Peer-reviewed article
Effect of acupoint hot compress on relieving pain in primiparous women during the latent phase of the first stage of labour: a study protocol for a prospective, multicentre, randomised controlled clinical trial.
Li X, Pu Y, Li N, Zhou T, Leng Y et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a study protocol describing a planned randomised controlled trial to evaluate acupoint hot compress therapy for pain relief during labour in first-time mothers in China. The study will involve 1,100 women across 18 institutions, comparing standard obstetrical care with standard care plus acupoint hot compress treatment. Pain intensity will be measured using a visual analogue scale at multiple time points during early labour. The trial is registered and ethics-approved but has not yet been conducted or reported.
Key points
- Study protocol for a prospective multicentre RCT across 18 institutions in China, planned for January 2024 to August 2025
- 1,100 primiparous women aged 20-34 years with singleton pregnancies at 37-41 weeks gestation will be enrolled
- Intervention: acupoint hot compress at 42±2°C for 4 hours starting 1 hour after onset of regular uterine contractions during latent phase labour
- Primary outcome: pain intensity measured by Visual Analog Scale at 1, 3, and 5 hours after onset of contractions
- Study is registered at Chinese Clinical Trial Registry (ChiCTR2300079244) and ethics-approved
Limitations
This is a protocol document describing a planned study, not a completed trial. No results, findings, or outcome data are available; the effectiveness of the intervention remains unknown.
Abstract
Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration number This trial is registered at Chinese Clinical Trial Registry, ChiCTR2300079244.