Planning, construction and use of handmade simulators to enhance the teaching and learning in Obstetrics*

Objective: to describe the development process and present the results of a pilot study on the use of low-cost handmade simulators for teaching and learning Obstetrics. Method: presentation of 3 low-cost simulators designing, based on educational needs identified in real-world training contexts. The developing process is presented in detail and each simulator was tested and re-tested, being submitted to improvements until their final version. The simulators presented are: delivery simulator shorts, Neoprene uterus for postpartum hemorrhage management, and perineal repair simulator. A pilot study was carried out to evaluate the perception of apprentices through a structured questionnaire, using the Kirkpatrick evaluation model. Data were descriptively analyzed. Results: the respondents (31 apprentices) positively evaluated the simulators, perceiving significant gains in theoretical knowledge, ability to solve clinical problems and decreased anxiety to deal with situations similar to those simulated. Conclusion: low-cost, handmade simulators are feasible and effective, resulting in positive learner evaluations. Their availability as open technology allows the dissemination of their use.


Introduction
Implementation of good obstetric practices and prevention of maternal and newborn morbidity and mortality are the focus of obstetric care. Thus training and education of health care providers towards better intrapartum practices and effective emergency management are key-points to improve care (1) . In this context, research and experimentation aimed at teaching good obstetric practices are particularly relevant for Nursing, considering the historical and growing insertion of direct-entry midwives and nurse midwives (MNM) in maternal and neonatal care in Brazil and worldwide (2) .
Since the 1970s, the Pan American Health The countries selected for the report (African, Asian and Latin American) are responsible for 96% of all global maternal deaths, 91% of fetal deaths and 93% of newborn deaths. The goals include adequate access for women to midwifery services; high-quality primary care and the possibility of transfer to next level when needed; increased availability of MNM and its beneficial interventions for the mother and baby dyad; and strengthening MNM local associations (3) .
Given the growing recognition of MNM role in the implementation of good obstetric practices, aiming to improve quality of care and prevent health problems with relevance from the public health perspective, new challenges associated with training and continuing education of these Nursing providers are highlighted.
Therefore, studies addressing simulation-based Nursing education demonstrate its potential in enabling the student to deal with situations of anxiety and stress typical of nursing clinical practice. Besides aspects of theoretical knowledge, technical skills and critical thinking, students may experience emotional, spiritual and ethical issues regarding the care for patients and their families, involved in the context of nursing simulation (4) .
In Nursing teaching, simulation-based educational practices have been reinforced in the national and international literature, as it allows an ethically appropriate approach and promotes patient safety, considering that the first experience of care will not be carried out with a real patient (5) . When teaching undergraduate students, not all interventions can be performed autonomously by them (such as emergency situations), so the simulation educational activities provide the opportunity to experience events that would not be possible in real-world settings (4)(5)(6) . Simulation environments replicate a controlled clinical scenario allowing detailed observation of students in action, feedback and repetition as many times as needed without any harm to patients (5) .
The use of simulators and simulation environments for teaching health professionals is well established in the literature (5,(7)(8) . Although the quality of studies is heterogeneous and with several different indicators, evidence has shown that simulation-based teaching is effective and leads to better and more lasting results than traditional teaching (7,9) . Its use can improve clinical, technical, communication, and teamwork skills, improve performance and reduce errors (5) . There is evidence that simulation-based medical education can improve both learning and patient care, as well as the clinical practice and still have a positive effect on public health (8,10) .
Particularly in Obstetrics teaching, the use of simulators and simulation environments has been studied in various settings (8) , mostly obstetric emergencies such as shoulder dystocia (11)(12) , postpartum hemorrhage (13)(14)(15)(16)(17)(18) , pre-eclampsia and eclampsia (16)(17) . There is also evidence on simulation to enhance surgical skills such as suturing of vaginal and severe lacerations (19) . A 2014 literature review showed that after simulations, it was possible to observe an increase in knowledge as well as technical, communication and teamwork skills (16) . A 10-year followup study of a simulation-based training for shoulder dystocia management identified an increasing in the number of diagnosis and a decreasing in the number of neonatal brachial plexus lesions (11) . At least one study conducted in Mexico (1) was able to demonstrate that the implementation of a continuing education program including simulations has successfully modified obstetric practice with better results in terms of good practices adoption. Another training program with simulation in Tanzania showed a 47% reduction in postpartum blood transfusion rates (13) .
Simulation environments and high-fidelity simulators, although proven to be useful, find barriers to their effective use in teaching, the main one being their cost (5,17) . With well-established learning objectives, the use of lowcost, handmade simulators can be a viable and effective alternative in the teaching and learning process ( (17)(18)(19)22) and other specialties/situations (23) . There is no evidence demonstrating that the hyper-reality of the simulator improves participant learning, the low cost and sometimes even the low fidelity of a simulator does not seem to represent an obstacle to its use (20)(21) .
However, cultural differences in the curriculum of

Method
This is a cross-sectional pilot study to assess apprentices' perception about the use of low-cost handmade simulators for Obstetrics teaching, based on the hands-on teaching experience of the developers.
The scope of the analysis is characterized as a study to improve the quality of health care, through the improvement of teaching and learning of health professionals. Thus, the SQUIRE guidelines for publications of this type were adopted. The methods section will be discussed in two stages: the process of developing the simulators and the methods used for the pilot study. The aim was to establish face (to evaluate the realism, aspect) and content (pedagogical value, effectiveness in solving the proposed problem) validity (5,24) . It should be noted that the face and content validity depends on the learning objective. A piece of curvy fabric (synthetic leather), for example, does not have the appearance of human skin, but with the proper assembly may be valid for suturing training. The structure of the simulation is considered to be a process, not a product, and the simulation training needs strategic planning in order to be effective (14) .
On many occasions, tests have determined changes in the prototype. This was redone and retested as many times as was necessary. At the time we obtained a version of each simulator that was considered appropriate, they were considered finished and available for implementation. Even after implementation, it must be considered that the simulators should continue to be tested and may undergo improvements and modifications. We hope that the simulators are recreated and adapted to different realities, with citation of the original authorship.
For the birth simulator shorts with a doll, the educational need identified was the need for training maneuvers that require changing the woman's position, such as for shoulder dystocia (25) and emergency breech vaginal birth (26) . The rigid plastic or rubber birth simulators (maternal pelvis and fetus) do not allow these maneuvers to be performed adequately  which is a high prevalence condition and one of the leading causes of maternal deaths in Brazil (27) . There are simulators on the market, even tested with excellent results (13,28) . However, although they are considered lowcost (compared to others in the market), they are not affordable in our reality.  (27) .
Also, when the instructor's hand compresses the ball internally, the return of uterine tonus after treatment is also simulated. After the initial tests, the same model presented in Figure 2 was improved to allow the insertion of a uterine tamponade balloon, which is an important conservative measure for postpartum hemorrhage treatment, as recommended in national and international guidelines (27) .
www.eerp.usp.br/rlae sequelae and pathologies if not properly repaired (19) . The obstetrician is technically responsible for this repair, but many residents and trained professionals feel insecure and unable to perform the suturing (19) , due to its rare need and their little exposure to the procedure during training.
Thus, regarding the suturing simulator of seconddegree and severe perineal tears, the educational need found was therefore training for postpartum perineal repair. Several models were tested and two different  There are several models for the evaluation of the simulation process effectiveness, and Kirkpatrick's model is one of the most used. This model, initially proposed by the author in the 1960s, is widely accepted and used since then (8,31) . The popularity of this model is due to the fact that it results in a well-defined system for demonstrating the results of an intervention or training (31) . Although it is subject to criticism (may be incomplete/may assume unrealistic causal associations), it simplifies the complex process of training evaluation (32) . To measure the impact

Results
For the simulators evaluation through the pilot study, 12 gynecology and obstetrics resident doctors, 15 undergraduate Medical students and 11 nurse midwives who participated in an obstetric emergency training using the simulators were invited to participate. We obtained 31 replies to the questionnaire: 10 resident doctors, 12 undergraduate medical students, and 9 nurse midwives, with an 81.58% response rate, similar in all groups.
The mean age of all respondents was 29.68 years (SD 6.36). Among midwives (already graduated and with specialization degree) the mean age was 35.44 (SD 7.45) years. Among residents, the mean age was 28. The questionnaire responses are summarized in Table 1. I was satisfied with the use of the simulator 31 0 0 The very simple simulator(s) does(do) not allow for optimal learning 3 3 25 The very simple simulator(s) prevents the student from feeling in a real clinical setting

5 23
The class in which the simulator was used increased my theoretical knowledge

Discussion
We aimed to describe the developing process of low-cost handmade simulators that allow apprentices to acquire knowledge, increase skills and train attitudes regarding various obstetric procedures. An evaluation of the perceptions of students and professionals who used the simulators in a real-world training context was also carried out, adopting an evaluation methodology for simulators that allowed to address the reaction of the learners. In our sample, all those who answered the questionnaire were satisfied with the simulation.
The self-perception of the learning acquired was positive, with all respondents considering that the simulator class increased their theoretical knowledge and skills. A fact also observed in several studies, especially when the evaluation is performed by the apprentice themselves (18)(19)(20)34) . The use of simulators presents several advantages such as the possibility of repeating the procedure, correcting errors, and perceiving the difficulties (personal and inherent to the procedure) (35) . This is expected to improve performance in real-world situations.
Currently, the evidence is quite consistent to state that simulation-based training in Obstetrics improves knowledge and skills. The improvement of clinical and surgical practices is emerging with great consistency.
Improvements in populational outcomes are less consistent, but there are some evidence mostly those related to neonatal outcomes (1,8,11,20) . The differences between low-and high-cost/high fidelity simulators are not established and warrants further studies (17)(18)28) . Almost all respondents also believe that the course where the simulator was used reduced their anxiety/stress to deal with a situation like the one presented. A fact that is corroborated in other studies (17,19,36) .
As a pilot study, the study scope was restricted to the opinion and experience of the apprentices. Some apprentices considered that, because the simulators were simple, they did not allow the ideal learning.
In fact, to allow the student to get involved with the simulation, it must be challenging and require effort to resolve. One of the questions was whether the simulator allowed the student to feel in a real clinical setting.
Eight respondents agreed with this statement. The data presented here may indicates that the more advanced the learner, the greater the fidelity of the simulator needed for them to feel immersed in the simulation (36) .
One of the limitations of the study is the small number of respondents due to its pilot study nature.
Additionally, there may be a courtesy bias in the responses received, although secrecy and confidentiality of the information source were guaranteed. We cannot rule out the hypothesis that precisely those less satisfied with the classes and simulations did not answer the questionnaire.
Also because it is a pilot study, an objective assessment of knowledge before and after the simulation was not made, as would be ideal (8) . Furthermore, the design and nature of the study did not allow a complete assessment of the 4 th level of Kirkpatrick (8,20) , which is the impact on results, which would need a more comprehensive analysis. This study demonstrated the effectiveness of handmade simulators, built by the teachers themselves and at a reduced cost to enhance Obstetrics teaching. It shows that it is possible not only that the simulators can be low-cost, but that they can be created by teachers and students, with good results. The use of this type of simulators went beyond the improvement in clinical practice, stimulating students to deepen their knowledge and even to develop new simulation environments.
It is a pioneer study in Brazil and it is expected that the models tested will be replicated and used in other locations and situations. The study is also expected to stimulate further research in the area.

Conclusion
The pilot study revealed that the apprentices perceive that simulators favor the expansion of theoretical knowledge and skills to solve clinical problems, in addition to the reduction of anxiety to deal with situations similar to those simulated. Simulation-based learning is widely recognized in the literature as an effective method in the context of health professionals' training, and the availability of simple, low-cost simulators contributes to broadening access to this resource for students, teachers, and professionals. Open source technology allows and encourages these simulators to be reproduced and improved in other scenarios.