taVNS for uterine contraction pain and early recovery after spontaneous vaginal birth: a three-arm randomized controlled trial protocol
6 affiliations
- 1The Second Clinical Medical College, Yunnan University of Chinese Medicine, Kunming, Yunnan, 650500 China
- 2Department of Obstetrics, Ludian County Maternal and Child Health Hospital, Ludian, Zhaotong, Yunnan 657100 China
- 3Department of Traditional Chinese Medicine, Ludian County Maternal and Child Health Hospitaly, Ludian, Zhaotong, Yunnan 657100 China
- 4Wearable BCI and Intelligent Rehabilitation Innovation Lab, Guangzhou Institute of Technology, Xidian University, Xian, Shaanxi 710000 China
- 5Engineering Research Center of Molecular and Neuro Imaging of the Ministry of Education, School of Life Science and Technology, Xidian University, Xian, Shaanxi 710000 China
- 6College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610075 China
Abstract
Background: Uterine contraction pain after spontaneous vaginal birth (SVB) hinders early maternal recovery. Transcutaneous auricular vagus nerve stimulation (taVNS), as a safe, and non-invasive alternative therapy, can alleviate pain and improve sleep and emotion. Although a recent trial has confirmed its benefits after cesarean delivery, direct evidence evaluating the clinical efficacy of taVNS among post-SVB populations remains absent.
Method: This is a single-center, prospective, sham-controlled, three-arm parallel-group randomized clinical trial. A total of 144 maternal participants after SVB will be enrolled and randomly assigned in a 1:1:1 ratio to the 1-Hz taVNS group, 20-Hz taVNS group, or the sham taVNS group. All participants will receive routine postpartum care and undergo a 30-minute daily intervention on the left ear for 3 consecutive days, beginning on the day of delivery. The primary outcome is the proportion of participants with a Visual Analog Scale (VAS) pain score ≥ 4 on postpartum day 3. Secondary outcomes include pain intensity and episode characteristics at other time points, rescue analgesia rate, lactation and breastfeeding status, vaginal bleeding, mood, sleep, and adverse events. Electrocardiogram (ECG) data will be monitored before and after each treatment session.
Discussion: This trial will evaluate the efficacy and safety of 1-Hz versus 20-Hz taVNS compared with sham stimulation for moderate-to-severe uterine contraction pain on postpartum day 3 among women after SVB, while assessing its effects on early recovery. Our findings may provide a rationale for scaling up this non-invasive technology in hospital settings, thereby contributing to improved postpartum care outcomes.
Trial registration: International Traditional Medical Clinical Trial Registry (ITMCTR), ITMCTR2026001275. Prospectively registered on 7 June 2026.
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BibTeX
@article{deng2026tavns,
title = {{taVNS for uterine contraction pain and early recovery after spontaneous vaginal birth: a three-arm randomized controlled trial protocol}},
author = {Yuan-zheng Deng and Xiao-li Li and Chang-yu Zhao and Xian-qiong Deng and Cheng-long Liu and Jin-bo Sun and Qian-qian Tian and Si-wen Zhao and Qi-fu Li and Chen-chen Cao and Qiang He and Tai-pin Guo},
journal = {BMC Pregnancy and Childbirth},
year = {2026},
month = aug,
doi = {10.1186/s12884-026-09775-x},
url = {https://doi.org/10.1186/s12884-026-09775-x},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - taVNS for uterine contraction pain and early recovery after spontaneous vaginal birth: a three-arm randomized controlled trial protocol
AU - Yuan-zheng Deng
AU - Xiao-li Li
AU - Chang-yu Zhao
AU - Xian-qiong Deng
AU - Cheng-long Liu
AU - Jin-bo Sun
AU - Qian-qian Tian
AU - Si-wen Zhao
AU - Qi-fu Li
AU - Chen-chen Cao
AU - Qiang He
AU - Tai-pin Guo
PY - 2026
DA - 2026/08/07
JO - BMC Pregnancy and Childbirth
DO - 10.1186/s12884-026-09775-x
UR - https://doi.org/10.1186/s12884-026-09775-x
AB - Background: Uterine contraction pain after spontaneous vaginal birth (SVB) hinders early maternal recovery. Transcutaneous auricular vagus nerve stimulation (taVNS), as a safe, and non-invasive alternative therapy, can alleviate pain and improve sleep and emotion. Although a recent trial has confirmed its benefits after cesarean delivery, direct evidence evaluating the clinical efficacy of taVNS among post-SVB populations remains absent. Method: This is a single-center, prospective, sham-controlled, three-arm parallel-group randomized clinical trial. A total of 144 maternal participants after SVB will be enrolled and randomly assigned in a 1:1:1 ratio to the 1-Hz taVNS group, 20-Hz taVNS group, or the sham taVNS group. All participants will receive routine postpartum care and undergo a 30-minute daily intervention on the left ear for 3 consecutive days, beginning on the day of delivery. The primary outcome is the proportion of participants with a Visual Analog Scale (VAS) pain score ≥ 4 on postpartum day 3. Secondary outcomes include pain intensity and episode characteristics at other time points, rescue analgesia rate, lactation and breastfeeding status, vaginal bleeding, mood, sleep, and adverse events. Electrocardiogram (ECG) data will be monitored before and after each treatment session. Discussion: This trial will evaluate the efficacy and safety of 1-Hz versus 20-Hz taVNS compared with sham stimulation for moderate-to-severe uterine contraction pain on postpartum day 3 among women after SVB, while assessing its effects on early recovery. Our findings may provide a rationale for scaling up this non-invasive technology in hospital settings, thereby contributing to improved postpartum care outcomes. Trial registration: International Traditional Medical Clinical Trial Registry (ITMCTR), ITMCTR2026001275. Prospectively registered on 7 June 2026.
SN - 1471-2393
ER -