includes four steps&#xD;
  &#xD;
          -  Perform the pre-test (assess knowledge, practice confidence surveys&#xD;
  &#xD;
          -  Education intervention knowledge and practice&#xD;
  &#xD;
          -  Perform the post-test 1 (assess knowledge, practice confidence surveys&#xD;
  &#xD;
          -  Perform post-test 2 (assess knowledge, practice confidence surveys&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The general objective of this study is to develop, validate and evaluate the effectiveness of&#xD;
        simulation in basic life support training (SBLST) among newly employed nurses in Jordanian&#xD;
        governmental hospitals; the study design is a basic experimental study design, randomized&#xD;
        control trial (RCT) design, the dependant variables measure in this study; knowledge,&#xD;
        practice and confidence by using a pre-test and two follow up tests, two groups are&#xD;
        participating in this study; experimental and control group. The control group treatment is&#xD;
        the standard intervention (brochure), and the experimental group intervention is a simulation&#xD;
        in basic life support training (SBLST); researchers' hypothesized that there are no&#xD;
        significant differences between the control and experimental group in the inclusion criteria&#xD;
        and pre-test score; furthermore, the simulation in basic life support training intervention&#xD;
        significantly improves knowledge, practice and confidence level among newly employed nurses&#xD;
        (NEN) in Jordanian governmental hospitals; moreover, the is a significant difference between&#xD;
        control and experimental group in the post-test scores in all dependant variables. The study&#xD;
        process include four steps&#xD;
  &#xD;
          -  Perform the pre-test (assess knowledge, practice confidence surveys&#xD;
  &#xD;
          -  Education intervention knowledge and practice&#xD;
  &#xD;
          -  Perform the post-test 1 (assess knowledge, practice confidence surveys&#xD;
  &#xD;
          -  Perform post-test 2 (assess knowledge, practice confidence surveys&#xD;
  &#xD;
        Study title:&#xD;
  &#xD;
        DEVELOPMENT, VALIDATION, AND EVALUATION OF THE EFFECTIVENESS OF SIMULATION IN BASIC LIFE&#xD;
        SUPPORT TRAINING (SBLST) ON NEWLY EMPLOYED NURSES IN GOVERNMENTAL JORDANIAN HOSPITALS&#xD;
  &#xD;
        Research Hypotheses i. The simulation in basic life support training intervention effectively&#xD;
        improves knowledge among newly employed nurses (NEN) in Jordanian governmental hospitals.&#xD;
  &#xD;
        ii. The simulation in basic life support training intervention effectively improves practice&#xD;
        among newly employed nurses (NEN) in Jordanian governmental hospitals.&#xD;
  &#xD;
        iii. The simulation in basic life support training intervention effectively improves the&#xD;
        confidence level among newly employed nurses (NEN) in Jordanian governmental hospitals.&#xD;
  &#xD;
        iv. There is no significant difference in means between the pre-test among the newly employed&#xD;
        nurses (NEN) among interventional and the control groups in all dependent variables.&#xD;
  &#xD;
        v. There is a significant mean difference between PRE-SBLST and all POST-SBLST results among&#xD;
        NEN in all dependent variables.&#xD;
  &#xD;
        Study Design The study design was a prospective, longitudinal, single-blind basic&#xD;
        experimental design, randomized control trial (RCT) design.&#xD;
  &#xD;
        Study Location The study was carried out in Jordan, Amman and Al-Zarqa City. The accessible&#xD;
        population was NEN in five hospitals. The researchers selected three Jordanian hospitals. The&#xD;
        selection was according to the capacity, capability of the institution and eligibility&#xD;
        criteria. Computer-generated randomization (Random Allocation Software, version 1.0) was&#xD;
        applied in blocks to allocate the hospitals by distributing them into two arms. The first arm&#xD;
        was the control group; selected from three hospitals; Prince Hamza Hospital, AL-Basheer&#xD;
        Hospital, and AL-Zarqa Governmental Hospital (n=51); the second arm was the interventional&#xD;
        group from two hospitals; Prince Faisal Governmental Hospital and Dr.Jameel AL-Totanji&#xD;
        Hospital.&#xD;
  &#xD;
        Randomization of the Hospitals To prevent data contamination between the control and&#xD;
        interventional groups, computer-generated randomization (Random Allocation Software, version&#xD;
        1.0) was applied in blocks to allocate the hospitals by distributing them into two arms. The&#xD;
        first arm was the control group; selected from three hospitals; Prince Hamza Hospital,&#xD;
        AL-Basheer Hospital, and AL-Zarqa Governmental Hospital (n=51); the second arm was the&#xD;
        interventional group from two hospitals; Prince Faisal governmental hospital and Dr.Jameel&#xD;
        AL-Totanji hospital. The control and interventional groups were selected from different&#xD;
        hospitals because the researchers are always worried about data contamination and try to&#xD;
        minimize it between the control and intervention groups; if the sample was selected from the&#xD;
        same area and both groups worked closely together, the data would be contaminated.&#xD;
  &#xD;
        The study consists of a pre-test, intervention, immediate post-test-1 after the intervention,&#xD;
        and post-test-2 three months after the intervention. This study measured knowledge, practice,&#xD;
        and confidence through pre- and post-tests in control and experimental groups. This study&#xD;
        used two interventions: SBLST for the interventional group and AHA-BLS 2020 brochure as a&#xD;
        standard treatment for the control group. Data collection proceeded using the Google Form&#xD;
        Platform (A web-based instrument Copyrighted by Google application).&#xD;
  &#xD;
        The evaluation process includes a pre-test and two follow-up assessments to measure&#xD;
        knowledge, practice and confidence. The researcher will analyze the means of each test; the&#xD;
        total dependent variables were 30 questions.&#xD;
  &#xD;
        Research Instruments&#xD;
  &#xD;
        Languages of the Tools According to the HCP educational level, all four sections of the tools&#xD;
        assessment are written in English; furthermore, the researchers' assistance clarified any&#xD;
        misunderstanding points or need for translation to the participants.&#xD;
  &#xD;
        Tools Sections The tools consist of five sections; research information sheet and consent&#xD;
        forms, demographical data, knowledge assessment tools, skills assessment tools, and&#xD;
        confidence level assessment tools.&#xD;
  &#xD;
        Research information sheet and Consent Forms The research information sheet is a piece of&#xD;
        brief researcher information and contact details; it also includes subject information and a&#xD;
        consent form with an area for the participant's signature when they are approved to&#xD;
        participate in this study. Furthermore, the research information sheets include a&#xD;
        participant's publication consent form.&#xD;
  &#xD;
        Demographical data Demographic parts are attached; these data consist of dichotomous&#xD;
        questions (Yes\NO), nominal data, ordinal data, and interval measurement questions. Nominal&#xD;
        measurements include sex and ordinal assessment as educational level and area of experience;&#xD;
        interval assessment questions include age and work experience. Dichotomous assessments&#xD;
        (Yes\NO), asking if the participant previously participated in a CPR episode or observed any&#xD;
        CPR before, if the participants had finished training the BLS using simulation previously,&#xD;
        and if the participant gained the certification of BLS training from formal and accredited&#xD;
        institutions.&#xD;
  &#xD;
        Knowledge and practice Nursing knowledge is the interaction of science and research to&#xD;
        improve practice. Researchers use a 13-question MCQ tool to assess knowledge. Nursing&#xD;
        practice is performing the knowledge learned before; the researchers assessed skills using a&#xD;
        tool consisting of ten MCQ. The participants got zero for each wrong answer and one mark for&#xD;
        each correct answer.&#xD;
  &#xD;
        Confidence Confidence is the building and accomplishment of the nursing profession through&#xD;
        knowledge acquisition, skills, and critical thinking. Confidence is the positive feeling of&#xD;
        faith and dependability to perform BLS without fear and free from risk to the patient. The&#xD;
        researchers assessed confidence level using seven statements rated as a dropdown in percent&#xD;
        value from the lowest value of 5% to the highest value of 100%.&#xD;
  &#xD;
        Study process steps&#xD;
  &#xD;
          1. Pre-test After NEN enrolled according to the inclusion criteria for both the control&#xD;
             group and experimental group (n= 102), the participants started by signing the informed&#xD;
             consent, filled out the demographical data and pre-test as proactive steps before the&#xD;
             intervention; many sessions of pre-test data collection and intervention were performed&#xD;
             according to the availability of NEN, the arrangement of the hospital's nursing&#xD;
             director. The estimated time to fill in the demographical data and pre-test is around 30&#xD;
             minutes. Oermann et al. (2020) addressed that the trainer performs a pre-test assessment&#xD;
             to assess the effectiveness of SBLST. The investigators discussed the purpose of the&#xD;
             study with the control group and explained to them the procedure to prevent any data&#xD;
             contamination and minimize the interpretation of the survey content by the other&#xD;
             research assistants.&#xD;
  &#xD;
          2. Intervention The control group read the brochure containing a brief guideline about&#xD;
             basic life support for 30-60 minutes before taking the post-test. Standard treatment ran&#xD;
             from Dec 2022 to Jan 2023. One full day for SBLST intervention, from 5 to 7 hours for&#xD;
             SBLST intervention, is required based on the recent research and uses AHA-2020&#xD;
             guidelines. The number of participants was ten NEN in each session. The interventional&#xD;
             treatment consists of theoretical and practical parts. The SBLST intervention was&#xD;
             conducted in an educational lab according to the hospital's capability; SBLST ran for&#xD;
             seven days, from 22 Nov 2022 to 20-Dec, 2022.&#xD;
  &#xD;
             Researchers combined two frameworks in the SBLST. Miller's Pyramid and Kolb's Cycle;&#xD;
             Miller's Pyramid focuses on teaching theoretical and practical aspects of the task&#xD;
             through simulation and allowing trainees to perform the procedure independently with&#xD;
             guidance; Kolb's Cycle suggests giving learners a scenario to practice until they&#xD;
             eliminate errors before moving to another scenario. The SBLST intervention was reviewed&#xD;
             by three experts in BLS and approved by the Jordanian Ministry of Health-Life Support&#xD;
             Center. It was found to be compliant, safe and covered all aspects of AHA-2020. English&#xD;
             experts provided feedback to improve clarity. A pilot study was conducted on 20 nurses&#xD;
             to calculate SBLST time, identify errors, monitor the progress and calculate Cronbach's&#xD;
             Alpha.A pilot study was performed to check the stability of the tools. Cronbach's alpha&#xD;
             of knowledge and skills assessment tools was 0.748, reflecting the suitability and&#xD;
             strength of using these tools. Moreover, Cronbach's alpha of confidence tools was 0.731,&#xD;
             reflecting the suitability and stability of the confidence tools.&#xD;
  &#xD;
             Adult half-body manikin and a pediatric full-body manikin are necessary; with lung bag&#xD;
             inflation and deflation characteristics, palpable carotid pulse, the chest includes&#xD;
             spring inside to facilitate chest recoil, and chest compression board,&#xD;
             bag-valve-mask-ventilation, chest compression performed on the Charlie simulator to&#xD;
             relieve choking. The principles investigator (PI) had a master's degree in critical care&#xD;
             nursing, eighteen years of experience between ICUs, lecturers and clinical instructors,&#xD;
             valid BLS and ACLS, training of trainers in nursing education, and randomized control&#xD;
             trial training. The facilitator must have CPR certifications in BLS and ACLS, enough&#xD;
             expertise in education and training, and good communication skills. The investigator had&#xD;
             a master's degree in critical care. Two research assistants supported the PI in&#xD;
             collecting data; one research assistant for the control group and the other for the&#xD;
             interventional group.&#xD;
  &#xD;
          3. post-test All participants completed the immediate post-test-1 after the interventions.&#xD;
             The post-tets-2 was conducted by providing the participants with a Google Form Platform&#xD;
             link through their phone and email addresses. The post-test after three months evaluates&#xD;
             whether the participants' level stayed at the same level or minimized by comparing the&#xD;
             mean value between all post-tests. Forty-eight participants in the experimental group&#xD;
             completed post-test-2 with a response rate of 94%, and 45 participants in the control&#xD;
             group with a response rate of 88%.&#xD;
  &#xD;
        Sample Size Estimation Sample size calculation is performed by using G*POWER software&#xD;
        (version 3.1); sample size calculation is summarized and consists of the following steps (1)&#xD;
        Select the test family (F-test family), (2) Select the statistical test (Select&#xD;
        ANOVA-repeated test, between factors), the preliminary test analysis the researchers used in&#xD;
        this study, the rationale for using the Select ANOVA-repeated test between factors due to&#xD;
        measuring many dependent variables means at different time points. (3) The parameters&#xD;
        selected to calculate sample size include one side tail, alpha (α) and equals (0.05)- type&#xD;
        one error, Power (P) and equal (0.8), effect size, the number of groups is two (each group =&#xD;
        n\2) n= the estimated sample size, number of measurements were four measurements (Pre-test,&#xD;
        Post-test immediately, Post-test after two months, and Post-test after three months).&#xD;
  &#xD;
        Effect Size (ES) = 0.26, automatically calculated by G*Power software, depending on the&#xD;
        sample size of the previous study, the effect size is calculated, the Control group's&#xD;
        post-test result M±SD was equal (25.03±3.04) with a sample size of 28 participants, and the&#xD;
        interventional group (26.64±2.64) with sample size 29 participants. The sample size is 72&#xD;
        participants; because the research study continued for three months, the invistigators added&#xD;
        a 10% drop rate for each month, so the drop rate is 30%. Final sample size estimation&#xD;
        including drop rate (n\1-dropout rate) = 72/(1-0.30) = 102 participants, the intervention&#xD;
        group arm is 51 participants, and The largest sample size was obtained from the&#xD;
        interventional group, more than the Control Group and the Control group arm 51 participants.&#xD;
  &#xD;
        Simple Random Sampling of the Participants After obtaining ethical approval and permission to&#xD;
        conduct the study from the Ministry of Health in Jordan, approval letter (Education/Info\&#xD;
        15177) and ethical approval letter (MOH/REC/2022/340), The researchers started the formal&#xD;
        face-to-face visits to arrange with the nursing director and a continuous education office in&#xD;
        the selected hospitals about the study objective and how the study would proceed; The&#xD;
        researchers received the activation letter to initiate the study and prepared the list of the&#xD;
        available participants who met the study's eligibility criteria. The number of participants&#xD;
        depends on the availability of newly employed nurses in the institution who meet the&#xD;
        inclusion criteria. The researchers randomly selected the participants from the participants'&#xD;
        list by randomly sampling from newly employed nurses in each hospital for interventional and&#xD;
        control groups.&#xD;
  &#xD;
        . The response of the control group hospitals was as the following; the nursing director and&#xD;
        continuous education in AL-Zarqa Governmental Hospital responded by providing all the&#xD;
        information about participants and selecting a time and day to perform the Pre-test, standard&#xD;
        treatment and the immediate post-test. Prince Hamzah Hospital and AL-Basheer Hospital gave&#xD;
        the researcher the names of departments in the hospital, including those with NEN, and the&#xD;
        invistigators visited these departments to select the available NEN randomly and performed&#xD;
        Pre-test, standard treatment, and immediate post-test in their departments.&#xD;
  &#xD;
        The response of the interventional group hospitals was as the following; Prince Faisal&#xD;
        Governmental Hospital and Dr.Jameel AL-Totanji Hospital scheduled many days and times to&#xD;
        perform the intervention, and the hospitals arranged with the available participants who met&#xD;
        the eligibility criteria; then, the researcher selected the participants randomly.&#xD;
  &#xD;
        Ethical Considerations&#xD;
  &#xD;
          1. Permission to Conduct the Study Regarding ethical considerations, approval for the study&#xD;
             was obtained from the Human Research Ethics Committee (HREC), Universiti Sains Malaysia&#xD;
             (USM). Moreover, ethical approvals to initiate SBLST intervention in Jordanian Hospitals&#xD;
             in Amman and AL-Zarqa city were obtained from the Ministry of Health in Jordan; the&#xD;
             study protocol was revised and approved for implementation by Jawatankuasa Etika&#xD;
             Penyilidikan Manusia Universiti Sains Malaysia (JEPeM-USM) with study protocol code&#xD;
             USM/JEPeM/22110681, which compliance with the Declaration of Helsinki, International&#xD;
             Conference on Harmonization (ICH) Guidelines, Good Clinical Practice (GCP) Standards,&#xD;
             Council for International Organizations of Medical Sciences (CIOMS) Guidelines, World&#xD;
             Health Organization (WHO) Standards and Operational Guidance for Ethics Review of&#xD;
             Health-Related Research and Surveying and Evaluating Ethical Review Practices, EC/IRB&#xD;
             Standard Operating Procedures (SOPs), and Local Regulations and Standards in Ethical&#xD;
             Review.&#xD;
  &#xD;
          2. Subject Vulnerability There is no vulnerability group in this study. All the&#xD;
             participants were nurses over 20 years old and working in hospitals; no participants had&#xD;
             handicaps or physical problems. The participants made the voluntary choice to take part&#xD;
             in the trial. The researchers discussed the study's objectives, methods, benefits and&#xD;
             risks. The study was free from any potential hazards or adverse effects on participants,&#xD;
             no intervention was applied in emergencies, and no medicine product will be used in this&#xD;
             study. The procedure was simple, the devices used in the intervention were safe, and the&#xD;
             investigator was instructed to frequently ask the participant about health and physical&#xD;
             condition, especially during chest compression.&#xD;
  &#xD;
             The participants who signed a hard copy of the consent are part of this trial study.&#xD;
             During all study phases, the participants will be asked using the electronic method;&#xD;
             Google Form Platform, if they would like to participate in this study, and they will&#xD;
             answer (YES\NO) before completing the questionnaires. Furthermore, the intervention will&#xD;
             be applied in simulation; the participant voluntarily withdraws from the study without&#xD;
             any influence or effect on annual evaluation or salary. The institutions took full&#xD;
             responsibility for the trial and protecting the participants and treated the&#xD;
             participants if there were unexpected adverse effects or physical harm.&#xD;
  &#xD;
             The research includes minimal risk toward participants, observable by the time length&#xD;
             and components of the intervention; participants may be feeling discomfort. This risk is&#xD;
             equal to the nurses' daily life activity. They can be adapted with this minimal risk;&#xD;
             only four components require a long time to cover the knowledge and practice in the&#xD;
             intervention, but the other four components are easy and need a short time. The&#xD;
             researchers planned to minimize the participant's discomfort due to the time and length&#xD;
             of the intervention by giving the participant &quot;break times&quot; between the components of&#xD;
             the intervention.&#xD;
  &#xD;
          3. Declaration of Absence of Conflict of Interest The researchers had declared that there&#xD;
             was no conflict of interest, and all co-authors had no financial interest to report. The&#xD;
             invistigators certify that the first author is purely a Ph.D. student's original work&#xD;
             and has not been given to submit to other universities or journals.&#xD;
  &#xD;
          4. Privacy and Confidentiality When the study was completed, the trial master files and&#xD;
             documents were protected and kept safe, and all records were kept confidential.&#xD;
             Furthermore, the data collected is not associated with individuals by name but only by&#xD;
             phone number and email to contact them later to complete the post-test; data is kept&#xD;
             properly and handled only in the research. In addition, the researchers also emphasized&#xD;
             that only research groups can access the relevant data in this research and not use it&#xD;
             in the future without consent from the participants; moreover, after finishing the&#xD;
             study, the data will archive properly according to the policy.&#xD;
  &#xD;
          5. Community Sensitivities and Benefits The intervention benefits of NEN as a part of a&#xD;
             contentious education, and the knowledge and practice shared through the natural&#xD;
             learning process in the classroom, face-to-face learning, and the questionnaires filled&#xD;
             using an electronic method, Google Forms Platform; there is no sensitive information&#xD;
             about the participants. The primary benefits of this study's findings toward&#xD;
             participants are to increase newly employed nurses' knowledge, practice skills, and&#xD;
             confidence level when facing critical situations inside or outside the hospitals,&#xD;
             increases professionalism in all healthcare delivery systems, self-esteem, improve newly&#xD;
             employed nurses' performance competency, decision-making, satisfaction, to decrease&#xD;
             turnovers and dissatisfaction. Furthermore, the benefits of this study are to develop&#xD;
             patient care processes and enhance the victims' survival and patient satisfaction,&#xD;
             maintain patient safety, enhance the welfare and hospital discharge outcomes, become&#xD;
             cost-effective for patients and their families, and keep patients away from hazards.&#xD;
  &#xD;
          6. Incentive and Reimbursement The researcher verbally thanked all participants for their&#xD;
             sincere cooperation following the completion. Furthermore, the researcher planned to&#xD;
             give the control group an SBLST on a selected day; finally, the participant received&#xD;
             feedback about the pre and post-result and a certification attendance of 4 hours from&#xD;
             the researcher, adding to the required job development hours in the yearly&#xD;
             self-evaluation form.&#xD;
  &#xD;
          7. Collaborative Study Terms of Reference: None&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 22, 2022</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Actual">June 8, 2023</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>
      <intervention_model_description>The study design is a basic experimental study design, randomized control trial (RCT) design, SBLST for the intervention group and standard intervention to the control group by using a brochure; the SBLST intervention among the control group was delayed until the end of data collection as an appreciation for their participation in the study, control group participants are wait-listed and exposed to the experimental treatment at a later point.&#xD;
  Pre-prepared Basic Life Support Guidelines 2020 Treatment (A): Standard Treatment The investigator will give the participants in the control group; the standard treatment by using an AHA-BLS 2020 brochure. The participants will read and understand this brochure over 30 minutes Treatment (B): Simulation in basic life support training The interventional tools, simulation in basic life support training (SBLST), were prepared in English. The researcher will use an already established BLS training from the American Guidelines 2020 (AHA, 2020c)</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Effectiveness of Simulation in basic life support training (SBLST) on the Knowledge Score</measure>
      <time_frame>6 Months after finish all data collection</time_frame>
      <description>To evaluate the effectiveness of SMBST on knowledge scores, investigators will conduct three measurements: a pretest, an immediate post-test after the intervention, and a post-test 2 after three months for both experimental and control groups. Participants will be sent a questionnaire consisting of 13 MCQ three times via Google Form Platforms. These questions will be sent to their cell phone numbers. Repeated measure ANOVA will be conducted for both groups and the mean knowledge scores between the pretest and post-test will be compared. The level of significance will be determined by the p-value to accept or reject the alternative hypothesis (The simulation in basic life support training intervention improves knowledge among newly employed nurses (NEN) in a Jordanian governmental hospital). The intervention is educational and poses no risk or adverse effects to the participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Effectiveness of Simulation in basic life support training (SBLST) on the Practice Score</measure>
      <time_frame>6 moths after finish all data collection</time_frame>
      <description>The investigators performed three measurements to assess the effectiveness of SMBST on practice score; Pretest, immediate-posttest after the intervention, and post-test-2 after three months of the intervention for both experimental and control groups. The practice questionnaires consist of ten MCQs, and the participants will answer this survey three times; these questions will send to the participant's cell phone numbers as a link from Google Form Platforms at all times off-test family, ANOVA for experimental and control groups, then comparing the mean between practice score in both groups and between pretest and post-test and finally identify the level of significant by p-value to reject or accept the alternative hypothesis&quot; The simulation in basic life support training intervention effectively improves practice among newly employed nurses (NEN) in Jordanian governmental hospital.&quot; The intervention is educational, and there is no adverse effect or risk to the participant.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Effectiveness of Simulation in basic life support training (SBLST) on the Confidence Level</measure>
      <time_frame>6 moths after finish all data collection</time_frame>
      <description>The effectiveness of SMBST on confidence levels will be assessed by measuring pretest, immediate posttest, and post-test-2 results for both experimental and control groups. Participants will complete the survey three times using a Google Forms link sent to their cell phones. Repeated measure ANOVA will be used to analyze the data and compare mean confidence levels between the groups and pretest/post-test scores. The intervention has proven effective in improving confidence levels with no adverse effects or risks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>There are no significant differences between the control and experimental groups in the knowledge score pretest</measure>
      <time_frame>2 month after finsh the pre-test of both group</time_frame>
      <description>Before implementing any interventions for the experimental and control groups, the investigator ensures that the pretest levels of both groups are significantly similar to ensure accurate measurement. After conducting an ANOVA analysis and pairwise comparison with means, standard deviation (SD), and P value results, the investigator will decide on this hypothesis. The intervention is educational and poses no adverse effects or risks to the participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>There are no significant differences between the control and experimental groups in the practice score pretest</measure>
      <time_frame>2 month after finsh the pre-test of both group</time_frame>
      <description>Before implementing any interventions for the experimental or control groups, the investigator takes measures to ensure that both groups possess comparable pretest scores, thus guaranteeing precise measurements. The validity of this hypothesis will be substantiated through ANOVA analysis, whereby means, standard deviation (SD), and P-values will be compared using pairwise comparisons. It is important to note that the educational intervention provided does not carry any risk or adverse effects for the participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>There are no significant differences between the control and experimental groups in the pretest regarding confidence level.</measure>
      <time_frame>2 month after finsh the pre-test of both group</time_frame>
      <description>Before performing any intervention for the intervention; and experimental groups, the investigator makes sure that the pretest of both groups is significantly the same level to ensure the accuracy of the measurement; the investigator will decide on this hypothesis after ANOVA analysis and use pairwise comparison with means, standard deviation (SD), and P value results. The intervention is educational, and there is no adverse effect or risk to the participant.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Significant differences exist between the control and experimental groups in the post-tests on knowledge scores.</measure>
      <time_frame>6 moths after finish all data collection</time_frame>
      <description>The investigator will assess the effectiveness of SBLST on the experimental group by comparing post-test mean and SD and assess the level of significance (p-value) for the control and experimental group to decide that the SBLST was effective on knowledge score using ANOVA repeated measure analysis. The intervention is educational, and there is no adverse effect or risk to the participant.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Significant differences exist between the control and experimental groups in the post-test after the interventions on practice score</measure>
      <time_frame>6 moths after finish all data collection</time_frame>
      <description>The investigator will assess the effectiveness of SBLST on the experimental group by comparing post-test mean and SD and assess the level of significance (p-value) for the control and experimental group to decide that the SBLST was effective on practice score using ANOVA repeated measure analysis. The intervention is educational, and there is no adverse effect or risk to the participant.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Significant differences exist between the control and experimental groups in the post-test after the interventions on the confidence level</measure>
      <time_frame>6 moths after finish all data collection</time_frame>
      <description>The investigator will assess the effectiveness of SBLST on the experimental group by comparing post-test mean and SD and assess the significance level (p-value) for the control and experimental group to decide that the SBLST was effective on confidence level using ANOVA repeated measure analysis. The intervention is educational, and there is no adverse effect or risk to the participant.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>There are no differences between the control and experimental groups in the inclusion criteria</measure>
      <time_frame>2 month after finsh the pre-test of both group</time_frame>
      <description>The investigators selected inclusion criteria for both the control and experimental group, and both groups should be Homogenous in the demographical data by using Mann-Witney U-test and checking the median and IQ range. The intervention is educational, and there is no adverse effect or risk to the participant</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">102</enrollment>
    <condition>Healthy Nurses</condition>
    <condition>Educational Activities</condition>
    <arm_group>
      <arm_group_label>SBLST Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment (B): Simulation in basic life support training The interventional tools, simulation in basic life support training (SBLST), were prepared in English. The researcher will use an already established BLS training from the American Guidelines 2020, a simplified two-part; PowerPoint presentation and clinical simulation training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The investigator will give the participants in the control group; the standard treatment by using an AHA-BLS 2020 brochure. The participants will read and understand this brochure over 30 minutes, including a brief guideline about basic life support guidelines, and after these 30 minutes, the participants will move to the post-test.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Simulation in basic life support training (SBLST)</intervention_name>
      <description>The interventional tools, simulation in basic life support training (SBLST), were prepared in English. The researcher will use an already established BLS training from the American Guidelines 2020, a simplified two-part; PowerPoint presentation, and clinical simulation training.</description>
      <arm_group_label>SBLST Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>standard treatment by using an AHA-BLS 2020 brochure</intervention_name>
      <description>The participants will read and understand this brochure over 30 minutes, including a brief guideline about basic life support guidelines, and after these 30 minutes, the participants will move to the post-test</description>
      <arm_group_label>Standard Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria The researchers tried to maintain homogeneity and minimize any&#xD;
          variations among the participants by&#xD;
  &#xD;
            1. selecting both interventional and control groups from newly employed nurses&#xD;
  &#xD;
            2. Male and female participants&#xD;
  &#xD;
            3. Participants only who understand the questionnaires and interventions in English&#xD;
  &#xD;
            4. Participants who were previously on-seat undergraduate nursing students last two&#xD;
               years, 2020 (4th year nursing bachelor level) and 2021 (3rd year nursing bachelor&#xD;
               level) in the period of the COVID-19 pandemic and received basic and clinical learning&#xD;
               by online method, and now became a newly employed nurse (NEN) in hospitals and&#xD;
               delivered care to the patient.&#xD;
  &#xD;
            5. Participants can attend five to seven hours of SBLST sessions.&#xD;
  &#xD;
            6. For more control, we selected nurses who rarely face CPR and do not attend BLS raining&#xD;
               the last two years.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            1. The researchers excluded the NEN participants working in intensive care units because&#xD;
               ICU nurses face CPR and perform BLS daily.&#xD;
  &#xD;
            2. Excluded participants with medical or physical health problems (e.g., pregnant women&#xD;
               and participants complaining of lower back pain).&#xD;
  &#xD;
            3. Participants who attended CPR training less than two years previously were also&#xD;
               excluded. Finally,&#xD;
  &#xD;
            4. NEN who upgraded their educational degree from a diploma to a bachelor's degree were&#xD;
               excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ministry of Health</name>
        <address>
          <city>Amman</city>
          <zip>11118</zip>
          <country>Jordan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
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      <url>https://doi.org/10.1016/j.ecns.2020.08.002</url>
      <description>Brown, D. K., &amp; Benson, S. N. K. (2020). Does Time in Team Training Matter ? Evaluation of Team-Level Attitudes With Interprofessional Education. Clinical Simulation in Nursing, 48, 38-45</description>
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      <PMID>28274986</PMID>
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      <citation>Toubasi S, Alosta MR, Darawad MW, Demeh W. Impact of simulation training on Jordanian nurses' performance of basic life support skills: A pilot study. Nurse Educ Today. 2015 Sep;35(9):999-1003. doi: 10.1016/j.nedt.2015.03.017. Epub 2015 Apr 16.</citation>
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      <citation>Umuhoza C, Chen L, Unyuzumutima J, McCall N. Impact of structured basic life-support course on nurses' cardiopulmonary resuscitation knowledge and skills: Experience of a paediatric department in low-resource country. Afr J Emerg Med. 2021 Sep;11(3):366-371. doi: 10.1016/j.afjem.2021.03.014. Epub 2021 Jul 22.</citation>
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      <citation>Uzen Cura S, Kocatepe V, Yildirim D, Kucukakgun H, Atay S, Unver V. Examining Knowledge, Skill, Stress, Satisfaction, and Self-Confidence Levels of Nursing Students in Three Different Simulation Modalities. Asian Nurs Res (Korean Soc Nurs Sci). 2020 Aug;14(3):158-164. doi: 10.1016/j.anr.2020.07.001. Epub 2020 Jul 9.</citation>
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      <citation>Van de Voorde P, Turner NM, Djakow J, de Lucas N, Martinez-Mejias A, Biarent D, Bingham R, Brissaud O, Hoffmann F, Johannesdottir GB, Lauritsen T, Maconochie I. European Resuscitation Council Guidelines 2021: Paediatric Life Support. Resuscitation. 2021 Apr;161:327-387. doi: 10.1016/j.resuscitation.2021.02.015. Epub 2021 Mar 24.</citation>
      <PMID>33773830</PMID>
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      <citation>Waldner MH, Olson JK. Taking the patient to the classroom: applying theoretical frameworks to simulation in nursing education. Int J Nurs Educ Scholarsh. 2007;4:Article18. doi: 10.2202/1548-923X.1317. Epub 2007 Sep 17.</citation>
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      <citation>Williams KL, Rideout J, Pritchett-Kelly S, McDonald M, Mullins-Richards P, Dubrowski A. Mock Code: A Code Blue Scenario Requested by and Developed for Registered Nurses. Cureus. 2016 Dec 23;8(12):e938. doi: 10.7759/cureus.938.</citation>
      <PMID>28123919</PMID>
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      <citation>Wilson C, Furness E, Proctor L, Sweetman G, Hird K. A randomised trial of the effectiveness of instructor versus automated manikin feedback for training junior doctors in life support skills. Perspect Med Educ. 2021 Mar;10(2):95-100. doi: 10.1007/s40037-020-00631-y. Epub 2020 Nov 26.</citation>
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      <citation>Wyckoff MH, Singletary EM, Soar J, Olasveengen TM, Greif R, Liley HG, Zideman D, Bhanji F, Andersen LW, Avis SR, Aziz K, Bendall JC, Berry DC, Borra V, Bottiger BW, Bradley R, Bray JE, Breckwoldt J, Carlson JN, Cassan P, Castren M, Chang WT, Charlton NP, Cheng A, Chung SP, Considine J, Costa-Nobre DT, Couper K, Dainty KN, Davis PG, de Almeida MF, de Caen AR, de Paiva EF, Deakin CD, Djarv T, Douma MJ, Drennan IR, Duff JP, Eastwood KJ, El-Naggar W, Epstein JL, Escalante R, Fabres JG, Fawke J, Finn JC, Foglia EE, Folke F, Freeman K, Gilfoyle E, Goolsby CA, Grove A, Guinsburg R, Hatanaka T, Hazinski MF, Heriot GS, Hirsch KG, Holmberg MJ, Hosono S, Hsieh MJ, Hung KKC, Hsu CH, Ikeyama T, Isayama T, Kapadia VS, Kawakami MD, Kim HS, Kloeck DA, Kudenchuk PJ, Lagina AT, Lauridsen KG, Lavonas EJ, Lockey AS, Malta Hansen C, Markenson D, Matsuyama T, McKinlay CJD, Mehrabian A, Merchant RM, Meyran D, Morley PT, Morrison LJ, Nation KJ, Nemeth M, Neumar RW, Nicholson T, Niermeyer S, Nikolaou N, Nishiyama C, O'Neil BJ, Orkin AM, Osemeke O, Parr MJ, Patocka C, Pellegrino JL, Perkins GD, Perlman JM, Rabi Y, Reynolds JC, Ristagno G, Roehr CC, Sakamoto T, Sandroni C, Sawyer T, Schmolzer GM, Schnaubelt S, Semeraro F, Skrifvars MB, Smith CM, Smyth MA, Soll RF, Sugiura T, Taylor-Phillips S, Trevisanuto D, Vaillancourt C, Wang TL, Weiner GM, Welsford M, Wigginton J, Wyllie JP, Yeung J, Nolan JP, Berg KM; COVID-19 Working Group. 2021 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Neonatal Life Support; Education, Implementation, and Teams; First Aid Task Forces; and the COVID-19 Working Group. Resuscitation. 2021 Dec;169:229-311. doi: 10.1016/j.resuscitation.2021.10.040. Epub 2021 Nov 11.</citation>
      <PMID>34933747</PMID>
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      <citation>Zideman DA, Singletary EM, Borra V, Cassan P, Cimpoesu CD, De Buck E, Djarv T, Handley AJ, Klaassen B, Meyran D, Oliver E, Poole K. European Resuscitation Council Guidelines 2021: First aid. Resuscitation. 2021 Apr;161:270-290. doi: 10.1016/j.resuscitation.2021.02.013. Epub 2021 Mar 24.</citation>
      <PMID>33773828</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Universiti Sains Malaysia</investigator_affiliation>
      <investigator_full_name>yousef Shukry Mohammad Abu-Wardeh</investigator_full_name>
      <investigator_title>PHD STUDENTS aCUTE AND CRITICAL CARE IN NURSING</investigator_title>
    </responsible_party>
    <keyword>pretest-post test and intervention</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Only the participant data related to the study after participate and publication consent without mentioned name, ID, email...and providing the privacy</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>after finish and publish the study and will not use in any other study</ipd_time_frame>
      <ipd_access_criteria>Data is kept properly and handled only in the research. In addition, the researchers also emphasized that only research groups can access the relevant data in this research and not use it in the future without consent from the participants; moreover, after finishing the study, the data will archive properly according to the policy.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>April 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT06001879/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>April 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT06001879/SAP_001.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>April 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT06001879/ICF_002.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06001879
  org study id: JEPeM Code :USM/JEPeM/22110681
  nct id: NCT06001879
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The general objective of this study is to develop, validate and evaluate the effectiveness of
        simulation in basic life support training (SBLST) among newly employed nurses in Jordanian
        governmental hospitals; the study design is a basic experimental study design, randomized
        control trial (RCT) design, the dependant variables measure in this study; knowledge,
        practice and confidence by using a pre-test and two follow up tests, two groups are
        participating in this study; experimental and control group. The control group treatment is
        the standard intervention (brochure), and the experimental group intervention is a simulation
        in basic life support training (SBLST). The study process includes four steps
  
          -  Perform the pre-test (assess knowledge, practice confidence surveys
  
          -  Education intervention knowledge and practice
  
          -  Perform the post-test 1 (assess knowledge, practice confidence surveys
  
          -  Perform post-test 2 (assess knowledge, practice confidence surveys
  The general objective of this study is to develop, validate and evaluate the effectiveness of
        simulation in basic life support training (SBLST) among newly employed nurses in Jordanian
        governmental hospitals; the study design is a basic experimental study design, randomized
        control trial (RCT) design, the dependant variables measure in this study; knowledge,
        practice and confidence by using a pre-test and two follow up tests, two groups are
        participating in this study; experimental and control group. The control group treatment is
        the standard intervention (brochure), and the experimental group intervention is a simulation
        in basic life support training (SBLST); researchers' hypothesized that there are no
        significant differences between the control and experimental group in the inclusion criteria
        and pre-test score; furthermore, the simulation in basic life support training intervention
        significantly improves knowledge, practice and confidence level among newly employed nurses
        (NEN) in Jordanian governmental hospitals; moreover, the is a significant difference between
        control and experimental group in the post-test scores in all dependant variables. The study
        process include four steps
  
          -  Perform the pre-test (assess knowledge, practice confidence surveys
  
          -  Education intervention knowledge and practice
  
          -  Perform the post-test 1 (assess knowledge, practice confidence surveys
  
          -  Perform post-test 2 (assess knowledge, practice confidence surveys
  
        Study title:
  
        DEVELOPMENT, VALIDATION, AND EVALUATION OF THE EFFECTIVENESS OF SIMULATION IN BASIC LIFE
        SUPPORT TRAINING (SBLST) ON NEWLY EMPLOYED NURSES IN GOVERNMENTAL JORDANIAN HOSPITALS
  
        Research Hypotheses i. The simulation in basic life support training intervention effectively
        improves knowledge among newly employed nurses (NEN) in Jordanian governmental hospitals.
  
        ii. The simulation in basic life support training intervention effectively improves practice
        among newly employed nurses (NEN) in Jordanian governmental hospitals.
  
        iii. The simulation in basic life support training intervention effectively improves the
        confidence level among newly employed nurses (NEN) in Jordanian governmental hospitals.
  
        iv. There is no significant difference in means between the pre-test among the newly employed
        nurses (NEN) among interventional and the control groups in all dependent variables.
  
        v. There is a significant mean difference between PRE-SBLST and all POST-SBLST results among
        NEN in all dependent variables.
  
        Study Design The study design was a prospective, longitudinal, single-blind basic
        experimental design, randomized control trial (RCT) design.
  
        Study Location The study was carried out in Jordan, Amman and Al-Zarqa City. The accessible
        population was NEN in five hospitals. The researchers selected three Jordanian hospitals. The
        selection was according to the capacity, capability of the institution and eligibility
        criteria. Computer-generated randomization (Random Allocation Software, version 1.0) was
        applied in blocks to allocate the hospitals by distributing them into two arms. The first arm
        was the control group; selected from three hospitals; Prince Hamza Hospital, AL-Basheer
        Hospital, and AL-Zarqa Governmental Hospital (n=51); the second arm was the interventional
        group from two hospitals; Prince Faisal Governmental Hospital and Dr.Jameel AL-Totanji
        Hospital.
  
        Randomization of the Hospitals To prevent data contamination between the control and
        interventional groups, computer-generated randomization (Random Allocation Software, version
        1.0) was applied in blocks to allocate the hospitals by distributing them into two arms. The
        first arm was the control group; selected from three hospitals; Prince Hamza Hospital,
        AL-Basheer Hospital, and AL-Zarqa Governmental Hospital (n=51); the second arm was the
        interventional group from two hospitals; Prince Faisal governmental hospital and Dr.Jameel
        AL-Totanji hospital. The control and interventional groups were selected from different
        hospitals because the researchers are always worried about data contamination and try to
        minimize it between the control and intervention groups; if the sample was selected from the
        same area and both groups worked closely together, the data would be contaminated.
  
        The study consists of a pre-test, intervention, immediate post-test-1 after the intervention,
        and post-test-2 three months after the intervention. This study measured knowledge, practice,
        and confidence through pre- and post-tests in control and experimental groups. This study
        used two interventions: SBLST for the interventional group and AHA-BLS 2020 brochure as a
        standard treatment for the control group. Data collection proceeded using the Google Form
        Platform (A web-based instrument Copyrighted by Google application).
  
        The evaluation process includes a pre-test and two follow-up assessments to measure
        knowledge, practice and confidence. The researcher will analyze the means of each test; the
        total dependent variables were 30 questions.
  
        Research Instruments
  
        Languages of the Tools According to the HCP educational level, all four sections of the tools
        assessment are written in English; furthermore, the researchers' assistance clarified any
        misunderstanding points or need for translation to the participants.
  
        Tools Sections The tools consist of five sections; research information sheet and consent
        forms, demographical data, knowledge assessment tools, skills assessment tools, and
        confidence level assessment tools.
  
        Research information sheet and Consent Forms The research information sheet is a piece of
        brief researcher information and contact details; it also includes subject information and a
        consent form with an area for the participant's signature when they are approved to
        participate in this study. Furthermore, the research information sheets include a
        participant's publication consent form.
  
        Demographical data Demographic parts are attached; these data consist of dichotomous
        questions (Yes\NO), nominal data, ordinal data, and interval measurement questions. Nominal
        measurements include sex and ordinal assessment as educational level and area of experience;
        interval assessment questions include age and work experience. Dichotomous assessments
        (Yes\NO), asking if the participant previously participated in a CPR episode or observed any
        CPR before, if the participants had finished training the BLS using simulation previously,
        and if the participant gained the certification of BLS training from formal and accredited
        institutions.
  
        Knowledge and practice Nursing knowledge is the interaction of science and research to
        improve practice. Researchers use a 13-question MCQ tool to assess knowledge. Nursing
        practice is performing the knowledge learned before; the researchers assessed skills using a
        tool consisting of ten MCQ. The participants got zero for each wrong answer and one mark for
        each correct answer.
  
        Confidence Confidence is the building and accomplishment of the nursing profession through
        knowledge acquisition, skills, and critical thinking. Confidence is the positive feeling of
        faith and dependability to perform BLS without fear and free from risk to the patient. The
        researchers assessed confidence level using seven statements rated as a dropdown in percent
        value from the lowest value of 5% to the highest value of 100%.
  
        Study process steps
  
          1. Pre-test After NEN enrolled according to the inclusion criteria for both the control
             group and experimental group (n= 102), the participants started by signing the informed
             consent, filled out the demographical data and pre-test as proactive steps before the
             intervention; many sessions of pre-test data collection and intervention were performed
             according to the availability of NEN, the arrangement of the hospital's nursing
             director. The estimated time to fill in the demographical data and pre-test is around 30
             minutes. Oermann et al. (2020) addressed that the trainer performs a pre-test assessment
             to assess the effectiveness of SBLST. The investigators discussed the purpose of the
             study with the control group and explained to them the procedure to prevent any data
             contamination and minimize the interpretation of the survey content by the other
             research assistants.
  
          2. Intervention The control group read the brochure containing a brief guideline about
             basic life support for 30-60 minutes before taking the post-test. Standard treatment ran
             from Dec 2022 to Jan 2023. One full day for SBLST intervention, from 5 to 7 hours for
             SBLST intervention, is required based on the recent research and uses AHA-2020
             guidelines. The number of participants was ten NEN in each session. The interventional
             treatment consists of theoretical and practical parts. The SBLST intervention was
             conducted in an educational lab according to the hospital's capability; SBLST ran for
             seven days, from 22 Nov 2022 to 20-Dec, 2022.
  
             Researchers combined two frameworks in the SBLST. Miller's Pyramid and Kolb's Cycle;
             Miller's Pyramid focuses on teaching theoretical and practical aspects of the task
             through simulation and allowing trainees to perform the procedure independently with
             guidance; Kolb's Cycle suggests giving learners a scenario to practice until they
             eliminate errors before moving to another scenario. The SBLST intervention was reviewed
             by three experts in BLS and approved by the Jordanian Ministry of Health-Life Support
             Center. It was found to be compliant, safe and covered all aspects of AHA-2020. English
             experts provided feedback to improve clarity. A pilot study was conducted on 20 nurses
             to calculate SBLST time, identify errors, monitor the progress and calculate Cronbach's
             Alpha.A pilot study was performed to check the stability of the tools. Cronbach's alpha
             of knowledge and skills assessment tools was 0.748, reflecting the suitability and
             strength of using these tools. Moreover, Cronbach's alpha of confidence tools was 0.731,
             reflecting the suitability and stability of the confidence tools.
  
             Adult half-body manikin and a pediatric full-body manikin are necessary; with lung bag
             inflation and deflation characteristics, palpable carotid pulse, the chest includes
             spring inside to facilitate chest recoil, and chest compression board,
             bag-valve-mask-ventilation, chest compression performed on the Charlie simulator to
             relieve choking. The principles investigator (PI) had a master's degree in critical care
             nursing, eighteen years of experience between ICUs, lecturers and clinical instructors,
             valid BLS and ACLS, training of trainers in nursing education, and randomized control
             trial training. The facilitator must have CPR certifications in BLS and ACLS, enough
             expertise in education and training, and good communication skills. The investigator had
             a master's degree in critical care. Two research assistants supported the PI in
             collecting data; one research assistant for the control group and the other for the
             interventional group.
  
          3. post-test All participants completed the immediate post-test-1 after the interventions.
             The post-tets-2 was conducted by providing the participants with a Google Form Platform
             link through their phone and email addresses. The post-test after three months evaluates
             whether the participants' level stayed at the same level or minimized by comparing the
             mean value between all post-tests. Forty-eight participants in the experimental group
             completed post-test-2 with a response rate of 94%, and 45 participants in the control
             group with a response rate of 88%.
  
        Sample Size Estimation Sample size calculation is performed by using G*POWER software
        (version 3.1); sample size calculation is summarized and consists of the following steps (1)
        Select the test family (F-test family), (2) Select the statistical test (Select
        ANOVA-repeated test, between factors), the preliminary test analysis the researchers used in
        this study, the rationale for using the Select ANOVA-repeated test between factors due to
        measuring many dependent variables means at different time points. (3) The parameters
        selected to calculate sample size include one side tail, alpha (α) and equals (0.05)- type
        one error, Power (P) and equal (0.8), effect size, the number of groups is two (each group =
        n\2) n= the estimated sample size, number of measurements were four measurements (Pre-test,
        Post-test immediately, Post-test after two months, and Post-test after three months).
  
        Effect Size (ES) = 0.26, automatically calculated by G*Power software, depending on the
        sample size of the previous study, the effect size is calculated, the Control group's
        post-test result M±SD was equal (25.03±3.04) with a sample size of 28 participants, and the
        interventional group (26.64±2.64) with sample size 29 participants. The sample size is 72
        participants; because the research study continued for three months, the invistigators added
        a 10% drop rate for each month, so the drop rate is 30%. Final sample size estimation
        including drop rate (n\1-dropout rate) = 72/(1-0.30) = 102 participants, the intervention
        group arm is 51 participants, and The largest sample size was obtained from the
        interventional group, more than the Control Group and the Control group arm 51 participants.
  
        Simple Random Sampling of the Participants After obtaining ethical approval and permission to
        conduct the study from the Ministry of Health in Jordan, approval letter (Education/Info\
        15177) and ethical approval letter (MOH/REC/2022/340), The researchers started the formal
        face-to-face visits to arrange with the nursing director and a continuous education office in
        the selected hospitals about the study objective and how the study would proceed; The
        researchers received the activation letter to initiate the study and prepared the list of the
        available participants who met the study's eligibility criteria. The number of participants
        depends on the availability of newly employed nurses in the institution who meet the
        inclusion criteria. The researchers randomly selected the participants from the participants'
        list by randomly sampling from newly employed nurses in each hospital for interventional and
        control groups.
  
        . The response of the control group hospitals was as the following; the nursing director and
        continuous education in AL-Zarqa Governmental Hospital responded by providing all the
        information about participants and selecting a time and day to perform the Pre-test, standard
        treatment and the immediate post-test. Prince Hamzah Hospital and AL-Basheer Hospital gave
        the researcher the names of departments in the hospital, including those with NEN, and the
        invistigators visited these departments to select the available NEN randomly and performed
        Pre-test, standard treatment, and immediate post-test in their departments.
  
        The response of the interventional group hospitals was as the following; Prince Faisal
        Governmental Hospital and Dr.Jameel AL-Totanji Hospital scheduled many days and times to
        perform the intervention, and the hospitals arranged with the available participants who met
        the eligibility criteria; then, the researcher selected the participants randomly.
  
        Ethical Considerations
  
          1. Permission to Conduct the Study Regarding ethical considerations, approval for the study
             was obtained from the Human Research Ethics Committee (HREC), Universiti Sains Malaysia
             (USM). Moreover, ethical approvals to initiate SBLST intervention in Jordanian Hospitals
             in Amman and AL-Zarqa city were obtained from the Ministry of Health in Jordan; the
             study protocol was revised and approved for implementation by Jawatankuasa Etika
             Penyilidikan Manusia Universiti Sains Malaysia (JEPeM-USM) with study protocol code
             USM/JEPeM/22110681, which compliance with the Declaration of Helsinki, International
             Conference on Harmonization (ICH) Guidelines, Good Clinical Practice (GCP) Standards,
             Council for International Organizations of Medical Sciences (CIOMS) Guidelines, World
             Health Organization (WHO) Standards and Operational Guidance for Ethics Review of
             Health-Related Research and Surveying and Evaluating Ethical Review Practices, EC/IRB
             Standard Operating Procedures (SOPs), and Local Regulations and Standards in Ethical
             Review.
  
          2. Subject Vulnerability There is no vulnerability group in this study. All the
             participants were nurses over 20 years old and working in hospitals; no participants had
             handicaps or physical problems. The participants made the voluntary choice to take part
             in the trial. The researchers discussed the study's objectives, methods, benefits and
             risks. The study was free from any potential hazards or adverse effects on participants,
             no intervention was applied in emergencies, and no medicine product will be used in this
             study. The procedure was simple, the devices used in the intervention were safe, and the
             investigator was instructed to frequently ask the participant about health and physical
             condition, especially during chest compression.
  
             The participants who signed a hard copy of the consent are part of this trial study.
             During all study phases, the participants will be asked using the electronic method;
             Google Form Platform, if they would like to participate in this study, and they will
             answer (YES\NO) before completing the questionnaires. Furthermore, the intervention will
             be applied in simulation; the participant voluntarily withdraws from the study without
             any influence or effect on annual evaluation or salary. The institutions took full
             responsibility for the trial and protecting the participants and treated the
             participants if there were unexpected adverse effects or physical harm.
  
             The research includes minimal risk toward participants, observable by the time length
             and components of the intervention; participants may be feeling discomfort. This risk is
             equal to the nurses' daily life activity. They can be adapted with this minimal risk;
             only four components require a long time to cover the knowledge and practice in the
             intervention, but the other four components are easy and need a short time. The
             researchers planned to minimize the participant's discomfort due to the time and length
             of the intervention by giving the participant "break times" between the components of
             the intervention.
  
          3. Declaration of Absence of Conflict of Interest The researchers had declared that there
             was no conflict of interest, and all co-authors had no financial interest to report. The
             invistigators certify that the first author is purely a Ph.D. student's original work
             and has not been given to submit to other universities or journals.
  
          4. Privacy and Confidentiality When the study was completed, the trial master files and
             documents were protected and kept safe, and all records were kept confidential.
             Furthermore, the data collected is not associated with individuals by name but only by
             phone number and email to contact them later to complete the post-test; data is kept
             properly and handled only in the research. In addition, the researchers also emphasized
             that only research groups can access the relevant data in this research and not use it
             in the future without consent from the participants; moreover, after finishing the
             study, the data will archive properly according to the policy.
  
          5. Community Sensitivities and Benefits The intervention benefits of NEN as a part of a
             contentious education, and the knowledge and practice shared through the natural
             learning process in the classroom, face-to-face learning, and the questionnaires filled
             using an electronic method, Google Forms Platform; there is no sensitive information
             about the participants. The primary benefits of this study's findings toward
             participants are to increase newly employed nurses' knowledge, practice skills, and
             confidence level when facing critical situations inside or outside the hospitals,
             increases professionalism in all healthcare delivery systems, self-esteem, improve newly
             employed nurses' performance competency, decision-making, satisfaction, to decrease
             turnovers and dissatisfaction. Furthermore, the benefits of this study are to develop
             patient care processes and enhance the victims' survival and patient satisfaction,
             maintain patient safety, enhance the welfare and hospital discharge outcomes, become
             cost-effective for patients and their families, and keep patients away from hazards.
  
          6. Incentive and Reimbursement The researcher verbally thanked all participants for their
             sincere cooperation following the completion. Furthermore, the researcher planned to
             give the control group an SBLST on a selected day; finally, the participant received
             feedback about the pre and post-result and a certification attendance of 4 hours from
             the researcher, adding to the required job development hours in the yearly
             self-evaluation form.
  
          7. Collaborative Study Terms of Reference: None
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study design is a basic experimental study design, randomized control trial (RCT) design, SBLST for the intervention group and standard intervention to the control group by using a brochure; the SBLST intervention among the control group was delayed until the end of data collection as an appreciation for their participation in the study, control group participants are wait-listed and exposed to the experimental treatment at a later point.
  Pre-prepared Basic Life Support Guidelines 2020 Treatment (A): Standard Treatment The investigator will give the participants in the control group; the standard treatment by using an AHA-BLS 2020 brochure. The participants will read and understand this brochure over 30 minutes Treatment (B): Simulation in basic life support training The interventional tools, simulation in basic life support training (SBLST), were prepared in English. The researcher will use an already established BLS training from the American Guidelines 2020 (AHA, 2020c)
  primary purpose: Health Services Research
  masking: Single (Participant)
  measure: The Effectiveness of Simulation in basic life support training (SBLST) on the Knowledge Score
  time frame: 6 Months after finish all data collection
  description: To evaluate the effectiveness of SMBST on knowledge scores, investigators will conduct three measurements: a pretest, an immediate post-test after the intervention, and a post-test 2 after three months for both experimental and control groups. Participants will be sent a questionnaire consisting of 13 MCQ three times via Google Form Platforms. These questions will be sent to their cell phone numbers. Repeated measure ANOVA will be conducted for both groups and the mean knowledge scores between the pretest and post-test will be compared. The level of significance will be determined by the p-value to accept or reject the alternative hypothesis (The simulation in basic life support training intervention improves knowledge among newly employed nurses (NEN) in a Jordanian governmental hospital). The intervention is educational and poses no risk or adverse effects to the participants.
  measure: The Effectiveness of Simulation in basic life support training (SBLST) on the Practice Score
  time frame: 6 moths after finish all data collection
  description: The investigators performed three measurements to assess the effectiveness of SMBST on practice score; Pretest, immediate-posttest after the intervention, and post-test-2 after three months of the intervention for both experimental and control groups. The practice questionnaires consist of ten MCQs, and the participants will answer this survey three times; these questions will send to the participant's cell phone numbers as a link from Google Form Platforms at all times off-test family, ANOVA for experimental and control groups, then comparing the mean between practice score in both groups and between pretest and post-test and finally identify the level of significant by p-value to reject or accept the alternative hypothesis" The simulation in basic life support training intervention effectively improves practice among newly employed nurses (NEN) in Jordanian governmental hospital." The intervention is educational, and there is no adverse effect or risk to the participant.
  measure: The Effectiveness of Simulation in basic life support training (SBLST) on the Confidence Level
  time frame: 6 moths after finish all data collection
  description: The effectiveness of SMBST on confidence levels will be assessed by measuring pretest, immediate posttest, and post-test-2 results for both experimental and control groups. Participants will complete the survey three times using a Google Forms link sent to their cell phones. Repeated measure ANOVA will be used to analyze the data and compare mean confidence levels between the groups and pretest/post-test scores. The intervention has proven effective in improving confidence levels with no adverse effects or risks.
  measure: There are no significant differences between the control and experimental groups in the knowledge score pretest
  time frame: 2 month after finsh the pre-test of both group
  description: Before implementing any interventions for the experimental and control groups, the investigator ensures that the pretest levels of both groups are significantly similar to ensure accurate measurement. After conducting an ANOVA analysis and pairwise comparison with means, standard deviation (SD), and P value results, the investigator will decide on this hypothesis. The intervention is educational and poses no adverse effects or risks to the participants.
  measure: There are no significant differences between the control and experimental groups in the practice score pretest
  time frame: 2 month after finsh the pre-test of both group
  description: Before implementing any interventions for the experimental or control groups, the investigator takes measures to ensure that both groups possess comparable pretest scores, thus guaranteeing precise measurements. The validity of this hypothesis will be substantiated through ANOVA analysis, whereby means, standard deviation (SD), and P-values will be compared using pairwise comparisons. It is important to note that the educational intervention provided does not carry any risk or adverse effects for the participants.
  measure: There are no significant differences between the control and experimental groups in the pretest regarding confidence level.
  time frame: 2 month after finsh the pre-test of both group
  description: Before performing any intervention for the intervention; and experimental groups, the investigator makes sure that the pretest of both groups is significantly the same level to ensure the accuracy of the measurement; the investigator will decide on this hypothesis after ANOVA analysis and use pairwise comparison with means, standard deviation (SD), and P value results. The intervention is educational, and there is no adverse effect or risk to the participant.
  measure: Significant differences exist between the control and experimental groups in the post-tests on knowledge scores.
  time frame: 6 moths after finish all data collection
  description: The investigator will assess the effectiveness of SBLST on the experimental group by comparing post-test mean and SD and assess the level of significance (p-value) for the control and experimental group to decide that the SBLST was effective on knowledge score using ANOVA repeated measure analysis. The intervention is educational, and there is no adverse effect or risk to the participant.
  measure: Significant differences exist between the control and experimental groups in the post-test after the interventions on practice score
  time frame: 6 moths after finish all data collection
  description: The investigator will assess the effectiveness of SBLST on the experimental group by comparing post-test mean and SD and assess the level of significance (p-value) for the control and experimental group to decide that the SBLST was effective on practice score using ANOVA repeated measure analysis. The intervention is educational, and there is no adverse effect or risk to the participant.
  measure: Significant differences exist between the control and experimental groups in the post-test after the interventions on the confidence level
  time frame: 6 moths after finish all data collection
  description: The investigator will assess the effectiveness of SBLST on the experimental group by comparing post-test mean and SD and assess the significance level (p-value) for the control and experimental group to decide that the SBLST was effective on confidence level using ANOVA repeated measure analysis. The intervention is educational, and there is no adverse effect or risk to the participant.
  measure: There are no differences between the control and experimental groups in the inclusion criteria
  time frame: 2 month after finsh the pre-test of both group
  description: The investigators selected inclusion criteria for both the control and experimental group, and both groups should be Homogenous in the demographical data by using Mann-Witney U-test and checking the median and IQ range. The intervention is educational, and there is no adverse effect or risk to the participant
  arm group label: SBLST Group
  arm group type: Experimental
  description: Treatment (B): Simulation in basic life support training The interventional tools, simulation in basic life support training (SBLST), were prepared in English. The researcher will use an already established BLS training from the American Guidelines 2020, a simplified two-part; PowerPoint presentation and clinical simulation training.
  arm group label: Standard Group
  arm group type: Active Comparator
  description: The investigator will give the participants in the control group; the standard treatment by using an AHA-BLS 2020 brochure. The participants will read and understand this brochure over 30 minutes, including a brief guideline about basic life support guidelines, and after these 30 minutes, the participants will move to the post-test.
  intervention type: Other
  intervention name: Simulation in basic life support training (SBLST)
  description: The interventional tools, simulation in basic life support training (SBLST), were prepared in English. The researcher will use an already established BLS training from the American Guidelines 2020, a simplified two-part; PowerPoint presentation, and clinical simulation training.
  arm group label: SBLST Group
  intervention type: Other
  intervention name: standard treatment by using an AHA-BLS 2020 brochure
  description: The participants will read and understand this brochure over 30 minutes, including a brief guideline about basic life support guidelines, and after these 30 minutes, the participants will move to the post-test
  arm group label: Standard Group
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Jordan
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  responsible party type: Sponsor-Investigator
  investigator affiliation: Universiti Sains Malaysia
  investigator full name: yousef Shukry Mohammad Abu-Wardeh
  investigator title: PHD STUDENTS aCUTE AND CRITICAL CARE IN NURSING
  sharing ipd: Yes
  ipd description: Only the participant data related to the study after participate and publication consent without mentioned name, ID, email...and providing the privacy
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: after finish and publish the study and will not use in any other study
  ipd access criteria: Data is kept properly and handled only in the research. In addition, the researchers also emphasized that only research groups can access the relevant data in this research and not use it in the future without consent from the participants; moreover, after finishing the study, the data will archive properly according to the policy.
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