Auricular Acupressure for Perimenopausal Insomnia
Key facts
- Where
- Hangzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 55 years old?
Source: NCT06856421, who can take part
Where in China
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhou, ChinaContact: Haipeng Xu, DoctorNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Trial code
- NCT06856421
- Record updated
- 30 April 2025
- Original description
This clinical trial aims to determine whether auricular Acupressure therapy can improve symptomatic insomnia in perimenopausal women.Read full original descriptionShow less
Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Clinical 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.
Inclusion: 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.
Exclusion: 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.); Presence of insomnia symptoms before the perimenopausal period; Infection in the areas near selected acupoints; ⑦ History of alcohol or substance abuse/addiction；; Co-existing mental or psychological disorders (e.g., depression, generalized anxiety disorder, bipolar disorder, obsessive-compulsive disorder, etc.) or suicidal tendencies, in addition to insomnia; ⑨ Receipt of auricular acupuncture therapy within the past 3 months; ⑩ Participation in other clinical trials in the past 3 months; Any known chronic pain disorders that could affect sleep.