• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

穴位刺激联合经皮电神经刺激对分娩疼痛的影响：一项阶梯楔形整群随机对照试验方案

The Effects of Acupoint Stimulation Combined With Transcutaneous Electrical Nerve Stimulation on Labor Pain: Protocol for a Stepped Wedge Cluster Randomized Controlled Trial.

作者信息

Gu Yiyun, Wang Xiaojiao, Zhu Chunxiang, Min Hui, Zhang Jialu, Mao Liping, Gao Hua, Sun Hangyun, Zhu Xinli, Gu Chunyi

机构信息

Department of Nursing, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.

School of Nursing, Fudan University, Shanghai, China.

出版信息

JMIR Res Protoc. 2025 May 26;14:e63050. doi: 10.2196/63050.

DOI:10.2196/63050
PMID:40418802
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12149766/
Abstract

BACKGROUND

Pain experienced during childbirth can significantly impact the progress of labor and the well-being of both the mother and the fetus. Effective management of labor pain is a crucial component of childbirth care. Nonpharmacological methods of pain relief offer notable advantages over pharmacological approaches, including enhanced maternal and fetal safety, equitable access to health care, and greater availability. Among the nonpharmacological options, transcutaneous electrical nerve stimulation (TENS) and acupoint stimulation are two commonly used methods for alleviating pain during labor. However, the clinical efficacy of these methods remains inconsistent, which hinders the generation of high-quality evidence for clinical practice.

OBJECTIVE

This study aims to assess the effects of acupoint stimulation combined with TENS on labor pain, delivery outcomes, and childbirth experience for women undergoing a trial of labor.

METHODS

This is a 12-month stepped wedge cluster randomized trial to be conducted in 4 labor and delivery units (LDUs) at the Obstetrics and Gynecology Hospital of Fudan University. Each unit will implement 4 types of interventions: TENS, acupoint stimulation, TENS combined with acupoint stimulation, and a control group. We aim to recruit approximately 588 pregnant women. The project will be evaluated using both quantitative and qualitative data. Quantitative data will include visual analog scale (VAS) scores, the nonpharmacological to pharmacological pain management interval (NPI), the rate of epidural analgesia, and childbirth outcomes. Qualitative data will include interviews with the women and midwives.

RESULTS

The study commenced on April 1, 2023, and as of March 29, 2024, a total of 600 eligible participants have been enrolled, surpassing the initial target of 588. Data collection has been completed, including quantitative assessments of labor pain intensity, analgesic use, and childbirth outcomes, alongside qualitative interviews with participating women. Currently, data analysis is in progress, with preliminary findings anticipated to be available by March 2025. We hypothesize that TENS combined with acupoint stimulation will demonstrate greater efficacy in managing labor pain compared with standard care. This effect may be observed in key outcome measures, including the VAS score and enhanced maternal childbirth experience.

CONCLUSIONS

This study protocol details the interventions of acupoint stimulation and TENS for women undergoing a trial of labor. We introduce a novel outcome indicator termed NPI, which monitors whether the application of nonpharmacological pain relief measures can delay or prevent the use of epidural analgesia. The integration of qualitative and quantitative methods will enrich the research on TENS and acupoint stimulation technology within the realm of nonpharmacological labor pain relief, providing high-quality evidence for the future establishment of industry standards and guidelines.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2300069705; https://tinyurl.com/2s3mkhr7.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63050.

摘要

背景

分娩期间经历的疼痛会对产程以及母亲和胎儿的健康产生重大影响。有效管理分娩疼痛是分娩护理的关键组成部分。与药物治疗方法相比，非药物性疼痛缓解方法具有显著优势，包括提高母婴安全性、公平获得医疗保健以及更高的可及性。在非药物性选择中，经皮电刺激神经疗法（TENS）和穴位刺激是分娩期间常用的两种缓解疼痛的方法。然而，这些方法的临床疗效仍不一致，这阻碍了为临床实践生成高质量证据。

目的

本研究旨在评估穴位刺激联合TENS对进行试产的女性的分娩疼痛、分娩结局和分娩体验的影响。

方法

这是一项为期12个月的阶梯楔形整群随机试验，将在复旦大学附属妇产科医院的4个分娩单元进行。每个单元将实施4种干预措施：TENS、穴位刺激、TENS联合穴位刺激以及一个对照组。我们的目标是招募约588名孕妇。该项目将使用定量和定性数据进行评估。定量数据将包括视觉模拟量表（VAS）评分、非药物性至药物性疼痛管理间隔时间（NPI）、硬膜外镇痛率和分娩结局。定性数据将包括对女性和助产士的访谈。

结果

该研究于2023年4月1日开始，截至2024年3月29日，共纳入600名符合条件的参与者，超过了最初设定的588名的目标。数据收集已完成，包括对分娩疼痛强度、镇痛药物使用情况和分娩结局的定量评估，以及对参与女性的定性访谈。目前，数据分析正在进行中，预计初步结果将于2025年3月可得。我们假设，与标准护理相比，TENS联合穴位刺激在管理分娩疼痛方面将显示出更大的疗效。这种效果可能在关键结局指标中观察到，包括VAS评分和改善的母亲分娩体验。

结论

本研究方案详细介绍了对进行试产的女性采用穴位刺激和TENS的干预措施。我们引入了一个名为NPI的新结局指标，该指标监测非药物性疼痛缓解措施的应用是否可以延迟或避免使用硬膜外镇痛。定性和定量方法的结合将丰富非药物性分娩疼痛缓解领域中关于TENS和穴位刺激技术的研究，为未来制定行业标准和指南提供高质量证据。

试验注册

中国临床试验注册中心ChiCTR2300069705；https://tinyurl.com/2s3mkhr7。

国际注册报告识别码（IRRID）：DERR1-10.2196/63050。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/2d326477db4d/resprot_v14i1e63050_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/912dbf7dc1d7/resprot_v14i1e63050_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/b419919d5a97/resprot_v14i1e63050_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/08d637df5c92/resprot_v14i1e63050_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/94fcd88e7b1c/resprot_v14i1e63050_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/2d326477db4d/resprot_v14i1e63050_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/912dbf7dc1d7/resprot_v14i1e63050_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/b419919d5a97/resprot_v14i1e63050_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/08d637df5c92/resprot_v14i1e63050_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/94fcd88e7b1c/resprot_v14i1e63050_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1cb/12149766/2d326477db4d/resprot_v14i1e63050_fig5.jpg

相似文献

1
The Effects of Acupoint Stimulation Combined With Transcutaneous Electrical Nerve Stimulation on Labor Pain: Protocol for a Stepped Wedge Cluster Randomized Controlled Trial.穴位刺激联合经皮电神经刺激对分娩疼痛的影响：一项阶梯楔形整群随机对照试验方案
JMIR Res Protoc. 2025 May 26;14:e63050. doi: 10.2196/63050.
2
Relaxation techniques for pain management in labour.分娩疼痛管理的放松技巧。
Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009514. doi: 10.1002/14651858.CD009514.pub2.
3
Parenteral opioids for maternal pain management in labour.用于分娩时产妇疼痛管理的胃肠外阿片类药物。
Cochrane Database Syst Rev. 2018 Jun 5;6(6):CD007396. doi: 10.1002/14651858.CD007396.pub3.
4
Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults.成人纤维肌痛的经皮电神经刺激（TENS）疗法
Cochrane Database Syst Rev. 2017 Oct 9;10(10):CD012172. doi: 10.1002/14651858.CD012172.pub2.
5
Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea.经皮电刺激神经疗法与针灸治疗原发性痛经
Cochrane Database Syst Rev. 2002;2002(1):CD002123. doi: 10.1002/14651858.CD002123.
6
Epidural versus non-epidural or no analgesia for pain management in labour.硬膜外镇痛与非硬膜外镇痛或无镇痛用于分娩疼痛管理的比较。
Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
7
Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults.经皮电刺激神经疗法（TENS）治疗成人神经性疼痛。
Cochrane Database Syst Rev. 2017 Sep 14;9(9):CD011976. doi: 10.1002/14651858.CD011976.pub2.
8
Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour.经皮电刺激神经疗法（TENS）用于分娩时缓解疼痛。
Cochrane Database Syst Rev. 2009 Apr 15(2):CD007214. doi: 10.1002/14651858.CD007214.pub2.
9
Position in the second stage of labour for women with epidural anaesthesia.硬膜外麻醉产妇在第二产程的体位
Cochrane Database Syst Rev. 2017 Feb 24;2(2):CD008070. doi: 10.1002/14651858.CD008070.pub3.
10
Acupuncture or acupressure for induction of labour.针刺或指压引产。
Cochrane Database Syst Rev. 2017 Oct 17;10(10):CD002962. doi: 10.1002/14651858.CD002962.pub4.

本文引用的文献

1
Latest Advancements in Transcutaneous Electrical Nerve Stimulation (TENS) and Electronic Muscle Stimulation (EMS): Revisiting an Established Therapy with New Possibilities.经皮电神经刺激（TENS）和电子肌肉刺激（EMS）的最新进展：以新的可能性重新审视一种既定疗法。
J Pain Res. 2025 Jan 9;18:137-153. doi: 10.2147/JPR.S493162. eCollection 2025.
2
Effects of epidural analgesia on intrapartum maternal fever and maternal outcomes: an updated systematic review and meta-analysis.硬膜外镇痛对产时产妇发热及产妇结局的影响：一项更新的系统评价和荟萃分析
J Matern Fetal Neonatal Med. 2024 Dec;37(1):2357168. doi: 10.1080/14767058.2024.2357168. Epub 2024 May 29.
3
Effectiveness of an Intervention to Improve HIV Service Delivery for People Who Inject Drugs in Kazakhstan: A Cluster Trial.
干预措施提高哈萨克斯坦注射吸毒者艾滋病毒服务提供效果的研究：一项群组试验
JAMA Netw Open. 2022 Dec 1;5(12):e2244734. doi: 10.1001/jamanetworkopen.2022.44734.
4
The barriers to offering non-pharmacological pain management as an initial option for laboring women: A review of the literature.将非药物性疼痛管理作为分娩女性的初始选择所面临的障碍：文献综述
Eur J Midwifery. 2022 Jun 10;6:37. doi: 10.18332/ejm/149244. eCollection 2022.
5
Labor Analgesia: A Systematic Review and Meta-Analysis of Non-Pharmacological Complementary and Alternative Approaches to Pain during First Stage of Labor.分娩镇痛：第一产程中非药物补充和替代疗法缓解疼痛的系统评价和荟萃分析。
Crit Rev Eukaryot Gene Expr. 2022;32(2):61-89. doi: 10.1615/CritRevEukaryotGeneExpr.2021039986.
6
Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study).经皮神经电刺激（TENS）治疗成人急性和慢性疼痛的疗效和安全性：381 项研究的系统评价和荟萃分析（meta-TENS 研究）。
BMJ Open. 2022 Feb 10;12(2):e051073. doi: 10.1136/bmjopen-2021-051073.
7
Evaluation of Epidural Analgesia Use During Labor and Infection in Full-term Neonates Delivered Vaginally.评估足月阴道分娩新生儿的硬膜外镇痛使用与感染。
JAMA Netw Open. 2021 Sep 1;4(9):e2123757. doi: 10.1001/jamanetworkopen.2021.23757.
8
Acupressure and Acupuncture Use in the Peripartum Period.穴位按压和针灸在围产期的应用。
Clin Obstet Gynecol. 2021 Sep 1;64(3):558-571. doi: 10.1097/GRF.0000000000000636.
9
The effects of transcutaneous electrical nerve stimulation during the first stage of labor: a randomized controlled trial.经皮神经电刺激在第一产程中的作用：一项随机对照试验。
BMC Pregnancy Childbirth. 2021 Feb 24;21(1):164. doi: 10.1186/s12884-021-03625-8.
10
The relationship between epidural analgesia and intrapartum maternal fever and the consequences for maternal and neonatal outcomes: a prospective observational study.硬膜外镇痛与产时产妇发热的关系及其对母婴结局的影响：一项前瞻性观察研究。
J Matern Fetal Neonatal Med. 2022 Dec;35(25):5354-5362. doi: 10.1080/14767058.2021.1879042. Epub 2021 Jan 27.