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临床试验/NCT06463197
NCT06463197尚未招募不适用

Self-acupressure for Insomnia in Perimenopausal Women: A Pilot Randomized Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Insomnia Severity Index

研究概览

简要总结

Insomnia is a common complaint in peri-menopausal women. Acupressure might be a potential way to treat insomnia. Although acupressure can be self-administered, it is uncertain that whether the effects of self-administered acupressure are comparable to that of the practitioner-administered acupressure, due to the variability in patients' capability of mastering the acupressure technique and self-compliance. Previous studies seemingly suggested that self-administered acupressure may improve sleep quality, their conclusion on the efficacy of self-administered acupressure for insomnia was limited due to the lack of standardized subjective and objective sleep assessments and unclear diagnostic method of insomnia. To fill out this research gap, the proposed study will explore the effectiveness of self-acupressure for improving sleep in perimenopasual women using an RCT approach.

详细描述

Insomnia is a common complaint in peri-menopausal women, with approximately one-third to half of the women aged 40-55 years suffering from insomnia. A recent clinical study indicated that the microbial composition in insomnia patients was different from healthy controls, and the immune factors and metabolic pathways could mediate the relationship between gut microbes and insomnia. However, such linkage needs more studies to verify.

Acupressure is a treatment modality in traditional Chinese medicine (TCM), in which the practitioner stimulates patient's acupoints using fingers, hands, or elbows according to TCM meridian theory.

Instead of practitioner-administered, the patients can be trained and perform acupressure on themselves. Such self-administered acupressure is less time-intensive and flexible to perform. Once the patient has learned the technique, self-administered acupressure does not cost anything, hence constitutes the lowest financial burden.

Although acupressure can be self-administered, it is uncertain that whether the effects of self-administered acupressure are comparable to that of the practitioner-administered acupressure, due to the variability in patients' capability of mastering the acupressure technique and self-compliance. Previous studies seemingly suggested that self-administered acupressure may improve sleep quality, their conclusion on the efficacy of self-administered acupressure for insomnia was limited due to the lack of standardized subjective and objective sleep assessments and unclear diagnostic method of insomnia. To fill out this research gap, the proposed study will explore the effectiveness of self-acupressure for improving sleep in perimenopasual women using an RCT approach.

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)

盲法说明

Researchers who will collect data from participants will be blinded

入排标准

年龄范围
35 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Insomnia Severity Index

时间窗: Week 4

The Insomnia Severity Index has 7 items that measured the severity of insomnia complaints and related daytime impairments. The total score ranges between 0 and 28, with the higher scores indicating more severe insomnia.

次要结局

  • Microbiota(Week 4)
  • A 7-day sleep diary(Measued one-week before the assessment time point.)
  • Hospital Anxiety and Depression Scale(Week 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YEUNG Wing Fai

Associate professor

The Hong Kong Polytechnic University

研究点 (1)

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