BMC pregnancy and childbirth · 2026
Preventive effect of transcutaneous auricular vagus nerve stimulation on postpartum depression in cesarean women with antenatal depressive tendency: a randomized controlled trial protocol.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Ji Tian-Zhen, Li Xiang, Shen Jun, Wang Wei-Jie, Xie Lei
Аннотация
BACKGROUND: Postpartum depression is one of the most common psychological disorders among women after childbirth, with a global prevalence of approximately 10-20% and an even higher rate of 21.4% reported in China. Women undergoing cesarean section are at increased risk for postpartum depression due to perioperative pain, delayed recovery, maternal-infant separation, and psychological stress. Antenatal depression is also a major risk factor for postpartum depression, highlighting the need for effective preventive interventions in this population. Transcutaneous auricular vagus nerve stimulation (taVNS), a noninvasive neuromodulation technique, has demonstrated antidepressant and anxiolytic effects in multiple neuropsychiatric conditions. However, its preventive value in perinatal depression remains unclear.
METHODS: This study is a prospective, randomized, double-blind, sham-controlled trial protocol. A total of 254 pregnant women (aged 18-45 years) with an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 9 before elective cesarean section will be enrolled and randomized 1:1 into the active taVNS group or the sham taVNS group. Participants in the active taVNS group will receive electrical stimulation to the left auricular concha (20 Hz, 200 μs, 30 min per session) before anesthesia, on postoperative day 1, and on postoperative day 2. The sham taVNS group will receive identical electrode placement without electrical output. The primary outcome is the incidence of postpartum depression (EPDS ≥ 9) at 6 weeks postpartum. Secondary outcomes include changes in EPDS and anxiety scores, sleep quality, postoperative pain, and recovery parameters.
DISCUSSION: This trial aims to determine whether taVNS is an effective and safe preventive intervention for postpartum depression in cesarean women with antenatal depressive tendency. The findings will provide new evidence supporting the integration of nonpharmacological neuromodulation strategies into perinatal mental health care.
TRIAL REGISTRATION: This study was registered with the Chinese Clinical Trial Registry (ChiCTR; Registration number: ChiCTR2600119584) on 28 February 2026.
METHODS: This study is a prospective, randomized, double-blind, sham-controlled trial protocol. A total of 254 pregnant women (aged 18-45 years) with an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 9 before elective cesarean section will be enrolled and randomized 1:1 into the active taVNS group or the sham taVNS group. Participants in the active taVNS group will receive electrical stimulation to the left auricular concha (20 Hz, 200 μs, 30 min per session) before anesthesia, on postoperative day 1, and on postoperative day 2. The sham taVNS group will receive identical electrode placement without electrical output. The primary outcome is the incidence of postpartum depression (EPDS ≥ 9) at 6 weeks postpartum. Secondary outcomes include changes in EPDS and anxiety scores, sleep quality, postoperative pain, and recovery parameters.
DISCUSSION: This trial aims to determine whether taVNS is an effective and safe preventive intervention for postpartum depression in cesarean women with antenatal depressive tendency. The findings will provide new evidence supporting the integration of nonpharmacological neuromodulation strategies into perinatal mental health care.
TRIAL REGISTRATION: This study was registered with the Chinese Clinical Trial Registry (ChiCTR; Registration number: ChiCTR2600119584) on 28 February 2026.