• Title/Summary/Keyword: non-randomized controlled trial

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A Review of the Domestic Study Trends on Obstetrics & Gynecological Diseases with Chuna Manual Therapy (한방여성의학에서 추나요법을 활용한 국내 연구 동향 분석)

  • Lee, Jin-Wook;Hwang, Young-Sik;Kim, Gyu-Tae;Park, Seung-Hyeok;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bok;Hwang, Deok-Sang
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.2
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    • pp.87-99
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    • 2019
  • Objectives: The aim of this study was to analyse the domestic trends of Chuna manual therapy on Obstetrics and Gynecological Diseases in Korean literature. Methods: We searched for papers which had Chuna manual therapy through 2 related journals and 5 Korean web databases. All relevant papers were selected and extracted to be analyzed according to their study designs, academic journals, and target disease. Results: Nine papers belonged to four types of study designs, systematic review, randomized or non-randomized controlled trial and case report. And they were published in four kinds of academic journals. There were four papers about postpartum pain, two low back pain during pregnancy, and a stress urinary incontinence. The exact Chuna techniques were explained in only seven papers. All of papers have been shown that Chuna manual therapy is useful for obstetrics and gynecological diseases. Conclusions: It has been identified that Chuna manual therapy could be a good treatment for obstetrics and gynecological diseases. However, more clinical and well-designed studies with Chuna manual therapy will be needed.

Analysis on Intervention Studies of Sasang Constitutional Diet : Participant, Intervention, Comparison, and Outcome (PICO) (사상체질 식이중재연구 현황분석 : Participant, Intervention, Comparison, Outcome (PICO)를 중심으로)

  • Kim, Ji Hwan
    • Journal of Sasang Constitutional Medicine
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    • v.33 no.1
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    • pp.90-101
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    • 2021
  • Objectives The purpose of this study was to evaluate intervention studies on Sasang Constitutional diet (SCD) through the checks of Participant, Intervention, Comparison, and Outcome (PICO) Methods Randomized controlled trial (RCT) and non-randomized study for intervention (NRSI) about SCD were searched in 4 Korean core databases and other sources, and then PICO was checked. Results 1. Total 10 studies were conducted with 1 RCT and 9 NRSIs. 2. Participants were people with no specific disease, or patients with essential hypertension, hyperlipidemia, obesity, or stroke with diabetes or hyperlipidemia. Most studies were conducted on groups of various Sasang Constitutional types except Taeyangin. 3. Two studies provided participants with meals and exercise. Three studies, instead of providing meals directly, taught participants how to eat SCD on their own. 4. NRSIs have tested the effectiveness of various outcome measures without the presentation of primary outcome, and then concluded that all outcomes were ineffective or some are effective. 5. There was no mention of adverse events. In most studies, a single doctor of Korean medicine diagnosed Sasang Constitution the QSCC II questionnaire. The intervention period ranged from three weeks to three months, and recent studies have conducted interventions for 12 weeks. Conclusions Intervention studies about SCD which were conducted so far have shown problems on the study design of PICO items. The study design and implementation that carefully consider how to maintain similarity between groups, minimize the risk of bias, set primary outcome measure, and control the diet are required.

Assessment of dehydrothermally cross-linked collagen membrane for guided bone regeneration around peri-implant dehiscence defects: a randomized single-blinded clinical trial

  • Lee, Jae-Hong;Lee, Jung-Seok;Baek, Won-Sun;Lim, Hyun-Chang;Cha, Jae-Kook;Choi, Seong-Ho;Jung, Ui-Won
    • Journal of Periodontal and Implant Science
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    • v.45 no.6
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    • pp.229-237
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    • 2015
  • Purpose: The aim of this study was to determine the clinical feasibility of using dehydrothermally cross-linked collagen membrane (DCM) for bone regeneration around peri-implant dehiscence defects, and compare it with non-cross-linked native collagen membrane (NCM). Methods: Dehiscence defects were investigated in twenty-eight patients. Defect width and height were measured by periodontal probe immediately following implant placement (baseline) and 16 weeks afterward. Membrane manipulation and maintenance were clinically assessed by means of the visual analogue scale score at baseline. Changes in horizontal thickness at 1 mm, 2 mm, and 3 mm below the top of the implant platform and the average bone density were assessed by cone-beam computed tomography at 16 weeks. Degradation of membrane was histologically observed in the soft tissue around the implant prior to re-entry surgery. Results: Five defect sites (two sites in the NCM group and three sites in the DCM group) showed soft-tissue dehiscence defects and membrane exposure during the early healing period, but there were no symptoms or signs of severe complications during the experimental postoperative period. Significant clinical and radiological improvements were found in all parameters with both types of collagen membrane. Partially resorbed membrane leaflets were only observed histologically in the DCM group. Conclusions: These findings suggest that, compared with NCM, DCM has a similar clinical expediency and possesses more stable maintenance properties. Therefore, it could be used effectively in guided bone regeneration around dehiscence-type defects.

Effect of Debriefing Based on the Clinical Judgment Model on Simulation Based Learning Outcomes of End-of-Life Care for Nursing Students: A Non-Randomized Controlled Trial (임상판단모델에 근거한 디브리핑 적용이 임종간호 학습성과에 미치는 효과: 비무작위 대조시험설계)

  • Jeong, Kyung In;Choi, Ja Yun
    • Journal of Korean Academy of Nursing
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    • v.47 no.6
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    • pp.842-853
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    • 2017
  • Purpose: This study was conducted to identify effects of debriefing based on the clinical judgment model for nursing students on their knowledge, skill performance, clinical judgment, self-confidence and learner satisfaction during simulation based end-of-life care (ELC) education. Methods: Simulation based ELC education was developed in six steps as follows: selection of learning subjects and objects, development of learning tools, a trial run of simulation-based education, students' skill training, and evaluators' training. Forty-eight senior nursing students (25 in the experimental group and 23 in the control group) participated in the simulation-based ELC education using a high-fidelity simulator. Debriefing based on the clinical judgment was compared with the usual debriefing. Results: ANCOVA showed that there were differences in knowledge (F=4.81, p=.034), skill performance (F=68.33, p<.001), clinical judgment (F=18.33, p<.001) and self-confidence (F=4.85, p=.033), but no difference in satisfaction (t=-0.38, p=.704) between the experimental and control groups. Conclusion: This study found that debriefing based on the clinical judgement model is effective for supporting nursing students for reflecting on clinical judgment and improving their diverse competencies in complex clinical settings such as ELC.

The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

Reducing Irrational Beliefs and Pain Severity in Patients Suffering from Non-Cardiac Chest Pain (NCCP): A Comparison of Relaxation Training and Metaphor Therapy

  • Bahremand, Mostafa;Moradi, Gholamreza;Saeidi, Mozhgan;Mohammadi, Samira;Komasi, Saeid
    • The Korean Journal of Pain
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    • v.28 no.2
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    • pp.88-95
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    • 2015
  • Background: Patients suffering from non-cardiac chest pain (NCCP) can interpret their chest pain wrongly despite having received a correct diagnosis. The objective of this study was to compare the efficacy of the relaxation method with metaphor therapy for reducing irrational beliefs and pain severity in patients with NCCP. Methods: Using a randomized controlled trial, 33 participants were randomly divided into a relaxation training group (n= 13), a metaphor therapy group (n = 10), and a control group (n = 10), and were studied for 4 weeks. The two tools used in this research were the Brief Pain Inventory (BPI) index for determining the degree of pain and the short version of the Jones Irrational Belief Test. Metaphor therapy and a relaxation technique based on ${\ddot{O}}$st's treatment were used as the interventions. The collected data were analyzed with a multivariate analysis of covariance (MANCOVA), a Chi-square test, and the Bonferroni procedure of post-hoc analysis. Results: The relaxation training method was significantly more effective than both metaphor therapy and the lack of treatment in reducing the patients' beliefs of hopelessness in the face of changes and emotional irresponsibility, as well as the pain severity. Metaphor therapy was not effective on any of these factors. In fact, the results did not support the effectiveness of metaphor therapy. Conclusions: Regarding the effectiveness of the relaxation method as compared with metaphor therapy and the lack of treatment in the control group, this study suggests that relaxation should be paid greater attention as a method for improving the status of patients. In addition, more studies are needed to determine the effectiveness of metaphor therapy in this area.

Effects of Non-Contact Complex Exercise Program on the Older over 65 Years of Age on Muscle Strength, Falling Efficacy and Balance Ability

  • Sam Ho Park;Youn Jung Oh;Myung Mo Lee
    • Physical Therapy Rehabilitation Science
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    • v.12 no.2
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    • pp.167-176
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    • 2023
  • Objective: The purpose of this study was to investigate the effects of anon-contact complex exercise program on muscle strength, fall efficacy, quality of life, and balance ability in older over 65 years of age. Design: A randomized controlled trial Methods: A total of 37 people in older over 65 years of age participated in the study. Random program was conducted and assigned to the experimental group (n=19) and the control group (n=18). Both groups performed the older people welfare center program. In addition, in the experimental group, a non-contact complex exercise program for muscle and balance exercise was performed. All interventions were performed 2 times a week, for a total of 6 weeks. chair stand test (CST), fall efficacy scale (FES), Euro quality of life 5 dimension (EQ-5D), Berg balance scale (BBS), timed up and go test (TUG), Fullerton advanced balance scale (FAB) were measured before and after the intervention to compare their effectiveness. Results: Both groups showed significant differences in CST, FES, EQ-5D, BBS, and TUG before and after intervention (p<0.05). FAB showed significant differences before and after intervention in all items except for FAB 8 and 9 items in the experimental group. In addition, the experimental group showed significant differences in CST, FES, BBS, TUG, FAB (except 1, 7, 8, 9) compared to the control group (p<0.05). Conclusions: The non-contact complex exercise program is an effective intervention method that has clinical significance in improving muscle strength, fall efficacy and static and dynamic balance abilities for the older over 65 years of age.

Effects of Suboccipital Muscle Inhibition and Neck Muscle Stabilization Exercise on Pain and Range of Motion in Patients with Chronic Non-Specific Neck Pain (뒤통수밑근 억제기법과 목 안정화 운동이 만성 비특이적 목 통증 환자의 통증과 관절가동범위에 미치는 영향)

  • Chool-Hyeong Rhee;Eun-Jin Lim
    • Journal of The Korean Society of Integrative Medicine
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    • v.12 no.1
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    • pp.125-138
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    • 2024
  • Purpose: The aim of this study was to apply suboccipital muscle inhibition combined with neck muscle stabilization exercise to 20~30s IT industry employees who suffer from chronic non-specific neck pain. Methods: This study was designed as single-blind and randomized controlled trial. The study participants were 20~30s IT industry employees with chonic non-specific neck pain (VAS 3/10) who were divided into an experimental group (n= 20) subjected to suboccipital muscle inhibition with neck muscle stabilization exercise, and control group (n= 20); suboccipital muscle inhibition only. The intervention was applied three times per week for eight weeks. The neck pain·pressure pain threshold·range of motion, and disability index were measured at the 1st, 8th, and 10th week at follow up, then analyzed with an analysis of variance(ANOVA) using the SPSS program. Results: The total number of study participants was 37 (experimental group 19, mean age 34.6±5.3, control group 18, mean age 35.7±4.9). The comparison and analysis of change in VAS, the pressure pain threshold, and the range of motion except the extension (p>.05) revealed a statistically significant decrease between groups over eight weeks and follow up measurement (p<.01). Regarding the within the group differences, the right side of the neck pressure pain threshold showed a statistically significant decrease over eight weeks in the control group (p<.01). The right and left lateral flexion, and the right and left rotation were statistically significant for the experimental group over eight weeks and follow up measurement, but only the left lateral flexion (p<.05) for the control group over eight weeks. The neck disability index showed a slight decrease but this was not satistically significant for the between-grop or the within-group differences (p>.05). Conclusion: The intervention of suboccipital muscle inhibition and a neck muscle stabilization exercise are more beneficial for neck pain and the range of motion than the application of suboccipital muscle inhibition alone.

The effect of physical training on glutamate transporter expression in an experimental ischemic stroke rat model

  • Kim, Gye-Yeop;Kim, Eun-Jung
    • Physical Therapy Rehabilitation Science
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    • v.2 no.2
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    • pp.87-91
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    • 2013
  • Objective: The present study was aimed at determining the effect of physical training on glutamate transporter activity in a middle cerebral artery occlusion (MCAO)-induced ischemia injury rat model. Design: Randomized controlled trial. Methods: In this study, we randomly divided them into three groups. Group I included non-occlusion sham controls (n=10), Group II included non-physical training after MCAO (n=10), and Group III included rats that were subjected to physical training after MCAO (n=10). Rats in the physical training group underwent treadmill training, which began at 24 h after MCAO and continued for 14 consecutive days. The training intensity was gradually increased from 5 m/min on the first day to 12 m/min on day 3, and it was maintained until day 14. Focal cerebral ischemia was examined in adult male Sprague-Dawley rats by using the MCAO model. We determined the functional outcomes for each rat on days 1, 7, and 14. Glutamate transporter-1 (GLT-1) activity in the cortex of rats from all three groups was examined at the end of the experiment. Results: Out result show that MCAO rats exhibited severe neurological deficits on the 1 day, and there was no statistically significant in each groups. We observed that the functional outcomes were improved at days 7 and 14 after middle cerebral artery occlusion, and GLT-1 activity was increased in the physical training group (p<0.05). Conclusions: These results indicated that physical training after focal cerebral ischemia exerts neuroprotective effects against ischemic brain injury by improving motor performance and increasing the levels of GLT-1 activity.

Effects of Aromatherapy on Stress Responses, Autonomic Nervous System Activity and Blood Pressure in the Patients Undergoing Coronary Angiography: A Non-Randomized Controlled Trial (아로마요법이 관상동맥조영술 대상자의 스트레스, 자율신경계, 혈압에 미치는 효과: 비무작위 대조군설계)

  • Song, Eun Jeong;Lee, Mi Young
    • Journal of Korean Academy of Nursing
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    • v.48 no.1
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    • pp.1-11
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    • 2018
  • Purpose: The purpose of this study was to examine the effects of aromatherapy on stress responses, autonomic nervous system (ANS) activity, and blood pressure in patients hospitalized to receive coronary angiography (CAG). Methods: A non-equivalent control group with a pretest-posttest design was used. The subjects were patients admitted to the day angiography room to receive CAG at E University Hospital (34 in the experimental group and 30 in the control group). The experimental group treatment was inhalation of the aroma oil blended with lavender, ylang-ylang, and neroli at a ratio of 4:2:1 twice before and after CAG. The measurements of stress index, ANS activity, and blood pressure were performed 5 times as follows: at admission, at pre-CAG after treatment I, at post-CAG, 2 hours after treatment II, and 4 hours after treatment II. The data were analyzed using the Mann-Whitney U Test and repeated-measures analysis of variance. Results: Significant interactions in the high frequency of ANS (F=5.58, p=.005) were observed between group and time. Stress index (z=2.14, p=.016), systolic blood pressure (z=4.14, p<.005), and diastolic blood pressure (z=3.28, p=.001) were significantly different between the experimental and control groups after 4 hours of treatment II. Conclusion: The findings showed that aromatherapy was not effective before CAG, but was effective after CAG. Therefore, aromatherapy can be used as a nursing intervention for patients receiving CAG.