The Effects of the Clinical Simulation of Transfusion Reactions on Nursing Students’ Knowledge Gain: A Pragmatic Clinical Trial

Abstract

Background: Blood transfusion is a therapeutic procedure characterized by the use of blood components for the treatment of certain pathologies. When applied properly, it is highly successful; however, it also has risks, such as transfusion reactions. Objective: This study aimed to evaluate the effects of the clinical simulation of transfusion reactions on the knowledge gain of nursing students. Methods: Two groups were compared: the intervention group, which used the educational intervention: “clinical simulation of transfusion reactions in adults”, and the control group, which did not use the strategy. The study was conducted at a Higher Education Institution from August 2022 to June 2023, with nursing students in the fifth semester. An instrument on the knowledge of transfusion reactions was applied before and seven days after the intervention. Data were analyzed descriptively and inferentially using the Mann–Whitney U and Wilcoxon tests. For both, p < 0.05 was accepted. Results: The Wilcoxon test revealed a statistically significant difference in pre- and post-test scores within the intervention group (p-value: 0.003), with a large effect size (Cohen’s d = 1.14). The average score in the pre-test was 16.47 and increased to 18.93 in the post-test (p = 0.002), while in the control group there was a drop from 14.53 to 12.07 (p = 0.053). In terms of overall scores, the intervention group went from an average of 8.10 to 9.67 (p = 0.001), while the control group went from 8.13 to 8.66 (p = 0.053). The reduction in errors was significant in topics such as hand hygiene (from 56.7% to 23.3%) and the maximum exposure time of the blood component at room temperature (from 66.7% to 20%). The data showed that the clinical simulation intervention had a significant positive effect on the acquisition of theoretical knowledge about transfusion reactions. Conclusions: Through the use of simulation as a teaching strategy, students gained greater knowledge.

1. Introduction

Blood transfusion is a therapeutic procedure characterized by the use of blood components for the treatment of certain pathologies (Danaoui et al., 2024; Uzun et al., 2024; Patel et al., 2024; Marcondes et al., 2019). When applied properly, it is highly successful, but there are also risks, known as transfusion reactions (TR) (Khan et al., 2024).

RTs are complications that occur as a result of blood or blood component transfusion, during or after its administration (Nitsche et al., 2023), classified as immediate (up to 24 h after transfusion), late (24 h after transfusion) (Bălăceanu et al., 2024; Cognasse et al., 2021; Manasa et al., 2024), immunological and non-immunological (Wahidiyat et al., 2024; Abdallah et al., 2021; Rocha et al., 2021; Wang et al., 2022). In Brazil, 94.62% of RT cases are immediate, followed by being of mild severity (84.21%) according to the signs and symptoms presented by patients (ANVISA, 2022; Sobral et al., 2020).

Therefore, it is necessary to guarantee the quality of blood and its components throughout the process, from collection to administration to patients (ANVISA, 2016; Debele et al., 2023). Hemovigilance plays a crucial role in reducing patient harm by ensuring the early detection of transfusion reactions and the careful monitoring of recipients (Chavez Ortiz et al., 2024; Choudhury et al., 2024). This process includes the verification and strict recording of vital signs, carried out immediately before the start and after the end of the transfusion, and ensures the safety of the procedure (Gurgel et al., 2019; Fialho & Porto, 2020).

There are various forms of harm, such as allergic reactions, volume overload, transmissible diseases, and human errors. For this reason, prevention during blood transfusion is essential to minimize the risks associated with the process and ensure patient safety. The main nursing precautions include the following: checking vital signs, double-checking, observing the patient during the transfusion and stopping the transfusion immediately if there is a transfusion reaction, avoiding administering drugs through the same access, warming the blood bag before infusion, advising the patient/family about the benefits and risks associated with blood transfusion and about transfusion reactions, checking and double-checking the medical prescription, using personal protective equipment (gloves and masks) and hand hygiene (Soares et al., 2025).

However, the literature regarding the transfusion process and transfusion reactions is scarce. In this sense, the use of educational strategies and technologies for the management of patients with transfusion reactions is an innovative, contextual proposal that can help in the apprehension of knowledge in the field of study, and above all, in the effectiveness of teaching and learning (Mello et al., 2024).

The implementation of active methodologies favors the nursing students’ learning (Aparicio-Gómez et al., 2024), since it stimulates critical and reflective thinking (Soares, 2021). To this end, clinical simulation with simulated patients is used as a pedagogical strategy guided by experiential learning, in which scenarios are developed in real contexts, such as blood transfusion, to apply theory and practice without harming the patient, thus creating a dynamic experience (Biswas & Thomas, 2024; Hoyt et al., 2024). Its use is necessary in disciplines such as semiology, semiotechnics and emergency, due to the approach to complex and non-complex procedures. This type of strategy has been increasingly used in the training of nurses, in accordance with the National Curriculum Guidelines, which regulate the use of active methodologies in teaching (Broch Porcar & Castellanos-Ortega, 2025).

The researchers’ experience in the areas of teaching emergencies, blood transfusion, simulation and educational interventions prompted this study, which asked, “What are the effects on cognitive learning regarding competencies, satisfaction, and self-confidence in undergraduate nursing students participating in a clinical simulation of transfusion reaction?”

Based on the potential of clinical simulation, the main alternative hypothesis (H1) was that clinical simulation would have a significant effect on the cognitive learning, satisfaction and self-confidence of nursing students after the intervention when compared to the control group. The null hypothesis was that the groups would have the same effect.

The aim of this study was to evaluate the effects of the clinical simulation of transfusion reactions on the cognitive knowledge, satisfaction and self-confidence of undergraduate nursing students.

2. Materials and Methods

2.1. Research Design

This was an experimental, prospective, parallel and pragmatic before-and-after study with a 1:1 allocation ratio. To write the article, the Consolidated Standards of Reporting Trials (CONSORT) guidelines were adopted (Schulz et al., 2010). The study was conducted at a private higher education institution in northwest Ceará, Brazil. Clinical simulations were performed at the Clinical Simulation Center, which had adequate equipment and physical space to perform the simulation. There were changes in the methods used after the start of the study.

2.2. Setting and Samples

The study participants were third-year undergraduate students regularly enrolled in the 5th semester of the Adult Clinical Care Process course, which covered topics such as clinical nursing care, prevention and control of health-related infections, procedures and diagnostic methods.

The inclusion criteria were as follows: a student regularly enrolled in the Nursing in the Adult Clinical Care Process course, over 18 years old and attending university during the data collection period. Students with previous practical experience in the management of hemotherapy (nursing technicians who worked in services and students performing extracurricular internships in the subject) and those who did not participate in all stages of the clinical simulation were excluded.

Before recruitment, a sample calculation was carried out using a formula based on McNemar’s Chi-squared test, with the following parameters adopted: a 95% confidence coefficient, statistical power of 80%, proportion of pairs that did not change with the application of the educational activity of 50% (this value was adopted as this parameter was considered unknown) and change in proportion of at least 20% between pairs of observations to reject the null hypothesis (i.e., there was no difference between the proportions before and after the educational activity), where Zα = 1.96; Zβ = 80%; PA = 0.2; qA = 0.8 and SD = 0.5. After the calculations, the sample was divided into two groups: the control group (CG) and the intervention group (IG), as shown in Figure 1.

2.3. Intervention

The intergroup design strategy was applied, characterized by the intervention group, that is, the group that received the intervention, and the control group, which received the usual intervention. Thus, for evaluation purposes, the two groups were compared, and each participant received a number and was randomly assigned to their target group. The allocation process was carried out through a website www.randomizer.org, using a computerized random number generator designed by a person not involved in recruiting the students, with a 1:1 allocation.

The control group (CG) received the traditional approach to the teaching process at the undergraduate level, that is, lectures and discussions. Knowledge gain was assessed using an instrument validated in a previous study based on ANVISA’s Hemovigilance Technical Manual, which regulates blood transfusion actions, with excellent agreement (Cronbach’s alpha > 0.90) (31). This instrument was applied in two stages: before and after the lectures. Ten dichotomous questions were used to highlight this issue.

Intervention Group (IG)—Received the traditional approach and the intervention with a simulated scenario, validated in a parallel study, in which a clinical simulation was applied to the management of RT in adults in the Briefing, Simulated Scenario and Debriefing stages, as recommended in the INACSL Simulation (Soares et al., 2024). This scenario showed excellent evidence of content with CVR > 0.80 and excellent agreement with Cronbach’s alpha of 0.94. We assessed knowledge gain by applying pre- and post-intervention tests.

The blinding of participants could not be implemented because the four teaching methods differed significantly, while the effect evaluation and data analysis were conducted in a blinded manner. Each participant was given a unique identifier to maintain anonymity throughout the study.

For both, matching was carried out based on homogeneity, namely, age, sex and the student performance index (SDI). Intervention data are shown in Figure 2.

2.4. Measurement and Data Collection

The data collection was conducted in four stages. The first consisted of making an appointment with the course coordinator to obtain information about the timetable for the subject Nursing in the Adult Clinical Care Process as well as the number of students enrolled. The second stage involved a visit to the classroom on scheduled days with the subject teachers to invite them verbally and explain the study to the students.

At this point, the participants were recruited, and meetings were scheduled to divide the participants and conduct the clinical simulation. To attract the largest number of participants to make up the sample, a workshop was offered on the main topics of Transfusion Reaction: Clinical Simulation in Nursing—Simulated Workshop for Critically Ill Patients, which was given by two professors with PhDs in nursing and expertise in transfusion nursing. The workshop was held to compensate for the voluntary participation of each student and took place after data collection. All the students who completed this process received a certificate of participation.

In the third stage, the data collection team was trained before the actual data collection with the application of the simulation. The main researcher participated in the collection at all times to ensure that the study was monitored. The third meeting was a practical preparation for simulation. The fourth meeting presented the instrument to clarify any doubts. In the fourth stage, a preliminary instrument was applied to identify students’ knowledge of RT (pre-test). This was followed by an educational intervention involving advanced clinical simulations in the teaching and management of transfusion reactions.

The simulation consisted of an approximation of reality using a controlled RT scenario with a simulated patient. In this scenario, information was provided about the case and the patient’s condition (briefing), after which the simulation itself took place, simulating a patient who evolved to RT and needed care from the nursing team. This moment lasted up to ten minutes, followed by a discussion of the strengths and factors that needed improvement (debriefing).

After the intervention, an evaluation of the development of cognitive skills was conducted (post-test).

2.5. Data Analysis

The database was developed using the Statistical Package for the Social Sciences (SPSS), version 23.0, and analyzed according to the protocol. Exploratory analysis was carried out using descriptive statistical tests, absolute and relative frequencies and means, presented in tables, and discussed in accordance with the relevant literature. The Shapiro–Wilk test was used to confirm adherence to a normal distribution. The Mann–Whitney U test was used to assess the mean differences between groups when the data may have been asymmetrical. Finally, the Wilcoxon signed-rank test was applied to confirm the hypothesis that there were intragroup differences in the pre-test and post-test scores. A significance level of p ≤ 0.05 was adopted for all analyses.

Cohen’s d index was also calculated to assess the effect size of the simulated intervention and the gain in knowledge. Cohen’s d index assesses the effect size of an intervention. Values below 0.19, between 0.20 and 0.49, between 0.50 and 0.79, between 0.80 and 1.29 and above 1.30 are classified as insignificant, small, medium, large and very large effects, respectively (Espirito Santo & Daniel, 2015).

2.6. Ethical Considerations

This study was approved by the Research Ethics Committee of the Higher Education Institution, to which it was linked, under process number 6.058.592/2023. It is listed in the Brazilian Registry of Clinical Trials UTN—U1111-1316-6713. All the participants signed an informed consent form (ICF).

3. Results

Of the 76 eligible students, 4 dropped out before the first meeting and 6 did not meet the eligibility criteria. As a result, this study analyzed a total of 60 participants, as shown in

Table 1. Distribution of participants, according to sociodemographic and educational variables of the sample.

Variables		N	%
Age		Average: 22.67
Sex (self-reported)
Students	Male	12	20.0
	Female	48	80.0
Attended a blood transfusion course
Students	Yes	60	100
Previously worked in blood transfusion services
Students	No	60	100
Certified licensed practical nurse
Students	Yes	10	16.7
	No	50	83.3
Total		60	100

.

Table 2. Intergroup comparison of the performance (average of ranks) of students in the intervention and control groups in the pre-test and post-test (N = 60).

Variables	Groups		p-Value *
	Intervention	Control
Total of correct answers in pre-test	16.47	14.53	0.053
Total of correct answers in post-test	18.93	12.07	0.002
Pre-test score	8.10	8.03	0.053
Post-test score	9.67	7.66	0.001

* Mann–Whitney U Test.

shows a detailed comparison of the performance of students in the intervention and control groups in the pre-test and post-test, highlighting the significant differences in the mean scores and grades. The intervention group showed a significant increase in average scores, from 16.47 in the pre-test to 18.93 in the post-test (p = 0.002), while the control group decreased from 14.53 in the pre-test to 12.07 in the post-test (p = 0.053). The average scores also showed a greater gain in the intervention group, which increased from 8.10 points in the pre-test to 9.67 in the post-test (p = 0.001), while in the control group the advance was from 8.03 in the pre-test to 7.66 in the post-test (p = 0.053).

In the intragroup analysis, as shown in Figure 3, both groups showed positive progress between the pre-test and post-test. In the intervention group, 20 participants showed positive progress, 4 showed negative progress and 6 maintained their results. In the control group, 14 participants showed positive progress, 11 regressed and (5) maintained the same performance. Despite this, the intervention group stood out significantly, as indicated by the non-parametric Wilcoxon test, which revealed statistically significant differences in scores between the pre- and post-tests (p = 0.003).

In determining the effect size between the IG and CG, Cohen’s d was = 1.14 and the effect on the difference between the groups was considered large after the intervention.

Table 3. Distribution of errors and correct answers in the pre-test and post-test questionnaires.

Item	Pre-Test		Post-Test
	Errors	Hits	Errors	Hits	%
Correct hand and body hygiene procedure trays with 70% alcohol.	34	26	14	46	76.92
Individual use of protective equipment for venipuncture and assembly of the blood component and equipment.	0	60	2	58	−3.33
The length of time this blood component is at the temperature environment is a maximum of 30 min.	40	20	12	48	140
Press lightly on the filter to remove air and fill 1/3 of the air chamber. Drip and open the equipment, filling it with the blood component to the end that will be connected to the patient.	8	52	14	46	−11.53
There is no need to inform the nurse who will start the transfusion of the patient.	0	60	2	58	−3.33
The following are considered immediate transfusion reactions that occur during transfusion or up to 24 h after.	26	34	16	44	−29.41
The following are considered late transfusion reactions that occur 24 h after transfusion is performed.	6	54	6	54	0
Monitor and report immediately transfusion reactions detected during blood component infusion.	0	60	0	60	0
Donation candidates do not have to go through a selection process before donating blood.	8	52	8	52	0
Check the blood component(s) against the receiver identification data before the procedure.	0	60	0	60	0
Vital signs should be measured and currently registered.	2	58	2	58	0
Check vital signs 10 min after bag installation.	18	42	0	60	25
Pay attention to the start time of the transfusion after receiving the material in the unit.	8	52	0	60	15.38
Ensure adequate venous access does not require an exclusive blood filter.	14	46	24	36	−21.73
Confirm the label of the bag, the data of the release label and the expiration date of the product; conduct a visual inspection of the bag (color and integrity) and check the temperature.	4	56	0	60	7.14
Transfusion should be stopped immediately and the doctor informed if there is any sign of an adverse reaction.	6	54	4	56	3.7
Check the permeability of the puncture and the catheter caliber.	4	56	4	56	0
The maximum infusion time should not exceed 4 (four) hours.	16	44	6	54	22.72
Staple the bag labels to the front from the checklist.	14	46	16	44	−4.34
In the event of an interruption of the infusion, forward the bag for analysis.	6	54	2	58	7.4

shows a comparative analysis of the students in the intervention and control groups in the pre- and post-test, considering the hit and miss rates for each item.

There was a significant reduction in errors and an increase in correct answers for several topics assessed. For correct hand hygiene and procedure trays, errors decreased from 34 (56.7%) in the pre-test to 14 (23.3%) in the post-test, whereas correct answers increased from 26 (43.3%) to 46 (76.7%).

When it came to characterizing the length of time that the blood component should stay at room temperature, errors fell from 40 (66.7%) to 12 (20%), whereas correct answers rose from 20 (33.3%) to 48 (80%). Regarding the characterization of the immediate transfusion reaction, errors decreased from 26 (43.3%) to 16 (26.7%), while correct answers increased from 34 (56.7%) to 44 (73.3%). When it came to checking vital signs 10 min after the infusion, errors fell from 18 (30%) in the pre-test to 0 (0%) in the post-test, while correct answers rose from 42 (70%) to 60 (100%). Regarding the maximum infusion time for blood components, errors decreased from 16 (26.7%) to 6 (10%), while correct answers increased from 44 (73.3%) to 54 (90%).

Several topics showed high consistency in terms of the correct answers. The characterization of the delayed transfusion reaction maintained 54 correct answers (90%) in the pre- and post-tests. When checking blood components and identifying the recipient, the number of correct answers remained at 60 (100%) at both times. Recording vital signs at the time of infusion was also stable, with 58 correct answers (96.7%) in the pre- and post-tests. For checking the vein patency for the puncture and the caliber of the catheter, 56 correct answers were maintained (93.3%). In cases of infusion intercurrence and interruption, the number of correct answers increased from 54 (90%) to 58 (96.7%), indicating that the participants had mastered these procedures.

4. Discussion

Transfusion reactions are a significant risk in the administration of blood products because they can occur in different clinical contexts, ranging from benign to life-threatening reactions (Abdallah et al., 2021). RTs are classified as immediate, occurring within 24 h of infusion, and delayed after 24h. Their main signs are fever, hypotension, anaphylactic reactions (Soutar et al., 2023; De La Vega-Méndez et al., 2024), headache, tachycardia, nausea, respiratory changes, pain at the infusion site and chest and abdominal pain (Fialho & Porto, 2020).

The main finding was the predominance of females among the students (80%; n = 48), with females making up the majority of the sample. The average age was 22.6 years for the class. There was a statistically significant difference between the intervention and control groups in terms of the mean scores obtained in the pre- and post-test. It can be inferred that in both groups, there was a positive evolution, which occurred when the post-test score was higher than the pre-test score; however, the intervention group had a significantly higher positive evolution score. Another study (Araújo et al., 2021) corroborated the findings of this one, which, in an analysis of cognitive performance, also identified statistically significant differences, with higher post-test scores in the intervention group.

The main errors in theoretical knowledge were found in the topics of care in the installation of blood and blood components and the identification of immediate transfusion reactions. Another study carried out in Turkey addressed the same errors with novice nurses in the intensive care unit, in which the initiative of practical and theoretical training was adopted. The majority of correct answers were related to hemovigilance and the identification of late transfusion reactions. A study carried out with nursing students showed that they had partial knowledge of the role of nurses in hemotherapy, as thirty-five (92.1%) got more than five of the nurses’ activities right, two (5.3%) got all the activities established by Resolution 709/2022 (COFEN) right and only one (2.6%) had less than five of the nurses’ duties right. This is a critical and relevant rate, given that nurses are responsible for the hemotherapy procedure (COFEN, 2022).

A positive effect of clinical simulation on knowledge acquisition was observed. The results corroborate the benefits of clinical simulation in research, improving students’ learning, skills, self-confidence and critical thinking, characterizing it not only as a complementary teaching technique but also as an essential component in the nursing curriculum. In line with another study with nursing students, the positive effect of the intervention was lasting knowledge, and it improved skills such as self-confidence and safety in performing technical procedures. It helped both inexperienced and experienced students to make decisions and perfect techniques that are essential for professional nursing practice (Lucena et al., 2023).

In this context, this study used a stage simulation with actors during the training. The simulation included an actor who was a simulated patient, an actress in the role of a companion and an actress as a blood bank nurse, all in a controlled setting to support the student’s performance. The application of this method constituted an even more realistic experience (Barboza et al., 2023).

Another advantage of simulation-based teaching is the possibility of repeating a given task with immediate feedback and in a protected environment, allowing students to make mistakes and succeed during the learning process and minimize risks for professionals and patients. Several studies have shown that this strategy promotes familiarity with the environment and safety and self-confidence among professionals, helping them develop their skills and remain calm in tense moments (Dönmez et al., 2023; Sarvan & Efe, 2022; Watts et al., 2021).

5. Implication and Limitations

This study highlights the effectiveness of clinical simulation as a pedagogical strategy to improve nursing students’ technical knowledge, critical thinking and decision-making, with a positive impact on patient safety. This research also reinforces the need for teacher training and investments in infrastructure to integrate this methodology into teaching, as well as highlighting the lack of recent studies in the area, encouraging new research and educational innovation in hemotherapy and nursing care.

This study has some important limitations. Students were hesitant to participate, which reduced the number of participants. In addition, the lack of recent studies on hemotherapy and nursing care in hematology limited the available scientific basis. In this sense, future studies could adopt multiple simulation sessions, as well as create strategies to increase student engagement, such as the use of interactive methods. Finally, the need for teacher training and the inclusion of this innovative methodology in practical classes to strengthen student learning in undergraduate courses is highlighted.

6. Conclusions

This study was effective in helping students learn about transfusion reactions through clinical simulation. The results showed that both the traditional learning strategy and clinical simulation showed an evolution in knowledge, but when using the intervention (simulation), it was found that there was a greater evolution in knowledge gain. This makes clinical simulation an excellent teaching strategy for undergraduate students’ cognitive development. Nurse educators can benefit from simulation as a teaching method; however, they need to receive sufficient training on how to get the most out of using these innovative teaching strategies in order to use them effectively. Future research may need to examine the impact of the implementation of these innovative teaching strategies on patient safety and care outcomes, and they need wider replication in other settings such as hospitals and with a larger sample size. Another recommendation is to verify long-term retention.