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.
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.
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.);
Parallel
Auricular point compression
BehavioralAcupuncture Points: Endocrine, Sympathetic, Shenmen, Heart Procedure Instructions: Disinfect the areas with 75% alcohol as per standard precautions. Treatments use only ear patches without Vaccaria seeds applied to these specific acupuncture points. Treatment sessions occur every Monday and Thursday. On Mondays, left ears are patched for three continuous days. Then on Thursdays, qualified medical personnel will remove the patches from the left ear and apply new patches to the right ear for four consecutive days. Any replacements must be performed at the hospital by qualified staff; patients should not attempt to do this themselves. This procedure is repeated weekly over a span of four weeks, resulting in eight total applications. Importantly, patients in this group do not perform acupoint stimulation as part of their treatment.
No pressure on the ear point
BehavioralAcupuncture Points: Endocrine, Sympathetic, Shenmen, Heart Procedure Instructions: Disinfect the areas with 75% alcohol as per standard precautions. Treatments use only ear patches without Vaccaria seeds applied to these specific acupuncture points. Treatment sessions occur every Monday and Thursday. On Mondays, left ears are patched for three continuous days. Then on Thursdays, qualified medical personnel will remove the patches from the left ear and apply new patches to the right ear for four consecutive days. Any replacements must be performed at the hospital by qualified staff; patients should not attempt to do this themselves. This procedure is repeated weekly over a span of four weeks, resulting in eight total applications. Importantly, patients in this group do not perform acupoint stimulation as part of their treatment.
Insomnia Severe Index
The ISI (Insomnia Severity Index) is a widely used self-assessment tool for evaluating the severity of insomnia. Its total score categorizes the severity of insomnia into four levels: no significant clinical insomnia (0-7 points), mild insomnia (8-14 points), moderate clinical insomnia (15-21 points), and severe clinical insomnia (22-28 points). The internal consistency of the ISI is Cronbach's α = 0.76, indicating good reliability. It is highly sensitive to changes after auricular acupuncture therapy, and a decrease in the ISI score of less than 8 points indicates improvement in insomnia symptoms.
Pittsburgh sleep quality index
The questionnaire examines in detail the seven key dimensions related to sleep over the past month: sleep duration, sleep disorders, latency to fall asleep, the effects of nighttime sleep on daytime function, sleep efficiency, the use of drugs needed to promote sleep, and overall sleep quality.
Sleep Diary
Multiple sleep parameters recorded in the sleep diary, including sleep latency, sleep efficiency, total sleep duration, and the number and duration of arousal during sleep. To comprehensively capture the participants' sleep patterns and quality changes, we asked them to fill in the sleep diary carefully daily during the 4-week intervention period and one week before each follow-up visit.
Kupperman Index
The KI score is currently widely used internationally to evaluate the severity of symptoms in the menopausal syndrome.
Menopause-specificquality of life
MENQOL Scale (total score of 174 points), different from the Kupperman score, patients should fill it out by themselves, and monitor the severity and progression of their symptoms in real time based on their own feelings.
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