scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

Efficacy and Safety of Traditional Chinese Medicine in COVID-2019: A Study Protocol for an Open-Label, Multicenter Randomized Controlled Trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Zhengzhong Yuan ◽  
Xiaoqiong Pan ◽  
Jizhou Zhang ◽  
Jiahui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Lung Injury Score ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Introduction: The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. It directly leads to high morbidity and mortality, but also results in a devastating effect on the global economy. Unfortunately, there are no effective therapies or vaccines for it. Hence, we designed a randomized trial to evaluate the efficacy and safety of Traditional Chinese Medicine for treating patients with COVID-19.Methods and analysis: This is an open-label, multicenter randomized controlled clinical trial. One hundred and twelve patients infected by SARS-CoV-2 will be randomly assigned to the experimental or the control group in an equal ratio. The patients in control group will accept routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in the experimental group will be asked to take traditional Chinese medicine depending on the different stages of the disease for consecutive 14 days in addition to supportive care. All data will be gathered at baseline and on days 3, 7, 10 and 14. The primary outcome measures will be the time of Reverse Transcription PCR testing of respiratory tract sample turns to be negative. Secondary outcome measures will include Murray lung injury score, MuLBSTA score and TCM ( Traditional Chinese Medicine ) Syndrome Scoring System. A laboratory test will be taken before and after treatment to assess the safety of TCM.Discussion: The study may help to identify the the efficacy and safety of Traditional Chinese Medicine in treating COVID-2019.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030759.Registered on March 13th 2020-Retrospectively registered, http://www.chictr.org.cn/.

scholarly journals Exercise for People in Early- or Mid-Stage Parkinson Disease: A 16-Month Randomized Controlled Trial

2012 ◽  
Vol 92 (11) ◽  
pp. 1395-1410 ◽  
Author(s):  
Margaret Schenkman ◽  
Deborah A. Hall ◽  
Anna E. Barón ◽  
Robert S. Schwartz ◽  
Pamela Mettler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Parkinson Disease ◽  
Outcome Measures ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Home Based ◽  
Walking Economy

BackgroundExercise confers short-term benefits for individuals with Parkinson disease (PD).ObjectiveThe purpose of the study was to compare short- and long-term responses among 2 supervised exercise programs and a home-based control exercise program.DesignThe 16-month randomized controlled exercise intervention investigated 3 exercise approaches: flexibility/balance/function exercise (FBF), supervised aerobic exercise (AE), and home-based exercise (control).SettingThis study was conducted in outpatient clinics.PatientsThe participants were 121 individuals with PD (Hoehn & Yahr stages 1–3).InterventionsThe FBF program (individualized spinal and extremity flexibility exercises followed by group balance/functional training) was supervised by a physical therapist. The AE program (using a treadmill, bike, or elliptical trainer) was supervised by an exercise trainer. Supervision was provided 3 days per week for 4 months, and then monthly (16 months total). The control group participants exercised at home using the National Parkinson Foundation Fitness Counts program, with 1 supervised, clinic-based group session per month.MeasurementsOutcomes, obtained by blinded assessors, were determined at 4, 10, and 16 months. The primary outcome measures were overall physical function (Continuous Scale—Physical Functional Performance [CS-PFP]), balance (Functional Reach Test [FRT]), and walking economy (oxygen uptake [mL/kg/min]). Secondary outcome measures were symptom severity (Unified Parkinson's Disease Rating Scale [UPDRS] activities of daily living [ADL] and motor subscales) and quality of life (39-item Parkinson's Disease Quality of Life Scale [PDQ-39]).ResultsOf the 121 participants, 86.8%, 82.6%, and 79.3% completed 4, 10, and 16 months, respectively, of the intervention. At 4 months, improvement in CS-PFP scores was greater in the FBF group than in the control group (mean difference=4.3, 95% confidence interval [CI]=1.2 to 7.3) and the AE group (mean difference=3.1, 95% CI=0.0 to 6.2). Balance was not different among groups at any time point. Walking economy improved in the AE group compared with the FBF group at 4 months (mean difference=−1.2, 95% CI=−1.9 to −0.5), 10 months (mean difference=−1.2, 95% CI=−1.9 to −0.5), and 16 months (mean difference=−1.7, 95% CI=−2.5 to −1.0). The only secondary outcome that showed significant differences was UPDRS ADL subscale scores: the FBF group performed better than the control group at 4 months (mean difference=−1.47, 95% CI=−2.79 to −0.15) and 16 months (mean difference=−1.95, 95% CI=−3.84 to −0.08).LimitationsAbsence of a non-exercise control group was a limitation of the study.ConclusionsFindings demonstrated overall functional benefits at 4 months in the FBF group and improved walking economy (up to 16 months) in the AE group.

scholarly journals Effect of Yoga on the Quality of Life of Nurses Working in Intensive Care Units. Randomized Controlled Clinical Trial

2019 ◽  
Vol 37 (3) ◽  
Author(s):  
Khatereh Rostami ◽  
Fariba Ghodsbin
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Intensive Care ◽  
Intensive Care Units ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Experimental Group

Objective. The work, herein, sought to determine the effect of yoga on the quality of life of nurses working in intensive care units (ICU). Methods. This was a randomized controlled clinical trial of a preventive intervention of three weekly sessions of yoga exercises, which included aspects of meditation, breathing control, and slow body movements. The study selected 70 nurses working in ICU and assigned them to two groups: experimental (n = 35) and control (n = 35). The World Health Organization Quality of Life brief questionnaire (WHOQoL-Bref) was used to evaluate on four moments (baseline, one, two, six months after the start of the study); this scale has 26 items with Likert-type response options ranging from 1 to 5; higher total score indicates better quality of life. Results. The baseline score of quality of life in the experimental group was 62.3, which increased to 70.7 on the first month and continued improving in the evaluations on the second month (72.8) and sixth month (74.1), with this change being statistically significant. Instead, the control group showed no differences in scores of the different moments of evaluation (baseline = 62, first month = 61.9, second month = 62.4, and sixth month = 60.4). In the four domains of the WHOQoL-Bref (physical, psychological, social relationships, and environment), it was also noted that the experimental group obtained better scores over time compared with the control group. Conclusion. The intervention of yoga exercises was effective in improving the quality of life of nurses working in ICU.Descriptors: yoga; exercise; meditation; nurses; quality of life; intensive care units; randomized controlled trial; surveys and questionnaires; encuestas y cuestionarios.How to cite this article: Rostami K, Ghodsbin F. Effect of Yoga on the Quality of Life of Nurses Working in Intensive Care Units. Randomized Controlled Clinical Trial. Invest. Educ. Enferm. 2019; 37(3):e06.

Impact of the I 2 AO 2 interdisciplinary program led by nursing on psychological comorbidity and quality of life: Randomized controlled clinical trial

2018 ◽  
Vol 32 (2) ◽  
pp. 268-277
Author(s):  
Virginia Esperanza Fernández-Ruiz ◽  
José Antonio Paniagua-Urbano ◽  
María Solé-Agustí ◽  
Alfonso Ruiz-Sánchez ◽  
José Gómez-Marín ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Interdisciplinary Program ◽  
Randomized Controlled ◽  
Psychological Comorbidity

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

scholarly journals The Effectiveness of Acceptance and Commitment Therapy on Quality of Life in a Patient with Myocardial Infarction: A Randomized Control Trial

2020 ◽  
Author(s):  
Leila Ahmadi Ghahnaviyeh ◽  
Reza Bagherian ◽  
Awat Feizi ◽  
Atefe Afshari ◽  
Firoozeh Mostafavi Darani
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Myocardial Infarction ◽  
Heart Failure ◽  
Clinical Trial ◽  
Acceptance And Commitment Therapy ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Acceptance And Commitment

Objective: Acceptance and commitment therapy (ACT) interventions increase psychological flexibility and improve mental health and quality of life in patients with myocardial infarction. Study design: A controlled clinical trial study was conducted to evaluate the efficacy of an ACT intervention in improving the quality of life in patients with MI in Isfahan, Iran. Method: The present controlled clinical trial with a pre and post-test design was conducted on a statistical population consisting of patients with MI admitted to hospitals in Isfahan (n = 60) who were selected through sequential sampling based on the study inclusion criteria and were randomly divided into an intervention and a control group (n1 = n2 = 30). The case group received 8 weekly 90-minute sessions of ACT and the control group received no interventions. The pretest-posttest design was administered in both groups using a demographic questionnaire and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) designed to assess the health status of patients with heart failure in terms of quality of life. The data obtained were analyzed in SPSS-20 using descriptive statistics and the ANCOVA. Results: In this study, 2 general areas of quality of life, including physical and mental health, were examined in the patients. There was a significant increase in the quality of life and subscales of mental and physical health in the experimental group (p < 0.001). Conclusion: Considering the effectiveness of ACT in improving quality of life in these patients, this method of intervention can be used as a complementary therapy in health care centers to reduce the side-effects experienced by these patients.

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