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临床试验/NCT07357246
NCT07357246
已完成
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The Effect of Breathing Exercises Applied Under the Guidance of Student Midwives During Birth on Labor Pain, Labor Duration and Birth Satisfaction: A Randomized Controlled Trial

Antalya Bilim University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年9月1日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Antalya Bilim University
入组人数
90
试验地点
1
主要终点
Labor pain intensity measured by the Visual Analog Scale (VAS) (0-10)

概览

简要总结

This randomized controlled trial aimed to evaluate the effect of breathing exercises applied under the guidance of student midwives during labor on labor pain, labor duration, and birth satisfaction. The intervention group received structured breathing exercises guided by student midwives throughout labor, while the control group received routine intrapartum care. Outcomes were assessed during labor and in the early postpartum period

详细描述

This study is designed to evaluate the effect of a midwifery-led intervention on labor pain intensity and birth satisfaction among women giving birth vaginally. The study will be conducted as a controlled clinical study in a maternity hospital setting. Eligible pregnant women who are admitted to the labor ward and meet the inclusion criteria will be invited to participate and will provide informed consent prior to enrollment.

The study aims to determine whether the midwifery-led intervention is associated with reduced labor pain intensity and improved birth satisfaction compared to routine care.

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
None

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

  • Women aged 18 years and older
  • Term pregnancy (≥37 weeks of gestation)
  • Singleton pregnancy
  • Planning vaginal birth
  • In the active phase of labor
  • Able to communicate and provide informed consent

排除标准

  • High-risk pregnancy (e.g., preeclampsia, placenta previa, severe medical complications)
  • Multiple pregnancy
  • Planned cesarean section
  • Use of pharmacological pain relief at admission (e.g., epidural analgesia)
  • Known fetal anomalies
  • Inability to participate in breathing exercises

研究组 & 干预措施

Breathing Exercises Guided by Student Midwives

Experimental

Participants in this group will receive structured breathing exercises in addition to routine intrapartum care. The breathing exercises will be guided by trained student midwives from admission to the labor ward until birth. The intervention will include slow-paced breathing, patterned breathing during contractions, and relaxation-focused breathing between contractions, with continuous guidance and encouragement provided according to a standardized protocol.

干预措施: Guided Breathing Exercises During Labor (Behavioral)

Routine Intrapartum Care

Active Comparator

Participants in this group will receive routine intrapartum care according to the standard clinical protocols of the maternity hospital. Routine care includes regular maternal and fetal monitoring, clinical assessment by midwives and obstetric staff, support during labor as per standard practice, and medical or obstetric interventions if clinically indicated. No structured breathing exercise program will be provided.

干预措施: Routine Intrapartum Care (Other)

结局指标

主要结局

Labor pain intensity measured by the Visual Analog Scale (VAS) (0-10)

时间窗: At admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.

Labor pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst pain imaginable." The outcome will be the VAS score reported by the participant at each assessment time point.

次要结局

  • Birth satisfaction measured by the Birth Satisfaction Scale Revised (BSS-R)(Within the first 24 hours postpartum)

研究者

发起方
Antalya Bilim University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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