NCT07229976尚未招募不适用
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women: A Multicenter Randomized Controlled Trial
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 198
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
A multicenter, randomized, controlled, blinded clinical trial was conducted to evaluate the effects of thumbtack needle on sleep in patients with chronic insomnia during perimenopause and menopause. Randomly divided into a treatment group and a control group using the central area method, with 99 patients in each group. The treatment group received thumbtack needle treatment, while the control group received placebo thumbtack needle treatment. The treatment course for both groups was 4 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria for perimenopause and menopause:
- •Perimenopausal period: a period of time from one year before the last menstrual period to the first year after the last menstrual period. Having at least one menstrual period in the past 12 months, or being under 55 years old, undergoing hysterectomy or endometrial ablation, but not bilateral oophorectomy;
- •Menopause: No menstruation in the past 12 months, or bilateral oophorectomy, or age 55 years or older, who has undergone hysterectomy or endometrial ablation;
- •Diagnostic criteria for chronic insomnia:
- •●The diagnostic criteria for insomnia in the third edition of the International Classification of Sleep Disorders (ICSD-3) of the American Academy of Sleep Medicine (all criteria A to F must be met).
- •Inclusion Criteria:
- •Women aged 40 to 65 who meet the diagnostic criteria for perimenopause and menopause mentioned above;
- •Evaluate ISI score ≥ 12 points through a scale;
- •Meets the diagnostic criteria for chronic insomnia mentioned above, i.e. ICSD-3 meets both criteria A to F;
- •Voluntarily participate in this study and sign an informed consent form.
排除标准
- •Patients who meet any of the following conditions will not be included;
- •Use hormone replacement therapy, anti anxiety drugs, antidepressants, or medications to improve insomnia within one month;
- •Individuals with a history of diagnosed sleep disorders before menopause;
- •Combined with other sleep disorders such as obstructive sleep apnea, restless leg syndrome, etc;
- •Patients with malignant tumors, especially estrogen dependent tumors (such as breast cancer and endometrial cancer);
- •Recent (within 6 months) history of myocardial infarction, stroke, venous thrombosis, etc;
- •Patients with mental illnesses, such as severe depression and uncontrolled schizophrenia;
- •Serious disorder of endocrine system, such as uncontrolled hyperthyroidism, diabetes ketoacidosis, etc
- •Patients with coagulation disorders, such as hemophilia, long-term use of anticoagulants (warfarin, aspirin, etc.), etc;
- •Long term alcohol consumption history (more than 5 years, daily alcohol consumption exceeding 12 taels, not quitting drinking);
- •Engaged in night shift work (>3 times a week);
- •Individuals with infections, ulcers, burns, rashes, or scars at acupoints;
- •Previously received acupuncture treatment;
- •I do not agree to sign the informed consent form for this study.
研究组 & 干预措施
thumbtack needle group
Experimental
The subject received thumbtack needle
干预措施: thumbtack needle (Other)
Placebo thumbtack needle group
Other
The subject received placebo thumbtack needle
干预措施: placebo thumbtack needle (Other)
结局指标
主要结局
Insomnia Severity Index
时间窗: 4 weeks
The Insomnia Severity Index (ISI) is a self-assessment tool used to evaluate the severity of insomnia. The ISI scale consists of 7 items, each rated on a scale of 0-4, with a total score range of 0-28 points. Evaluate the difference in scores between the Insomnia Severity Index (ISI) scale at the end of week 4 and baseline ISI scores.
次要结局
- Pittsburgh sleep quality index(4 weeks, 2 months)
- Epworth Sleepiness Scale(4 weeks, 2 months)
- the number of awakenings per night(2 weeks, 4 weeks and 2 months)
- Corticotropin-Releasing Hormone(4 weeks)
- Norepinephrine(4 weeks)
- Fatigue Severity Scale(4 weeks, 2 months)
- Zung Self Rating Anxiety Scale(4 weeks, 2 months)
- Zung Self Rating Depression Scale(4 weeks, 2 months)
- Sleep efficiency(2 weeks，4 weeks and 2 months)
- wake-up time after sleep onset(2 weeks, 4 weeks and 2 months)
- The latent period of sleep onset(2 weeks, 4 weeks and 2 months)
- Total sleep time(2 weeks, 4 weeks and 2 months)
- the average wake-up time(2 weeks, 4weeks and 2 months)
- Adrenaline(4 weeks)
- 5-hydroxytryptamine(4 weeks)
- Gamma aminobutyric acid(4 weeks)
- Dopamine(4 weeks)
- Melatonin(4 weeks)
- β - endorphin(4 weeks)
- insomnia remission rate(4 weeks)
- Insomnia Treatment Response Rate(4 weeks)
- Fatigue Severity Scale(4 weeks)
- Pittsburgh sleep quality index(4 weeks)
- Epworth Sleepiness Scale(4 weeks)
- Zung Self Rating Anxiety Scale(4 weeks)
- Zung Self Rating Depression Scale(4 weeks)
- Sleep efficiency(2 weeks，4 weeks)
- wake-up time after sleep onset(2 weeks, 4 weeks)
- the number of awakenings per night(2 weeks, 4 weeks)
- The latent period of sleep onset(2 weeks, 4 weeks)
- Total sleep time(2 weeks, 4 weeks)
- the average wake-up time(2 weeks, 4weeks)
- Insomnia Severity Index(2 weeks)
- Menopause Rating Scale(4 weeks)
研究者
Dongmei Huang
Dr
Huazhong University of Science and Technology
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