• Title/Summary/Keyword: Clinical investigator

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The Effect of Imagery on the Stress of Clinical Nurses (심상요법이 간호사의 스트레스에 미치는 효과)

  • Kim, Hea Jeong
    • Korean Journal of Occupational Health Nursing
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    • v.9 no.2
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    • pp.79-85
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    • 2000
  • All clinical nurses are not only faced with the physical and emotional needs of patients but also exposed to the heavy workload. In clinical settings, the nurses' stress becomes more and more critical. Understanding the stress experienced by nurses is essential for planning programs to enhance patient care and to promote nurses health. Many methods to reduce the stress were practiced for patients. In this study, the investigator examined how the imagery influence the reducing the stress of clinical nurses. For this study, the recorded tape for imagery developed in the Society of Rheumatics was applied. In order to evaluate the effect of imagery on the stress of clinical nurse, stress score, serum cortisol, blood pressure, and pulse were measured on 20 clinical nurses for 20 days. The results were as follows: 1. Stress score decreased significantly in the experimental group. And the rate of decrease in stress score was significantly higher in experimental group than in the control group. 2. The level of serum cortisol decreased significantly after the application of imagery. 3. Systolic blood pressure decreased significantly after the application of imagery. These results indicate that after applying the method of imagery on the nurses, stress score, serum cortisol level, and systolic blood pressure were significantly decreased. Therefore, this study proves that imagery is one of the methods to reduce the stress of clinical nurses.

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Oriental Medicine Therapy in the Treatment of Men with Androgenetic Alopecia (남성의 안드로겐성 탈모증에 대한 한의학적 치료 효과)

  • Yi, Tae-Hoo;Moon, Jung-Bae;Kim, Young-Jin;An, Kyung-Eh
    • Journal of Acupuncture Research
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    • v.23 no.1
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    • pp.179-186
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    • 2006
  • Background : Recently the demand was increasing on the data describing treatment rates and the outcome of Androgenetic Alopecia using Oriental Medicine. Thus this study was designed to observe androgenetic Alopecia treatment using Oriental Medicine including acupuncture and herb because there has been no such statistics. Objectives : Our purpose was determine whether oriental medicine treatment leads to clinical improvement in men with androgenetic alopecia. Methods : Eighty two Men, 17 to 53 years of age, with male pattern hair loss according to a modified Norwood/Hamilton classification scale(II to VI) were enrolled in this study. Patients were treated with multidisciplinary Korean oriental medicine treatment (herbal acupuncture, acupuncture, herb, chuna therapy) at twice a week for 6 months to 12 months. Efficacy was evaluated by patient and investigator assessment, and global photographic review. Results : Oriental medicine treatment improved scalp hair by all evaluation. Patient self assessment demonstrated that Oriental medicine treatment slowed hair loss, increased hair growth, and improvement appearance of hair. These improvements were corroborated by investigator assessments and assessments of photographs. Conclusion : Oriental medicine treatment has significant effects on the androgenetic alopecia. Longer follow up studies are needed to examine whether its effects last long enough for the patients with androgenetic alopecia.

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The Effects of Major Health Issues and Job Stress on Presenteeism among Clinical Nurses (임상간호사의 주요 건강문제와 직무 스트레스가 프리젠티즘에 미치는 영향)

  • Jang, In-Sun;Park, Ji-Young;Jo, Eun-Jeong;Jung, Myung-Hee
    • Korean Journal of Occupational Health Nursing
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    • v.27 no.2
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    • pp.121-130
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    • 2018
  • Purpose: The purpose of this study was to investigate the effects of major health issues and job stress on presenteeism among clinical nurses. Methods: The investigator conducted a survey on 226 clinical nurses at a general hospital in Seoul from March 3 to April 15, 2017, and analyzed their responses. Results: The findings showed that job stress did not have a significant effect on the nurses' presenteeism. Fatigue (t=3.55,p<.001) impacted job loss, one of the subcategories of presenteeism, with an explanatory power of 12.1%. Premenstrual syndrome (t=-2.67,p=.008) and fatigue (t=-2.46,p=.015) affected perceived productivity with an explanatory power of 23.6%. Conclusion: Based on these findings, the study highlighted the need for effective management programs to tackle fatigue and premenstrual syndrome among clinical nurses' major health issues in order to reduce their productivity loss.

Current Status of Institutional Review Boards and Approvals of Clinical Research in Oriental Medical Hospitals in Korea: A Survey (국내 한방병원의 IRB 및 임상시험 실태조사)

  • Jung, Hee-Jung;Park, Ji-Eun;Choi, Snu-Mi
    • The Journal of Korean Medicine
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    • v.31 no.1
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    • pp.122-129
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    • 2010
  • Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

Comparison of the Perceptions between Investigators and Clinical Research Associates in Role Performances of Clinical Research Coordinators (임상연구코디네이터의 역할수행에 대한 연구자와 임상시험모니터요원의 인식비교)

  • Ko, Il-Sun;Hwang, Youn-Sun;Kim, Ho-Kon
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.15 no.8
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    • pp.5095-5108
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    • 2014
  • The aim of this study was to compare the perceptions of the role performance of a clinical research coordinator (CRC) between the investigators and clinical research associates (CRAs). Data was collected using a structured questionnaire from 39 investigators and 68 CRAs in 4 hospitals from March 7 to November 30, 2011 and analyzed using descriptive statistics and a t-test. The investigators and CRAs were aware of the importance of CRC's role and they all gave the highest values for patients care management. On the other hand, the score of the role performance items showed perceptional differences between investigators and CRAs. Therefore, the development of detailed job descriptions and manuals will be needed to reduce the perceptional differences in the role performance of the CRC.

A Survey on Motivation and Satisfaction of Subjects in Acupuncture & Moxibustion Clinical Trial (침구임상시험 피험자의 참여 동기 및 만족도 조사)

  • Jung, Hee Jung;Park, Ji Eun;Kim, Ae Ran;Liu, Yan;Lee, Min Hee;Kim, Jung Eun;Shin, Kyung Min;Choi, Sun Mi
    • Journal of Acupuncture Research
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    • v.30 no.3
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    • pp.109-115
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    • 2013
  • Objectives : This study was aimed to find the motivation and satisfaction of subjects who participated in acupuncture and moxibustion clinical trials and to suggest ways to improve clinical trial management. Methods : We conducted a survey and collected the data of 233 subjects of acupuncture and moxibustion clinical trials from 6 university hospitals. Results : For all 233 subjects, the mean of the total satisfaction score was 4.07 (perfect score 5.0), and the score was particularly high in aspects of the investigator and clinical research coordinator, but low in the site and sponsor aspects. There were no differences in the satisfaction degree with general characteristics. The satisfaction degree of the acupuncture and moxibustion clinical trials was strong positive correlated with participation benefits(r=0.595) and easy contact with the research team (r=0.500). Conclusions : Most subjects showed positive perception and interest in the clinical trials. Future studies should investigate how personal factors influence the satisfaction of subjects, should identify a specific classification criterion, and create a standardized protocol for the clinical trials.

An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers (의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석)

  • Lee, Yoon Jin;Jang, Hye Yun;Lee, Yu-Mi
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.19-27
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    • 2021
  • Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

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Attitude and awareness of Sasang Constitution Investigators on the Informed Consent (체질의학 임상연구자의 피험자 동의서 취득에 대한 인식도 조사)

  • Yoo, Jong-Hyang;Kim, Yun-Young;Kwon, Ji-Hye;Park, Ki-Hyun;Lee, Si-Woo
    • Journal of Sasang Constitutional Medicine
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    • v.23 no.3
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    • pp.318-329
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    • 2011
  • 1. Objectives: We surveyed the attitude and awareness of Sasang Constitution investigators on informed consent in clinical study. This study was performed in order to improve the quality of ethical aspects in clinical study by surveying the process of obtaining informed consent. 2. Methods: We sent the questionnaire by email to Sasang Constitution investigators who had the experience in clinical study. The question was about the necessity of informed consent and the process of obtaining it. 3. Results: Twenty-two out of 24 questionnaires were collected. All of investigators recognized that informed consent is needed for clinical study. Sixty-four percent of the respondents 'fully' or 'mostly' explained the informed consent but they added only 41% of participants 'fully' or 'mostly' understood. Fifty-four point five percent of respondents provided participants enough time and opportunity to inquire the study in details to decide whether or not to participate in the study, the rest of respondents obtained informed consent without providing enough time for decision. 4. Conclusions: Sasang Constitution investigators had high awareness of necessity for informed consent in clinical study. But participants' understanding was low despite of the degree of investigators' explanation. A various strategies should be designed for improving consent forms and process. Most of all, investigators should make sure that informed consent intends to protect participants and promote ethical research conduct.

Korean Red Ginseng Powder in the Treatment of Melasma: An Uncontrolled Observational Study

  • Song, Margaret;Mun, Je-Ho;Ko, Hyun-Chang;Kim, Byung-Soo;Kim, Moon-Bum
    • Journal of Ginseng Research
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    • v.35 no.2
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    • pp.170-175
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    • 2011
  • Exposure to the sun, ultraviolet radiation, and oxidative stress are the chief etiologic factors responsible for melasma. The ingredients of Korean red ginseng powder, which include ginsenoside and phenolic compounds, have antioxidative effects and reduce ultraviolet B-induced pigmentation. This study was designed to evaluate the effectiveness and safety of Korean red ginseng powder in patients with melasma. In 25 female patients, 3 g of Korean red ginseng powder was orally administered for a 24 week period. The level of pigmentation and erythema were determined and clinical improvement was evaluated by the melasma area and severity index (MASI), melasma quality of life scale (MELASQoL), and patient- and investigator-rated global improvement scale. After 24 weeks, the MASI score decreased from 8.8 to 5.6, and MELASQoL showed improvement in 91% of patients (p<0.05). The mean level of pigmentation decreased from 184.3 to 159.7 and erythema levels decreased from 253.6 to 216.4 (p<0.05). Additionally, 74% of the patients showed some improvement in both patient- and investigator-rated global improvement scales at week 24. Korean red ginseng powder was well tolerated by most of the patients. In conclusion, Korean red ginseng powder showed good tolerability and beneficial effects in patients with melasma. The use of Korean red ginseng would be counted as a useful adjunctive therapy for patients with melasma.

A Music Technology-Based Interactive Music-Making for Improving the Social Communication Skills of Children With Autism Spectrum Disorder (자폐스펙트럼장애 아동의 사회적 의사소통 향상을 위한 음악제작 앱 기반 상호적 음악만들기 사례)

  • Yoon, Sol
    • Journal of Music and Human Behavior
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    • v.18 no.2
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    • pp.19-43
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    • 2021
  • The purpose of this case study was to examine whether an interactive music-making intervention using GarageBand was applicable to improve the social communication skills of school-age children with autism spectrum disorder (ASD). Two children with ASD (both male, ages = 8 and 11 yrs.) participated in this study. The interactive music-making intervention included three stages: 1) musical imitation, 2) musical expression and coordination, and 3) musical interaction. Each session lasted 40 minutes, and sessions took place twice a week over 4 weeks. The participants' social communication behaviors were observed and analyzed in terms of exchanging ideas with each other. Engagement in interactive behaviors (e.g., turn-taking, imitating or reflecting the investigator's music, and creating one's own music using the motive from the investigator) during music making was also analyzed. During the sessions, increases in the attempts to express their opinions on music making processes and requests for help for the process were observed. Engagement in turn-taking form of interactive playing and reflecting the musical motive from a partner (i.e., investigator) were also improved. The Social Responsiveness Scale-2 (SRS-2) ratings indicated negative social behaviors decreased after intervention in both participants. The findings of this study suggest that interactive music-making activities using GarageBand can be an effective method in clinical practice to improve social communication skills for school-aged children with ASD.