Auricular Acupressure for Perimenopausal Insomnia

This is a multicenter, randomized, controlled clinical trial. Perimenopausal insomnia patients will be randomly assigned to the ear acupoint pressing group or the sham ear acupoint pressing group in a 1:1 ratio.

2.2 Randomization and Blinding Sequence Generation

• Allocation ratio: 1:1 randomization between groups
• Randomized groups: Genuine auricular acupressure group vs. Sham auricular acupressure group
• Randomization tool: SAS software version 9.3 (SAS Institute Inc.)
• Sequence generation: Performed by an independent statistician with no involvement in trial execution or statistical analysis Allocation Concealment Mechanism
• Sequence storage: Secured in a dedicated randomization sequence management system inaccessible to study personnel
• Implementation: Centralized web-based randomization system assigns participants with equal probability after baseline assessments
• Coordination: Clinical research coordinators initiate randomization requests Blinding Procedures
• Blinded parties: Participants, outcome assessors, and statisticians remain blinded to group assignments
• Treatment isolation: Concurrent treatments for ≥2 participants conducted in separate rooms to prevent cross-communication
• Data confidentiality: Intervention details withheld until final statistical analysis completion
• Blind maintenance: Comprehensive measures implemented to preserve blinding integrity
• Emergency unblinding:

Permitted only for acute medical emergencies requiring urgent clinical management Unblinded participants discontinued from efficacy analysis but retained in safety datasets Alternative therapeutic options provided to affected participants • Ethical disclosure: Participants informed about two distinct intervention arms while maintaining blinding integrity

Training:

Acupuncture doctors supervising medical staff at various centers will provide training on techniques, ensuring uniform implementation across all sites.

2.3 Blinding Assessment for Assessors and Participants Data Collection

• Administer post-treatment questionnaires to participants and assessors to document perceived group assignments Blinding Indices Calculation
• James Blinding Index (JBI):

Range: 0 (complete unblinding) to 1 (perfect blinding) Blinding failure threshold: Two-sided confidence interval upper limit <0.5

• Bang Blinding Index (BBI): Range: -1 (ideal blinding) to 1 (complete unblinding) Blinding failure threshold: One-sided confidence interval excludes 0 Statistical Implementation

• Analysis performed using R statistical software (version ≥4.2.0) for index calculations and confidence interval estimation Interpretation & Reporting
• Investigate root causes if indices suggest compromised blinding
• Full documentation of methodology, results, and conclusions in clinical study reports Emergency Unblinding Protocol
• Strict adherence to predefined Standard Operating Procedures (SOPs) for urgent unmasking scenarios Blinding Quality Assurance
• Regular monitoring/auditing of blinding integrity
• Preventive measures against accidental unmasking

Evaluation Indicators:

Primary Outcome: Insomnia Severity Index (ISI) Secondary Outcomes: Pittsburgh Sleep Quality Index (PSQI), Sleep Diary, Kupperman Index (KI), Menopause-Specific Quality of Life (MENQOL), Heart Rate Variability (HRV)

Emergency Medication:

Eszopiclone (Pharmaceutical Co., Ltd, China) will be used as emergency medication under the guidance of a psychiatric expert. The usage frequency, dosage, number of patients, and administration details during the trial will be recorded for subsequent analysis.

Follow-Up: Follow-up assessments will take place at 4 weeks post-treatment for secondary outcomes and at 8 weeks post-treatment for ISI (primary outcome).

Inclusion criteria

• 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 criteria

• 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.