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临床试验/NCT05234814
NCT05234814已完成不适用

Clinical Study of Auricular Point Seed Burying Combined With Fire Dragon Pot Moxibustion in Perimenopausal Women With Insomnia

Weihua Yu1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
The score of Pittsburgh Sleepiness Quantifier Inventory

研究概览

简要总结

Insomnia in perimenopausal women is normal. Studies have shown that insomnia occurs in 75-81% of perimenopausal women and is 2.4 times more common than in premenopausal participants. Western medicine often uses sedative sleeping drugs in the treatment of insomnia in perimenopausal women, which have better effects but have more side effects, and whether they are suitable for long-term application is still controversial. Non-pharmacological traditional therapies in Traditional Chinese Medicine have achieved significant clinical efficacy in the treatment of perimenopausal insomnia patients in recent years. This study aims to explore the efficacy of auricular point seed burying combined with fire dragon pot moxibustion in the treatment of the insomnia symptoms of perimenopausal women.

详细描述

Female menopausal participants often experience physical and psychological symptoms such as anxiety, depression and sleep disturbances due to the weakening of the ovaries and hormonal changes in the body, with insomnia being the most typical symptom. Studies have shown that insomnia occurs in 75-81% of perimenopausal women and is 2.4 times more common than in premenopausal participants. The main symptoms are difficulty falling asleep, early awakening and easy waking, which may be accompanied by anxiety, irritability and sweating. Long-term insomnia will lead to impairment of multi-system function and endanger the physical and mental health of perimenopausal women. The treatment of insomnia during menopause in Western medicine is mainly based on pharmacological treatment, but it is controversial whether it is suitable for long-term clinical application due to drug dependency and other side effects. Non-pharmacological traditional therapy in Traditional Chinese Medicine is more acceptable to participants because of its efficacy, non-chemical and non-toxic side effects. Furthermore, it has been used in the clinical application of insomnia in perimenopausal participants with good efficacy in recent years. In this study, we used auricular seeds burying combined with fire dragon pot moxibustion as an appropriate Chinese medicine technique to treat perimenopausal women with insomnia, hoping to improve the life quality of perimenopausal women with insomnia.

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 (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • All participants met the diagnosis of perimenopausal insomnia as described in the Chinese Guidelines for the Diagnosis and Treatment of Adult Insomnia (2017 Edition).
  • Pittsburgh Sleep Quality Index (PSQI) >
  • Insomnia at least 3 times per week and lasting for more than 1 month.
  • Onset around menopause with menstrual disorders.
  • No contraindications to auricular seed burial and fire dragon pot moxibustion treatment
  • Informed consent.

排除标准

  • Those with a duration of less than 1 week or those who have received other relevant treatment within the last month that affects the observation of efficacy
  • Secondary insomnia due to physical illness or psychological disorders.
  • Participants with severe co-morbidities and psychiatric disorders.
  • Those who refuse to cooperate with treatment.
  • Those who use other methods of treatment during the treatment period, which affects the judgment of efficacy.

结局指标

主要结局

The score of Pittsburgh Sleepiness Quantifier Inventory

时间窗: one month

The score of Pittsburgh Sleepiness Quantifier Inventory (PSQI) was compared between the two groups of patients before and after the intervention (For details, please refer to the literature: The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research). A PSQI score \<7 is considered good sleep quantity and ≥7 is poor sleep quality, and the higher the patient score, the worse the sleep quality.

次要结局

  • Adverse reactions(one month)

研究者

发起方
Weihua Yu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Weihua Yu

Director of nursing department

Anhui Medical University

研究点 (1)

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