Introduction

Countless innovations and paradigmatic changes in the academic context of nursing graduation in recent years have focused on the training of professionals with competence not restricted to the execution of technical skills, but, above all, to the improvement of attitudes and feelings that will be crucial to dealing in a balanced and safe way with the activities inherent to the complexity of the profession.(¹,²)

Outcomes present in clinical practice call for the need to direct efforts to correct care weaknesses, as human errors related to care, in addition to not being rare, directly or indirectly impact the treatment of sick and hospitalized individuals, such as medication errors committed by nursing professionals.(³,⁴) The administration of medications in health units is the legal responsibility of nursing and must guarantee therapeutic precision, an essential condition to minimize risks to patients’ health, essentially based on technical and non-technical skills.(⁵,⁶)

Investing in active strategies that encourage undergraduate students to develop non-technical skills, such as satisfaction and self-confidence, can be useful for improving the work process of future professional nurses.(⁷-⁹)

Satisfaction can be defined as a feeling of pleasure or disappointment resulting from the performance expected and the performance achieved, given each individual’s expectations regarding the experience.(¹⁰) In turn, self-confidence refers to the belief in oneself or the conviction of being able to accomplish something and achieve your own goals. This feeling provides significant benefits, culminating in positive results for learning and, consequently, for the quality of the service performed.(¹¹)

The use of manikins in simulation-based education (SBE) during nurse training is not new and is linked to the need to develop skills in the absence of the risk of harming human patients.(¹²) High-fidelity manikins (HFM) have characteristics who value the idea of realism when replicating human responses. On the other hand, low-fidelity manikins (LFM) are static and have minimal ability to replicate human responses, therefore they are generally limited to skills training.(¹³)

Manikins for simulating human patients are being widely used in the training of nursing professionals and it is believed that the levels of self-confidence and satisfaction of students can be even greater with the help of simulation.(¹⁴)

A systematic review points out that SBE contributes to student learning in several ways, but there is still no consensus on whether differences in the manikins’ fidelity in simulated scenarios have an effect on satisfaction and self-confidence in the learning process.(¹²)

In this context, the objective of this study was to compare the effect of different fidelities of manikins used in the simulation on the levels of satisfaction and self-confidence with the learning of undergraduate nursing students in relation to the administration of intravenous medication to critically ill patients.

Methods

Randomized clinical trial (RCT), controlled and double blind developed in a public higher education institution (HEI) in the Federal District, Central-West region of Brazil, between March and December 2019. The recommendations of the Study Assessment Rubric were adopted in Simulation(¹⁵) and the CONSORT initiative standards aimed at simulation studies.(¹⁶)

The main researcher and the person responsible for statistical analysis were blinded. Participants were not blinded due to the expected contamination effect between the groups,(¹⁷) which was reduced by the confinement strategy during the intervention, when the groups were kept in separate environments.

The sample size was calculated considering a significance of 5%, medium effect size (d = 0.6), average intraclass correlation (ρ = 0.50), two comparison groups (g = 2) and three measurements in each student (n = 3). Thus, 30 was the number of students in each group to guarantee a minimum power of 80%.

The study population comprised 88 students regularly enrolled in the seventh semester of the HEI undergraduate nursing course. Students aged 18 or over and actively enrolled in the subject of nursing care for critical patients, offered in mandatory and in-person mode, were included. Those who declined at any stage or refused to participate in the study were excluded.

Initially, six students refused to participate in the study, with the remaining 82 being randomized between groups. Randomization was carried out by a trained external collaborator and occurred through manual drawing using a sealed brown envelope with the intervention code numbers. Each student was coded by alphanumeric combination. All questionnaires and scales were identified by individual coding for each participant and this occurred at all stages of the study to maintain blinding and anonymity.

After randomization, a total of 41 students constituted the Experimental Group (EG) and the remaining 41 constituted the Control Group (CG). During monitoring, there was a loss of 10 students from the EG and 12 students from the CG due to discontinuation. Thus, the study sample included 60 students, 31 from the EG and 29 from the CG (Figure 1).

The simulated scenario was prepared following the standard of good practices recommended by the International Nursing Association for Clinical Simulation and Learning (INACSL).(¹⁸) The theme of the scenario was pulmonary sepsis with emphasis on the administration of intravenous medication, both for the EG and for the CG. The difference was the type of patient manikin, for EG being the HFM Laerdal SimMan®, equipped with a technological device capable of reliably mimicking physiological actions and responses, providing the learner with a high standard of interaction, close to the real thing. For the CG, a static LFM was adopted, incapable of reproducing physiological responses and promoting interaction.

The scenario was validated by a panel of judges made up of five nursing professors with experience in simulation, who, upon watching the execution of the simulated scenario, filled out an instrument adapted from the proposal by Nascimento and Teixeira.(¹⁹) The intraclass correlation coefficient of 0.83 (p<0.001) represented the reliability of the measurements carried out by the five evaluators, who considered the scenario valid and suitable for implementation in the study.

The simulation included the following moments: 1) prebriefing, lasting 15 minutes, to present the available materials and read the clinical case to the student by a trained facilitator; 2) simulation, lasting 15 minutes, for the student to act and administer the medication; and 3) debriefing, lasting approximately 15 minutes, for students to reflect on the simulated experience.

The clinical case of the simulation included a simulated patient with pulmonary sepsis, atrial fibrillation, productive cough for five days and pain in the retrosternal region, which progressed to worsening hemodynamics and the need for administration of intravenous antiarrhythmic medication.

The demographic (gender and age) and independent variables (percentage distribution of failure in subjects during graduation, previous simulated experience and previous training in the health area) were obtained through a Semi-structured Student Characterization and Identification Questionnaire (SSCIQ).

The dependent variables (satisfaction with learning and self-confidence in learning) were obtained after filling out the Student Satisfaction and Self-Confidence in Learning Scale (SCLS), composed of 13 items assessed using a 5-point Likert scale, with 1 – strongly disagree with the affirmation; 2 – I disagree with the statement; 3 – undecided, neither disagree nor agree; 4 – I agree with the statement; and 5 – I strongly agree with the statement. The SCLS has internal content validity for the Portuguese language expressed by Cronbach’s Alpha of 0.86 for the satisfaction construct, 0.77 for the self-confidence construct and 0.84 for the general scale.(¹¹)

The 13 items of the SCLS are subdivided into two parts. There are five items related to satisfaction with current learning: item 1) The teaching methods used in this simulation were useful and effective; item 2) The simulation provided me with a variety of teaching materials and activities to promote my learning of the medical-surgical curriculum; item 3) I liked the way my teacher taught through simulation; item 4) The teaching materials used in this simulation were motivating and helped me learn; and item 5) The way my teacher taught through simulation was suitable for the way I learn. Self-confidence in learning is assessed through the other eight items, as follows: item 6) I am confident that I have mastered the content of the simulation activity that my teacher presented to me; item 7) I am confident that this simulation included the content necessary to master the medical-surgical curriculum; item 8) I am confident that I am developing skills and obtaining the necessary knowledge from this simulation to perform the necessary procedures in a clinical environment; item 9) My teacher used useful resources to teach the simulation; item 10) It is my responsibility as the student to learn what I need to know through the simulation activity; item 11) I know how to get help when I don’t understand the concepts covered in the simulation; item 12) I know how to use simulation activities to learn skills; and item 13) It is the teacher’s responsibility to tell me what I need to learn in the theme developed in the simulation during the class.(¹¹)

At time 0 (T0) or baseline, prior to the intervention, students completed the SSCIQ and SCLS, which were used to assess self-confidence and satisfaction with the learning process prior to the simulation. Such a strategy was necessary and motivated by the possibility of identifying the baseline of the students’ self-perception of these feelings, thus making it possible to trace an ascending or descending profile of the study variables.

One week after T0, students were gathered in the HEI auditorium, where their cell phones were collected and stored safely to prevent communication with the external environment. At this stage, students participated in a 60-minute theoretical, expository and dialogued class, preparatory and necessary for leveling their knowledge to experience the simulation session. The theme of the class was “Safety in the administration of intravenous medications prescribed to patients in intensive care units”. Immediately after the theoretical class, randomization occurred by drawing lots. Respecting the random allocation, students were individually assigned to high-fidelity (EG) or low-fidelity (CG) simulation in different spaces in the laboratory. The scenarios were replicated 31 times with HFM and 29 times with LFM.

It was necessary to establish an itinerary to guarantee continuous and controlled flow based on a breakpoint model. This way, upon leaving the auditorium and being sent to the simulation laboratory (breakpoint 1), the student would no longer have contact with the other confined people. Likewise, the EG student participating in the simulated activities with HFM in environment 1 of the laboratory had no contact with the CG student who was in environment 2 carrying out the simulation activity with LFM (breakpoint 2). A third breakpoint was also implemented to prevent student contact during the debriefing, carried out in anteroom 1 for the EG and in anteroom 2 for the CG. At all times, students were accompanied by research collaborators. The flow of students on the day of the intervention followed the breakpoint model, as can be seen in detail in figure 2.

The researcher reapplied the SCLS immediately after the simulation and debriefing (Time 1 - T1). It was decided to re-evaluate the students’ satisfaction and self-confidence after 30 days of the intervention (Time 2 - T2), to check whether there was change or stability during the period in which there was no contact with the simulation methodology, since the measure when performed only at T1 may present a tendency to overestimate or underestimate, given the recently experienced feelings.

The data were coded in Microsoft Excel® spreadsheets and exported to the Statistical Package for the Social Sciences (SPSS®) version 23. The abnormality of the variables was verified by the Kolmogorov Smirnov test, highlighting the need to use non-parametric tests. The Chi-square, Mann-Whitney and Fisher’s exact tests were applied for comparisons between the EG and the CG and the Wilcoxon test for intragroup analyses. Results with p-values ≤ 0.05 were considered significant.

The study was approved by the Research Ethics Committee of the Faculty of Health Sciences (CEP/FS) of the University of Brasília (UnB) under number CAAE 02151218.1.0000.0030/(Opinion: 3.125.812), in compliance with the precepts established by Resolution nº 466/2012 of the National Health Council. All participants signed the Free and Informed Consent Form. After approval by the CEP, the study was registered in Clinical Trials with identifier NCT03828526.

Results

There was equivalence between the groups for all characterization and identification variables (p value > 0.05). Of the total of 60 participants, 29 constituted the control group and 31 the experimental group, the majority of whom were female (EG = 80.6%; CG = 82.2%, p = 0.9), with a median age of 22 (21 – 23) years in the EG and 22 (21 – 23) years in the CG (p = 0.3), which showed demographic homogeneity between the groups. Only in EG did participants declare the nursing technician course as their previous training (6.5%). The percentage of failure was higher in the EG compared to the CG (83.9% vs. 51.7%). Previous simulated experience was declared by more than half of the students in both groups (EG = 64.6%; CG = 65.5%, p = 0.9). Previous training in another health course was observed in 9.7% of EG students and 6.9% of CG students (p = 0.9). There was no significant difference between the groups for the constructs satisfaction (p = 0.4) and self-confidence (p = 0.7) at baseline/T0, indicating initial leveling between participants. The lack of significant difference between the groups remained at T1 and T2 (Table 1).

The box plot graph shows, in the intragroup evaluation, that there was no significant change in the satisfaction of EG students over time, even with the use of a high-fidelity manikin, nor in self-confidence (p > 0.05). Especially over the 30-day period, a significant reduction in satisfaction was identified in the CG (p = 0.02). Even though immediately after the simulation (T1) the students demonstrated significantly high self-confidence (p = 0.03), this feeling was not sustained over the 30-day period and, on the contrary, there was a significant decline with the use of the simulation manikin low fidelity (p < 0.001), as seen in figure 3.

Discussion

The use of innovative practices and techniques in nursing education helps students to actively participate in the learning process and develop cognitive, psychomotor and attitudinal behaviors.(²⁰) When analyzing non-technical skills, it is observed that the satisfaction of nursing students did not change with the use of HFM, but with static LFM after experiencing the simulation it declined significantly (p=0.02). The feeling of self-confidence with learning, despite improving immediately after the simulation session, also showed a significant decline in the CG (low-fidelity simulator) up to 30 days after the simulation session (p < 0.001).

The results of the present investigation help to reinforce that the use of an active methodology based on simulation, regardless of the fidelity of the manikin can contribute to and favor the development of non-technical skills, such as satisfaction and self-confidence with learning.

Meta-analysis of 37 experimental and quasi-experimental studies showed that HFS has almost the same effect on self-confidence compared to other teaching methods, as well as being ineffective for learning satisfaction,(²¹) results that are corroborated in our investigation. It is noteworthy that the students who participated in the GE and were exposed to the use of the high-fidelity manikin in the present study aimed at administering intravenous medications to critically ill patients maintained sustained levels of satisfaction and self-confidence over time.

Even in the absence of significant differences between the groups, EBS proved to be beneficial for satisfaction and self-confidence in the development of non-technical skills in our study. This result makes us rethink at least the importance of using active methodologies, since the development of skills directly in the patient can act as a potential trigger for anxiety due to the fear of harming the patient and making mistakes.(²⁰)

In the Jeffries/NLN Simulation Theory, self-confidence and satisfaction are among the most important concepts.(²²) Self-confidence is important for both nursing students and professionals.(²⁰) Being self-confident will allow for more autonomous practice and, in ultimately, it will contribute to nurse and patient satisfaction.(²³) Gaining self-confidence and satisfaction before graduation allows students to achieve satisfaction in their professional lives.(²⁴)

The level of clinical experience or prior learning of students must be considered and more substantial data are needed to identify the effects of high-fidelity simulation at different stages of education.(²⁵) It should not be underestimated that the fidelity effect is also influenced by teachers , students and teaching design.(²⁶) In our study, the class on the topic covered in the simulation session was taught to ensure greater homogeneity among participants and the facilitators were guided to maintain the same standard when executing the simulated scenario.

Appropriate teaching strategies based on student autonomy can develop self-confidence.(²⁷) Students who have self-confidence can be ready to face future barriers and establish positive beliefs to achieve goals.(²⁸) In this way, learning in the more active model, whether with high, medium or low fidelity resources,(²¹) as evidenced in the current study.

A recent integrative review of 14 national and international RCTs and quasi-experiments summarized evidence of simulation as an active, innovative and promising methodology for teaching medication administration, including in relation to gains in satisfaction and self-confidence among nursing students.(²⁹) Still Although simulation is universally recognized as a promising strategy, the effect of different simulator fidelities on the learning process has not yet been fully consolidated,(¹²) which illuminates and highlights the scientific relevance of our findings.

High levels of satisfaction and self-confidence can be achieved when, based on the simulation strategy, the student can train as many times as necessary to be able to perform activities with quality.(³⁰) In the present study, each student was able to participate in the high or low scenario fidelity individually once, which reduced the possibility of repeating the scenario to correct flaws, with such reflection emerging at the time of debriefing.

The students participating in the present study were exposed to a short simulation time without repeating the scene, which represents a reduced opportunity for complete consolidation of what was learned and exacerbates the perception of failures to the detriment of successes and positive points, culminating in negative feelings, which were reflected in lower scores in the SCLS constructs, even if they had previous experience of simulation-based learning. This result can be explained as the dose of learning is proportional to the development of technical and non-technical skills, such as satisfaction and self-confidence.(³¹)

These findings add another step towards understanding simulation as a promising strategy and potential generator of feelings of self-confidence and satisfaction in nursing students.

Statistically, the small sample size may have made it difficult to establish causal relationships between interventions and outcomes. As the data were collected at a single HEI, caution should be taken when generalizing the findings to different contexts. Even so, our result is different because it is one of the few studies to propose this assessment at three different moments in time, making it possible to evaluate the students’ learning curve.

Conclusion

The high-fidelity manikin was not effective for the development of non-technical skills, such as satisfaction and self-confidence, when compared to low fidelity in the administration of intravenous medications to critically ill patients by nursing students.

Acknowledgements

The Coordination for the Improvement of Higher Education Personnel (CAPES; Master’s scholarship for Santana BS).

References

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