Auricular Acupressure for Depressive and Anxiety Symptoms in Women with Premenstrual Dysphoric Disorder: Protocol for...

Premenstrual dysphoric disorder (PMDD) induces disabling anxiety and depression, impairing mental health and academic performance in Chinese female undergraduates with high prevalence. Auricular acupressure (AA), a non-invasive Traditional Chinese Medicine modality, has potential in emotional regulation but lacks robust evidence for PMDD. This pilot study seeks to evaluate the feasibility, adherence, preliminary safety and efficacy of AA for PMDD-related emotional symptoms, as well as its potential neurophysiological mechanisms, so as to inform the design of subsequent large-scale RCTs.

Sixty-six eligible participants with PMDD will be randomly allocated in a 1:1 ratio to either the active AA group or the sham AA group. The intervention will be administered once weekly for 3 consecutive menstrual cycles, totaling 12 sessions; participants will perform self-acupressure three times daily for 10 minutes per session, with auricular plasters retained for at least 2 days per application to ensure compliance. Primary outcomes (severity of depressive and anxiety symptoms) will be assessed using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) at baseline and post each cycle's final intervention. Secondary outcomes include emotional state (measured by the Positive and Negative Affect Schedule-20 [PANAS-20]) and health-related quality of life (HRQoL). Additionally, brain activity will be quantified via electroencephalography. Adverse events will be closely monitored throughout the trial.

ITMCTR2025002451 (International Traditional Medicine Clinical Trial Registry).

This study is designed to collect feasibility data and preliminary evidence on the safety and efficacy of AA, alongside initial insights into its underlying mechanisms. Findings will optimize protocols and sample size for future RCTs, facilitating AA's clinical translation for PMDD.