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.
Phase: NA
Conditions: Healthy Nurses, Educational Activities
Sponsor: yousef Shukry Mohammad Abu-Wardeh

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DEVELOPMENT, VALIDATION, AND 
EVALUATION OF THE EFFECTIVENESS OF 
SIMULATION IN BASIC LIFE SUPPORT TRAINING 
(SBLST), ON NEWLY EMPLOYED NURSES IN 
GOVERNMENTAL JORDANIAN HOSPITALS 
 
 
Study Protocol  
 
Last update 0n 20-4-2023 
Malaysian Human subjects protection review board date: 20-4-2023 
 
 
 

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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 
Objective  
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 

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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  

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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. 
Inclusion Criteria 
The researchers tried to maintain homogeneity and minimize any variations among the 
participants by  
1. selecting both interventional and control groups from newly employed nurses 
2. Male and female participants  
3.  Participants only who understand the questionnaires and interventions in English 
4. Participants who were previously on-seat undergraduate nursing students last two 
years, 2020 (4th year nursing bachelor level) and 2021 (3rd year nursing bachelor 
level) in the period of COVID-19 pandemic and receive basic and clinical learning by 
online method, and now became a newly employed nurse (NEN) in hospitals and 
delivered care to the patient. 
5. Participants can attend five to seven hours of SBLST session. 
6.  For more control, we selected nurses who rarely face CPR and do not attend BLS 
raining the last two years.  
 
 
 

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Exclusion Criteria 
1. The researchers excluded the NEN participants working in intensive care units because 
ICU nurses face CPR and perform BLS daily.  
2. Excluded participants with medical or physical health problems (e.g., pregnant women 
and participants complaining of lower back pain).  
3. Participants who attended CPR training less than two years previously were also 
excluded. Finally,  
4. NEN who upgraded their educational degree from a diploma to a bachelor's degree 
were excluded.  
 
Research Instruments 
The study consists of a pre-test, intervention, immediate post-test-1 after the 
intervention, and finally, the 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 analyse the means of 
each test; the total dependent variables were 30 questions listed in. 
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.  
 
 

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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 in; 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 previously. 
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. 

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Confidence  
Confidence is the build 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 
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 
with the other 
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 

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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. 
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 degree in critical care. Two research assistants supported the 

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PI in collecting data; one research assistant for the control group and the other for the 
interventional group. 
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 measure 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 

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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, we 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 

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hospital, including those with NEN, and we 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 
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. 
Subject Vulnerability 

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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 

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and length of the intervention by giving the participant "break times" between the 
components of the intervention. 
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. We 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. 
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.  
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, 

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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. 
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.