Effects of Acupoint Stimulation Combined with Low-frequency Pulsed Electrotherapy on Labor Pain in Women undergoing Trial of Labor: protocol for a stepped wedge cluster randomized controlled trial

Abstract Background: Pain experienced during childbirth can have significant impacts on the progress of labor, as well as on the well-being of the mother and the fetus. The effective management of labor pain is a crucial aspect of childbirth management. Non-pharmacological methods of pain relief offer notable advantages compared to pharmacological approaches, including enhanced maternal and fetal safety, equitable healthcare access, and increased availability. Among the non-pharmacological options, transcutaneous electrical nerve stimulation (TENS) and acupoint stimulation are two commonly used methods for pain relief during labor. However, the clinical effects of these options are still inconsistent, inhibiting the generation of high-quality evidence for clinical practice. The purpose of this study is to determine the effect of acupoint stimulation combined with low-frequency pulsed electrotherapy on labor pain in women undergoing trial of labor. Methods: This is a 12-month stepped wedge cluster randomized trial that will be conducted in 4 labor and delivery units (LDU) at the Obstetrics and Gynecology Hospital of Fudan University. Each unit will receive four types of interventions: TENS, acupoint stimulation, TENS combined acupoint stimulation, and control. We aim to recruit approximately 588 pregnant women. The project will be evaluated using both quantitative and qualitative data. Quantitative data will include the visual analog scale (VAS) scores, non-pharmacological to pharmacological pain management interval (NPI), rate of epidural analgesia, and childbirth outcomes. Qualitative data will include interviews with the women and midwives. Discussion: We introduce a new outcome indicator called nonpharmacological to pharmacological pain management interval (NPI) in our study to monitor whether the use of non-pharmacological pain relief measures can delay or avoid the use of epidural analgesia, in order to improve women’s childbirth experience and maternal-fetal health outcomes. In addition, the combination of qualitative and quantitative methods will also enrich the research of TENS and acupoint stimulation technology in the field of non-pharmacological labor pain relief and provide high-quality evidence for the future development of industry standards and guidelines. Trial registration: The study has been registered in the Chinese Clinical Trial Registry on March 23, 2023, with registration number ChiCTR2300069705.Trial registration number ChiCTR2300069705.