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临床试验/NCT06003946
NCT06003946已完成不适用

Effectiveness of a Breathing and Relaxation Technique in Antenatal Education (BreLax Study): a Randomised Controlled Trial

Zurich University of Applied Sciences2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Self-efficacy

研究概览

简要总结

The aim of this randomised controlled trial is to compare the effects of an antenatal education class including a breathing and relaxation technique on self-efficacy compared to a standard antenatal education class without a focus on breathing and relaxation techniques.

详细描述

Antenatal education classes were developed to inform expectant mothers about pregnancy, labour and birth and the postpartum period with the aim of improving pregnancy and childbirth experience. They were based, for example, on concepts of Lamaze and Grantly Dick-Read. Studies indicate positive emotional effects on labour and birth outcomes in women who attended antenatal education classes. This includes lower levels of fear of childbirth, lower rates of caesarean birth at the women's request, a higher rate of spontaneous births, and a stronger involvement of the partner, better chances of initiating breastfeeding, a lower likelihood of developing depression symptoms during the postpartum period. There is limited evidence on the link between birth preparation and neonatal outcomes. Considering recent evidence suggesting that antenatal education classes may positively influence maternal and neonatal birth outcomes, we intend to analyse an antenatal education class focusing on a breathing and relaxation technique and assess the impact of such a class on self-efficacy, as well as other maternal and neonatal birth outcomes.

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
Double (Participant, 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 women with a singleton low-risk pregnancy
  • receiving antenatal care
  • being willing to attend an antenatal education class
  • planning a vaginal birth
  • sufficient oral and written German language knowledge

排除标准

  • women, who plan an elective caesarean section
  • pregnant with multiples
  • do not have sufficient oral and written German language knowledge

结局指标

主要结局

Self-efficacy

时间窗: 13 weeks till 37 weeks of pregnancy

Changes from baseline to after the antenatal education class measured with the german version of the childbirth self-efficacy inventory (CBSEI). The CBSEI is a 32-item scale that measures women's perceived self-efficacy towards labour. Items are scored on a scale of 1 to 10. A higher score indicates that participants are better able to cope with difficult tasks.

次要结局

  • Feasibility and effectiveness BreLax(13 weeks of pregnancy till 4 weeks after birth)
  • birthing position(within 4 weeks after birth)
  • Bonding(within 4 weeks after birth)
  • Duration of labour(within 4 weeks after birth)
  • 5-minute Apgar-Score(within 4 weeks after birth)
  • Childbirth experience(within 4 weeks after birth)
  • pain management(within 4 weeks after birth)
  • arterial umbilical cord pH(within 4 weeks after birth)

研究者

发起方
Zurich University of Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa Leutenegger

PhD Student

Zurich University of Applied Sciences

研究点 (2)

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