• Title/Summary/Keyword: Clinical Trial Design

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Research Trends of Traditional Chinese Medicine Containing Haematitum in the Neuropsychiatric Clinical Scene (대자석의 중의 신경정신과 임상연구 현황)

  • Jung, Jin-Hyeong;Choi, Yun-Hee;Kim, Tae-Heon;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.25 no.4
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    • pp.401-410
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    • 2014
  • Objectives: This study was intended to review the research trends of treating neuropsychiatric diseases and symptoms with Traditional Chinese Medicine containing Haematitum. Methods: Articles were obtained through the CNKI (China National Knowledge Infrastructure) by searching with 'Haematitum' as the main key word, and supportive words related with neuropsychiatric diseases and symptoms were selected. There were 61 articles related to clinical fields, which were then classified according to study design. Results: The 61 articles were categorized into the following types of study design: 3 randomized controlled trials, 1 quasi-randomized trial, 3 simple-designed clinical trials, and 54 case studies. Decoctions containing Haematitum were used to treat diseases and symptoms such as vertigo, headache, stroke, epilepsy, neurosis, globus hystericus, fishbilepoisoning, insomnia, mania, post-traumatic brain syndrome, and kinesia. All articles reported a good rate of effectiveness. There was no poor responsiveness regarding the effects of Haematitum in 9 studies, but it was not mentioned in the other 52 studies. Decoctions self-prepared by the authors were used in 28 studies. Modified Seonbokdeja-tang, modified Banhabeakchulcheonma-tang, modified Ondam-tang were used in that order of frequency. The daily dosage of Haematitum provided was 0.2~6 g in powder, and 9~60 g in decoction. Conclusions: Decoctions containing Haematitum are used restrictively in the neuropsychiatric clinical scene. While there were no reports of poor responsiveness of the effects of Haematitum, more research is needed to confirm its clinical stability.

Development of Web-based Nursing Education Program for Ostomy Care (장루 관리를 위한 Web 기반 간호교육 프로그램 개발)

  • Hong, Hae-Sook
    • Journal of Home Health Care Nursing
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    • v.10 no.2
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    • pp.141-147
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    • 2003
  • The purpose of this study was to develop and apply a Web-based Nursing Education & Instruction Program to help the clinical nurses improving their knowledge and skills of ostomy care. This program was developed in three different steps: analysis. design. and development. The results of the study were as follows: The analysis step was designed to select the study contents for effective and easy educationthrough the analyses of specialized books. This surveyed and analyzed study contents were categorized into five different sections. Introduction. ostomy classification. ostomy management. elimination management. and life style. After that each section describes necessary information of each category. In the design step. the image files used in this program were created using Adobe Photoshop 6.0. and HTML files were designed and developed using Namo Editor 5.0. In the development step. the developed program was published into Web using FTP (File Transfer Protocol) and then finalized after trial operation for testing of real users. In addition. this Web-based Nursing Education & Instruction Program will be used as excellentand effective tool for continuous and lifelong education in nursingfield. In this study. computer-aided education program was developed for ostomy management and managed at the Web-Server (http://hshong.knu.ac.kr/ostomy) in order to help nurses real-time education in clinical field by this program.

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A Review Studies on the Treatment of Anorexia Nervosa in Traditional Chinese Medicine (신경성 식욕부진증의 치료에 관한 임상연구 동향 -중의학 논문을 중심으로-)

  • Min-Jae Kim;Chan-Young Kwon
    • Journal of TMJ Balancing Medicine
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    • v.13 no.1
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    • pp.1-12
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    • 2023
  • Objectives: This study was performed to review the research trends in the treatment of anorexia nervosa (AN) in Traditional Chinese Medicine (TCM). Methods: Studies were searched through The China National Knowledge Infrastructure (CNKI) database. The search term for the subject were 'Eating Disorder', and 'Anorexia Nervosa'. Clinical research that conducted TCM treatment for AN patients were included. Studies were analyze according to study design, therapy method, diagnostic criteria, population and intervention. Results: 23 articles were selected. According to study design, studies were classified into two randomized controlled trial (RCT), three single group before-and-after studies, and 18 case reports. According to therapy method, they included 19 herbal medicine studies, two acupuncture treatment studies, and two complex treatment studies. The most common pattern identification was 'liver depression with spleen deficiency' (肝鬱脾虛), and the most used herb was 'Root of Bupleurum falcatum' (柴胡). Most of the studies showed effective results in increasing appetite and weight. Conclusions: The results of our study demonstrate that TCM treatments for AN has been effective in alleviating chief symptoms. However, in terms of evidence-based medicine, lack of RCT on TCM treatments for AN and absence of objective diagnostic criteria in case reports are limitations. Therefore well-designed further clinical studies should be performed based on the results of this study are recommended.

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Effect of Paretic and Non-paretic Side Spine Taping on Balance Ability in Patients with Stroke

  • Cho, Yonghun;Park, Shinjun;Kim, Soonhee
    • Journal of International Academy of Physical Therapy Research
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    • v.10 no.2
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    • pp.1779-1784
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    • 2019
  • Background: A number of researchers have attempted to improve the balance of stroke patients, however there is still a question as to whether taping is effective in increasing balance. Objective: To determine the effect of paretic and non-paretic side taping on the balance ability in patients with stroke. Design: A single-blind randomized controlled trial Methods: This randomized single-blind controlled clinical trial with a repeated measures study included 45 subjects who were randomly assigned to paretic side taping groups (n=15), non-paretic side taping groups (n=15), and trunk exercise groups (n=15). Trunk exercise and paretic side taping groups had taping on the paralyzed erector spinae, while the non-paretic side taping group had taping on the non-paralyzed erector spinae. Trunk exercises were performed for 30 minutes to promote core muscles. The balance ability measured the center of pressure movement (paretic side, non-paretic side,forward, backward, limit of stability) in the sitting position. All measurements were evaluated using BioRescue. Results: All three groups showed significant increase in all variables after 4 weeks. The paretic and non-paretic side taping groups had a significant increase in all variables after 30 min of attachment. However, there was no significant difference among the three groups. Conclusions: Paralysis and non-paralysis taping improved the balance ability of patients with stroke in an immediate effect of 30 min. However, after 4 weeks of intervention, taping with trunk exercise did not differ from single trunk exercise. In future studies, various analyses need to be conducted through more diverse evaluations.

Clinical Trial of Herbal formula (Slim-diet) on Weight Loss in Obese Pre-menopausal Korean Females (비만환자의 체중감량에 있어 슬림다이어트 처방의 유용성 평가를 위한 임상시험)

  • Chung, Won-Suk;Shin, Hyun-Dae;Song, Mi-Yeon
    • Journal of Korean Medicine for Obesity Research
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    • v.3 no.1
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    • pp.1-6
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    • 2003
  • Background: Recently, Obesity has become a social problem in all over the world including Korea. Dietary regulation, exercise and behavior modification therapy are used in the treatment of obesity, but until now, there have been many difficulties in treating it. Objectives: To examine in obese pre-menopausal Korean females the short-term efficacy for weight loss of an herbal formula (Slim-diet). Design: A 6-week longituidinal evaluation of a herbal formula (Slim-diet) in 35 pre-menopausal females (baseline age $31.6\;{\pm}\;6.1$) with body mass index > $25kg/m^2$. Body composition was measured using bioimpedence analysis (BIA) and dual energy X-ray absorptiometry (DXA). Anthropometry was done by same observer. Total cholesterol, total lipid, triglyceride, and LDL-cholesterol were measured. Results: Herbal formula (Slim-diet) treatment produced significant loss of weight (P < 0.001), percent of body fat (P < 0.001, both BIA and DXA) and waist circumference (P < 0.001). It also produced significant reduction of total cholesterol and total lipid levels (P < 0.05).

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Comparison of the effects of transcutaneous electrical nerve stimulation, low level laser, and placebo treatment on temporomandibular joint disorders: a single-blind randomized controlled trial

  • Kim, Hyunjoong
    • Physical Therapy Rehabilitation Science
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    • v.9 no.4
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    • pp.244-251
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    • 2020
  • Objective: Physical therapy techniques are required for patients with temporomandibular joint disorder (TMD), but the effects of treatment have not been compared. Therefore, effects of transcutaneous electrical nerve stimulation (TENS) and low level laser (LLL), which are most commonly used interventions, were compared. Design: Randomized controlled trial. Methods: Thirty-six participants with pain in the temporomandibular joint were enrolled, and 12 participants were randomly assigned to either the TENS group, LLL group, or placebo group. Each intervention was performed for a total of 6 sessions for 2 weeks. For the evaluation of the participants, the mouth opening (MO), pressure pain threshold (PPT), and stress were measured at three time periods: baseline, post-test, and follow-up at 2 weeks. Results: Significant interaction between groups according to each evaluation point was found only in PPT-masseter (p<0.05). The evaluation time point at which a significant difference appeared was at the post-test and follow-up at 2 weeks time periods. As a result of the post-test, the LLL group showed a significant improvement compared to the TENS group (p<0.05), and at 2 weeks follow-up, the TENS group showed a significant improvement compared to the placebo group (p<0.05). Conclusions: In this study, an experiment was conducted to compare the treatment effects when TENS, LLL, and placebo were given to patients with TMD. In addition, by quantitatively presenting the effect size of each treatment, this study suggests clinical use of TENS and LLL treatment for TMD.

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.

Comparison of the effects of articaine and bupivacaine in impacted mandibular third molar tooth surgery: a randomized, controlled trial

  • Tokuc, Berkay;Coskunses, Fatih Mehmet
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.6
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    • pp.575-582
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    • 2021
  • Background: The aim of this randomized, triple-blind trial was to determine the anesthetic, analgesic, and hemodynamic effects of articaine and bupivacaine in the extraction of impacted mandibular third molar teeth. Methods: Twenty-six patients who underwent removal of bilaterally symmetric mandibular third molars were randomly assigned to articaine and bupivacaine groups in a split-mouth design. The onset of anesthetic action, intraoperative comfort, total amount of solution used, duration of postoperative anesthesia and analgesia, rescue analgesic use, postoperative pain, intraoperative bleeding, and hemodynamic parameters were evaluated. Results: In the articaine group, the onset of anesthetic activity was faster, intraoperative comfort was greater, and effective anesthesia required less local anesthetic solution. The bupivacaine group showed a significantly longer duration of postoperative anesthesia and analgesia, in addition to lower visual analog scale values at 6 and 48 hours postoperatively. There were no significant differences between the two solutions regarding rescue analgesic medication use, intraoperative bleeding, or hemodynamics. Conclusion: Articaine showed greater clinical efficacy than bupivacaine in intraoperative anesthesia, achieving faster onset of anesthetic action and greater patient comfort while also requiring less reinforcement during surgery. However, bupivacaine was superior in terms of postoperative anesthesia, reducing postoperative pain due to its residual anesthetic and analgesic effects. Both anesthetic solutions led to similar hemodynamics at low doses in mandibular third molar surgery

Effect of Lower Trapezius Strengthening Exercise Program on Unstable Support Surface for Neck Pain Patients with Forward Head Posture: A Randomized Controlled Trial

  • Park, Sam-Ho;Lee, Myung-Mo
    • Physical Therapy Rehabilitation Science
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    • v.11 no.2
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    • pp.189-197
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    • 2022
  • Objective: The purpose of this study was to investigate the effect of a lower trapezius strengthening exercise program on an unstable support surface on pain, neck dysfunction, psychosocial factors, and postural alignment in neck pain patients with forward head posture. Design: A randomized controlled trial Methods: A total of 36 neck pain patients participated in this study. Screening tests were performed and assigned to experimental group (n=18) and control group (n=18) using randomization program. Both groups performed the lower trapezius strengthening exercise program. In addition, in the experimental group, an exercise program for lower trapezius muscle strengthening was performed on an unstable support surface. All interventions were performed 3 times a week, for a total of 5 weeks. quadruple visual analogue scale (QVAS), neck disability index (NDI), short form (SF)-12, and postural alignment were measured before and after the intervention to compare their effectiveness. Results: Both groups showed significant differences in QVAS, NDI, SF-12, and postural alignment before and after intervention (p<0.05). In addition, the experimental group showed significant differences in NDI and postural alignment compared to the control group (p<0.05). Conclusions: The lower trapezius strengthening exercise program on unstable support surfaces is an effective intervention method with clinical significance in improving neck disability and postural alignment in patients with neck pain with forward head posture.

Development and Effects of Dongsasub Training Program with Application of Aroma Necklace for Nursing Students taking Clinical Practicum (임상실습 중인 간호대학생을 위한 아로마목걸이를 병용한 동사섭 훈련의 개발과 효과)

  • Kim, Myoungsuk
    • Journal of muscle and joint health
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    • v.26 no.1
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    • pp.15-26
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    • 2019
  • Purpose: The purpose of this study was to develop a Dongsasub training applying aroma necklace for nursing students in clinical practicum, and to evaluate the training programs' effects on perceived stress, self-esteem, depression, and clinical competence of the participants. Methods: This study used a cluster-randomized controlled trial design. Participants were 56 nursing students taking clinical practicum courses (26 in the experimental group and 30 in the control group). The training program consisted of four sessions of Dongsasub training and wearing a necklace where a mixture of aroma oils attached. Participants in experimental group were given a necklace with essential oil mixture of lavender, bergamot, and geranium with the ratio of 1:1:1 for 2 weeks. The control group received no intervention. Outcome variables included perceived stress, self-esteem, depression, and clinical competence. Data were analyzed with Fisher's exact test, Chi-square, Independent t-test using the SPSS/WIN 21.0. Results: Independent t-test revealed that perceived stress (t=3.15, p=.003), depression (t=4.62, p<.001) were significantly lower in the experimental group than the control group; self-esteem (t=-3.03, p=.004), clinical competence (t=-2.15, p=.036) scored significantly greater than the control group. Conclusion: The results indicate that the Dongsasub training with application of the aroma necklace can be used as an effective nursing intervention for lowering perceived stress, depression and improving self-esteem, clinical competence of nursing students.