跳至主要内容
临床试验/NCT05720962
NCT05720962已完成不适用

The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 110 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
2
主要终点
Personal information form

研究概览

简要总结

This study was planned to determine the effect of continuous accompanying support during the active phase on labor pain, duration and satisfaction.

详细描述

Participants who comes into childbirth needs the support of people around her in order to cope with the stress, anxiety and labor pain she experiences. This support is the continuous birth support given from the time the participants comes to the hospital until the birth of the baby. Having someone who supports the woman during the birth process will provide a positive birth experience for pregnant women. At the same time, the feeling of pain of the supported woman will be reduced and the delivery time will be shortened.

This randomized controlled study was planned to be performed on primiparous pregnant women between January 2023 and January 2024. The data of the study will be collected with "Personal Information Form", "Visual Analog Scale".

The study was divided into two groups as experimental and control groups. 55 participants in the experiment -55 participants will be randomized to the control group. Participants meeting the inclusion criteria will be asked to rate their pain and satisfaction from 0 to 10 with the VAS 4 cm, 6 cm, 8 cm and fully open. While both groups receive routine midwife support, when the experimental group reaches 4 cm, a person they want will be taken with them and continuous support will be given until there is a dilation of 10 cm.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-35 years old
  • Being literate
  • Fluent and speaking Turkish
  • Primiparous
  • Spontaneous vaginal delivery planned
  • At the beginning of the active phase (dilatation 4 cm)
  • Pregnant women who agreed to participate in the research

排除标准

  • Presence of a health problem in the mother during pregnancy
  • At risk of fetal anomaly
  • Having multiple pregnancy
  • Administering analgesic medication during labor

研究组 & 干预措施

experimental group

Experimental

The experimental group will be provided with routine midwife support and uninterrupted accompanying support.

干预措施: uninterrupted accompanying support (Procedure)

control group

No Intervention

Only routine midwife support will be provided to the control group.

结局指标

主要结局

Personal information form

时间窗: "through study completion, an average of 1 year".

It is a form that includes questions that determine socio-demographic characteristics and perception of support. The form also includes questions about the process of the birth period.

Visual Analog Scale (VAS)

时间窗: "through study completion, an average of 1 year"

It is a reliable and easily applicable scale accepted in the world literature. It is used to measure the values that cannot be measured numerically in the evaluation of the pain intensity and satisfaction of the patients. A minimum of 0 and a maximum of 10 points can be obtained from the scale. Additionally, higher scores indicate higher pain intensity, higher satisfaction.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

dilan cömert

Principal Investigator

Istanbul University - Cerrahpasa

研究点 (2)

Loading locations...

相似试验