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临床试验/NCT05778435
NCT05778435已完成不适用

The Effect Of The Wireless Fetal Monitoring Used During Birth On The Women's Comfort, Labour Pain And Birth Satisfaction

Tokat Gaziosmanpasa University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年9月11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
88
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

Wireless EFM shortens labor duration, increases birth satisfaction, and reduces perceived pain during labor. With wireless EFM, comfort in labor increases and higher labor comfort increases birth satisfaction. As perceived pain in labor decreases, birth satisfaction increases. Therefore, wireless EFM practice is recommended during the antepartum and intrapartum periods.

详细描述

Problem Wired Electronic Fetal Monitoring (EFM) limits the woman's freedom of movement during labor, causes inability to cope with labor pain, lack of comfort, and a decrease in labor satisfaction.

Background While EFM is performed as wired and wireless in the antepartum and intrapartum periods, wired application is common in the world and in our country.

Aim This randomized controlled study was conducted to evaluate the effect of the wireless fetal monitoring, which is used during birth, on the woman's comfort, labor pain and birth satisfaction.

Methods The study population consisted of 88 women, divided into two groups the experimental group (n=44) and the control group (n=44). The data were collected with the Personal Information Form, Childbirth Comfort Questionnaire (CCQ), Visual Pain Scale (VAS), and Birth Satisfaction Scale-Revised (BSS-R). During the intrapartum period, the wireless fetal monitoring system was used in the experimental group and the wired fetal monitoring system was used in the control group.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women who are willing to participate in the study,
  • •Aged 18-40 years,
  • •Having a healthy pregnancy,
  • •With a gestational age of > 37+0 weeks,
  • •With a cervical dilatation of 4-5 cm,
  • •With a singleton pregnancy,
  • •With a live fetus,
  • •Can speak Turkish,
  • •Do not have comprehension, perception, and communication problems participated in the study.

排除标准

  • •Pregnant women who did not comply with the study had communication problems,
  • •Had complications,
  • •Needed urgent cesarean delivery and wanted to withdraw from the study were excluded from the study

研究组 & 干预措施

wireless fetal monitoring group

Experimental

wireless fetal monitoring system was applied to the experimental group

干预措施: wireless fetal monitoring system (Device)

Control group

No Intervention

Standard wired fetal monitoring system was applied to the control group.

结局指标

主要结局

Visual Analogue Scale

时间窗: When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the VAS were filled out by the researcher between contractions, when the pregnant feels good.

To measure the level of the pain, mostly a 10-cm-long vertical or horizontal line labeled from "No pain" to "Unbearable pain" is used. The participants are asked to mark their pain level on the line by a line, dot, or simply showing. The distance between the "no pain" point and the marked point indicates the level of pain

Birth Satisfaction Scale-Revised

时间窗: The BSS-R was conducted 1 h after the mother was taken from the labor room to the gynecology and obstetrics service. The time required for the rest need of the postpartum mother, to meet her personal needs and breastfeed her baby was also provided

The lowest and the highest scores that can be obtained from the scale were 0 and 40, respectively. Higher scores indicate higher satisfaction. Satisfaction is classified as low satisfaction (0-13), medium satisfaction (14-27), and high satisfaction (28-40). The scale is implemented within the first three days after delivery birth.

Childbirth Comfort Questionnaire

时间窗: When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the CCQ were filled out by the researcher between contractions, when the pregnant feels good.

The participants rated the questionnaire through a Likert-type scale ranging from 1 to 5. The scores that can be obtained from the scale vary from 9 to 45. Higher scores indicate higher comfort during labor, whereas lower scores mean lower comfort

次要结局

未报告次要终点

研究者

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

Demet Cakir

Assist.Prof.Dr.

Tokat Gaziosmanpasa University

研究点 (1)

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