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Back to Journal »Medical Devices: Evidence and Research» Volume 14
Satisfaction with the internal nasal foreign body removal model: a randomized controlled trial
Author Pitathawatchai P, Anuntaseree S, Yunyongviwat V
Published on August 20, 2021, the 2021 volume: 14 pages 249-256
DOI https://doi.org/10.2147/MDER.S326575
Single anonymous peer review
Editor approved for publication: Dr. Scott Fraser
Pittayapon Pitathawatchai,1 Sittichoke Anuntaseree,2 Varah Yunyongviwat2 1 Department of Otorhinolaryngology Head and Neck Surgery, Prince of Songkhla University School of Medicine, Hat Yai, Thailand; 2 Department of Orthopedics, Prince of Songkhla University School of Medicine, Hat Yai, Thailand Address: Varah Yunyongviwat Prince of Songkhla University of Medicine Department of Orthopedics, 15 Karnjanavanich Road, Hat Yai, Songkhla, 90110, Thailand Email [email protected] Introduction: Foreign bodies in the nasal cavity can cause life-threatening diseases. Therefore, doctors must be well trained in the proper procedures for removing nasal foreign bodies. However, training real patients is not only impractical, but also too dangerous due to the risk of inhaling foreign objects during the procedure. Therefore, our goal is to build a human body model with a specific design to meet all possible training needs. Method: We developed an internal mannequin using 2 materials; these are flexible polyurethane foam and silicone. Silicone, which has elasticity similar to the wing of the nose, is used to develop a detachable nose and nasal cavity, while polyurethane foam, which is lightweight and easy to carry, is used to develop the head. After conducting a randomized controlled trial with a crossover design, 37 doctors performed nasal foreign body removal surgery in the two groups, and compared the satisfaction of the internal mannequin with the commercial mannequin. Results: The satisfaction scores of self-made mannequins were significantly higher than those of commercial mannequins in all six dimensions: appropriate size, ease of use, ease of maintenance, flexibility of the nose relative to the actual anatomical structure, and human body Similarity of the model. Compared with the actual anatomy and the human body model, the nasal cavity can improve the confidence of medical students in the ability to practice on real patients (p value <0.05). Conclusion: The design of this internal nasal foreign body removal model is highly satisfactory for training and can be used to further develop the nasal foreign body removal model in the future. Keywords: human body model, nasal foreign body removal
Foreign bodies in the ear, nose and throat (ENT) account for approximately 10% of the ENT cases observed in the emergency department. 1 Among all foreign bodies in otolaryngology, the nasal cavity is a common structure, and as many as 50% of foreign bodies in otolaryngology can be found. 2,3 The most common location for nasal foreign bodies is between the inferior turbinate and the base of the nose. 4 Generally, most patients diagnosed with a foreign body in the nose are children under 5 years of age. 5 Reasons Foreign objects are very common in this age group, which may be related to their curiosity about the surrounding environment and more autonomous exploration of the environment. 6 The typical manifestations of nasal foreign bodies are sneezing and unilateral runny nose. In the initial stage, unilateral purulent nasal discharge for several days. 7
Although some complications, including rhinosinusitis, epistaxis, lacerations, and rhinolith formation can be observed without serious consequences8, when foreign bodies are transferred from the nasal cavity to the respiratory tract, life-threatening situations may occur, such as Inhalation of foreign objects. Airway: cause obstruction of the airway. Therefore, it is essential that doctors be able to diagnose and treat foreign bodies in the nasal cavity without causing unnecessary complications. However, minor complications; for example, lacerations and pain may occur at any time during the removal of the foreign body. 9 In addition, improper techniques for removing foreign bodies from the nasal cavity can remove the foreign body from the nose, but it can completely block the airway and lead to a life-threatening situation; this should always be kept in mind. 10 According to reports, these complications are usually related to repeated attempts during the removal of foreign bodies in the nasal cavity. 5 Therefore, doctors must be trained in proper nasal foreign body removal procedures. Dispose of the dead body safely and successfully with minimal attempts.
To have practical skills to remove foreign bodies in the nasal cavity requires adequate training; even if two obstacles are encountered. First, since the success rate of removal is negatively related to the number of attempts11, the most experienced doctor is given priority to maximize the success rate; in addition to minimizing any life-threatening situations. Therefore, doctors with less experience are often the least ideal choice for performing such procedures. In addition, in the aforementioned incidents, it is almost impossible for any trainer to be responsible. Secondly, foreign bodies in the nasal cavity are generally considered as emergencies in otolaryngology; therefore, it is impractical to provide trainers with real cases under supervision during a specific training period. Although it is possible to train as a simulated patient by putting a foreign body into the nasal cavity of a healthy person, no one can guarantee that serious complications will occur; for example, the inhalation of foreign body will not happen to the simulated patient. Therefore, this approach is dangerous and potentially unethical. In order to overcome any problems related to real human training, using simulated human models instead of actual or simulated patients is another option. This also takes into account that the training can be carried out at any time period without any minor or serious complications. In fact, the simulated human body model is a useful substitute for simulating patients, which can significantly improve students' knowledge and confidence before contacting real patients. 12 However, it should be noted that currently available in the market is somewhat expensive and does not always meet all actual needs of end users. For example, in the case of a nasal foreign body removal model, the softness or structure of the model may not be similar to the actual human anatomy. This depends on the quality of the design and the quality of the materials used, which will also greatly increase the cost. In addition, in the foreign body removal procedure, the nose wing of the mannequin; where a nasal speculum must be placed to expand the entrance of the nasal cavity, it is easy to tear due to repeated attempts to remove it during training activities. Once this happens, in order to continue using the simulated mannequin, the torn nose needs to be repaired immediately; the manufacturer, otherwise the mannequin will not be suitable for foreign body removal procedures. Therefore, not only does maintenance increase costs, but the time spent during maintenance also affects the training plan. Therefore, not only has the use of mannequins become expensive, but maintenance downtime is sometimes an issue in meeting the needs of end users.
Therefore, the purpose of this study is to design a low-cost human body model with a specific design to meet all possible needs of the end user, while still maintaining the functions required for its training.
The internal mannequin prototype was developed with 2 materials; these are flexible polyurethane (PU) foam and silicone. PU foam is lightweight and easy to carry. It was originally made by mixing polyether polyol and isocyanate together and used to build the head. Silicone has similar elasticity to the wings of the nose and is used to develop a detachable nose and nasal cavity. This self-made mannequin is specially designed to have a detachable nose and nasal cavity, so that spare parts can be replaced in time when immediate repair is required; for example, when the nose wing is accidentally torn after repeated attempts during training. In addition, the detachable nose and nasal cavity can be removed as a whole, so that the user can completely check the location of foreign body placement, or explain the anatomy of the nose and nasal cavity during training to enhance useful feedback to trainees (Figure 1A). The head size of the mannequin is 21 x 16 x 18 cm (height x width x depth), and the total size including the base is 42 x 20 x 27.5 cm (height x width x depth). Figure 1 Internal human body model (A) and commercial human body model (B).
Figure 1 Internal human body model (A) and commercial human body model (B).
The current business model (E001, BRILLIANT RUBBER CO, LTD, Songkhla, Thailand) has a different design from our internal model. Specifically, the head of this commercial mannequin is made with a half head, and the nasal cavity is viewed from the inside. In addition, the side of this commercial mannequin can only remove the nasal cavity, while the nose is fixed to the head and cannot be separated (Figure 1B).
A randomized controlled trial with a crossover design was conducted. 37 participants including otolaryngology residents, otolaryngologists, and otolaryngology surgeons were included, who had experience in removing nasal foreign bodies. The study followed the principles of the Declaration of Helsinki, followed the principles of good clinical practice and the Uniform Standards for Reporting Trial Statements (CONSORT) (Figure 2). The trial is registered on Clinical Trials.gov (NCT04901026). The study was approved by the institutional review board. Figure 2 Flow chart.
Participants were divided into 2 groups, and four groups were randomly assigned and sealed envelope system generated by the computer. The first group of 19 participants performed a procedure for nasal foreign body removal using internal mannequins. Later, they performed the exact same procedure using the aforementioned commercial mannequin. The second group of 18 people first used the same commercial mannequin to perform the same nasal foreign body removal procedure; after that, they used the same procedure to perform the same procedure on the internal mannequin. All participants were instructed to use only the headlights, nasal speculum, and right-angle hooks to remove the red beads. The red beads were placed inside and on the bottom of the right nose between the inferior turbinate and septum of the commercial mannequin.
Regarding the questionnaire on the satisfaction of using the two mannequins, a Likert 5-point scale (1-very dissatisfied to 5-very satisfied) was used to interview all participants immediately after the procedure was completed. The questionnaire includes 9 dimensions, including: appropriate size, appropriate weight, ease of use (how easy it is to insert foreign objects), easy to clean, easy to maintain, the flexibility of the nose relative to the actual anatomical structure, and the similarity of the nasal cavity relative to Whether the actual anatomical structure is well-designed for teaching, and the confidence that the human body model can improve the ability of medical students to practice on real patients. All these dimensions are explained by the first author before the participants execute the procedure to ensure that they understand and answer the questions correctly; in addition, any questions raised by the first author before, during or after the procedure will be answered immediately.
The Wilcoxon signed rank test is used to compare the satisfaction scores between the internal model and the business model. AP values below 0.05 are considered statistically significant.
Use simple and multiple linear regression to assess which variables are independently correlated, and the difference in total satisfaction scores between internal and commercial mannequins. Baseline characteristics, including medical specialty, age, gender, and time experience as a general practitioner or ENT specialist, were designated as independent variables. The difference in total satisfaction scores between internal and commercial mannequins is designated as the dependent variable. This total satisfaction score difference is calculated based on the sum of the different scores for each dimension of the internal and commercial mannequins. The Shapiro-Wilk test is used to test the normality of the dependent variable. In simple regression analysis, a p-value threshold of less than 0.1 is used to determine the candidates included in the multiple linear regression.
R software version 3.1.0 (R Foundation, Vienna, Austria) was used for statistical analysis.
Finally, the study included 15 otolaryngology surgeons, 2 otolaryngology researchers, and 20 otolaryngology residents, aged between 24 and 57. Table 1 shows a summary of demographic data for all participants. Table 1 Demographic data of study participants (N=37)
Table 1 Demographic data of study participants (N=37)
The Wilcoxon signed rank test shows that the satisfaction score of the own mannequin is statistically significantly higher than the satisfaction score of the commercial mannequin in six dimensions: appropriate size, ease of use, ease of maintenance, and relative flexibility of the nose. The similarity with the actual anatomy, the nasal cavity relative to the actual anatomy, and the human body model can increase the confidence of medical students in their ability to practice on real patients. On the other hand, the satisfaction score of the internal mannequin is not statistically significant, and is significantly different from the satisfaction score of the commercial mannequin in three dimensions: appropriate weight, easy cleaning, and well-designed teaching (Table 2). Table 2 Wilcoxon Signed-Rank test used to evaluate the satisfaction scores of internal and commercial mannequins
Table 2 Wilcoxon Signed-Rank test used to evaluate the satisfaction scores of internal and commercial mannequins
A simple linear regression showed that none of the variables, including medical specialty, age, gender, and time experience as a general doctor or ENT specialist, were independently related to the difference in total satisfaction between internal and commercial human models (Table 3). Since the p-values of these independent variables all exceeded 0.1, no further analysis of multiple linear regression was performed. Table 3 Simple linear regression of variables related to the difference in total satisfaction scores between internal and commercial human models
Table 3 Simple linear regression of variables related to the difference in total satisfaction scores between internal and commercial human models
Since nasal foreign bodies may lead to a life-threatening situation called foreign body inhalation, it is necessary to fully train nasal foreign body removal techniques to ensure successful removal; minimal attempts are made in actual patients. Although training in real or simulated patients is impractical and too dangerous, due to the risk of inhaling foreign bodies during the operation, it has been proven that the use of simulated human models can enhance the learning experience of students and prepare them for real patients Practice, increase knowledge and confidence. 13
Although the existing commercial mannequins for removing foreign bodies in the nasal cavity sometimes cannot meet the needs of all end users, our research shows that it is possible to design an internal mannequin with high satisfaction. The satisfaction score of the internal mannequin is significantly higher than that of the commercial mannequin in multiple dimensions, including proper size, ease of use, ease of maintenance, flexibility of the nose relative to the actual anatomical structure, similarity, etc. Compared with the actual anatomy and confidence of the nasal cavity, the human body model can improve the ability of medical students to practice on real patients.
Specifically, the size of the mannequin and the flexibility of the nose are designed with PU foam and silicone to ensure that it resembles the actual anatomy as much as possible. In addition, the special design of the detachable nose and nasal cavity allows users to replace these components at any time if they are torn during training. These factors make the internal mannequin easy to use and quick to maintain. However, the limitation of this product is that the head of the mannequin is made of PU foam. Although PU foam has the advantages of being lighter and lower cost than silica gel, silica gel is more durable than PU foam. Therefore, if durability is more of a concern than weight and production cost, the future development of the entire mannequin can be made of silicone.
It should be noted that there is no statistically significant difference between the satisfaction scores of certain dimensions of the internal mannequin and the satisfaction scores of the commercial mannequin, for example, in order to enhance useful feedback regarding the anatomy and the trainer's procedures. No, the special design of the detachable nose and nasal cavity of the self-made mannequin makes the satisfaction score of the excellent teaching design dimension not significantly different from that of the commercial mannequin; among them, the nasal cavity part can also be removed from the side. In addition, there is no statistically significant difference between the satisfaction scores of the internal mannequin in the two dimensions of proper weight and ease of cleaning and the commercial mannequin. This means that the weight of the two mannequins is not too light, causing the mannequin to be moved farther during the operation, or it is not too heavy to make the mannequin difficult to carry. In addition, the surfaces of both mannequins are easy to clean. There are no grooves or corners that may cause cleaning problems. However, based on simple linear regression to evaluate variables, these variables may be related to the satisfaction score of the human body model, and the total satisfaction score difference between the two human body models is calculated. We found that no factors, including medical profession, age, gender, and time experience as a general practitioner or ENT specialist are related to this difference. In other words, different professions, age, gender, and time experience are not the same as The internal mannequin score is higher than the commercial mannequin.
This study has some limitations. First, only use a commercial mannequin from a company provided by our medical center to compare with an internal mannequin. Obtaining more commercial mannequins from different companies can provide more information about the advantages and disadvantages of internal mannequins and other commercial mannequins. Second, the participants may already know that the internal models were developed by our research, so they may have some biases when evaluating the satisfaction of each model. However, the author tried to limit this bias by not affecting the participants before the study, and all participants had never seen the internal model before the start of the study.
This newly designed internal nasal foreign body removal model is highly satisfied with training and can be used to develop further nasal foreign body removal models in the future.
The data set generated during this research period can be obtained from the corresponding author upon reasonable request.
The study was approved by the Ethics Committee and Institutional Review Board of Prince of Songkla University School of Medicine. All participants provided informed consent to participate in this study.
We would like to thank Dr. Alan Geater and Assistant Professor Thara Tunthanathip for their useful suggestions on statistical analysis. The author would also like to thank Andrew Jonathan Tait of the International Affairs Department for proofreading the English of this report.
All authors who contributed to the data analysis, drafting, or revision of the article agree to which journal the article should be submitted to. In addition, the author has finally approved the version to be published and agreed to be responsible for all aspects of the work it contains.
Funding for this study was provided by the School of Medicine, Prince of Songkhla University, Songkhla, Thailand. The funder had no role in research design, data collection and analysis, publication decision or manuscript preparation.
Dr. Pittayapon Pitathawatchai reported the patent 2003002767 granted to Kittiphos Anuntaseree; Dr. Sittichoke Anuntaseree reported a small patent pending, application number 2003002767. The authors report no other conflicts of interest in this work.
1. da Silva BS, Souza LO, Camera MG, Tamiso AG, Castanheira LV. Foreign bodies in otolaryngology: a study of 128 cases. Int Arch Otorhinolaryngol. 2009; 13: 394-399.
2. Endican S, Garap JP, Dubey SP. Analysis of 1037 cases of ENT foreign bodies in Melanesian children[J]. Int J Pediatr Otorhinolaryngol. 2006;70(9):1539-1545. doi:10.1016/j.ijporl.2006.03.018
3. Afolabi OA, Suleiman AO, Aremu SK, etc. Audit of pediatric nasal foreign bodies in Ilorin, Nigeria. J Children's health. 2009;3(2):64–67.
4. Kiger JR, Brenkert TE, Losek JD. Removal of nasal foreign body in children. Pediatric emergency care. 2008;24(11):785-792. doi:10.1097/PEC.0b013e31818c2cb9
5. Tong MC, Ying SY, van Hasselt CA. Foreign body in children's nasal cavity. Int J Pediatr Otorhinolaryngol. 1996;35(3):207-211. doi:10.1016/0165-5876(95)01305-9
6. Regonne PE, Ndiaye M, Sy A, Diandy Y, Diop AD, Diallo BK. A foreign body in the nasal cavity of a child in a pediatric hospital in Senegal: a three-year evaluation. Eur Ann Otorhinolaryngol Head Neck Dis. 2017;134(5):361–364. doi:10.1016/j.anorl.2017.02.013
7. Balatsouras D, Eliopoulos P, Kaberos A, Economou C. Rhinolithiasis: an unusual cause of nasal congestion. Rhinology. 2002;40:162-164.
8. Awad AH, ElTaher M. ENT Foreign body: an experience. Int Arch Otorhinolaryngol. 2018;22(02):146–151. doi:10.1055/s-0037-1603922
9. Mackle T, Conlon B. Foreign bodies in children's nose and ears. Should these be managed in accidents and emergencies? Int J Pediatr Otorhinolaryngol. 2006;70(3):425–428. doi:10.1016/j.ijporl.2005.07.007
10. Cohen HA, Goldberg E, Horev Z. Removal of foreign bodies in children's nose. Clinical Pediatrics (Philadelphia). 1993;32(3):192. doi:10.1177/000992289303200319
11. Schulze SL, Kerschner J, Beste D. Foreign bodies in the external auditory canal of children: a review of 698 cases. Otorhinolaryngology Head and Neck Surgery. 2002;127(1):73-78. doi:10.1067/mhn.2002.126724
12. Halm BM, Lee MT, Franke AA. Use human model simulation to improve medical students' toxicology knowledge and self-confidence. Hawaii Medical Journal 2010; 69: 4-7.
13. Swamy M, Sawdon M, Chaytor A, Cox D, Barbaro-Brown J, McLachlan J. A study investigating the effectiveness of SimMan® as an adjunct to teaching preclinical skills to medical students. BMC medical education. 2014;14(1):231. doi:10.1186/1472-6920-14-231
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