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临床试验/NCT05312502
NCT05312502已完成不适用

Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor: A Randomized Controlled Trial

Selcuk University1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2020年3月1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
111
试验地点
1
主要终点
Introductory Information Form

研究概览

简要总结

H0: There is no difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during labor.

H1: There is a difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during the birth process.

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
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 47 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • the consent of the pregnant women to participate in the study,
  • have signed the informed consent form,
  • be over the age of 18,
  • Vaginal opening was determined as 4 cm

排除标准

  • Having a psychologically diagnosed disorder
  • Pregnant women diagnosed with risky pregnancy

结局指标

主要结局

Introductory Information Form

时间窗: pre-intervention

The form consisting of 13 questions was prepared by the researcher in order to describe the sociodemographic characteristics and current health status of women.

Birth Process Follow-up Form

时间窗: during the intervention

It was created by the researcher in order to obtain information about the progress of birth and the characteristics of the fetus during the birth process of the pregnant. In the form, there are questions including the hour and subsequent follow-up hours when the vaginal opening is 4 cm, dilatation, fetal heartbeat, whether there is oxytocin administration, the duration and frequency of contractions, and the characteristics of the amniotic fluid.

次要结局

  • Visual Analog Scale (VAS)(during the intervention)
  • Birth Satisfaction Scale-Short Form (DME-F)(in the first hour in postpartum period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin ERKAL AKSOY

Asistant Prof. Dr.

Selcuk University

研究点 (1)

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