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).

• Pittsburgh sleep quality index [Срок оценки: Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks after end of treatment]
• Sleep Diary [Срок оценки: Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks after end of treatment）]
• Kupperman Index [Срок оценки: Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks after end of treatment）]
• Menopause-specificquality of life [Срок оценки: Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks and 8 weeks after end of treatment）、]
• Heart Rate Variability [Срок оценки: Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks and 8 weeks after end of treatment）、]