Exploring the Impact of 3D-Modeled Berlin Hearts on Patient Education and Anxiety: A Protocol Paper Abstract The Berlin Heart is a state-of-the-art machine that significantly advances congenital heart disease treatment by sustaining life while patients with severe cardiac dysfunction either await a heart transplant or recover from surgery. The transplant process, though life-extending, can significantly heighten anxiety and stress, severely impacting quality of life. Due to its advanced nature, the workings of the Berlin Heart can be better explained to patients and their families through a physical model of the device. We propose that the patient groups that utilize the 3D Berlin Heart Model for educational purposes will exhibit (Preprint)

BACKGROUND Review of Literature In recent years, integrating surgical models into medical practice has gained traction due to their potential to enhance patient education and understanding of their procedures. By creating the Berlin Heart (BH) model for the pediatric population, we wanted to explore the effectiveness of this unique model in alleviating patient anxiety. Psychological Impact When studying anxiety in the pediatric population, it is essential to understand the parents' role. In a study conducted by Holly Clisby, eight parents of children supported by the Berlin Heart were interviewed. The study captured the anxiety-inducing effects of prolonged hospitalization. The research suggested that patient and family education about the BH model can mitigate psychological burden, further supporting that models alleviate stress. Additionally, Dr. Tilman Humpl studied the effectiveness of VADs, with a particular focus on the BH model in pediatric patients. The study supported that VADs, particularly the BH model, offer efficient and extended support for pediatric patients until they receive a transplant. However, the wait time can induce anxiety in patients because the device may not support them long enough as they await a transplant (Humpl et al., 2010). Furthermore, Ronald Hetzer and his team investigated the effectiveness of the device. Their study found that the Berlin Heart provided support for up to 841 days before a heart transplantation became viable for a 5-year-old boy. Another patient, a 14-month-old boy with decompensated dilated cardiomyopathy, remained stable with the BVAD for 547 days until heart transplantation. Therefore, it was reported that a pediatric mechanical circulatory support device, the Berlin Heart, can be reliable for circulation for extended periods. Perioperative Education and Reducing Anxiety Several studies have been conducted to understand how models have reduced perioperative anxiety and improved patient anxiety. For instance, Mark Biro and his colleagues had a compelling case for the impact of their three-dimensional printed Mohs Micrographic surgery (MMS) model with standardized education. The study used the Visual Analog Scale (VAS) and State-Trait Anxiety Inventory (STAI) to assess anxiety and understanding. One group received the MMS model and standardized education; the other received standardized education (verbal counseling). It was found that anxiety levels significantly decreased when given a combination of verbal education and the model versus just standardized education (Biro et al., 2019) Despite this, the study had a mean age of 67.8 years; thus, it was vital to continue research to understand the implications of a model in the pediatric population. When educating patients on their procedure, specificity is a critical approach. That being so, the models used should pertain to their diagnosis and anatomy, as this will ensure optimal understanding and reduction of anxiety. In a pilot study, seven patients with a kidney tumor underwent a four-phase multidetector computerized tomography (MDCT) scanning from which renal volume data were extracted to create life-size patient-specific 3D printed models. Patient knowledge and understanding were evaluated before and after presenting the model, and there was a significant improvement in understanding their surgical procedure (44.6%, p = 0.026). As a result, it can be concluded that personalized 3D-printed models enhance patients' subjective satisfaction (Zhuang et al., 2019). OBJECTIVE To properly assess the effect that education using the 3D-printed Berlin Heart Model has on patient anxiety levels and surgical outcomes, preoperative anxiety levels of the patients and their parents must be measured (qualitatively and quantitatively) and then statistically contrasted with anxiety levels of patients and their parents after education on the BH model. METHODS Inclusion/Exclusion Criteria The study subjects selected for the test population will be predicated on the patient and their respective nuclear family receiving a Berlin Heart LVAD surgery. This will present two subsets within the inclusion population: the actual patient being the first subset and the second subset being the patient's parents. Patients who have already received a Berlin Heart LVAD transplant and or patients who have received similar heart transplants like the Berlin Heart will be disqualified from testing. Study Design Before proceeding with the study, around half of the selected subjects will be randomly assorted into a control group. This control group will only receive a standard education compared to the test control group, which will receive standard education supplemented by the 3-D-printed Berlin Heart Model. Both groups will undergo the same outlined study phases. For the pre-education phase of this study, patients will be administered the PARS inventory for the quantitative assessment of anxiety and the Wong-Baker face scale for the qualitative evaluation of anxiety. During the pre-education phase, parents will be administered the STAI-AC inventory and a modified Likert Anxiety scale for quantitative and qualitative anxiety assessment, respectively. The education phase of the study will be composed of regular education that families undergo before operations, supplemented by the 3D-printed Berlin Heart model. There are two separate Berlin Heart models, with the first being a handheld version that will be handed out during the presentation and showcasing how a Berlin Heart works, complete with flowing water and pumps. The second is a heavier interactive model, more aimed at pediatric patients, with a drawing surface that showcases the Berlin Heart’s placement and functionality in the body of a friendly man. During the post-education phase of the study, the PARS and the STAI-AC are administered to the patient and parents, respectively, to assess post-education anxiety levels quantitatively. For qualitative assessment, the Wong-Baker Face scale will be distributed to the patients, and the modified Likert Anxiety Scale will be given to the parents to determine anxiety levels. Statistical Analysis If the data from the inventories and surveys appear to be in normal distribution, a one-way ANOVA should be used to compare the model's effectiveness on patient and parent anxiety levels. The pre-education anxiety levels and the post-education anxiety levels are linked events where one event influences the other. Therefore, a one-way ANOVA should be done on the PARS and STAI-AC inventory. Regarding the qualitative data, the Wong-Baker face survey can be converted into numerical data, which can then be run through a one-way ANOVA to determine the effectiveness of the 3D-printed learning aid. Moreover, the Likert scores can be converted and understood as interval data, which can also be used within a one-way ANOVA. This assumes the data has been corrected for no outliers and a normal distribution. If the data has no normal distribution and outliers, a Wilcox-signed rank test could be used with regression tests to determine the correlation between patient education and anxiety levels. RESULTS Data is yet to be collected. CONCLUSIONS The present study sought to assess the impact of employing a 3D-printed model of the Berlin Heart on alleviating preoperative and postoperative anxiety among pediatric patients and their families. The absence of empirical data herein highlights the challenges inherent in pioneering research fields, particularly those intersecting medical innovation with patient psychological well-being. The theoretical implications of our study, however, contribute to a broader understanding of patient education mechanisms and their potential to transform patient experiences. Moreover, the established methodological framework sets a precedent for subsequent empirical inquiries into the use of tangible educational aids in clinical settings. Future research must empirically validate the proposed benefits of 3D-printed models in medical education and anxiety reduction. Subsequent studies should refine the approach based on the lessons learned during the preliminary phases of this research, possibly extending the investigation to include diverse patient cohorts and a broader spectrum of medical devices.

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