• 제목/요약/키워드: Intervention trial

검색결과 551건 처리시간 0.024초

Efficacy and Safety of Banhahubak-Tang for Depression Treatment: Study Protocol for a Randomized, Waitlist-Controlled Trial

  • Seung-Ho, Lee;Yunna, Kim;Dohyung, Kwon;Seung-Hun, Cho
    • 동의신경정신과학회지
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    • 제33권4호
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    • pp.389-400
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    • 2022
  • Objectives: Depression is a highly prevalent disease, and the market for antidepressant drugs continues to grow at a steady rate. Although current antidepressants are reported to be effective, because of their low remission rate and side effects, new antidepressants are needed. The use of Banhahubak-tang (BHT) to treat the symptoms of depression is supported by experimental evidence. The proposed study will evaluate the efficacy and safety of BHT in treating depression. Methods: A randomized, waitlist-controlled, parallel clinical trial will be conducted to assess the efficacy of BHT in depression. A total of 84 participants with depression will be randomized into the intervention group or waitlist-control group at a 1:1 ratio. Patients in the intervention group will be administered BHT three times a day for four weeks and followed up for four more weeks after therapy completion. Patients in the waitlist-control group will undergo the same intervention and follow-up after a four-week waiting period. The primary outcome is change in the Korean version of the Hamilton Depression Rating Scale (K-HDRS) scores for major depressive disorders after four weeks. The secondary outcomes include scores on the K-HDRS, Korean Symptom Check List 95 (KSCL-95), Insomnia Severity Index (ISI), State-Trait Anxiety Inventory-Korean version (STAI-K), State-Trait Anger Expression Inventory-Korean version (STAXI-K), and the Instrument on Pattern Identifications for Depression and EuroQol-5 Dimension (EQ-5D). Conclusions: This trial will provide high-quality clinical evidence of the efficacy and safety of BHT in the management of depression.

암환자의 신약개발 임상시험 참여 경험 (Experience of Patients with Cancer Participating in a Clinical Trial for the Development of a New Drug)

  • 김현영
    • 종양간호연구
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    • 제6권2호
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    • pp.121-132
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    • 2006
  • Purpose: The purpose of this study was to describe the lived experience of the patients with cancer participating in a clinical trial for the development of a new drug. Method: This study was based on a phenomenological approach. The eight patients participating in a clinical trial were selected as the participations of this study. The data were obtained through in-depth interviews from the participants and were analyzed using the Giorgi method. Results: Essential experiences of the patients with cancer under a clinical trial consisted of anticipating recovery of physical health and a social role, passing the strict criteria of a clinical trial, diminishing economic burden, satisfaction with special treatment receiving, social contribution, concerns about side effects and withdrawal from the clinical trial, conflicts as a participant, pain, limited administration of other treatments, regret for giving up other treatments, strict compliance with instructions, prevention of side effects and maintaining desirable life-style. Integrated units of meaning of these components were hope, good luck, a sense of satisfaction, fear, distress, and the will of self-control. Conclusion: The most essential meaning of the cancer patients participating in a clinical trial was hope. Hope was found to be a primary factor reinforcing the will of self-management. The results of this study can be of great help to the research nurses to understand the lived experience of the patients with cancer and to plan an effective nursing intervention for the patients.

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Effects of Energy Conservation Strategies on Cancer Related Fatigue and Health Promotion Lifestyle in Breast Cancer Survivors: a Randomized Control Trial

  • Sadeghi, Elham;Gozali, Nahid;Tabrizi, Fatemeh Moghaddam
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권10호
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    • pp.4783-4790
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    • 2016
  • Purpose: Cancer-related fatigue is frequently experienced by patients during and after therapy. The present study was conducted to assess the impact of energy conservation strategies and health promotion in breast cancer survivors. Methods: A randomized controlled trial was carried out to compare the intervention effect (n=69.0) with controls (n=66.0) based on routine oncology ward care. The intervention was five weekly sessions for groups of 6-8 breast cancer survivors. Data on fatigue and health promotion lifestyle were obtained before and after completion the intervention and then 8 weeks later for analysis of variance (ANOVA) with repeated measures. Results: Our findings showed cancer-related fatigue to be reduced in the intervention group from pre- to post-intervention, and this persisted over the 8-weeks follow-up period (F = 69.8, p<0.001). All subscales of the cancer fatigue scale demonstrated statistically significant effects with partial eta-squared values ranging from 0.15 (the smallest effect in cognitive fatigue) to 0.21 (the largest for affective fatigue). Changes in the health promotion life style indicated a significant promotion from pre- to post-intervention, and this again continued after 8-weeks follow-up (F = 41.6, p < 0.001). All six domains of a health promoting life style featured significantly elevated values, the largest effect being seen in the interpersonal relations subscale (F=57.7, partial ${\eta}^2=0.21$, p<0.001) followed by physical activity (F=51.9, partial ${\eta}^2=0.18$, p<0.001). Conclusions: The program was effective in decreasing cancer related fatigue and promoting a healthy lifestyle.

암위험사정이 직장인의 혈변검사에 미친 영향에 관한 실험연구 (A Randomized Controlled Trial To Motivate Worksite Fecal Occult Blood Testing)

  • 이정렬
    • 대한간호학회지
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    • 제20권3호
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    • pp.300-306
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    • 1990
  • Colorectal cancer is second only to lung cancer as a cause of death due to cancer in the united States. Studies have shown that fecal occult blood(FOB) tests are effective in detecting colorectal cancer in its early stages. To motivate worksite FOB testing, a randomized controlled trial was conducted. Employees 40 years or older from three federal agencies in Washington State were randomized to a control group(n=139) which received a letter stating the availability of the FOB test at the worksite clinic or to an intervention group(n=139) which received the letter about facts on colorectal cancer and a Colorectal Cancer Risk Appraisal. The Colorectal Cancer Risk Appraisal included a feedback on an individual's risk of developing colorectal cancer compared to his / her peers in terms of ‘normal’, ‘moderate’, or ‘high’ risk status. After 3 months, a follow-up questionnaire was sent to all participants to measure the effectiveness of the intervention. In the analysis of the three major outcomes, two possible confounding factors(dietary fat and family history of colorectal cancer) were controlled by logistic regression. Based on a review of the worksite clinic records, the Intervention group had 4.3% higher compliance rate with the FOB test during the follow-up period compared to the control group(p=.10). The largest effect of the intervention was on the employees' intention to get a FOB test within the next year(62.6% in the intervention group vs. 36.2% in the control group, OR=3.18, p<.001). In the final Multivariate logistic model, the employees who were more likely to intend to get a FOB test within the next year were in the intervention group ; were at ‘moderate’ or ‘high’ risk of colorectal cancer ; knew more about the availability of the FOB test at the worksite clinic ; and had a FOB test during the last three years.

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아로마테라피가 수면에 미치는 효과: 체계적 문헌고찰 및 메타분석 (Effects of Aromatherapy on Sleep Quality: A Systematic Review and Meta-Analysis)

  • 김미은;전지희;허명행
    • 대한간호학회지
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    • 제49권6호
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    • pp.655-676
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    • 2019
  • Purpose: The purpose of this study was to investigate the effects of aromatherapy on sleep quality. Methods: This is a systematic review of randomized controlled trial studies (PROSPERO registration number CRD42017064519). In this study, the PICO were adults and the elderly, aromatherapy intervention, a comparative intervention with the control and placebo oil groups, and sleep. The selected articles were in English, Korean, and Chinese. Results: The results of the meta-analysis showed that the effect sizes of the experimental group were 1.03 (n=763, SMD=1.03, 95% CI 0.66 to 1.39) (Z=5.47, p<.001). In the aromatherapy intervention group, the effect size of sleep was statistically significant (QB=9.39, df=2, p=.009), with a difference of 0.77 for inhalation, 1.12 for oral intake and 2.05 for massage. A post-analysis showed that the effect of massage on sleep was significantly greater than the inhalation method. The regression coefficient of the intervention period, B=0.01 (Z=1.43, p=.154), also showed that the longer the intervention period, the larger the effect size; however, it was not statistically significant. Conclusion: A total of 23 literature analyses showed that aromatherapy is effective in improving quality of sleep, and the massage method is more effective in improving quality of sleep than the inhalation method. A meta-ANOVA showed that the aromatherapy intervention affected the high heterogeneity of the effect size. Thus, future research with stricter control in methods and experimental procedures is necessary.

MARS-PD: Meridian Activation Remedy System for Parkinson's Disease

  • Miso S. Park;Chan-young Kim;In-woo Choi;In-cheol Chae;Wangjung Hur;SangSoo Park;Horyong Yoo
    • 대한한방내과학회지
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    • 제44권1호
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    • pp.1-11
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    • 2023
  • Objective: There are currently no disease-modifying medications or definite long-term sustainable interventions for patients with Parkinson's disease (PD), indicating an unmet treatment need. Our goal was to create a long-term sustainable intervention for PD patients that can be used in Korean medicine clinics. Methods: The Meridian Activation Remedy System (MARS) was created to stimulate a patient's 12 meridians and sinew channels using a combination of acupoint stimulation and exercise. The acupoints and motions used in MARS were selected through literature studies and expert advice. The methodologies were refined using observational and case studies. With slow and fast movements, the MARS intervention was intended to activate both slow- and fast-twitch muscle fibers. Intradermal acupuncture and motion that shift the center of gravity were employed to enhance the patient's balance and proprioception. In addition, the intervention included alternating movement exercises to address the complex cognitive decline commonly occurring in PD patients. Results: The following acupoints were chosen for the MARS intervention: bilateral Hegu (LI4), Houxi (SI3), Waiguan (TE5), Neiguan (PC6), Zhongchong (PC9), Yuji (LU10), Zusanli (ST36), Yanglingquan (GB34), Taichong (LR3), Kunlun (BL60), and Taixi (KI3). We also developed actions that can stimulate the body's 12 meridians. Conclusion: We developed the MARS intervention, which combines acupuncture and exercise, to address the unmet therapeutic needs of PD patients. We hope that with additional research, the MARS intervention can be set as an effective therapeutic program for PD patients.

고혈압 침 임상연구에서 환자의 기대치와 치료효과 간의 상관관계 (The Relationship between Patients' Expectations of Treatment Effect and Clinical Outcome in a Trial of Acupuncture for Hypertension)

  • 김준범;류연;김정은;박지은
    • Journal of Acupuncture Research
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    • 제33권4호
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    • pp.33-38
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    • 2016
  • Objectives : To identify potential correlation between patients' expectations and clinical outcome in a randomized control study of acupuncture. Methods : In a clinical trial of acupuncture for hypertension, 60 participants with pre and mild hypertension were randomized into an acupuncture group and a control group. After randomization, all participants were asked to rate their expectation for the intervention on a scale of 0 to 10. To analyze the effect of expectation on clinical outcome, change of blood pressure was compared between high and low expectation groups. Results : There was no significant difference of baseline blood pressure between low expectation group and high expectation group. Proportion of acupuncture group and control group was also not different between low and high expectation groups (p = 0.638). The change of systolic blood pressure was -1.55 mmHg in low expectation group and -3.07 mmHg in high expectation group, and it was not significantly different (p = 0.54). There was no significant difference in the change of diastolic blood pressure between two groups (p = 0.58), with -3.24 mmHg in low expectation group and -2.34 mmHg in high expectation group. Conclusion : In this study, the expectation of intervention (including acupuncture treatment) was not associated with the effect of intervention.

Effects of a Cognitive Rehearsal Program on Interpersonal Relationships, Workplace Bullying, Symptom Experience, and Turnover Intention among Nurses: A Randomized Controlled Trial

  • Kang, Jiyeon;Kim, Jeung-Im;Yun, Seonyoung
    • 대한간호학회지
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    • 제47권5호
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    • pp.689-699
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    • 2017
  • Purpose: This research aimed to investigate the effects of a cognitive rehearsal program (CRP) on workplace bullying among nurses. Methods: A randomized controlled trial was performed. Participants were 40 nurses working in different university hospitals in B city, South Korea. The experimental group was provided with a 20-hour CRP comprising scenarios on bullying situations, standard communication, and role-playing. To evaluate effects of the CRP, we measured interpersonal relationships, workplace bullying, symptom experience, and turnover intention at preand post-intervention. Follow-up effect was measured in the experimental group only at 4 weeks after the intervention. Results: After the intervention, there were significant differences in interpersonal relationships (F=6.21, p=.022) and turnover intention (F=5.55, p=.024) between experimental and wait-list groups. However, there was no significant difference in workplace bullying or symptom experience between the 2 groups. The beneficial effects on interpersonal relationships and turnover intention lasted at least up to 4 weeks after CRP. Conclusion: The CRP for workplace bullying improves interpersonal relationships and decreases turnover intention. So it can be utilized as one of the personal coping strategies to reduce the the turnover among nurses. Further studies on the effects of unit- or hospital-based CRP and on the long-term effects of CRP are necessary.

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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    • 제11권2호
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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.

Effects of Inspiratory Training on Respiratory Function and Balance in Stroke Patients: A Randomized Controlled Trial

  • Ku Man;Park Dae-Sung
    • Physical Therapy Rehabilitation Science
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    • 제13권1호
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    • pp.26-35
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    • 2024
  • Objective: The aim of this study is to explore how using inspiratory training affects the respiratory function and balance of stroke patients. We also plan to compare the results with a control group that does not receive the intervention. Design: A Randomized Controlled Trial Methods: In this study, 27 chronic stroke patients were randomly assigned to either a control group (n=14) or an experimental group (n=13). Both groups underwent six weeks of common interventions involving standard physiotherapy and treadmill training. Additionally, the experimental group received inspiratory training. Respiratory function and balance were evaluated using Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP), Peak Expiratory Flow (PEF), Five times Sit-to-Stand (FTSTS), Seated Center of Pressure (S-COP), and Timed Up and Go (TUG) tests. Results: Respiratory function and balance were compared within each group before and after intervention. The experimental group, which received inspiratory training, showed significant improvements in FVC (0.26±0.18), FEV1 (0.35±0.32), MIP (11.54±12.39), PEF (1.12±1.52), and TUG (-3.39±2.45) compared to pre-intervention values (p<0.05). When comparing changes between groups post-intervention, the experimental group demonstrated significant increases in FVC, FEV1, MIP, PEF, and TUG compared to the control group (p<0.05). However, there were no significant differences in MEP, FTSTS, and S-COP. Conclusions: The results of this study indicate a positive effect of inspiratory training on chronic stroke patients. These findings suggest that with further research involving a larger sample size and enhanced intervention methods, inspiratory training could be employed positively in the rehabilitation of stroke patients.