Li Xinyue, Pu Yuqun, Li Nan, Zhou Tianyi, Leng Youjing, Zhu Yuhang, Xu Dong, Wang Fangfang, Qu Fan
Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China.
Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China
BMJ Open. 2025 May 22;15(5):e094226. doi: 10.1136/bmjopen-2024-094226.
Labour pain is an unavoidable feature of childbirth and is characterised by extreme intensity. Adequate pain management is thus essential not only from the aspect of physiological pain but also due to the adverse effects of pain on the psychological well-being of parturients. Many studies have shown the benefits of acupoint hot compress. However, to date, little is known about its use for alleviating labour pain. The purpose is to evaluate the effect of acupoint hot compress on relieving pain in primiparous women during the latent phase of the first stage of labour, as well as its effects on key maternal and neonatal outcomes.
This prospective, multicentre, randomised controlled trial will be conducted across 18 institutions in China from January 2024 to August 2025. A total of 1100 primiparous women aged 20-34 years, with singleton pregnancies at 37-41 weeks of gestation, will be enrolled and randomly allocated to two groups using a central stratified block randomisation method. The controls will be treated only with obstetrical care, while those in the intervention group will receive the same obstetrical care as the control group, with the addition of acupoint hot compress therapy at 42±2°C for 4 hours, starting 1 hour after the onset of regular uterine contractions during the latent phase of labour. The primary outcome will be the pain intensity measured at 1, 3 and 5 hours after the onset of regular uterine contractions using a Visual Analog Scale.
The study has been approved by the ethics committee of Women's Hospital, School of Medicine, Zhejiang University (No. IRB-20230379-R). The results of the main trial will be submitted for publication in a peer-reviewed journal.
This trial is registered at Chinese Clinical Trial Registry, ChiCTR2300079244.
分娩疼痛是分娩过程中不可避免的特征，其特点是强度极大。因此，充分的疼痛管理不仅在生理疼痛方面至关重要，而且由于疼痛对产妇心理健康的不利影响也很关键。许多研究已经表明穴位热敷的益处。然而，迄今为止，对于其用于减轻分娩疼痛的情况知之甚少。目的是评估穴位热敷对初产妇第一产程潜伏期疼痛的缓解效果，以及对关键母婴结局的影响。
本前瞻性、多中心、随机对照试验将于2024年1月至2025年8月在中国的18家机构进行。总共将招募1100名年龄在20 - 34岁之间、单胎妊娠37 - 41周的初产妇，并使用中心分层区组随机化方法将其随机分为两组。对照组仅接受产科护理，而干预组将接受与对照组相同的产科护理，此外在分娩潜伏期规律宫缩开始1小时后，接受42±2°C的穴位热敷治疗4小时。主要结局将是使用视觉模拟评分法在规律宫缩开始后1、3和5小时测量的疼痛强度。
该研究已获得浙江大学医学院附属妇产科医院伦理委员会批准（编号：IRB - 20230379 - R）。主要试验结果将提交至同行评审期刊发表。
本试验已在中国临床试验注册中心注册，注册号为ChiCTR2300079244。
