About this trial
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.
Eligibility criteria
Qualifiers
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;
Women aged 40 to 65 who meet the diagnostic criteria for perimenopause and menopause mentioned above;
Evaluate ISI score ≥ 12 points through a scale;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- thumbtack needle
- placebo thumbtack needle