跳至主要内容
临床试验/NCT04662424
NCT04662424Unknown不适用

Effect of Music in Labor in Women Who Underwent Induction of Labor

Federico II University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
mean pain level during the active phase of labor

研究概览

简要总结

Women's experience of pain during labor varies greatly, and pain control is a major concern for obstetricians. Several methods have been studied for pain management for women in labor, including drug and non-drug interventions Most methods of non-pharmacological pain management are non-invasive and appear to be safe for mother and baby, including immersion in water, relaxation, acupuncture, and massage. However, their efficacy is unclear, and based mostly on non-randomized studies. On the other hand, there are strong data to support the efficacy of pharmacological methods, including epidural analgesia, which improves pain relief but increase the incidence of operative vaginal delivery Recently a clinical trial showed that music in labor was associated with maternal benefits in women who underwent spontaneous vaginal delivery. However, the effect of music in labor in women undergoing induction of labor is still a subject of debate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Nulliparous women
  • Singleton gestation
  • Vertex presentation
  • Induction of labor, i.e. cervical ripening with prostaglandins
  • Gestational age between 37 and 42 weeks

排除标准

  • Multiparous womne
  • Multiple gestations
  • Preterm labor
  • Preterm premature rupture of membranes
  • Induction of labor with oxytocin and without prostaglandins
  • Induction of labor with balloon
  • High risk pregnancies, including hypertensive disorders of pregnancies, diabetes, intrauterine growth restriction, fetal abnormalities.

结局指标

主要结局

mean pain level during the active phase of labor

时间窗: at the time of the active phase of labor

assessed by Visual Analog Scale (VAS) for Pain

次要结局

  • Mean anxiety level during the active phase of labor, second stage, and at post-partum(at the time of the active phase of labor)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriele Saccone

Principal Investigator

Federico II University

研究点 (2)

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