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临床试验/NCT06200688
NCT06200688已完成不适用

The Effect of Peanut Ball Application on the Delivery Process, Birth Pain, and Birth Process: a Randomized Controlled Study

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年7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
102
试验地点
2
主要终点
Birth duration

研究概览

简要总结

This study was carried out to evaluate the effect of peanut ball application on labor process, birth pain, and birth comfort. The data of the study were collected between July 2021 and July 2022 in a Training and Research Hospital in Istanbul. 115 pregnant women who met the inclusion criteria of the study were included in the sampling, and the study was completed with 102 (experimental n: 51; control n: 51) pregnant women. Data were collected with an introductory information form, visual and verbal pain scales, Birth Comfort Scale, and birth follow-up form.

详细描述

A group was determined to be involved in the study after obtaining consent from the pregnant women participating in the research. The purpose of the study was explained to all pregnant women, informing them that the data would be anonymized and privacy principles would be adhered to.

Experimental Group: Pregnant women who received the peanut ball application were provided with necessary information about the ball and how to use it through visual aids showing the positions provided by the midwife. A total of 5 positions were shown to the pregnant women. The peanut ball was used when the cervical dilation reached 6 cm. Pregnant women in active labor, the transition phase, and the second stage with the peanut ball were directed to change positions every 30-45 minutes. Emphasis was placed on selecting positions in which the pregnant women felt comfortable.

Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was observed that pregnant women generally spent the time before delivery lying down and connected to electronic fetal monitoring.

In the Birth Monitoring Form, the gestational week found in the patient's file, interventions and medications applied in the first stage of labor, the situation of episiotomy application in the second stage, the newborn's birth time, and 1st and 5th APGAR scores, newborn's length, weight, head circumference, and gender were recorded. In both groups, labor pains during the dilation stage were evaluated three times using the Visual Anolog Scale (VAS) when the dilation was at 6 cm, 9 cm, and 10 cm. During this period, the pregnant women were asked to rate the pain they felt on the VAS scale from 1 to 10, and the values expressed were recorded by the researcher. The childbirth comfort scale and the form indicating mothers' views

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Primiparous pregnant women
  • 37w-40w gestational week (term)
  • Pregnant women over the age of 18 years

排除标准

  • Pregnant women who gave birth by cesarean section
  • who had received epidural anesthesia/analgesia

结局指标

主要结局

Birth duration

时间窗: 1 day

Birth duration was assessed using a partograph.

Birth pain

时间窗: 8 hours

Labor pains in the dilatation phase: dilation 6 cm, 9 cm and 10 cm with VAS It was evaluated 3 times in total during the time it was cm. During this period, pregnant women were asked to VAS They were asked to score the pain they felt between 1 and 10, and the expressed values were recorded by the researcher.

Birth comfort

时间窗: 15 minutes

The birth comfort scale was administered to pregnant women by the researcher within the first 4 hours after birth.

次要结局

  • Pregnancy introductory information(15 minutes)
  • Birth Follow-up(1 day)

研究者

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

YELİZ YILDIRIM VARIŞOĞLU

Prof. Asist.

Istanbul Medipol University Hospital

研究点 (2)

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