• Title/Summary/Keyword: Clinical study

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Study on Significance and limitations of the Enactment of the Advanced Regenerative Bio Act (첨단재생바이오법의 제정 의의와 제한점)

  • Sohn, Seong Goo;Kwon, Kyeng Hee
    • The Korean Society of Law and Medicine
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    • v.22 no.4
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    • pp.159-184
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    • 2021
  • The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

A Study on Degree of Satisfaction on Clinical Practice of Physical Therapy Students (일부 물리치료과 학생의 임상실습 만족도에 대한연구)

  • Choi, Byung-Ok
    • Journal of Korean Physical Therapy Science
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    • v.3 no.3
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    • pp.93-104
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    • 1996
  • The purpose of this study is improvement of clinical practice education through examination of satisfaction on clinical practice of physical therapy students and grasping the factor have on effect on satisfaction of clinical practice. The students of the survey were 328 junior college students and 41 University students selected from 8 junior college and 2 University by questionnaire from Oct. 6 to Oct. 26, 1993. The collected data was analyzed by ANOVA, T-test, Multiple range test (Tukey, LSD, Duncan), principal factor analysis according to purpose of study. The results were as follows : The degree of satisfaction according to the item on clinical practice was low as 0.346 of a total 1.0. The degree of satisfaction of instruction(0.40) revealed to be high. Compared with the degree of satisfaction on contents(0.39), practice environment(0.38), satisfaction after practice(0.36), practice hours(0.35), personalrelations(0.33), problem of practice place(0.31), practice evaluation(0.25) revealed to be low. 1. The degree of satisfaction on clinical practice according to education system was lower junior college than University. 2. The degree of satisfaction on clinical practice according to volitional group and another intention group and another intention group was not different. 3. The degree of satisfaction on clinical practice according to the order of merit was not difference A group, B group, C group, but it of D group was low. 4. The degree of satisfaction on clinical practice according to the time of practise, the group that clinical enforce during a session was higher than the group that it enforce during vacation. 5. The degree of satisfaction on clinical practice according to clinical practice place was high in University hospital and general hospital, but was low in hospital and clinic. 6. The degree of satisfaction on clinical practice according to existence or non-existence of a hospital in affiliation was higher existence a hospital in affiliation group than non-existencea hospital in affiliation group. 7. The degree of satisfaction on clinical practice according to satisfaction of major was high in group of high satisfaction major.

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The Influencing Factors on Nursing Perspectives and Satisfaction of Clinical Practice in Nursing Students (임상실습시 간호학생이 지각하는 간호 가치관과 실습 만족도에 영향을 미치는 요인)

  • Yang, Jin-Ju
    • The Journal of Korean Academic Society of Nursing Education
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    • v.6 no.2
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    • pp.276-286
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    • 2000
  • The purpose of this study was designed to analyze the influencing factors on nursing perspectives and satisfaction of clinical practice in nursing students. The data was collected through structured questionnaire. The subjects in this study were 192 nursing students who had been educated in three colleges and one university in Kwangju. Data collection was done from January to February, 1999. The data was analyzed by using SAS program. The results from this study were as follows; 1. The mean score of total nursing perspectives was $4.24{\pm}0.40$ and that of total clinical practice satisfaction was $2.63{\pm}0.38$. 2. Self experience of admission was significant in satisfaction of clinical practice(t=2.09, p=.03). 3. Nursing perspectives by religion was significant(t=2.26, p=.02). 4. The nursing perspectives was significant according to the classifications of clinical instructor(F=4.50, p=.01) and the most difficult interpersonal relationships of the clinical practice(F=4.14, p=.02). 5. The satisfaction of clinical practice was significant according to the most difficult interpersonal relationships of the clinical practice(F=3.61, p=.03). 6. The correlation between the scores of nursing perspectives and satisfaction of clinical practice was not significant(r=.191, p=.060). In conclusion, it was found that the more positive interpersonal relationships of clinical practice, the more higher degree of perceived satisfaction of clinical practice and nursing perspectives. And the clinical instructors should play a good role model to gain positive satisfaction of clinical practice perceived by nursing students.

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Influencing Factors on Clinical Competency in Nursing Students who have Experienced non-Face-to-Face Clinical Practice (비대면 임상실습을 경험한 간호대학생의 임상수행능력에 미치는 영향 요인)

  • Hwang, Sung-woo;Cha, Hyun-su
    • Journal of the Korea Convergence Society
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    • v.12 no.12
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    • pp.539-550
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    • 2021
  • The purpose of this study was to identify the influencing factors of satisfaction for clinical practice, critical thinking disposition on clinical competency in nursing students who have experienced non-face-to-face clinical practice. The participants in this study were 163 nursing students at four university. A on line survey was conducted from January 2021 to February, 2021. The data were analyzed using t-test, ANOVA, scheffé test, pearson correlation coefficients, and multiple regression analysis by SPSS 22.0 version. The results of this study indicate that satisfaction for clinical practice, and critical thinking disposition have an influence on clinical competency in nursing students. The total explanation of clinical competency was 60.6%. Based on this, it is suggested to develop a program to improve clinical practice satisfaction and critical thinking tendency to increase clinical performance of nursing students who have experienced non-face-to-face clinical practice.

The Effects of Clinical Practice Stress, Grit and Self-Efficacy on Clinical Competency in Nursing Students (간호대학생의 임상실습 스트레스, 그릿, 자기효능감이 임상 수행 능력에 미치는 영향)

  • Kim, Young-Sook
    • The Journal of the Korea Contents Association
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    • v.22 no.9
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    • pp.451-460
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    • 2022
  • This study was conducted to understand the correlation between clinical practice stress, grit, self-efficacy, and clinical performance of nursing students and to identify factors affecting clinical performance. A survey was conducted on 160 students in 3rd and 4th grade students enrolled in a nursing department located in G city. As a result of the study, clinical performance was negatively correlated with clinical practice stress(r=-.383, p< .001) and positively correlated with grit(r=.310, p< .001), self-efficacy (r=.327, p< .001). Factors affecting the clinical performance of nursing students were clinical practice stress(β=-.37, p<.001), clinical practice satisfaction (β=.35, p< .001), self-efficacy (β=.31, p< .001), grit (β=.28, p< .001) and the explanatory power was 42.8%. Based on the results of this study, in order to improve the clinical performance of nursing students, it is necessary to reduce the clinical practice stress and make them satisfied with the clinical practice. In addition, it is necessary to develop a program to improve self-efficacy and grit

Experience of Patients with Cancer Participating in a Clinical Trial for the Development of a New Drug (암환자의 신약개발 임상시험 참여 경험)

  • Kim, Hyun-Young
    • Asian Oncology Nursing
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    • v.6 no.2
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    • pp.121-132
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    • 2006
  • Purpose: The purpose of this study was to describe the lived experience of the patients with cancer participating in a clinical trial for the development of a new drug. Method: This study was based on a phenomenological approach. The eight patients participating in a clinical trial were selected as the participations of this study. The data were obtained through in-depth interviews from the participants and were analyzed using the Giorgi method. Results: Essential experiences of the patients with cancer under a clinical trial consisted of anticipating recovery of physical health and a social role, passing the strict criteria of a clinical trial, diminishing economic burden, satisfaction with special treatment receiving, social contribution, concerns about side effects and withdrawal from the clinical trial, conflicts as a participant, pain, limited administration of other treatments, regret for giving up other treatments, strict compliance with instructions, prevention of side effects and maintaining desirable life-style. Integrated units of meaning of these components were hope, good luck, a sense of satisfaction, fear, distress, and the will of self-control. Conclusion: The most essential meaning of the cancer patients participating in a clinical trial was hope. Hope was found to be a primary factor reinforcing the will of self-management. The results of this study can be of great help to the research nurses to understand the lived experience of the patients with cancer and to plan an effective nursing intervention for the patients.

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Learning Contracts Based Self-Directed Clinical Practicum (학습계약에 기반한 자기주도 임상실습 운영사례)

  • Kim, Eun-Jung;Cho, Dong-Sook
    • The Journal of Korean Academic Society of Nursing Education
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    • v.18 no.2
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    • pp.268-275
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    • 2012
  • Purpose: The purpose of this study was to implement and evaluate the learning contracts based self-directed learning in a final clinical placement for senior nursing students. Methods: This study was a case study and 82 senior nursing students at a university participated in a learning contract based practice placement. Data were collected from written learning contracts and questionnaires after a clinical practice. Results: The students' learning needs were knowledge, clinical skills, and attitudes frequently encountered in a ward in which clinical skills were most common. The students' formulated learning contracts were varied but most of them were basic and simple. A self-directed clinical course was beneficial and a satisfactory experience to senior students. There was an increase in the students' motivation in learning, confidence in own capability, and satisfaction with the use of the learning contract. Conclusion: Self-directed clinical practicum would result in a degree of attitude change in the students. This study suggests that learning contract based self-directed clinical practice is effective to improve learning satisfaction, confidence in own capability, and competency.

A Preliminary Study for Development of Clinical Practice Guidelines of Korean Medicine in Breast Cancer (유방암 치료에 대한 한의 임상 가이드라인 개발을 위한 기초연구)

  • Lee, Kang-Wook;Yoo, Hwa-Seung;Lee, Jin-Sun;Lee, Nam-Hun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.29 no.2
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    • pp.47-66
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    • 2016
  • Objectives : The purpose of this study was to present the clinical practice guidelines for breast cancer through the analysis of existing clinical practice guidelines in Western and Chinese medicine. Methods : The literature search was performed regarding conventional and integrative medical treatment of breast cancer using Google Scholar, KIOM OASIS, PUBMED and Jisan library of Daejeon university. Results : Breast cancer is the fifth most common cancer in Korea. Recent studies revealed that combining conventional and integrative medical treatment can reduce the sequela of surgical operation and improve survival rate. However there isn’t still a systemic clinical guideline for breast cancer in korean medicine. This study will be a preliminary study to establish clinical practice guidelines of Korean Medicine for breast cancer.Conclusions : Further objective and systemic clinical studies related to Korean Medicine are needed to develope more advanced clinical practice guidelines of breast cancer.

Satisfaction of Practice and Clinical Skill in Participation Learning and Observation Learning (참여학습과 관찰학습의 실습만족도 및 임상수기술)

  • Shin, Eun-Ju
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.2
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    • pp.195-207
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    • 2008
  • Objective: The purpose of this study was to compare satisfaction of practice and clinical skill in different participation learning and observation learning, and to offer the basic data to promote quality of nursing education. Method: The study used a quasi-experimental, nonequivalent control group post-test design. The subjects were 62 nursing students of K college in Jeonbuk, and the period of data gathering was limited from 19 Nov. 2006 to 30 Nov. 2006. Experience group was taught by hand-on education and control group was taught by conventional education. The instrument tools included self-efficacy, satisfaction of practice and clinical skill. The collected data were analyzed by SPSS-PC programme. Result: The results of this study were as follows: There was statistically a significance difference between the two group about satisfaction of practice(t=2.011 p=.043), and clinical skill(t=11.997, p=.000). Self-efficacy showed a significantly positive correlation with satisfaction of practice(r=.476, p=.000) and clinical skill(r=.178, p=.014). Also, satisfaction of practice showed a significantly positive correlation with clinical skill(r=.l82, p=.000). Conclusion: In conclusion, this study suggests that hand-on education is an effective learning method to nursing students. By utilizing hand-on education, makes nursing students plan self-directed nursing performance and improve their clinical skills.

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A Study on Nursing Students' Experience during Clinical Practice at a Public Health Center (내러티브 탐구를 통한 일 대학 간호학생들의 보건소실습 경험 연구)

  • Choi, Hye-Jung
    • Journal of Korean Public Health Nursing
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    • v.19 no.2
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    • pp.217-228
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    • 2005
  • Purpose: The purpose of this study is to understand nursing students' experiences during clinical practice at a public health center. Method: This research used narrative inquiry far data collection. From April 2005 to June 2006, data collection was conducted by open-ended interview, questionnaire and close observation. The participants, who were student nurses, were willing to take part in this study. Results: On the basis of these data, the experiences of clinical practice at public health center were: 1) when the student nurses begin clinical practice at public health centers for the first time, most of the students feel fearful, nervous and stressed. They also mentioned having a hard time being polite to clients and the staff. 2) The students had new experiences at the health public center compared with clinical practice. Especially, the student nurses who were determined to be good nurses were doing home visiting care service. Not only did they have the opportunity to confirm their identity as nurses, but also the students change their career course from clinical nursing to public health nursing. 4) They reflected on themselves after home visiting care service. Conclusion: On the basis of these findings, the following recommendations are made. 1) Data collection and analysis are needed, net only through the narrative method, but also through other various qualitative methods. 2) Comparative study is necessary to enhance clinical experiences through the analysis of the interfering factors and the original experiences.

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