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临床试验/NCT05711472
NCT05711472已完成不适用

The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction

Selcuk University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年11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
120
试验地点
2
主要终点
Personal information form before intervention

研究概览

简要总结

It has been reported that the birth ball has benefits such as decreasing the perception of labor pain, reducing the anxiety level, shortening the duration of the first stage of labor, increasing the satisfaction of birth, and facilitating the descent of the fetal head, but the literature is quite limited. So, this randomized controlled experimental study aimed to examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction.

详细描述

This randomized controlled experimental study aimed to examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction. The sample of the study consisted of 120 primiparous pregnant women presented to the delivery room between November 2021 and April 2022. Pregnant women were randomly assigned to the Intervention Group (IG, n=60) or the Control Group (KG, n=60). After the cervical dilatation reached at 4 cm, the pregnant women in the IG performed birth ball exercises, adhering to the birth ball guide created by the researcher. No intervention was made in the control group other than standard midwifery care practices.

A Personal Information Form,a Visual Analog Scale (VAS), the Childbirth Comfort Questionnaire (CCQ), a Labor and Postpartum Follow-up Form, and the Mackey Childbirth Satisfaction Rating Scale (MCSRS) were used for data collection. Women in both groups underwent VAS when cervical dilatation was 4 cm and 9 cm, and the CCQ was applied when dilatation was 8 cm. The MCSRS was administered two hours after delivery.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • being 18 years or older;
  • being in 37-42 weeks of pregnancy;
  • having a singleton pregnancy;
  • having a cervical dilatation of 1-4 cm;
  • being primiparous;
  • not having any complications that prevent vaginal delivery;
  • not having any extremity problems for using the birth ball and performing activities;
  • being able to speak and understand Turkish.
  • Exclusion criteria:
  • Having maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature rupture of membranes, presentation anomalies, intrauterine growth retardation, fetal anomaly, intrauterine death, fetal macrosomia, fetal distress, etc.),
  • getting pregnant by assisted reproductive techniques,
  • electing cesarean section.
  • Exclusion criteria in the research process:
  • To receive induction (oxytocin, prostaglandins, and misoprostol);
  • having a cesarean delivery due to any complications;
  • the baby admitted to the neonatal intensive care unit for any reason;
  • receiving analgesics.

排除标准

  • 未提供

结局指标

主要结局

Personal information form before intervention

时间窗: First 24 hours

Assessed using personal information. This instrument includes questions about women's sociodemographic, obstetric and childbirth readiness characteristics.

Evaluation of labor pain

时间窗: First 24 hours

Pain of pregnant women during labor was evaluated with Visual Analogue Scale (VAS). VAS scale, which would be applied to evaluate episiotomy pain in the postpartum period, was used to convert some values that cannot be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line. The participant was asked to indicate where his or her condition is suitable on this line by drawing a line or by placing a dot or pointing. "No pain" is written on one end and "very severe pain" on the opposite end; the participant was asked to mark the pain condition on this line.was used to convert some values that could not be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line.

Evaluation of Childbirth Satisfaction

时间窗: Postpartum 1sth hours (after birth first 1 hour)

Mackey Childbirth Satisfaction Rating Scale (MCSRS) evaluation to determine birth satisfaction form has been applied. The scale assesses women's satisfaction with the birth process. The scale consists of six 34-item subscales (nine items about self-satisfaction, two items about spouse's satisfaction, three items about baby's satisfaction, nine items about midwife-nurse satisfaction, eight items about doctor's satisfaction, three items about labor pain and labor. satisfaction). The scale is 5-point Likert type and is scored between 1 and 5. The lowest score in the scale is 32 and the highest score is 169, and as the total score increases, birth satisfaction also increases.

Evaluation of birth

时间窗: First 24 hours

Birth Follow-up Form was used to evaluate labor. This Birth Follow-up form is evaluating; partograph, effacement-dilatation at first admission to the hospital, presence of amniotic sac at first admission, presence of episiotomy, time from active phase of labor until dilation is complete, time until the baby's head comes out after full dilation.

Evaluation of Childbirth Comfort Questionnaire

时间窗: First 24 hours

Childbirth Comfort Questionnaire (CCQ) scales were applied to measure their comfort at the time of birth. The scale determines the comfort levels of women during childbirth. The real name of the scale is "Childbirth Comfort Questionnaire". The original scale consists of 14 items and is in a five-point Likert type. Each item is scored between 1-5.

Birth results information

时间窗: Postpartum 1sth hours (after birth first 1 hour)

Birth results information form evaluates; APGAR score at the 1st, 5th, and 10th minutes of the newborn; baby's gender.

次要结局

未报告次要终点

研究者

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

Seyhan Çankaya

Principal Investigator Seyhan Çankaya

Selcuk University

研究点 (2)

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