Efficacy of auricular acupressure for insomnia in pregnant women: a randomized, double-blind, controlled trial

PURPOSE: Insomnia is prevalent among pregnant women, yet safe and effective treatment options remain limited. While preliminary evidence suggests that Auricular Acupressure (AA) may alleviate insomnia, its efficacy during pregnancy has not been thoroughly investigated. This study aimed to evaluate the effectiveness of AA in improving sleep quality among pregnant women with insomnia. METHODS: In this randomized, double‐blind trial, 86 pregnant women (≥28 weeks' gestation) with insomnia were randomized to AA (n = 43) or sham AA (SAA, n = 43); 77 participants (AA, n = 37; SAA, n = 40) completed the trial and were included in the final analysis. The AA group received targeted acupressure at insomnia‐related acupoints, while SAA involved non‐specific points. Sleep quality (Pittsburgh Sleep Quality Index, PSQI), mental health symptoms, and salivary cortisol were assessed over 5 weeks. RESULTS: A total of 86 participants were randomized (43 to the AA group and 43 to the SAA group), and 77 (37 in the AA group and 40 in the SAA group) completed the study and were included in the analysis. Participants in the AA group exhibited significant improvements in sleep quality, as evidenced by a reduction in the PSQI score by 3.51 points (p < 0.01) and increased nightly sleep duration (p < 0.01). No significant changes were observed in the SAA group. Additionally, AA was associated with reduced depressive and anxiety symptoms and improved diurnal cortisol rhythms. No adverse events occurred in either group. CONCLUSIONS: AA is a safe, effective, and non‐invasive intervention for improving insomnia symptoms during pregnancy. These findings suggest that AA may also benefit maternal mental health and pregnancy outcomes, offering a viable alternative to pharmacological treatments. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: ITMCTR2024000282.