• Title/Summary/Keyword: Intervention design

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Analysis of Existing Guidelines and Controlled Clinical Trials for Development of [Guideline of Clinical Trials with Herbal Medicinal Products for Colorectal Cancer] (결장직장암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 대조군 임상시험 고찰)

  • Park, Eunjoo;Seong, Sin;Kim, Sungsu;Kim, Jinsung;Park, Jae-Woo;Ko, Seok-Jae;Han, Gajin
    • The Journal of Korean Medicine
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    • v.40 no.1
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    • pp.124-152
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

Development and Effectiveness of a Spiritual Care Education Program for Nurses (간호사를 위한 영적간호교육프로그램의 개발 및 효과)

  • Choi, Soo-Kyung;Kim, Jin;Kim, Se-Young
    • Journal of Convergence for Information Technology
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    • v.9 no.9
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    • pp.67-77
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    • 2019
  • This study was conducted to examine effects of the spiritual care education program on self esteem, communication, existential well-being and spiritual care competence in nurses. A non-equivalent control group, non-synchronized with pre-posttest design was used. The participants were 63 nurses(30 in an experimental group and 33 in a control group)attending a bachelor program of C Colledge in G metropolitan city. The experimental group attended 7 sessions of a SCE(Spiritual Care Education) program. Sessions were 90 minutes each, held once per week for 7 weeks. The scores for self-esteem, communication, existential well-being and spiritual care competence were measured before and after the treatment. Data were collected between October 10 and December 5, 2017 in an experimental group, April 24 and June 5, 2018 in a control group. Data were analyzed using Chi-square, Fisher's exact test, independent t-test using SPSS/WIN 21.0. The existential well-being(p<.025) and spiritual care competence(p<.001) were significantly increase in the experimental group compared to the control group after the intervention. Results suggest that this SCE program could be effective in increasing the existential well-being and spiritual care competence of nurses.

A Systematic Review of Korean Medicine for Non-Alcoholic Fatty Liver Disease (비알콜성 지방간질환의 한방치료에 대한 체계적 문헌고찰)

  • Lee, Yu-ri;Cho, Na-kyung;Choi, Hong-sik;Kim, Seung-mo;Kim, Kyung-soon
    • The Journal of Internal Korean Medicine
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    • v.40 no.1
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    • pp.13-37
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    • 2019
  • Objectives: The purpose of this study was to assess the effects of Korean medicine for non-alcoholic fatty liver disease (NAFLD). We analyzed the result of randomized controlled trials (RCTs) that applied Korean medicine to NAFLD patients through meta analysis and systematic review. Methods: The key question was to the effects of Korean medicine for NAFLD patients according to the PICO-SD (participants, intervention, comparison, outcome, study design) and we included only RCTs. We searched 10 databases including NDSL, KMBASE, KISS, KISTI, KoreaMed, Koreantk, OASIS, Cochrane, Pubmed, EMBASE without a language restriction. We assessed risk of bias by Cochrane group's Risk of Bias tool. Results: The finally selected 12 RCTs were analyzed. Total number of participants was 1189 (male 719, female 470) as 684 and 505 in the oriental medicine group (i.e. herbal drugs, acupuncture, acupoint embedding therapy) and control group (conventional drugs, placebo), respectively. The meta analysis results of examining 7 RCTs comparing the therapeutic efficacy of herbal medicine with that of Western medicine showed statistically significant (p<0.05) differences in the efficacy evaluation, liver function test results, blood lipids, and TNF-${\alpha}$. Furthermore, the meta analysis results of investigating 3 RCTs comparing the therapeutic efficacy of herbal medicine with that of a placebo showed statistically significant (p<0.05) differences in the liver function test results, blood lipids, and waist circumference. Conclusions: The research showed that Korean medicine for NAFLD can be effective treatment. But more studies are required to enhance the level of evidence and we should report on safety.

Characteristics of Clinical Trials in Korea for Atopic Dermatitis - Focus on ClinicalTrials.gov Registered Clinical Trials - (식약처 승인 아토피 피부염 의약품 국내 임상 시험의 특성 - ClinicalTrials.gov 등록 임상시험을 중심으로-)

  • Hwang, Mi-Lee;Ahn, Jae-Hyun;Jea, Ha-Kyung;Kim, Soo-Young;Jung, Hyun-A
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.2
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    • pp.68-93
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    • 2019
  • Objective : This study summarized the characteristics of clinical trials for atopic dermatitis medicines approved by the Ministry of Food and Drug Safety(MFDS). This study may be a reference for the design of clinical trials of atopic dermatitis herbal medicine treatment which may be carried out later. Method : The characteristics of the clinical trial were analyzed for clinical trials registered with ClinicalTrials.gov, CRIS, and the Korea Health Industry Development Institute among the clinical trial approval statuses posted on the website of the MFDS. Result : 1. Clinical trial drugs were developed in various formulations such as oral medicines, injections, dermatologic agents, and similar proportions. Relatively little clinical trials were found for herbal medicine. 2. In the control evaluation test, most of the treatments for the control group were performed with placebo using Vehicle. 3. In most clinical trials, one intervention group was in the form of a parallel assignment with only one treatment. 4. The age of the subjects was 11 out of 28 studies including minors, and clinical trials targeting minors were also found to be significant. 5. In the case of atopic dermatitis, the cases of subacute chronic or atopic dermatitis more than 6 months or more than 1 year were often used. 6. Most clinical trials were divided into mild to moderate atopic dermatitis or moderate to severe atopic dermatitis. The SCORAD index, EASI, IGA, BSA, and NRS were used as the evaluation criteria. 7. Regulations for the drugs used prior to the trial period for the treatment of atopic dermatitis vary somewhat from one clinical trial to another. 8. IGA was used most often as a primary efficacy tool, and SCORAD index, EASI, and NRS were also used.

A Convergent Study of Mediating Effect of Time Spent on Internet Use and Amount of Alcohol Drinking in the Influence of High School Students' Perceived Stress on Suicidal Thoughts -Based on 2019 Adolescent Health Behavior Survey- (고등학생의 스트레스인지가 자살생각에 미치는 영향과 인터넷 사용시간 및 음주량의 매개효과에 대한 융복합적 연구 -2019년 청소년건강행태조사를 바탕으로-)

  • Nam, EunJu;Sohn, Aeree
    • Journal of the Korea Convergence Society
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    • v.12 no.4
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    • pp.77-86
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    • 2021
  • This study explored the role of perceived stress in Korean high school students' suicidal thought. In so doing, we also investigated the mediating role of high school students' internet use time and amount of drinking alcohol. For this, 2019 Korean adolescent health behavior survey was used. Complex design multivariage logistic regression analysis revealed that high school students' perceived stresss(OR:5.607, 95%CI:5.077-6.191) and amount of drinking(ranging from OR:1.412, 95%CI:1.159-1.720 to OR:2.325, 95%CI:1.928-2.803) played a significant role in their suicidal thoughts. Internet use time and amount of alcohol consumed were found to play a mediating role. Implications of the results are discussed. Therefore, since internet use mediated suicidal thinking among adolescents, it is necessary to develop a intervention program or message for them.

The immediate effect of electrical muscle stimulation on rectus femoris thickness during resisted knee extension exercise (전기근육자극을 적용한 무릎 폄 저항운동 시 넙다리곧은근의 두께 변화에 미치는 즉각적 효과)

  • Kim, Kang-hoon
    • Journal of the Korea Convergence Society
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    • v.12 no.6
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    • pp.27-32
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    • 2021
  • The purpose of this study was to compare the immediate effect of EMS (electrical muscle stimulation) on rectus femoris thickness during resisted knee extension exercise in healthy adults. This experiment was conducted on 20 healthy adults as pretest-posttest nonequivalent one group design. The subject's 1RM of both knee extension was measured indirectly using an elastic band, and the knee extension resistance exercise using an elastic band was applied to high intensity (80% of 1RM) on the right leg and low intensity (50% of 1RM with EMS) on the left leg, which were applied with 5 sets. Muscle measurements were performed on the rectus femoris (1/2 site, 1/4 site) using ultrasonography before and after exercise. There was a statistically significant difference on the thickness of the rectus femoris in low intensity exercise of the elastic band applied with EMS between pre-test and post-test (p<.05). The results of this study showed that elastic band low intensity exercise combined with EMS had an immediate effective in increasing the thickness of rectus femoris. Based on this result, it is also necessary to verify the effectiveness of intervention methods incorporating low-intensity resistance exercises applying EMS to elderly who cannot exercise high-intensity resistance training in the future, and to develop exercise programs for various body parts.

The Effects of END Smoking Cessation Motivational Program on Carbon monoxide, Smoking Abstinence Self-efficiency, Smoking days and Daily smoking amount of Smoking High School Students (END금연동기유발 프로그램이 흡연고등학생의 일산화탄소, 금연 자기효능감, 흡연일수, 1일 흡연량에 미치는 효과)

  • Kim, Eun Jung;Lee, Hye-Kyung
    • Journal of the Korean Applied Science and Technology
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    • v.38 no.3
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    • pp.669-679
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    • 2021
  • This is a quasi-experimental study using the design before and after time gap of non-equivalence with comparative group performed to confirm the effects of END smoking cessation motivational program on the Carbon monoxide, Smoking Abstinence Self-efficiency, Days of smoking, Amount of smoking in the smoking high school students. The study subjects were the smoking students in a general high school located in C-City who were interested in the smoking cessation including 27 students in test group and 28 in the control group. Data collection period was from July 12 to October 4, 2018. END smoking cessation motivational program, the test intervention in this study, The study results are as follows. "There will be a difference of physiological factors between the test group that participates in END smoking cessation motivational program and the control group that does not" is supported. smoking cessation self-efficiency(z=110.00, p<.001), Days of smoking (z=640.00, p<.001), Daily smoking amount (z=520.50, p<.016), Considering these results, the application of this program is suggested to lower the smoking rate of the smoking high school students and to motivate the smoking cessation at the schools.

A Systematic Review and Meta-Analysis of the Effects of Simultaneous Dual-Task Training on Executive Function in Older Adults (동시적 이중과제 훈련이 노인의 실행기능에 미치는 효과: 체계적 고찰 및 메타분석)

  • Jeun, Yu-Jin;Park, Jin-Hyuck
    • Therapeutic Science for Rehabilitation
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    • v.10 no.3
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    • pp.23-41
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    • 2021
  • Objective : The purpose of this study was to analyze the effects of simultaneous dual-task training to assess executive function in older adults. Methods : We searched the PubMed, EMBASE, Cochrane, Web of Science, and RISS databases of publicated studies in the past decade. Seven studies were selected based on the inclusion and exclusion criteria. Qualitative assessment and meta-analysis were performed for the seven studies. Results : A randomized controlled trial design was used in the selected studies, and PEDro Scores above seven were obtained. The Trial Making Test (TMT) evaluated the effects of dual-task training on executive function in four studies. The Color Trail Test (CTT) was used in two studies, and Stroop test was used in three studies. The effect size for total executive function was 0.38, which was small. The effect sizes for TMT and CTT were 0.37. Stroop Test was 0.34, demonstrating that their effect sizes were also small. Only significant effects in total executive function, TMT, and CTT showed significant effects (all p<0.05). Conclusion : This study confirmed that dual-task training was effective in improving executive function in older adults. To improve the effectiveness of dual-task training, the difficulty of the dual-task training should be considered. It is also necessary to implement assessments that can evaluate performance under dual-task conditions as well as conventional test tools for executive function. In the future, dual-task training could be used as an appropriate intervention for executive function in older adults to delay the onset of dementia.

A Study on the Effectiveness of Group Reminiscence Approach among the Elderly Using Daycare Center : Focusing on the Mental Health related Quality of Life(MHRQoL) (주간보호센터 노인의 집단회상프로그램 효과성 검증에 관한 연구 : 정신건강 관련 삶의 질(MHRQoL)을 중심으로)

  • Kwon, OhGyeong;Hur, Junsoo
    • The Journal of the Korea Contents Association
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    • v.22 no.4
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    • pp.592-608
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    • 2022
  • This study conducted a group reminiscence program for the elderly who use the elderly daycare center. And this study verified the effectiveness of the elderly's mental health related quality of life to identify the relationship between the participating elderly and the non-participating elderly in a group reminiscence program. To this end, in order to examine the effectiveness of a group reminiscence programs for the elderly using the daycare center on MHRQoL, and the difference between the experimental group and the control group was compared with the non-equivalent control group pre-post test design. The research results are as follows. First, the experimental group that conducted the group reminiscence program in this study had a higher quality of life than the control group that did not participate the group reminiscence program. Second, significant results were found in vitality and mental health in the sub-factors of MHRQoL of the experimental group, and emotional role restriction and social function did not show significant results. Based on the results of this study, to develop and improve programs that encompass the entire sub-areas of MHRQoL, and to implement programs that positively affect the psycho-social intervention for the elderly persons. Finally, it was suggested to link and cooperate with senior welfare centers and general social welfare centers.

The Effect of a Physical Touch Play Program in Children: A Systematic Review and Meta-analysis (아동의 신체접촉놀이 프로그램에 대한 효과 : 체계적 문헌고찰 및 메타분석)

  • Yoon, Jeong Ah
    • Journal of Life Science
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    • v.32 no.10
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    • pp.821-831
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    • 2022
  • This study evaluated the effects of physical touch play programs in children through a systematic literature review and meta-analysis. A literature search for journal articles published before August 2022 was conducted using KERIS, KISS, DBpia, and ScienceON. The keywords used for the search were 'child', 'infant', 'physical touch', 'physical touch play', 'physical touch activities' and 'physical touch play program'. For the study's purpose, seven studies were selected through a systematic process of using several databases and were used to estimate the effect size of physical touch play programs. A meta-analysis was performed using a random effects model, and the effect size on cognitive function was calculated. Hedges' g of the physical touch play program was 6.20 (95% CI: 3.74-8.66), indicating a large effect size. To determine heterogeneity (I2= 95.4%, Q = 417.30, p<0.001), moderator analysis was performed using the total number of times and intervention duration. The total number of times was statistically significant; the other moderators did not differ significantly. This study systematically analyzed the results of physical touch play programs on children in Korea. It also provides insights that can be applied to the design of physical touch play programs for children. To present more evidence that supports the effectiveness of physical touch programs, further research is warranted.