Search results for: ethically problematic situations in clinical psychology
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 6041

Search results for: ethically problematic situations in clinical psychology

2741 Personality Profiles, Emotional Disturbance and Health-Related Quality of Life in Patients with Epilepsy

Authors: Usha Barahmand, Ruhollah Heydari Sheikh Ahmad, Sara Alaie Khoraem

Abstract:

Introduction: The association of epilepsy with several psychological disorders and reduced quality of life has long been recognized. The present study aimed at comparing the personality profiles, quality of life and symptomatology of anxiety and depression in patients with epilepsy and healthy controls. Materials and Methods: Forty seven patients (29 men and 18 women) with diagnosed epilepsy participated in this study. Forty seven healthy controls who matched the patients in age and gender were also recruited. The participants’ personality and psychological profiles were assessed using the Depression, Anxiety, and Stress Scale (DASS-21), the Short-Form Health Survey (SF-36) and the HEXACO Personality Inventory (HEXACO-PI). Scoring algorithms were applied to the SF-36 produce the physical and mental component scores (PCS and MCS). Results: There were statistically significant differences in the total SF-36 score, anxiety, depression and stress scores of the DASS-21 between patients and controls. Anxiety, stress and depression scores significantly correlated inversely with the PCS and MCS. Data analysis showed that females had higher depression scores than males in both patients and controls, while males in both groups scored higher on stress. Patients’ personality scores were also different from those reported by controls on emotional, agreeableness and extroversion. Patients scored higher on emotionality, and lower on agreeableness and extraversion. Patients also scored lower on indices of quality of life. Regression analysis revealed that emotionality, anxiety, stress and MCS accounted for a significant proportion of the variance in severity of epileptic seizures. Conclusion: Stressful situations and psychological conditions as well as the personality trait of neuroticism were related to the occurrence of recurrent epileptic seizures.

Keywords: anxiety, depression, epilepsy, neuroticism, personality, quality of life, stress

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2740 A Critical Reflection of Ableist Methodologies: Approaching Interviews and Go-Along Interviews

Authors: Hana Porkertová, Pavel Doboš

Abstract:

Based on a research project studying the experience of visually disabled people with urban space in the Czech Republic, the conference contribution discusses the limits of social-science methodologies used in sociology and human geography. It draws on actor-network theory, assuming that science does not describe reality but produces it. Methodology connects theory, research questions, ways to answer them (methods), and results. A research design utilizing ableist methodologies can produce ableist realities. Therefore, it was necessary to adjust the methods so that they could mediate blind experience to the scientific community without reproducing ableism. The researchers faced multiple challenges, ranging from questionable validity to how to research experience that differs from that of the researchers who are able-bodied. Finding a suitable theory that could be used as an analytical tool that would demonstrate space and blind experience as multiple, dynamic, and mutually constructed was the first step that could offer a range of potentially productive methods and research questions, as well as bring critically reflected results. Poststructural theory, mainly Deleuze-Guattarian philosophy, was chosen, and two methods were used: interviews and go-along interviews that had to be adjusted to be able to explore blind experience. In spite of a thorough preparation of these methods, new difficulties kept emerging, which exposed the ableist character of scientific knowledge. From the beginning of data collecting, there was an agreement to work in teams with slightly different roles of each of the researchers, which was significant especially during go-along interviews. In some cases, the anticipations of the researchers and participants differed, which led to unexpected and potentially dangerous situations. These were not caused only by the differences between scientific and lay communities but also between able-bodied and disabled people. Researchers were sometimes assigned to the assistants’ roles, and this new position – doing research together – required further negotiations, which also opened various ethical questions.

Keywords: ableist methodology, blind experience, go-along interviews, research ethics, scientific knowledge

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2739 Study on Effective Continuous Assessments Methods to Improve Undergraduates English Language Skills

Authors: K. M. R. Siriwardhana

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Sri Lanka is a developing country in South Asia which uses English as its second language. Today, most of the university students in Sri Lanka are eagerly exploring knowledge giving special consideration to English as their 2nd Language with the understanding that to climb up the career ladder, English is inevitable both in local and international contexts. However, still a considerable failing rate in English can also be seen among the Sri Lankan undergraduates Further, most of the Sri Lankan universities now practice English as their medium of instructions making English a credited Subject to brighten the future of the Sri Lankan students. Accordingly, in many universities an array of assessments are employed to evaluate undergraduates’ competence in English language. The main objective of this study was to ascertain the effective assessment methods to improve the 2nd language skills of the Sri Lankan university students which also create a more interest in them to learn English. Accordingly, hundred (100) undergraduates were selected as the research sample and the primary data was collected employing a semi structured questionnaire along with class room observations and semi structured interviews. Data was mainly analyzed descriptively employing graphical illustrations. According to the research findings, it was revealed that practical assessments such as oral tests, competitive drama and presentations are more effective in improving their language skills and preferred by the majority of students than written assignments and papers. Further, most of the students have scored better in practical assignments than in the written assignments. Hence, the study concludes that best and the benefited way of improving English language skills of Sri Lankan undergraduates is practical assessments as it gives them the opportunity to apply the language with much confidence and competence in actual situations. Further, the study recommends the language teachers to improve their own skills and creativity in practicing and employing such assessments as it will develop both second language teaching and learning skills. Ultimately, the university graduates will be able to secure their positions internationally as they are well capable in English, the lingua franca of the world.

Keywords: assessments, second language, Sri Lanka, undergraduates

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2738 An Interpretable Data-Driven Approach for the Stratification of the Cardiorespiratory Fitness

Authors: D.Mendes, J. Henriques, P. Carvalho, T. Rocha, S. Paredes, R. Cabiddu, R. Trimer, R. Mendes, A. Borghi-Silva, L. Kaminsky, E. Ashley, R. Arena, J. Myers

Abstract:

The continued exploration of clinically relevant predictive models continues to be an important pursuit. Cardiorespiratory fitness (CRF) portends clinical vital information and as such its accurate prediction is of high importance. Therefore, the aim of the current study was to develop a data-driven model, based on computational intelligence techniques and, in particular, clustering approaches, to predict CRF. Two prediction models were implemented and compared: 1) the traditional Wasserman/Hansen Equations; and 2) an interpretable clustering approach. Data used for this analysis were from the 'FRIEND - Fitness Registry and the Importance of Exercise: The National Data Base'; in the present study a subset of 10690 apparently healthy individuals were utilized. The accuracy of the models was performed through the computation of sensitivity, specificity, and geometric mean values. The results show the superiority of the clustering approach in the accurate estimation of CRF (i.e., maximal oxygen consumption).

Keywords: cardiorespiratory fitness, data-driven models, knowledge extraction, machine learning

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2737 Mental Illness on Youtube: Exploring Identity Performance in the Virtual Space

Authors: P. Saee, Baiju Gopal

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YouTube has seen a surge in the recent years in the number of creators opening up about their mental illness on the video-sharing platform. In documenting their mental health, YouTubers perform an identity of their mental illness in the online world. Identity performance is a theory under identity research that has been readily applied to illness narratives and internet studies. Furthermore, in India, suffering from mental illnesses is regarded with stigma, making the act of taking mental health from a personal to a public space on YouTube a phenomenon worth exploring. Thus, the aim of this paper is to analyse the mental illness narratives of Indian YouTubers for understanding its performance in the virtual world. For this purpose, thematic narrative analysis on the interviews of four Indian YouTubers was conducted. This data was synthesized with analysis of the videos the YouTubers had uploaded on their channel sharing about their mental illness. The narratives of the participants shed light on two significant presentations that they engage in: (a) the identity of a survivor/fighter and (b) the identity of a silent sufferer. Further, the participants used metaphors to describe their illness, thereby co-constructing a corresponding identity based on their particular metaphors. Lastly, the process of bringing mental illness from back stage to front stage on YouTube involves a shift in the audience, from being rejecting and invalidating in real life to being supportive and encouraging in the virtual space. Limitations and implications for future research were outlined.

Keywords: cyber-psychology, internet, media, mental health, mental illness, technology

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2736 Evaluating Language Loss Effect on Autobiographical Memory by Examining Memory Phenomenology in Bilingual Speakers

Authors: Anastasia Sorokina

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Graduate language loss or attrition has been well documented in individuals who migrate and become emersed in a different language environment. This phenomenon of first language (L1) attrition is an example of non-pathological (not due to trauma) and can manifest itself in frequent pauses, search for words, or grammatical errors. While the widely experienced loss of one’s first language might seem harmless, there is convincing evidence from the disciplines of Developmental Psychology, Bilingual Studies, and even Psychotherapy that language plays a crucial role in the memory of self. In fact, we remember, store, and share personal memories with the help of language. Dual-Coding Theory suggests that language memory code deterioration could lead to forgetting. Yet, no one has investigated a possible connection between language loss and memory. The present study aims to address this research gap by examining a corpus of 1,495 memories of Russian-English bilinguals who are on a continuum of L1 (first language) attrition. Since phenomenological properties capture how well a memory is remembered, the following descriptors were selected - vividness, ease of recall, emotional valence, personal significance, and confidence in the event. A series of linear regression statistical analyses were run to examine the possible negative effects of L1 attrition on autobiographical memory. The results revealed that L1 attrition might compromise perceived vividness and confidence in the event, which is indicative of memory deterioration. These findings suggest the importance of heritage language maintenance in immigrant communities who might be forced to assimilate as language loss might negatively affect the memory of self.

Keywords: L1 attrition, autobiographical memory, language loss, memory phenomenology, dual coding

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2735 Threats to the Business Value: The Case of Mechanical Engineering Companies in the Czech Republic

Authors: Maria Reznakova, Michala Strnadova, Lukas Reznak

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Successful achievement of strategic goals requires an effective performance management system, i.e. determining the appropriate indicators measuring the rate of goal achievement. Assuming that the goal of the owners is to grow the assets they invested in, it is vital to identify the key performance indicators, which contribute to value creation. These indicators are known as value drivers. Based on the undertaken literature search, a value driver is defined as any factor that affects the value of an enterprise. The important factors are then monitored by both financial and non-financial indicators. Financial performance indicators are most useful in strategic management, since they indicate whether a company's strategy implementation and execution are contributing to bottom line improvement. Non-financial indicators are mainly used for short-term decisions. The identification of value drivers, however, is problematic for companies which are not publicly traded. Therefore financial ratios continue to be used to measure the performance of companies, despite their considerable criticism. The main drawback of such indicators is the fact that they are calculated based on accounting data, while accounting rules may differ considerably across different environments. For successful enterprise performance management it is vital to avoid factors that may reduce (or even destroy) its value. Among the known factors reducing the enterprise value are the lack of capital, lack of strategic management system and poor quality of production. In order to gain further insight into the topic, the paper presents results of the research identifying factors that adversely affect the performance of mechanical engineering enterprises in the Czech Republic. The research methodology focuses on both the qualitative and the quantitative aspect of the topic. The qualitative data were obtained from a questionnaire survey of the enterprises senior management, while the quantitative financial data were obtained from the Analysis Major Database for European Sources (AMADEUS). The questionnaire prompted managers to list factors which negatively affect business performance of their enterprises. The range of potential factors was based on a secondary research – analysis of previously undertaken questionnaire surveys and research of studies published in the scientific literature. The results of the survey were evaluated both in general, by average scores, and by detailed sub-analyses of additional criteria. These include the company specific characteristics, such as its size and ownership structure. The evaluation also included a comparison of the managers’ opinions and the performance of their enterprises – measured by return on equity and return on assets ratios. The comparisons were tested by a series of non-parametric tests of statistical significance. The results of the analyses show that the factors most detrimental to the enterprise performance include the incompetence of responsible employees and the disregard to the customers‘ requirements.

Keywords: business value, financial ratios, performance measurement, value drivers

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2734 Machiavellian Language at Work: The Signs of Machiavellianism in Work-Related Interviews

Authors: Gyongyver Csapo, Andrea Czibor

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Machiavellianism is a personality trait based on the exploitation and deception of others. Machiavellian individuals are motivated to gain and to maintain power with the help of their strategic thinking, manipulation tactics, and interpersonal skills. Consequently, Machiavellianism is treated as a personality trait that can affect an individual’s career and work-related behavior. The aim of our research is to provide a narrative psychological approach to Machiavellianism in order to get a more comprehensive picture about the attitudes, values, and work-related behaviors of Machiavellian individuals. In this study, semi-structured interviews were made with employees (N=275) about their work-related experiences. Additionally, participants completed questionnaires about their turnover intention and perceived stress. The interviews were examined with narrative psychological content analysis and thematic analyzes. Based on the thematic analysis, mentioning of two topics (recognition at work and control) were associated with Machiavellianism. Scientific narrative psychological content analysis showed a negative association between Machiavellianism and positive emotions. Turnover intention and the magnitude of perceived work-related stress showed a significant positive correlation with Machiavellianism. In this study, qualitative and quantitative methodologies were combined in order to get a deeper insight of Machiavellianism from an organizational psychological perspective. Our research can contribute to a better understanding of this personality trait and provides an excellent basis for further investigations.

Keywords: machiavellianism, narrative psychology, turnover intention, work-related stress

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2733 How Obesity Sparks the Immune System and Lessons from the COVID-19 Pandemic

Authors: Husham Bayazed

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Purpose of Presentation: Obesity and overweight are among the biggest health challenges of the 21st century, according to the WHO. Obviously, obese individuals suffer different courses of disease – from infections and allergies to cancer- and even respond differently to some treatment options. Of note, obesity often seems to predispose and triggers several secondary diseases such as diabetes, arteriosclerosis, or heart attacks. Since decades it seems that immunological signals gear inflammatory processes among obese individuals with the aforementioned conditions. This review aims to shed light how obesity sparks or rewire the immune system and predisposes to such unpleasant health outcomes. Moreover, lessons from the Covid-19 pandemic ascertain that people living with pre-existing conditions such as obesity can develop severe acute respiratory syndrome (SARS), which needs to be elucidated how obesity and its adjuvant inflammatory process distortion contribute to enhancing severe COVID-19 consequences. Recent Findings: In recent clinical studies, obesity was linked to alter and sparks the immune system in different ways. Adipose tissue (AT) is considered as a secondary immune organ, which is a reservoir of tissue-resident of different immune cells with mediator release, making it a secondary immune organ. Adipocytes per se secrete several pro-inflammatory cytokines (IL-6, IL-4, MCP-1, and TNF-α ) involved in activation of macrophages resulting in chronic low-grade inflammation. The correlation between obesity and T cells dysregulation is pivotal in rewiring the immune system. Of note, autophagy occurrence in adipose tissues further rewire the immune system due to flush and outburst of leptin and adiponectin, which are cytokines and influencing pro-inflammatory immune functions. These immune alterations among obese individuals are collectively incriminated in triggering several metabolic disorders and playing role in increasing cancers incidence and susceptibility to different infections. During COVID-19 pandemic, it was verified that patients with pre-existing obesity being at greater risk of suffering severe and fatal clinical outcomes. Beside obese people suffer from increased airway resistance and reduced lung volume, ACE2 expression in adipose tissue seems to be high and even higher than that in lungs, which spike infection incidence. In essence, obesity with pre-existence of pro-inflammatory cytokines such as LI-6 is a risk factor for cytokine storm and coagulopathy among COVID-19 patients. Summary: It is well documented that obesity is associated with chronic systemic low-grade inflammation, which sparks and alter different pillars of the immune system and triggers different metabolic disorders, and increases susceptibility of infections and cancer incidence. The pre-existing chronic inflammation in obese patients with the augmented inflammatory response against the viral infection seems to increase the susceptibility of these patients to developing severe COVID-19. Although the new weight loss drugs and bariatric surgery are considered as breakthrough news for obesity treatment, but preventing is easier than treating it once it has taken hold. However, obesity and immune system link new insights dispute the role of immunotherapy and regulating immune cells treating diet-induced obesity.

Keywords: immunity, metabolic disorders, cancer, COVID-19

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2732 Low-Impact Development Strategies Assessment for Urban Design

Authors: Y. S. Lin, H. L. Lin

Abstract:

Climate change and land-use change caused by urban expansion increase the frequency of urban flooding. To mitigate the increase in runoff volume, low-impact development (LID) is a green approach for reducing the area of impervious surface and managing stormwater at the source with decentralized micro-scale control measures. However, the current benefit assessment and practical application of LID in Taiwan is still tending to be development plan in the community and building site scales. As for urban design, site-based moisture-holding capacity has been common index for evaluating LID’s effectiveness of urban design, which ignore the diversity, and complexity of the urban built environments, such as different densities, positive and negative spaces, volumes of building and so on. Such inflexible regulations not only probably make difficulty for most of the developed areas to implement, but also not suitable for every different types of built environments, make little benefits to some types of built environments. Looking toward to enable LID to strength the link with urban design to reduce the runoff in coping urban flooding, the research consider different characteristics of different types of built environments in developing LID strategy. Classify the built environments by doing the cluster analysis based on density measures, such as Ground Space Index (GSI), Floor Space Index (FSI), Floors (L), and Open Space Ratio (OSR), and analyze their impervious surface rates and runoff volumes. Simulate flood situations by using quasi-two-dimensional flood plain flow model, and evaluate the flood mitigation effectiveness of different types of built environments in different low-impact development strategies. The information from the results of the assessment can be more precisely implement in urban design. In addition, it helps to enact regulations of low-Impact development strategies in urban design more suitable for every different type of built environments.

Keywords: low-impact development, urban design, flooding, density measures

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2731 Epidemiological Patterns of Pediatric Fever of Unknown Origin

Authors: Arup Dutta, Badrul Alam, Sayed M. Wazed, Taslima Newaz, Srobonti Dutta

Abstract:

Background: In today's world, with modern science and contemporary technology, a lot of diseases may be quickly identified and ruled out, but children's fever of unknown origin (FUO) still presents diagnostic difficulties in clinical settings. Any fever that reaches 38 °C and lasts for more than seven days without a known cause is now classified as a fever of unknown origin (FUO). Despite tremendous progress in the medical sector, fever of unknown origin, or FOU, persists as a major health issue and a major contributor to morbidity and mortality, particularly in children, and its spectrum is sometimes unpredictable. The etiology is influenced by geographic location, age, socioeconomic level, frequency of antibiotic resistance, and genetic vulnerability. Since there are currently no known diagnostic algorithms, doctors are forced to evaluate each patient one at a time with extreme caution. A persistent fever poses difficulties for both the patient and the doctor. This prospective observational study was carried out in a Bangladeshi tertiary care hospital from June 2018 to May 2019 with the goal of identifying the epidemiological patterns of fever of unknown origin in pediatric patients. Methods: It was a hospital-based prospective observational study carried out on 106 children (between 2 months and 12 years) with prolonged fever of >38.0 °C lasting for more than 7 days without a clear source. Children with additional chronic diseases or known immunodeficiency problems were not allowed. Clinical practices that helped determine the definitive etiology were assessed. Initial testing included a complete blood count, a routine urine examination, PBF, a chest X-ray, CRP measurement, blood cultures, serology, and additional pertinent investigations. The analysis focused mostly on the etiological results. The standard program SPSS 21 was used to analyze all of the study data. Findings: A total of 106 patients identified as having FUO were assessed, with over half (57.5%) being female and the majority (40.6%) falling within the 1 to 3-year age range. The study categorized the etiological outcomes into five groups: infections, malignancies, connective tissue conditions, miscellaneous, and undiagnosed. In the group that was being studied, infections were found to be the main cause in 44.3% of cases. Undiagnosed cases came in at 31.1%, cancers at 10.4%, other causes at 8.5%, and connective tissue disorders at 4.7%. Hepato-splenomegaly was seen in people with enteric fever, malaria, acute lymphoid leukemia, lymphoma, and hepatic abscesses, either by itself or in combination with other conditions. About 53% of people who were not diagnosed also had hepato-splenomegaly at the same time. Conclusion: Infections are the primary cause of PUO (pyrexia of unknown origin) in children, with undiagnosed cases being the second most common cause. An incremental approach is beneficial in the process of diagnosing a condition. Non-invasive examinations are used to diagnose infections and connective tissue disorders, while invasive investigations are used to diagnose cancer and other ailments. According to this study, the prevalence of undiagnosed diseases is still remarkable, so extensive historical analysis and physical examinations are necessary in order to provide a precise diagnosis.

Keywords: children, diagnostic challenges, fever of unknown origin, pediatric fever, undiagnosed diseases

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2730 Improvement of the Quality Services of Social Robots by Understanding Requirements of People with Dementia

Authors: Konrad Rejdak, Agnieszka Korchut, Sebastian Szklener, Urszula Skrobas, Justyna Gerlowska, Katarzyna Grabowska-Aleksandrowicz, Dorota Szczesniak-Stanczyk

Abstract:

Introduction: Neurodegenerative diseases are frequently accompanied by loss and unwanted change in functional independence, social relationships, and economic circumstances. Currently, the achievements of social robots to date is being projected to improve multidimensional quality of life among people with cognitive impairment and others. Objectives: Identification of particular human needs in context of the changes occurring in course of neurodegenerative diseases. Methods: Based on the 110 surveys performed in Medical University of Lublin from medical staff, patients, and caregivers we made prioritization of the users' needs as: high, medium, and low. The issues included in the surveys concerned four aspects: user acceptance, functional requirements, design of the robotic assistant and preferred types of human-robot interaction. Results: We received completed questionnaires: 50 from medical staff, 30 from caregivers and 30 from potential users. Above 90% of the respondents from each of the three groups, accepted robotic assistant as a potential caregiver. High priority functional capability of assistive technology was to handle emergencies in a private home like recognizing life-threatening situations and reminding about medication intake. With reference to design of the robotic assistant, the majority of the respondent would like to have an anthropomorphic appearance with positive emotionally expressive face. The most important type of human-robot interaction was voice-operated system and by touchscreen. Conclusion: The results from our study might contribute to a better understanding of the system and users’ requirements for the development of a service robot intended to support patients with dementia.

Keywords: social robot, dementia, requirements, patients needs

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2729 Exploration of Bullying Perceptions in Adolescents in Sekolah Menengah Kejuruan Negeri 1 Manado

Authors: Madjid Nancy, Rakinaung Natalia, Lumowa Fresy

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Background: Bullying becomes one of the problems that concern the world of education, especially in adolescents, which has a negative impact on learning achievement, psychology, and physical health. The psychological impact is shame, depression, distress, fear, sadness, and anxiety, so that if prolonged leave can lead to depression in the victim. While the impact on physical health in the form of bruises on the hit area, blisters, swelling and in more severe cases will lead to death. Objectives: This study aims to explore the perception of bullying in adolescent students Sekolah Menengah Kejuruan (SMK) Negeri 1 Manado and the people associated with that adolescent students. Methods: This research uses descriptive qualitative research design and using thematic analysis, and supported by Urie Bronfenbrenner Ecological Framework. The data collection that will be used is by in-depth interview. Sampling using purposive sampling and snowball techniques. This research was conducted at SMK Negeri 1 Manado. Result: From the analysis obtained three themes with the categories: 1) the perception of bullying with categories are: Understanding of Bullying and The Impact of Bullying, 2) the originator of bullying with categories are: Fulfillment of Youth Development Tasks and Needs, Peers Influence, and Family Communication; 3) the effort to handle bullying with categories are: the Individual Coping and Teacher Role. Conclusion: This research get three themes, those are perception of bullying, bullying’s originator and the effort of handling bullying.

Keywords: adolscent, students, bullying, perception

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2728 The Bicycle-Related Traumatic Situations That Consulted Our Hospital

Authors: Yoshitaka Ooya, Daishuke Furuya, Manabu Nemoto

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Some countries such as Canada and Australia have mandatory bicycle helmet laws for all citizens and age groups. As of 2008 Japan has also adopted a helmet law but it is restricted to people 13 years old and under. People over 13 years of age are not required to wear helmets in Japan. Currently, the rate that people 0-13 years old actually wear helmets is low. In 2013 a number of patients came to Saitama University Hospital International Medical Center for treatment due to bicycle-related trauma. The total number of patients was 89 (55 male and 34 female). The average age of the patients was 40.9 years old (eldest; 83 y/o, median; 40 y/o, youngest; 1 y/o with a standard deviation ± 2.8). 54 of these patients (61%) experienced head trauma as well as some experiencing multiple injuries associated with their accident. 13 patients were wearing helmets, 50 patients were not wearing helmets and it is unknown if the remaining 26 patients were wearing helmets. This information was acquired from the patient`s medical charts. Only one patient who was wearing a helmet had a severe head injury, and this patient also experienced other multiple injuries. 17 patients who were not wearing helmets had severe head injuries and out of the 17, two had multiple injuries. The mechanism for injury varied. 12 patients were injured in an accident with a vehicle, only one of which was wearing a helmet. This patient also had multiple injuries. Of the other 11 patients, two had multiple injuries. The remaining patient`s injuries were caused by other accidents (3; fell over while riding, 2; crashed into an inanimate object, 1; collided with a motorcycle). The ladder of which had a severe head injury. All of these patients had light energy accidents and were all over 13 years of age. In Japan it is not mandatory for people over the age of 13 years to wear a bicycle helmet. Research shows that light energy accidents were mostly present in people over the age of 13, to which the law does not require the wearing of helmets. It is important that all people in all age groups be required to wear helmets when operating a bicycle to reduce the rate of light energy severe head injuries.

Keywords: bicycle helmet, head trauma, hospital, traumatic situation

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2727 The Lessons Learned from Managing Malignant Melanoma During COVID-19 in a Plastic Surgery Unit in Ireland

Authors: Amenah Dhannoon, Ciaran Martin Hurley, Laura Wrafter, Podraic J. Regan

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Introduction: The COVID-19 pandemic continues to present unprecedented challenges for healthcare systems. This has resulted in the pragmatic shift in the practice of plastic surgery units worldwide. During this period, many units reported a significant fall in urgent melanoma referrals, leading to patients presenting with advanced disease requiring more extensive surgery and inferior outcomes. Our objective was to evaluate our unit's experience with both non-invasive and invasive melanoma during the COVID-19 pandemic and characterize our experience and contrast it to that experienced by our neighbors in the UK, mainland Europe and North America. Methods: a retrospective chart review was performed on all patients diagnosed with invasive and non-invasive cutaneous melanoma between March to December of 2019 (control) compared to 2020 (COVID-19 pandemic) in a single plastic surgery unit in Ireland. Patient demographics, referral source, surgical procedures, tumour characteristics, radiological findings, oncological therapies and follow-up were recorded. All data were anonymized and stored in Microsoft Excel. Results: A total of 589 patients were included in the study. Of these, 314 (53%) with invasive melanoma, compared to 275 (47%) with the non-invasive disease. Overall, more patients were diagnosed with both invasive and non-invasive melanoma in 2020 than in 2019 (p<0.05). However, significantly longer waiting times in 2020 (64 days) compared to 2019 (28 days) (p<0.05), with the majority of the referral being from GP in 2019 (83%) compared to 61% in 2020. Positive sentinel lymph node were higher in 2019 at 56% (n=28) compared to 24% (n=22) in 2020. There was no statistically significant difference in the tutor characteristics or metastasis status. Discussion: While other countries have noticed a fall in the melanoma diagnosis. Our units experienced a higher number of disease diagnoses. This can be due to multiple reasons. In Ireland, the government reached an early agreement with the private sector to continue elective surgery on an urgent basis in private hospitals. This allowed access to local anesthetic procedures and local skin cancer cases were triaged to non-COVID-19 provider centers. Our unit also adapted a fast, effective and minimal patient contact strategy for triaging skin cancer based on telemedicine. Thirdly, a skin cancer nurse specialist maintained patient follow-ups and triaging a dedicated email service. Finally, our plastic surgery service continued to maintain a virtual complex skin cancer multidisciplinary team meeting during the pandemic, ensuring local clinical governance has adhered to each clinical case. Conclusion: Our study highlights that with the prompt efficient restructuring of services, we could reserve successful management of skin cancer even in the most devastating times. It is important to reflect on the success during the pandemic and emphasize the importance of preparation for a potentially difficult future

Keywords: malignant melanoma, skin cancer, COVID-19, triage

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2726 Parkinson's Disease and Musculoskeletal Problems

Authors: Ozge Yilmaz Kusbeci, Ipek Inci

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Aim: Musculoskeletal problems are very common in Parkinson’s disease (PD). They affect quality of life and cause disabilities. However they are under-evaluated, and under-treated. The aim of this study is to evaluate the prevalence and clinical features of musculoskeletal problems in patients with Parkinson disease (PD) compared to controls. Methods: 50 PD patients and 50 age and sex matched controls were interviewed by physicians about their musculoskeletal problems. Results: The prevalence of musculoskeletal problems was significantly higher in the PD group than in the control group (p < 0.05). Commonly involved body sites were the shoulder, low back, and knee. The shoulder and low back was more frequently involved in the PD group than in the control group. However, the knee was similarly involved in both groups. Among the past diagnoses associated with musculoskeletal problems, frozen shoulder, low back pain and osteoporosis more common in the PD group than in the control group (p < 0.05). Furthermore, musculoskeletal problems in the PD group tended to receive less treatment than that of the control group. Conclusion: Musculoskeletal problems were more common in the PD group than in the controls. Therefore assessment and treatment of musculoskeletal problems could improve quality of life in PD patients.

Keywords: parkinson disease, musculoskeletal problems, quality of life, PD disease

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2725 Development of Wave-Dissipating Block Installation Simulation for Inexperienced Worker Training

Authors: Hao Min Chuah, Tatsuya Yamazaki, Ryosui Iwasawa, Tatsumi Suto

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In recent years, with the advancement of digital technology, the movement to introduce so-called ICT (Information and Communication Technology), such as computer technology and network technology, to civil engineering construction sites and construction sites is accelerating. As part of this movement, attempts are being made in various situations to reproduce actual sites inside computers and use them for designing and construction planning, as well as for training inexperienced engineers. The installation of wave-dissipating blocks on coasts, etc., is a type of work that has been carried out by skilled workers based on their years of experience and is one of the tasks that is difficult for inexperienced workers to carry out on site. Wave-dissipating blocks are structures that are designed to protect coasts, beaches, and so on from erosion by reducing the energy of ocean waves. Wave-dissipating blocks usually weigh more than 1 t and are installed by being suspended by a crane, so it would be time-consuming and costly for inexperienced workers to train on-site. In this paper, therefore, a block installation simulator is developed based on Unity 3D, a game development engine. The simulator computes porosity. Porosity is defined as the ratio of the total volume of the wave breaker blocks inside the structure to the final shape of the ideal structure. Using the evaluation of porosity, the simulator can determine how well the user is able to install the blocks. The voxelization technique is used to calculate the porosity of the structure, simplifying the calculations. Other techniques, such as raycasting and box overlapping, are employed for accurate simulation. In the near future, the simulator will install an automatic block installation algorithm based on combinatorial optimization solutions and compare the user-demonstrated block installation and the appropriate installation solved by the algorithm.

Keywords: 3D simulator, porosity, user interface, voxelization, wave-dissipating blocks

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2724 The Relationship between Transcendence and Psychological Well-Being: A Systematic Scientific Literature Review

Authors: Monir Ahmed

Abstract:

The main purpose of this literature review was to investigate the existing quantitative clinical studies on the relationship between transcendence and psychological well-being. The primary objective of the literature review is to determine whether the existing studies adequately demonstrate the relationship between transcendence and psychological well-being, including spiritual well-being. A further objective of this literature review is to see if the ‘creatio ex nihilo’ doctrine is necessary to understand transcendence and its relationship with psychological well-being. Systematic literature review methods including studies identified from search engines, extracting data from the studies and assessing their quality for the planned review were used. The outcome of this literature review indicates that self-transcendence (STa), spiritual transcendence (STb) are positively related to psychological well-being. However, such positive relationships present limited scope for understanding transcendence and its relationship with well-being. The findings of this review support the need for further research in the area of transcendence and well-being. This literature review reveals the importance of developing a new transcendence tool for determining an individual’s ability to transcend and the relationship between his/her ability for transcendence and psychological well-being. The author of this paper proposes that the inclusion of the theological doctrine (‘creatio ex nihilo’) in understanding transcendence and psychological well-being is crucial, necessary and unavoidable.

Keywords: transcendence, psychological well-being, self-transcendence, spiritual transcendence, ‘creatio ex nihilo’

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2723 An Investigation the Effectiveness of Emotion Regulation Training on the Reduction of Cognitive-Emotion Regulation Problem in Patients with Multiple Sclerosis

Authors: Mahboobeh Sadeghi, Zahra Izadi Khah, Mansour Hakim Javadi, Masoud Gholamali Lavasani

Abstract:

Background: Since there is a relation between psychological and physiological factors, the aim of this study was to examine the effect of Emotion Regulation training on cognitive emotion regulation problem in patients with Multiple Sclerosis(MS) Method: In a randomized clinical trial thirty patients diagnosed with Multiple Sclerosis referred to state welfare organization were selected. The sample group was randomized into either an experimental group or a nonintervention control group. The subjects participated in 75-minute treatment sessions held three times a week for 4weeks (12 sessions). All 30 individuals were administered with Cognitive Emotion Regulation questionnaire (CERQ). Participants completed the questionnaire in pretest and post-test. Data obtained from the questionnaire was analyzed using Mancova. Results: Emotion Regulation significantly decreased the Cognitive Emotion Regulation problems patients with Multiple sclerosis (p < 0.001). Conclusions: Emotion Regulation can be used for the treatment of cognitive-emotion regulation problem in Multiple sclerosis.

Keywords: Multiple Sclerosis, cognitive-emotion regulation, emotion regulation, MS

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2722 Indian Bankruptcy Code 2016: Impact On Cross-Border Insolvency, an Analysis

Authors: Astha Sinha, Anjali Kanagali

Abstract:

India has been tackling with less than sophisticated legislations when it comes to recovery of debt and bankruptcy situations for a while now. There were multiple overlapping laws and adjudication forums dealing with financial failures and insolvency of companies/individuals in India without really aiding the timely recover of defaulted assets. It remained dicey for businesses to invest in India since there was a lack of legal and institutional machinery for dealing with debt defaults as per the global standards. After much deliberation, the Indian Draft Insolvency code received the presidential assent on May 28, 2016 bringing the Bankruptcy and Insolvency Code, 2016 into existence. The Code is expected to bring about great progress for the country and specifically has the two standout developments. The first is that it calls for resolution of corporate insolvency within a period of 180 days extendable by 90 days hence bringing about security in the minds of investors. Second is that it calls for the creation of a new class of insolvency professionals whose primary function shall be helping sick companies and banks with their takeovers, provides for setting up an Insolvency and Bankruptcy Board to regulate the same and provides for a two stage process of liquidation. The Code is estimated to help India move up its ranking on the World Bank’s ease of doing business index. It is currently ranked at the 130th position lower than some of the sub-saharan African countries. Besides this, however, there are various areas in which the Code falls short such as lack of provisions for aiding the issue of cross-border insolvency, impact on Medium and Small Enterprises in India etc. This paper aims to analyze the provisions of the new Bankruptcy and Insolvency Code, 2016 and its contribution in making India a more desirable location for doing business. It shall also emphasize on the cross-border insolvency issues, practices followed by other countries to resolve the same and the way forward for India to strengthen its Bankruptcy and Insolvency framework.

Keywords: bankruptcy and insolvency code 2016, cross-border insolvency provisions in the 2016 code, Ease of doing business and bankruptcy code, highlights of the new Indian bankruptcy code 2016

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2721 Protection of Human Rights in Polish Centres for Foreigners – in the Context of the European Human Rights System

Authors: Oktawia Braniewicz

Abstract:

The phenomenon of emigration and migration increasingly affects Poland's borders as well. For this reason, it is necessary to examine the level of protection of Human Rights in Polish Centres for Foreigners. The field study covered 11 centers for Foreigners in the provinces Kujawsko-Pomorskie Region, Lubelskie Region, Lodzkie Region, Mazowieckie Region and Podlaskie Region. Photographic documentation of living and social conditions, conversations with center employees and refugees allow to show a comprehensive picture of the situation prevailing in Centres for Foreigners. The object of reflection will be, in particular, the standards resulting from art. 8 and 13 of the Convention for the Protection of Human Rights and Fundamental Freedoms and article 2 of Protocol No. 1 to the Convention for the Protection of Human Rights and Fundamental Freedoms. The degree of realization of the right to education and the right to respect for family and private life will be shown. Issues related to learning the Polish language, access to a professional translator and psychological help will also be approximated. Learning Polish is not obligatory, which causes problems with assimilation and integration with other members of the new community. In centers for foreigners, there are no translators - a translator from an external company is rented if necessary. The waiting time for an interpreter makes the refugees feel anxious, unable to communicate with the employees of the centers (this is a situation in which the refugees do not know either English, Polish or Russian). Psychologist's help is available on designated days of the week. There is no separate specialist in child psychology, which is a serious problem.

Keywords: human rights, Polish centres, foreigners, fundamental freedoms

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2720 The Employees' Classification Method in the Space of Their Job Satisfaction, Loyalty and Involvement

Authors: Svetlana Ignatjeva, Jelena Slesareva

Abstract:

The aim of the study is development and adaptation of the method to analyze and quantify the indicators characterizing the relationship between a company and its employees. Diagnostics of such indicators is one of the most complex and actual issues in psychology of labour. The offered method is based on the questionnaire; its indicators reflect cognitive, affective and connotative components of socio-psychological attitude of employees to be as efficient as possible in their professional activities. This approach allows measure not only the selected factors but also such parameters as cognitive and behavioural dissonances. Adaptation of the questionnaire includes factor structure analysis and suitability analysis of phenomena indicators measured in terms of internal consistency of individual factors. Structural validity of the questionnaire was tested by exploratory factor analysis. Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Factor analysis allows reduce dimension of the phenomena moving from the indicators to aggregative indexes and latent variables. Aggregative indexes are obtained as the sum of relevant indicators followed by standardization. The coefficient Cronbach's Alpha was used to assess the reliability-consistency of the questionnaire items. The two-step cluster analysis in the space of allocated factors allows classify employees according to their attitude to work in the company. The results of psychometric testing indicate possibility of using the developed technique for the analysis of employees’ attitude towards their work in companies and development of recommendations on their optimization.

Keywords: involved in the organization, loyalty, organizations, method

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2719 Isolation and Identification of Fungal Pathogens in Palm Groves of Oued Righ

Authors: Lakhdari Wassima, Ouffroukh Ammar, Dahliz Abderrahmène, Soud Adila, Hammi Hamida, M’lik Randa

Abstract:

Prospected palm groves of Oued Righ regions (Ouargla, Algeria) allowed us to observe sudden death of palm trees aged between 05 and 70 years. Field examinations revealed abnormal clinical signs with sometimes a quick death of affected trees. Entomologic investigations have confirmed the absence of phytophagous insects on dead trees. Further investigations by questioning farmers on the global management of palm groves visited (Irrigation, water quality used, soil type, etc.) did not establish any relationship between these aspects and the death of palm trees, which naturally pushed us to focus our investigations for research on fungal pathogens. Thus, laboratory studies were conducted to know the real causes of this phenomenon, 13 fungi were found on different parts of the dead palm trees. The flowing fungal types were identified: 1-Diplodia phoenicum, 2-Theilaviopsis paradoxa, 3-Phytophthora sp, 4-Helminthosporium sp, 5-Stemphylium botryosum, 6-Alternaria sp, 7-Aspergillus niger, 8-Aspergillus sp.

Keywords: palm tree, death, fungal pathogens, Oued Righ

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2718 Access to Livelihoods for Urban Refugees in Kenya: The Case Study of Somalis Living in Eastleigh

Authors: Nancy Njoka, Manuela Ramos Cacciatore

Abstract:

In Kenya, refugee situations are becoming increasingly protracted, stretching over the years or even decades. As urbanization rates increase, so do the numbers of urban refugees in the country. Refugees living in urban areas face a range of challenges. In their efforts to pursue livelihoods, refugees have identified strategies to confront these challenges. In the same manner, humanitarian actors have come up with different interventions to promote access to livelihoods working through obstacles and barriers created by host governments. This paper seeks to understand the experience of Somali urban refugees living in the urban area of Eastleigh, Nairobi, both by investigating their own actions towards creating avenues to access livelihoods and by understanding their social, economic and policy context in which they forge livelihoods. The empirical data collected through fieldwork in Nairobi in 2020 serves as the basis of this qualitative case study. Drawing upon the themes of urban refugee movement, Somali ethnicity, citizenship discrimination and the livelihoods of refugees, the paper highlights how the actions of the Kenyan government and international non-governmental organization (INGO)s affect access to livelihoods and the consequences of these actions for Somali urban refugees. The results of the paper found that Somali urban refugees are taking active steps to create livelihoods for themselves. This is seen in the growth of Eastleigh as an economic hub in Kenya which is owned and run mostly by Somalis. Indeed, the Somali community is central to the establishment of networks in the neighborhood. Somali urban refugees are marginalized by the Kenyan government, reducing their opportunity to create dignified lives in Eastleigh. Findings also point out the community-based approaches used by INGOs in livelihood interventions. The relevance of this research lies in the interconnection of humanitarian development interventions for protracted refugees and the promotion of livelihoods in an urban and global context.

Keywords: Kenya, livelihoods, Somali, urban refugees

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2717 Promises versus Realities: A Critical Assessment of the Integrated Design Process

Authors: Firdous Nizar, Carmela Cucuzzella

Abstract:

This paper explores how the integrated design process (IDP) was adopted for an architectural project. The IDP is a relatively new approach to collaborative design in architectural design projects in Canada. It has gained much traction recently as the closest possible approach to the successful management of low energy building projects and has been advocated as a productive method for multi-disciplinary collaboration within complex projects. This study is based on the premise that there are explicit and implicit dimensions of power within the integrated design process (IDP) in the green building industry that may or may not lead to irreconcilable differences in a process that demands consensus. To gain insight on the potential gap between the theoretical promises and practical realities of the IDP, a review of existing IDP literature is compared with a case study analysis of a competition-based architectural project in Canada, a first to incorporate the IDP in its overall design format. This paper aims to address the undertheorized power relations of the IDP in a real project. It presents a critical assessment through the lens of the combined theories of deliberative democracy by Jürgen Habermas, with that of agonistic pluralism by political theorist Chantal Mouffe. These two theories are intended to more appropriately embrace the conflictual situations in collaborative environments, and shed light on the relationships of power, between engineers, city officials, architects, and designers in this conventional consensus-based model. In addition, propositions for a shift in approach that embraces conflictual differences among its participants are put forth based on concepts of critical spatial practice by Markus Meissen. As IDP is a relatively new design process, it requires much deliberation on its structure from the theoretical framework built in this paper in order to unlock its true potential.

Keywords: agonistic pluralism, critical spatial practice, deliberative democracy, integrated design process

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2716 Easy Way of Optimal Process-Storage Network Design

Authors: Gyeongbeom Yi

Abstract:

The purpose of this study is to introduce the analytic solution for determining the optimal capacity (lot-size) of a multiproduct, multistage production and inventory system to meet the finished product demand. Reasonable decision-making about the capacity of processes and storage units is an important subject for industry. The industrial solution for this subject is to use the classical economic lot sizing method, EOQ/EPQ (Economic Order Quantity/Economic Production Quantity) model, incorporated with practical experience. However, the unrealistic material flow assumption of the EOQ/EPQ model is not suitable for chemical plant design with highly interlinked processes and storage units. This study overcomes the limitation of the classical lot sizing method developed on the basis of the single product and single stage assumption. The superstructure of the plant considered consists of a network of serially and/or parallelly interlinked processes and storage units. The processes involve chemical reactions with multiple feedstock materials and multiple products as well as mixing, splitting or transportation of materials. The objective function for optimization is minimizing the total cost composed of setup and inventory holding costs as well as the capital costs of constructing processes and storage units. A novel production and inventory analysis method, PSW (Periodic Square Wave) model, is applied. The advantage of the PSW model comes from the fact that the model provides a set of simple analytic solutions in spite of a realistic description of the material flow between processes and storage units. The resulting simple analytic solution can greatly enhance the proper and quick investment decision for plant design and operation problem confronted in diverse economic situations.

Keywords: analytic solution, optimal design, process-storage network

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2715 The Effect of Simultaneous Application of Laser Beam and Magnet in Treatment of Intervertebral Disc Herniation

Authors: Alireza Moghtaderi, Negin Khakpour

Abstract:

Disc Herniation is a common complication in the society and it is one of the main reasons for referring to physical medicine and rehabilitation clinics. Despite of various methods proposed for treatingthis disease, still there is disagreement on success of these methods especially in non-surgical methods, and thus current study aims at determining effect of laser beam and magnet on treatment of Intervertebral Disc Herniation. During a clinical trial study, 80 patients with Intervertebral Disc Herniation underwent a combined package of treatment including magnet, laser beam, PRP and Prolotherapy during 6 months. Average age of patients was 51.25 ± 10.7 with range of 25 – 71 years. 30 men (37.5%) and 50 women (62.5%) took part in the study. average weight of patients was 64.3 ± 7.2 with range of 49 – 79 kg. highest level of Disc Herniation was L5 – S1 with frequency of 17 cases (21.3%). Disc Herniation was severe in 30 cases before treatment, but it reduced to 3 casesafter treatment. This study indicates effect of combined treatment using non-invasive laser beam and magnet therapy on disco genic diseases and mechanical pains of spine is highly effective.

Keywords: hallux, valgus, botulinum toxin a, pain

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2714 Values in Higher Education: A Case Study of Higher Education Students

Authors: Bahadır Erişti

Abstract:

Values are the behavioral procedures of society based communication and interaction process that includes social and cultural backgrounds. The policy of learning and teaching in higher education is oriented towards constructing knowledge and skills, based on theorist framework of cognitive and psychomotor aspects. This approach makes people not to develop generosity, empathy, affection, solidarity, justice, equality and so on. But the sensorial gains of education system provide the integrity of society interaction. This situation carries out the necessity of values education’s in higher education. The current study aims to consider values education from the viewpoint of students in higher education. Within the framework of the current study, an open ended survey based scenario of higher education students was conducted with the students’ social, cognitive, affective and moral developments. In line with this purpose, the following situations of the higher education system were addressed based on the higher education students’ viewpoint: The views of higher education students’ regarding values that are tried to be gained at the higher education system; The higher education students’ suggestions regarding values education at the higher education system; The views of the higher education students’ regarding values that are imposed at the higher education system. In this study, descriptive qualitative research method was used. The study group of the research is composed of 20 higher education postgraduate students at Curriculum and Instruction Department of Educational Sciences at Anadolu University. An open-ended survey was applied for the purpose of collecting qualitative data. As a result of the study, value preferences, value judgments and value systems of the higher education students were constructed on prioritizes based on social, cultural and economic backgrounds and statues. Multi-dimensional process of value education in higher education need to be constructed on higher education-community-cultural background cooperation. Thus, the act of judgement upon values between higher education students based on the survey seems to be inherent in the system of education itself. The present study highlights the students’ value priorities and importance of values in higher education. If the purpose of the higher education system gains on values, it is possible to enable society to promote humanity.

Keywords: higher education, value, values education, values in higher education

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2713 Enhancing Experiential Education in Teacher Education Classes Through Simulated Person Methodology

Authors: Karen Armstrong

Abstract:

This study is a narrative inquiry into the use of simulated person methodology (SPM) in teacher education classes. This methodology -often used in medical schools- has tremendous benefits in terms of enhancing experiential education in teacher education classes. Literacy education is a major focus in elementary schools. New teachers must work with parents to ensure that children learn to read and expand their literacy horizons. The classes used in this narrative inquiry research consist of one graduate class on family literacy and two pre-service teacher education classes: literacy and culture and early and family literacy. Two scenarios were devised, both of which simulated a parent-teacher interview. In the first scenario, the parent is a reluctant father who is ashamed of his lack of reading ability and does not understand why literacy is important. His seven-year-old son, wanting to emulate his father, has suddenly transformed from an eager student to one who rejects the value of reading in loyalty to his father who cannot read. In the second scenario, a father is called in by the teacher because his son has started acting out in class. The mother in this scenario is temporarily absent from the home, and the father is now the sole caregiver. In each of the scenarios, students are the teachers who are problem-solving these dilemmas in a safe environment with the 'parent' who is a specially trained simulated person. Teacher candidates enact, with the trained simulated person, their strategies for encouraging parents to engage in the literacy development of their children. Teacher candidates attempt to offer support and encouragement to parents. This simulation strategy offers both beginning and more experienced teachers the opportunity to practice an interview with two distinct and contrasting family situations with regard to the literacy of young children. The paper discusses the details of the scenarios enacted in class and the reflective discussion through which students learn from the simulation.

Keywords: experiential education, literacy, simulated person methodology, teacher education

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2712 “MaxSALIVA-II” Advancing a Nano-Sized Dual-Drug Delivery System for Salivary Gland Radioprotection, Regeneration and Repair in a Head and Neck Cancer Pre-Clinical Murine Model

Authors: Ziyad S. Haidar

Abstract:

Background: Saliva plays a major role in maintaining oral, dental, and general health and well-being; where it normally bathes the oral cavity acting as a clearing agent. This becomes more apparent when the amount and quality of saliva are significantly reduced due to medications, salivary gland neoplasms, disorders such as Sjögren’s syndrome, and especially ionizing radiation therapy for tumors of the head and neck, the 5th most common malignancy worldwide, during which the salivary glands are included within the radiation field/zone. Clinically, patients affected by salivary gland dysfunction often opt to terminate their radiotherapy course prematurely as they become malnourished and experience a significant decrease in their QoL. Accordingly, the formulation of a radio-protection/-prevention modality and development of an alternative Rx to restore damaged salivary gland tissue is eagerly awaited and highly desirable. Objectives: Assess the pre-clinical radio-protective effect and reparative/regenerative potential of layer-by-layer self-assembled lipid-polymer-based core-shell nanocapsules designed and fine-tuned for the sequential (ordered) release of dual cytokines, following a single local administration (direct injection) into a murine sub-mandibular salivary gland model of irradiation. Methods: The formulated core-shell nanocapsules were characterized by physical-chemical-mechanically pre-/post-loading with the drugs, followed by optimizing the pharmaco-kinetic profile. Then, nanosuspensions were administered directly into the salivary glands, 24hrs pre-irradiation (PBS, un-loaded nanocapsules, and individual and combined vehicle-free cytokines were injected into the control glands for an in-depth comparative analysis). External irradiation at an elevated dose of 18Gy was exposed to the head-and-neck region of C57BL/6 mice. Salivary flow rate (un-stimulated) and salivary protein content/excretion were regularly assessed using an enzyme-linked immunosorbent assay (3-month period). Histological and histomorphometric evaluation and apoptosis/proliferation analysis followed by local versus systemic bio-distribution and immuno-histochemical assays were then performed on all harvested major organs (at the distinct experimental end-points). Results: Monodisperse, stable, and cytocompatible nanocapsules capable of maintaining the bioactivity of the encapsulant within the different compartments with the core and shell and with controlled/customizable pharmaco-kinetics, resulted, as is illustrated in the graphical abstract (Figure) below. The experimental animals demonstrated a significant increase in salivary flow rates when compared to the controls. Herein, salivary protein content was comparable to the pre-irradiation (baseline) level. Histomorphometry further confirmed the biocompatibility and localization of the nanocapsules, in vivo, into the site of injection. Acinar cells showed fewer vacuoles and nuclear aberration in the experimental group, while the amount of mucin was higher in controls. Overall, fewer apoptotic activities were detected by a Terminal deoxynucleotidyl Transferase (TdT) dUTP Nick-End Labeling (TUNEL) assay and proliferative rates were similar to the controls, suggesting an interesting reparative and regenerative potential of irradiation-damaged/-dysfunctional salivary glands. The Figure below exemplifies some of these findings. Conclusions: Biocompatible, reproducible, and customizable self-assembling layer-by-layer core-shell delivery system is formulated and presented. Our findings suggest that localized sequential bioactive delivery of dual cytokines (in specific dose and order) can prevent irradiation-induced damage via reducing apoptosis and also has the potential to promote in situ proliferation of salivary gland cells; maxSALIVA is scalable (Good Manufacturing Practice or GMP production for human clinical trials) and patent-pending.

Keywords: cancer, head and neck, oncology, drug development, drug delivery systems, nanotechnology, nanoncology

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