电针对阴期失眠的认知行为治疗的影响:非劣质性随机对照试验的协议
Huixian Wang1, Xintong Yu2, Jing Hu1
1Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
JMIR research protocols
|November 9, 2023
概括
这项研究比较了在绝经前妇女的电针 (EA) 和对失眠的认知行为疗法 (CBT-I). 这些发现将指导治疗这种常见的睡眠障碍.
科学领域:
- 综合医学是一个整体的医学.
- 睡眠科学 睡眠科学
- 妇女健康 妇女健康
背景情况:
- 绝经前失眠 (PMI) 是中年女性普遍存在的疾病,通常比非绝经失眠更严重.
- 需要有效,安全和一致的PMI治疗方法.
- 针和对失眠的认知行为疗法 (CBT-I) 都显示出有希望的结果,但直接比较是有限的.
研究的目的:
- 为了比较电针 (EA) 与CBT-I对绝经前失眠 (PMI) 的初步有效性和安全性.
- 进行一项随机控制的非劣等性试验,以评估这两种干预措施.
主要方法:
- 一个评估者盲目的,非劣势的,随机对照试验,涉及160名PMI参与者.
- 参与者将被随机分配,接受8周的EA (与特定的针点) 或8周的每周CBT-I会话.
- 主要结局:失眠严重程度指数. 二次结果包括睡眠质量,生活质量,情绪和荷尔蒙水平.
主要成果:
- 目前正在招募参与者,注册将于2023年1月开始.
- 预计招聘将于2025年1月结束,随后进行数据收集.
- 目前还没有结果,因为这项研究处于招聘阶段.
结论:
- 这项试验是一个先进的努力,将EA和CBT-I与PMI进行比较.
- 预计这些发现将为管理PMI的临床医生提供有价值的见解.
- 局限性包括单一中心的行为和仅有中国参与者队列.
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