Study of Transcutaneous Vagus Nerve Stimulation to Support Mental Health After Giving Birth Using Wearable Devices and Hormone Tests to Monitor Effects

What this Trial Is About

Researchers are studying the effects of transcutaneous vagus nerve stimulation tVNS on mood swings and depressive symptoms in women during the postpartum period. The study aims to determine if tVNS can help prevent mood changes and serve as an additional intervention for mood symptoms after childbirth. The investigation will focus on the first 12 weeks following delivery, examining various factors including physiological functions, stress, hormones, environment, and personality traits. The study uses a crossover design with three groups of women who have recently given birth. Two groups will receive different intensities of tVNS stimulation for six weeks each, switching protocols after this period. One group will have high-intensity stimulation, the other low-intensity, and a third group will receive no stimulation but will be monitored similarly. The tVNS device used is CE-certified and stimulates the vagus nerve non-invasively through the ear. Participants will be guided on device use and monitored using smartwatches, questionnaires, and hormone sampling. Participants will complete psychometric and neuropsychological tests at multiple time points, provide hair and blood samples for hormone analysis, and report daily mood and mental health through app-based assessments. Assessments will occur during pregnancy, and at 6 and 12 weeks postpartum, with a follow-up planned at 6 and 9 months postpartum. The study will measure changes in depression symptoms, mood, sleep quality, stress levels, heart rate variability, and daily activity, aiming to gather a comprehensive view of postpartum mental health and tVNS effects.

Investigation of TVNS Administration on Postpartum Mental Health