About this trial
This clinical trial aims to determine whether auricular Acupressure therapy can improve symptomatic insomnia in perimenopausal women.
Can ear acupressure therapy significantly improve sleep quality in perimenopausal women with insomnia? What medical issues or adverse reactions might participants experience during the treatment? Researchers will compare ear acupressure therapy with traditional treatments in a control group to assess its effectiveness and safety.
Participants will:
Receive auricular acupressure on Monday and Thursday, applying pressure for 3 consecutive days each week. This process will continue for 4 weeks, totaling 8 sessions.
Record assessment points as follows: Baseline (2 weeks before treatment to Week 0), mid-treatment (2 weeks after treatment begins), end of treatment (4 weeks after treatment begins), and follow-up (4 weeks after treatment ends) for primary and secondary outcome indicators. Eight weeks after treatment concludes, only the primary outcome indicator (Insomnia Severity Index) will be recorded.
This trial seeks to evaluate the potential benefits and safety profile of auricular acupressure therapy for managing insomnia in perimenopausal women.
Eligibility criteria
Qualifiers
Age between 45 and 55 years;
Meetingperimenopause defined by the Staging of Reproductive Aging Workshop (STRAW);
Patients must satisfy at least one diagnostic criterion for insomnia in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); ④ Nighttime sleep disturbances and associated perimenopausal symptoms persisting for at least 4 weeks; ⑤ No use, or stable long-term use (>2 months) of medications for treating insomnia;
No prior auricular acupuncture therapy, good compliance, understanding of the study protocol, and signed informed consent.
Disqualifiers
Does not meet inclusion criteria;
Non-natural menopausal transition due to premature ovarian failure, drug intake, or surgeries (e.g., oophorectomy);
Currently pregnant or breastfeeding;
Insomnia caused by systemic diseases (e.g., stroke, Parkinson's disease, surgery, etc.);
Trial design
Treatments tested in this trial
- Auricular point compression
- No pressure on the ear point