• Title/Summary/Keyword: preliminary clinical trial

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Effects of a Cognitive Behavior Therapy Program for Patients with Fibromyalgia Syndrome: A Randomized Controlled Trial (섬유근통 증후군 환자를 위한 인지행동 프로그램의 효과: 무작위 대조군 전후실험설계)

  • Kong, Kyoung Ran;Lee, Eun Nam
    • Journal of Korean Academy of Nursing
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    • v.51 no.3
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    • pp.347-362
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    • 2021
  • Purpose: This study developed a cognitive behavioral therapy program aimed at altering the physical condition, emotions, and behaviors of fibromyalgia patients, and confirmed the program's clinical applicability. The program was developed by analyzing previous studies conducting in-depth interviews with fibromyalgia patients, drawing on cognitive behavior theory to establish the program contents, recruiting experts to test its validity, and conducting a preliminary survey. Methods: To confirm the program's effect, this study used a randomized controlled trial design. The participants were outpatients diagnosed with fibromyalgia in Dong-A University Hospital, Busan. The 30 patients in the experimental group took part in the program, which comprised 8 sessions (90 to 120 minutes) based on cognitive behavior theory, delivered over 8 weeks. Hypothesis testing was carried out using the repeated measures ANOVA. Results: The analysis revealed significant differences between the experimental and control groups in positive automatic thoughts, pain, fatigue, depression, and interpersonal relationships. However, there was no significant difference between the groups in terms of sleep disorders and negative automatic thoughts. Conclusion: This program is a positive effect on physical condition, emotions, and behaviors. It is thus expected to be used to help fibromyalgia patients improve their disease conditions.

Optical Skin-fat Thickness Measurement Using Miniaturized Chip LEDs: A Preliminary Human Study

  • Ho, Dong-Su;Kim, Ee-Hwa;Hwang, In-Duk;Shin, Kun-Soo;Oh, Jung-Taek;Kim, Beop-Min
    • Journal of the Optical Society of Korea
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    • v.13 no.3
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    • pp.304-309
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    • 2009
  • We tested the feasibility of measuring fat thickness using a miniaturized chip LED sensor module, testing 12 healthy female subjects. The module consisted of a single detector and four sources at four different source-detector distances (SD). A segmental curve-fitting procedure was applied, using an empirical algorithm obtained by Monte-Carlo simulation, and fat thicknesses were estimated. These thicknesses were compared to computed-tomography (CT) results; the correlation coefficient between CT and optical measurements was 0.932 for bicep sites. The mean percentage error between the two measurements was 13.12%. We conclude that fat thickness can be efficiently measured using the simple sensor module.

Effectiveness of the novel impression tray "cleftray" for infants with cleft lip and palate: a randomized controlled clinical trial

  • Kalaskar, Ritesh;Bhaje, Priyanka;Balasubramanian, Shruti;Kalaskar, Ashita
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.47 no.2
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    • pp.82-90
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    • 2021
  • Objectives: Cleft lip and palate (CLP) is one of the most common congenital deformities with worldwide prevalence. It causes a range of issues for infants that mainly involve difficulty in feeding due to abnormal oronasal communication. For this purpose, feeding plates are provided to infants to act as an artificial palate to aid in feeding. The most crucial procedure in fabrication of a feeding plate is creation of the impression using the traditional finger technique or impression trays. This preliminary research aims to compare the effectiveness of novel impression trays with that of the traditional finger technique for recording impressions of infants with CLP. Materials and Methods: This randomized controlled trial was conducted among 30 infants who were divided into two groups based on the method of obtaining impressions: Group I, finger technique; Group II, specialized acrylic tray (cleftray). Results: Use of cleftray required less impression time, a reduced amount of material, no incidence of cyanosis/choking in infants, and lower anxiety among doctors compared to the traditional method. Additionally, there was no distortion of cleft impressions, recorded maxillary tuberosity, or other fine details. Therefore, the novel impression tray (cleftray) exhibited superior outcomes in all the parameters compared to the finger technique. Conclusion: Within the limitations of this study, we conclude that impression trays are superior to the traditional finger, spoon, or ice cream stick methods of creating impressions of CLP. However, it is necessary to conduct more clinical trials on a larger population based on other parameters to compare the effectiveness of the two techniques to draw definitive conclusions.

A Preliminary Study on the Korean Version of Quality of Life-Alzheimer's Disease (QOL-AD) Scale in Community-dwelling Elderly with Dementia (지역사회 거주 치매환자에서 한국판 삶의 질 -알쯔하이머병 척도 개발을 위한 예비연구)

  • Shin, Hee-Young
    • Journal of Preventive Medicine and Public Health
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    • v.39 no.3
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    • pp.243-248
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    • 2006
  • Objectives: The Quality of Life-Alzheimer's Disease (QOL-AD) scale is a reliable and valid tool for assessing the quality of life (QOL) in the elderly with dementia. This study aimed to develop the Korean version of Quality of Life-Alzheimer's Disease (KQOL-AD) scale for the demented elderly living in the community. Methods: KQOL-AD was administered to two groups: 24 demented elderly and 72 cognitively impaired elderly with no dementia (CIND) who were living in the community Each elderly person and their caregiver rated the elderly QOL. The Korean version of mini-mental state examination (MMSE-K), the clinical dementia rating (CDR), the activities of daily living (ADL), and the neuropsychiatric inventory (NPI) were also assessed. The reliability and validity of the KQOL-AD were examined. Results: In the dementia group, the internal consistency (Cronbach's $\alpha$), the split half and the test-retest reliabilities of the KQOL-AD were excellent. Scores on the KQOL-AD were significantly correlated with the scores of the NPI, but they were not significantly correlated with scores of the MMSE-K, CDR and ADL. In addition, the CIND group showed similar results to the dementia group. Conclusions: KQOL-AD might be a reliable and valid instrument for assessing QOL in the elderly with dementia It could be used as an important outcome measure for research on the demented elderly.

A Survey of the Recognition on the Practice Pattern, Diagnosis, and Treatment of Korean Medicine of Dementia and Mild Cognitive Impairment - Focusing on the Differences between Neuropsychiatrists of Korean Medicine and General Physicians - (치매, 경도인지장애의 한의진료 현황, 진단 및 치료에 대한 한의사의 인식도 조사 연구 - 한방신경정신과 전문의와 일반의의 차이를 중심으로 -)

  • Seo, Young Kyung;You, Dong Keun;Kim, Hwan;Kim, Siyeon;Lee, Go eun;Kim, Sang-Ho;Kang, Hyung-Won;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.3
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    • pp.263-274
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    • 2017
  • Objectives: To identify the current status of Korean medical practice pattern, diagnosis and treatment of dementia through recognition survey, and to use it as a preliminary data for various dementia research. Methods: Questionnaires were developed through expert meetings. The disease was defined as dementia and mild cognitive impairment, and areas were designated to practice pattern, diagnosis and treatment. From December 18, 2016-January 18, 2017, 221 respondents, including 36 neuropsychiatrists of Korean Medicine and 185 general physicians (including other medical specialists) were included. Results: 1. In both groups, the most commonly used KCD (Korean standard classification of disease and cause of death) were in the order of Unspecified Alzheimer's Dementia (F00.9), Mild Cognitive Impairment (F06.7), and Unspecified Dementia (F03). 2. The most commonly used pattern identification were zang-fu and qi-blood-yin-yang in both groups. 3. Diagnostic evaluation tools were mainly conducted by MMSE, radiologic examination, K-DRS, GDS and CDR in both groups. 4. Both groups reported using acupuncture and herbal medicine mainly. 5. In both groups, the acupuncture method was used extensively in the order of Body, Scalp, and Sa-Am. 6. Neuropsychiatrists used a variety of herbal medicines such as Wonjiseokchangpo-san (Yuanzhushichangpu-san), Yukmijihwang-tang (Liuweidihuang-tang), Palmijihwang-won (Baweidihuang-won), Sunghyangjungki-san (Xingxiang Zhengqi-san) and Ondam-tanggami (Wendan-tangjiawei). General physicians used a variety of herbal medicines such as Ondam-tanggami (Wendan-tangjiawei), Bojungikgi-tang (Buzhongyiqi-tang), Yukmijihwang-tang (Liuweidihuang-tang). 7. Neuropsychiatrists used a variety of Korean herbal preparation products (benefit and non-benefit) such as Ekgan-sangajinpibanha (Yigan-sanjiachenpibanxia), Yukmijihwang-tang (Liuweidihuang-tang), Jodeung-san (houteng-san), Palmijihwang-won (Baweidihuang-won). General physicians used a variety of Korean herbal preparation products such as Bojungikgi-tang (Buzhongyiqi-tang), Banhabaegchulcheonma-tang (banxiabaizhutianma-tang), Yukmijihwang-tang (Liuweidihuang-tang), Ekgan-sangajinpibanha (Yigan-sanjiachenpibanxia), Palmijihwang-won (Baweidihuang-won). Conclusions: By confirming awareness of Korean medical doctors treating dementia in clinical fields and understanding differences between neuropsychiatrists of Korean medicine and general physicians, it can be used to understand guideline users' needs and confirm clinical questions during development of future clinical practice guidelines for dementia.

Study on an Image Reconstruction Algorithm for 3D Cartilage OCT Images (A Preliminary Study) (3차원 연골 광간섭 단층촬영 이미지들에 대한 영상 재구성 알고리듬 연구)

  • Ho, Dong-Su;Kim, Ee-Hwa;Kim, Yong-Min;Kim, Beop-Min
    • Progress in Medical Physics
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    • v.20 no.2
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    • pp.62-71
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    • 2009
  • Recently, optical coherence tomography (OCT) has demonstrated considerable promise for the noninvasive assessment of biological tissues. However, OCT images difficult to analyze due to speckle noise. In this paper, we tested various image processing techniques for speckle removal of human and rabbit cartilage OCT images. Also, we distinguished the images which get with methods of image segmentation for OCT images, and found the most suitable method for segmenting an image. And, we selected image segmentation suitable for OCT before image reconstruction. OCT was a weak point to system design and image processing. It was a limit owing to measure small a distance and depth size. So, good edge matching algorithms are important for image reconstruction. This paper presents such an algorithm, the chamfer matching algorithm. It is made of background for 3D image reconstruction. The purpose of this paper is to describe good image processing techniques for speckle removal, image segmentation, and the 3D reconstruction of cartilage OCT images.

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An Exploratory Study on the Possibility of Quantitative Measurement during Abdominal Examinations - A Preliminary Study on the Development of a Diagnostic Device for Abdominal Examinations (한의복진법의 정량화를 위한 탐색적 임상연구 - 한의 복진기기 개발을 위한 예비 연구 -)

  • Lee, Jae-hong;Kim, Sang-jin;Ko, Seok-jae;Park, Jae-woo
    • The Journal of Internal Korean Medicine
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    • v.37 no.6
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    • pp.940-948
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    • 2016
  • Objectives: This exploratory trial evaluated the possibility of quantitatively measuring several aspects during the "abdominal examination" of traditional Korean medicine. The main results of this study will be used to develop a new diagnostic device for abdominal examinations. Methods: Fifteen healthy volunteers were recruited for this study. Three certified Korean medical doctors assessed the existence of pressure pain, the elasticity of the abdominal muscle, and the tonus at CV12 as gold standards. Then, 2 well-trained investigators measured the pressure pain threshold (PPT), the indentation depth of a bar, and repelling force by pressing CV12. Each investigator measured the above 3 variables 2 times at 1 min intervals using a modified digital algometer. Reliability and validity tests of the 3 variables were performed. Results: There were statistically significant coefficients of intraclass correlation on the 3 variables both between and within the investigators (P<0.001). Also, PPT and repelling force showed statistically significant high sensitivity and specificity in a ROC curve. However, the indentation depth of the bar presented relatively low sensitivity. Conclusions: This new diagnostic method using a modified digital algometer could be a useful tool for quantitative measurement in "abdominal examinations". However, future rigorous clinical studies with a large population will be needed for the verification of its usefulness.

The Clinical Effect of Phellinus linteus Grown on Germinated Brown Rice in the Treatment of Atopic Dermatitis (소아 아토피 피부염에서 발아현미 상황버섯의 임상적 치료효과)

  • Hong, Won-Kyu;Shin, Jeong-Hyun;Lee, Yeon-Hee;Park, Dong-Ki;Choi, Gwang-Seong
    • The Korea Journal of Herbology
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    • v.23 no.1
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    • pp.103-108
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    • 2008
  • Objective: Atopic dermatitis is the most common chronic inflammatory skin disease in childhood. Phellinus linteus, an orange color mushroom, has been used as a traditional herb medicine for years. Recent preliminary animal experiments suggest that Phellinus linteus grown on germinated brown rice is effective in chronic inflammatory disease. The aim of this study was to evaluate the efficacy of Phellinus linteus grown on germinated brown rice in the treatment of atopic dermatitis(AD). Methods: 35 patients, 2 to 14 years of age, with mild to moderate AD were treated with Phellinus linteus grown on germinated brown rice powder per oral, $6{\sim}12g$/day adjusted by the body weight, divided three for up to 12 weeks without other treatment. The mean age of patients was 7.3 years. The disease activity has been monitored by objective SCORAD index. The symptom score of the pruritus was measured by using a traditional visual analogue scale (VAS). In addition, the global assessments of clinical response were also monitored by patients or their parents. Results: After 12 weeks of the study, significant reductions in mean severity scores and mean symptom scores were observed. The mean objective SCORAD indices of 35 patients decreased from 25.31${\pm}$8.96 to 18.73${\pm}$13.89(p<0.05). And the mean symptom score of pruritus assessment decreased from 7.37${\pm}$1.33 to 4.6${\pm}$2.3(p<0.05). The patient's global assessment of clinical response were also improved through the period of treatment(p<0.05). Conclusions: Phellinus linteusgrown on germinated brown rice may play a role in the treatment of mild and moderate AD in Children.

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Overview of four subgroups in Soeum(Lessor Yin) Constitution, Which are classified based on 'Chang(=Viscera) and Fu(=Bowels) meridian theory' (소음인(小陰人)의 장부경락론적(臟腑經絡論的) 고찰(考察))

  • Yom, Tae-hwan
    • Journal of Sasang Constitutional Medicine
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    • v.12 no.1
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    • pp.10-23
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    • 2000
  • Four-constitutional theory proposed by Dr. Lee, Je-ma has been evolve for last 100years by his followers. One of the major progresses was the emergence of constitutional acupuncture proposed by Dr. Kwan Doh-won. Constitutional acupuncture included the new pulse diagnostic method to determine the body type, pulse diagrams and corresponding acupuncture method called five element acupuncture in which five-element points in 12 meridian channels are used. Dr. Sa-ahm proposed five-element acupuncture three and a half hundred years age. Conjunction of Dr Lee's theory to Dr. Kwan proposed eight constitutions with eight pulse diagrams. He also adopted eight acupuncture prescriptions out of twenty-four Sa-ahm's acupuncture prescriptions. The author, Dr. Yom Tae-hwa, proposed more inclusive theory of 24 constitutions with 24 diagnostic pulse diagrams in Las Vegas International Acupuncture Convention in 1986. This article reviews history of constitutional medicine briefly. Each step of theoretical evolution from four-constitutional theory to twenty-four-constitutional theory is explained. By understanding the theoretical connection between twelve meridian channels based on five-element theory and four-constitutional theory in the article, one will easily accept the emergence of twelve of twenty four constitutional theory. Next, the article is focused on four subcategories under Sao-Yin constitution, which are one-sixth of 24 constitution. in this section classification, pulse diagnostic method, pulse diagram acupuncture prescriptions and herbal prescriptions are explained in detail. Then, clinical trial reports of acupuncture treatment and/or herbal formulas for such constitutions are attached for the rest part of the article. the purpose of this paper is to present the new hypothesis with the result of preliminary clinical trial hoping that additional clinical reports from other practitioners in this field triggers well-designed clinical study in future.

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Preliminary Study to Develop the Instrument on Pattern Identifications for Insomnia (불면증 변증도구 개발을 위한 기초 연구)

  • Lee, Hun-Soo;Kim, Hwan;Yun, Yong-Gi;Lee, Sujin;Jeon, Ju-Hyun;Kim, Bo-Kyung;Lee, Eun Jung;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.27 no.4
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    • pp.223-234
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    • 2016
  • Objectives: This study was carried out to develop a standard tool of pattern identifications for insomnia in Korean Medicine. Methods: The advisory committee for this study was organized by 17 Korean Medicine neuropsychiatry professors who were faculty members of different Korean Medicine colleges. The pattern identifications and symptoms for this tool were extracted from published Korean and Chinese literature. The Instrument on Pattern Identifications for Insomnia was developed following discussions among internal experts and after consultations with members of the advisory committee. Results: 1) Five pattern identifications were set for the tool. 2) The mean weights which represent the importance of each symptom and scored on a hundred-point scale were obtained. 3) The Instrument on Pattern Identifications for insomnia was designed in the self-reporting format composed of 47 questions. Conclusions: An Instrument on Pattern Identifications for Insomnia was created in this study. However, owing to any clinical trials has not been set yet. Therefore its validity and reliability were not confirmed. To make up for this limitation, the further clinical study would be performed in the near future.