Effectiveness of simulation in teaching immunization in nursing: a randomized clinical trial*

Objective: to evaluate the effectiveness of the clinical simulation on the cognitive performance of nursing students in adult immunization scenarios in the context of Primary Health Care. Method: a controlled and randomized pre-test and post-test clinical trial applied to random intervention and control groups. 34 undergraduate nursing students were selected and divided into two groups: classes with active participation of students and skills training (control); and classes with active participation of students, skills training, and clinical simulation (intervention). Results: the students in the intervention group performed better than those in the control group in the four assessments of cognitive performance, with statistical significance in the assessments of immediate (p=0.031) and late (1-20 days) (p=0.031) knowledge. Conclusion: from the simulation, students learn more in the short and medium terms. The information learned is retained for longer and the students are better prepared for the professional practice. Universal Trial Number: u1111-1195-2580


Introduction
In Brazil, the National Immunization Program (Programa Nacional de Imunização, PNI) is recognized for its great contribution in reducing the indicators of morbidity and mortality caused by vaccine-preventable diseases. In addition, in the international scenario, it is considered the program that offers the largest number of free immunobiologicals (1) .
It is important to highlight the important role of nurses to achieve the good results presented by the PNI since, within the scope of health units and services, these professionals contribute positively to processes that enable the immunization of the population.
Some of these professionals' attributions include the following: management of the vaccine room, training and coordination of the nursing staff for maintenance and administration of immunobiologicals, application of doses of immunobiologicals, appointments, planning and development of strategies to expand and enable access to immunobiologicals (1) .
In identifying and recognizing the duties and contribution of professional nurses in making the processes that lead to immunization feasible and effective, it is important to consider the need for qualification of the nursing students during graduation.
For example, practical internships by themselves do not guarantee that the students will be prepared to deal with the different situations commonly encountered in the realities of the health services, especially in the vaccination room.
When entering the Basic Health Units (BHUs), for example, the newly-graduated nurse has the same responsibilities as the other nurses in these services. From this perspective, failures during their training can compromise the execution of tasks and culminate in unwanted performance and damage to the population's health (2) . Therefore, it is necessary to rethink topics such as the curriculum, the contents, and methodological approaches adopted in teaching in the context of Primary Health Care (PHC). In this way, the Pan American Health Organization (PAHO) and the World Health Organization (WHO) have encouraged countries to promote reforms and improvements in the education of health professionals focused on PHC, especially in the Latin American context (3) .
However, in the education context, more traditional strategies have still been used on a large scale (4) .
In undergraduate nursing courses, for example, the strategies most used in PHC teaching are the following: workshops, teaching by projects, teaching by research, and internships (5) . Therefore, there is an urgent need to diversify the teaching and learning strategies used during the training of nurses. Furthermore, this learning needs to be significant in terms of applicability in the professional practice.
In this sense, simulation gains a prominent position when compared to other more traditional teaching and learning strategies since, in nursing education, simulation is identified as a teaching technique that uses technologies to replicate scenarios that simulate practice, in a controlled and realistic environment, where the student participates actively in the teaching and learning process in order to exhaustively practice, learn, reflect and evaluate products and processes (6)(7) .
Corroborating this relevance and applicability in nursing education, a study involving 25 countries in Latin America and the Caribbean, in 246 nursing schools, recommends the development and implementation of clinical simulation experiences centered on PHC (8) . The same study also suggests the need to identify leaders in this area; however, difficulties such as the lack of funding, the deficit in simulation training for teachers and lack of support from funding institutions are some of the challenges for researches in this area (9) . Few nursing studies have compared the results of the students' simulated clinical experiences with the results of the traditional clinical setting (10) . The students participating in the study were regularly enrolled in the 5 th to 9 th semester of the Nursing Undergraduate course. The option to prioritize these students was due to their availability to take the course that made data collection possible. The initial non-probability convenience sample was of 58 students.
After consolidating the instrument of characterization of the population in an electronic spreadsheet, the data were forwarded to an independent statistician for randomization. In this procedure, the following variables were taken into account: gender, age,  Rev. Latino-Am. Enfermagem 2020;28:e3305.   (4) . In addition, the dimensions of the S.M.A.R.T structure (objectives, measurement of results, achievement of objectives, realism, and time) were taken into account (12) . The scenarios were tested and validated by specialists for appearance and content. The specialists consulted were the researchers of the project.

Follow-up
The scenarios were previously tested. For the simulations, the standard-patient tool was used, with actors trained to act and reproduce user behaviors in different situations and health care establishments (13) .
The three scenarios were executed on the same day.
At the end of the simulations, the intervention group participated in the discussion and reflection, using the debriefing technique, stage in which all the students can discuss about the experienced scene.
At that moment, the students had the opportunity to explore the scenarios experienced in order to help them consolidate the information acquired, identify and reflect on areas in which they could improve (14) . Each session lasted 30 minutes. With regard to the time of the session, it is important that it is not too long. It is recommended to be the double or triple of the scenario execution time (15) .

Results
Most of the students who participated in the study were female (79.6%) and young adults. Regarding cognitive performance, Table 1 shows the values of the previous, immediate and late (20 and 40 days) evaluations. The intervention group (with simulation) had the best performance in all the evaluations, with an initial mean of 3.38 (maximum of 7.40 and minimum of 0.50) and a final mean of 6.55 (maximum of 9.00 and minimum of 3.00).
Although with lower performances, the students in the control group also showed an improvement during the four assessments, with an initial mean of 3.35 and a final one of 6.01. Both groups obtained increasing rates of performance in the short, medium and long terms.
The students in the intervention group (IG) had a better performance compared to the control group (CG) in the Post 1 (p-value = 0.031) and Post 2 (p-value = 0.031) assessments. This result suggests that, with the simulation, the students learn more in the short term and that the information learned is retained for longer.

Discussion
The study evaluated the effectiveness of the clinical simulation in the cognitive performance of nursing students in adult immunization scenarios in the context of PHC. It is known that Nursing has essential roles to guarantee the processes related to immunization, such as management of the vaccine room, organization and disposal of materials and supplies, conservation of immunobiologicals, and the nursing conduct (16) .
Although the relevance and contribution of the nursing professionals in the context of immunization are recognized, nursing errors are recurrent, such as the Adverse Events Following Immunization (AEFIs). Reports of these events after immunization are considered relevant worldwide (16) .
A Brazilian study that analyzed the occurrence of AEFIs due to immunization errors showed a significant increase in cases over a period of ten years. Thus, a disturbing scenario is observed since this type of error, linked to the nursing practice, can be avoidable (17) . This result raises concern as errors can interfere with the population's confidence and, consequently, in the control of vaccine-preventable diseases (16)(17) .
It is known that the PNI is the largest immunization program in the world. In this perspective, the offer and expansion of the number of immunobiologicals, the countless vaccination teams, the inadequate practices of conservation and administration of doses, and the constant updates in immunization schedules can contribute to errors (17) .
In this perspective, it is urgent to think about actions that promote safety and quality in immunization. Thus, thinking about teaching and learning strategies that promote meaningful learning is relevant and current (17)(18) .
Several studies indicate strategies for improving safety in the scope of immunization, such as the use of protocols (15) and improving the education Rev. Latino-Am. Enfermagem 2020;28:e3305.
of both (18) students and professionals through continuing education (19) .
In the educational field, educational approaches that consider practical experiences have a substantial character. Thus, it is essential to rethink nursing education, especially when it comes to revisiting old assumptions, such as that the student's learning is mainly related to the amount of information received from the teacher. The students are deemed to build their own cognitive structures and, from their interaction with the environment, to consolidate their knowledge (20) .
In this way, it is understood that learning becomes significant when there are relations, built by the students, between previous knowledge and new knowledge. Meanwhile, it is considered that when these relationships occur, there is effective, consolidated, and lasting learning (21) .
Significant learning is identified by the student when the acquired knowledge has applicability in the work practice (22) . Thus, the clinical simulation, as it has a realistic nuance, can be a teaching strategy to promote more consistent and significant knowledge (23) .
In this research, the students who participated in the training with the simulation had better performances -in the short and medium terms -when compared to those who were exposed to traditional teaching strategies. and high-fidelity simulation. However, the scores of the group with simulation were higher, both in terms of acquisition and of retention (24) .  (26) .
Thus, traditional teaching methodologies, used occasionally, do not support quality education. In the context of nursing education, as science evolves, teaching and learning must be improved to keep up with the current health needs and changes (27) . In addition, the premise for having a quality training of nurses demands adequate and proper infrastructure, structured syllabus, and partnerships (28) .
When thinking about quality training and its requirements, one should consider the current job market, new technologies, current health demands, patient safety, and ethical issues (27) . To this end, it is necessary to use teaching and learning methodologies that consider these aspects, such as the clinical simulation, which is seen as a potential teaching and learning strategy as it is based on the aforementioned factors.
Regarding the stages of the simulation strategy and its potential for meaningful learning, the student's participation in the debriefing stands out. In this phase, students can be guided in identifying gaps in the performance of tasks and their improvement (29)(30) .
In summary, there is the possibility of reflecting on the actions and on improving learning for future situations (31) .
Compared to other teaching strategies, the clinical simulation has the advantage of promoting organized and planned knowledge, where the student is the active participant in this process. Combined with the simulation, this structure has a greater impact on the students compared to feedback (32) . Questioning, exchange of experiences and knowledge about the experiences, the performance, the strategies for improving the actions and the transposition of this experience into work practice are part of this teaching and learning strategy.
High-quality simulated learning has the potential to be transformative, to engage emotions and to enable students to be directly involved in activities that reflect experiences in the workplace (33) .
The use of simulation has been increasingly present in nursing education (34) . Several research studies report benefits and acquisition of skills and abilities such as empathy, articulation between theory and practice, reduction of errors, decision making, leadership development, improvement in the health service processes and even increase in the levels of satisfaction, autonomy and self-confidence (35)(36)(37)(38)(39)(40)(41) .
Some benefits of the simulation include flexibility of access -without depending on the scheduling of days and hours in the clinical practice; a safe setting, both physically and psychologically, so that students can develop skills and make mistakes without causing damage to the users; the prior use of technologies that exist in the real practice; and the possibility of experiencing situations that are not commonly found in the practice -due to the impossibility of diagnoses, patient discharge, and/or lack of opportunities (42) .
Given the recognition of the possibilities and benefits of using the simulation in the context of teaching and learning in health and nursing, the WHO recommends its use in this context (43) . In this sense, better designed studies contribute to the production of evidence, to the expansion of the applicability of its use, and to the improvement of the quality of vocational training (45) .
While recognizing the relevance of training skills related to immunization practices, both in undergraduate courses and for the work practice, these trainings are not usually available in adequate formats in the educational institutions.