The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder: Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
Poststroke depression is seen with a frequency of up to 30%. Drug options for depression and accompanying sleep problems are limited; In addition, effective doses cannot be increased depending on the comorbidities of the patients and the side effect profiles and drug interactions of the drugs used. Acupuncture has been used in Chinese traditional medicine for more than 2000 years and there are findings that it has positive effects in post-stroke depression and anxiety disorders.
The aim of this study is to examine the effectiveness and reliability of acupuncture treatment in depression and anxiety disorders developing after stroke and to reduce the need for multiple drugs and / or high-dose medication in the treatment of these complications.
The hypothesis of the study: Acupuncture is an effective and reliable treatment method for depression and anxiety disorders in stroke patients.
详细描述
Patients who receive inpatient stroke rehabilitation at Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, will be included in the study by the inclusion and exclusion criteria. Their informed consent will be received. Initially, clinical and demographic data of all patients will be noted. Participants who volunteered for the study will be separated into the acupuncture treatment group and the control group by simple random sampling. Both the acupuncture treatment group and the control group will be included in the conventional rehabilitation program 2 hours a day, 7 days a week, for 8 weeks. In addition the acupuncture treatment group will get acupuncture treatment which will be applied to Baihui (DU20), Yintang (EX-HN3) points and bilateral Tai Chong (LR3), Hegu (LI4) points for 4 weeks, twice a week. During the application, the feeling of De Qi will be taken and the application will take 20 minutes. Measurements; Hamilton Depression Rating Scales, Hamilton Anxiety Rating Scales, Pittsburg Sleep Quality Index, Barthel Index, and change in psychiatric drug use will be assessed at baseline (week 0), 4th and 8th week post-treatment. The adverse events observed during the study will be noted and the compliance of patients in each application will be questioned by visual analog scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 2 months maximum 6 months after stroke
- •Volunteering for study
- •Mini-Mental State Examination >17
- •Patients with Hamilton Depression Rating Scale> 7 and/or Hamilton Anxiety Rating Scale> 4 assessed by the psychiatrist
排除标准
- •Insomnia and depression before a stroke
- •Aphasic patients
- •Sleep Apnea Syndrome
- •Psychiatric Disorders (Learning disabilities, Mental disorder, Autism)
- •Decompensated cardiac, kidney, hepatic failure
- •Infection on Acupuncture Points
- •Pregnancy
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: 1 month
Assessed on 17 definitions, regarding the status of patient with a scale between 0 to 4.
Hamilton Anxiety Rating Scale
时间窗: 1 month
Assessed on 14 definitions, regarding the status of patient with a scale between 0 to 4.
次要结局
- Pittsburgh Sleep Quality Index(1 month)
- Barthel Index(1 month)
- Up-to-date Psychiatric Drug Use(1 month)