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临床试验/NCT06502418
NCT06502418已完成不适用

Impact of Acupuncture on Pain Management During Induced Labor with Cook's Balloon At the Beaumont Maternity in Roubaix

Centre Hospitalier de Roubaix2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Impact of 7 acupuncture points on pain

研究概览

简要总结

In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method but this technique can provide pain.

At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this pain.

No studies where found about an effect of acupuncture therapy on pain provoked by labor induction with Cook's balloon.

详细描述

Investigators aim to demonstate that acupuncture therapy during labor induction with Cook's balloon can reduced pain and improved patient's experience. Investigators will use 7 acupuncture points (YIN TANG/ 4 GI bilateral/ 36 E bilateral and 5TR bilateral) before the application of the balloon. A visual analog scale will be used before and after balloon insertion to collect pain level.

a questionnary will be filled by patient to collect their experiences. Investigators will collect data about analgesia, failed of induction and cesarean section to see effect of acupuncture on them.

Patients will be randomised.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant woman with a gestational age of 37 weeks and above
  • age>=18 years old
  • having medical indication to be labor induced by Cook's Balloon
  • speaking French
  • agreeing to participate by signing informed consent form

排除标准

  • patient having contraindication for the use of Cook's balloon
  • patients under curatorship and/or guardianship

结局指标

主要结局

Impact of 7 acupuncture points on pain

时间窗: Day 1

Assessment of pain with Visual Analogic Scale before and after the use of Cook's balloon

次要结局

  • Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups(Day 2)
  • Evaluate experiences of the patient during labor induction between the 2 groups(Day 1)
  • Evaluate the consumption of analgesics between the 2 groups(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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