Perimenopausal period and chronic insomnia during menopause
Conditions
Interventions
control group:Placebo thumbtack needle
Sponsors
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.1 Diagnostic criteria for perimenopause and menopause: 1) 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; 2) Menopause: No menstruation in the past 12 months, or bilateral oophorectomy, or age 55 years or older, who has undergone hysterectomy or endometrial ablation; 1.2 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 1) Women aged 40 to 65 who meet the diagnostic criteria for perimenopause and menopause mentioned above; 2) Evaluate Insomnia Severity Index score = 12 points through a scale; 3) Meets the diagnostic criteria for chronic insomnia mentioned above, i.e. ICSD-3 meets both criteria A to F; 4) Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions will not be included; 1) Use hormone replacement therapy, anti anxiety drugs, antidepressants, or medications to improve insomnia within one month; 2) Individuals with a history of diagnosed sleep disorders before menopause; 3) Combined with other sleep disorders such as obstructive sleep apnea, restless leg syndrome, etc; 4) Patients with malignant tumors, especially estrogen dependent tumors (such as breast cancer and endometrial cancer); 5) Recent (within 6 months) history of myocardial infarction, stroke, venous thrombosis, etc; 6) Patients with mental illnesses, such as severe depression and uncontrolled schizophrenia; 7) Serious disorder of endocrine system, such as uncontrolled hyperthyroidism, diabetes ketoacidosis, etc; 8) Patients with coagulation disorders, such as hemophilia, long-term use of anticoagulants (warfarin, aspirin, etc.), etc; 9) Long term alcohol consumption history (more than 5 years, daily alcohol consumption exceeding 12 taels, not quitting drinking); 10) Engaged in night shift work (>3 times a week); 11) Individuals with infections, ulcers, burns, rashes, or scars at acupoints; 12) Previously received acupuncture treatment; 13) I do not agree to sign the informed consent form for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index;Epworth Sleepiness Scale;Flinders Fatigue Scale;Zung Self-rating Anxiety Scale;Zung Self - Rating Depression Scale;sleep efficiency;Wake up time after sleep begins;Number of awakenings per night;Sleep onset latency period;Total sleep time;The average time it takes to wake up each time;corticotropin-releasing hormone;Norepinephrine;adrenaline;5-hydroxytryptamine;Gamma-Aminobutyric Acid;dopamine;melatonin;ß-Endorphin; | — |
Countries
China
Contacts
Public ContactDongmei Huang
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed