跳至主要内容
临床试验/CTRI/2025/04/084229
CTRI/2025/04/084229尚未招募不适用

Comparing the Efficacy of 30 Minutes to 60 Minutes Swiss Ball Exercise During Labor: A Randomized Controlled Trial

Shreya Sharma1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
47
试验地点
1
主要终点
Intensity of pain assessed by Visual Analog Scale

研究概览

简要总结

Pain that is both acute and continuous during labor can have negative effects on both the mother and the fetus, sometimes even changing the course of childbirth. The WHO suggests non-pharmacological pain management techniques for laborers, which is the standard phrase for physiotherapy interventions and other non-pharmacological techniques that include biomechanical and psychological therapies Italian plastics producer Aquilino Cosani created the Swiss ball in 1963. American physiotherapists gave this moniker in 1989 after adopting it in the United States and seeing its advantages in Switzerland. This device, also known as a birth ball, has been used to help women during labor for a few years now as it helps with pain relief and the progression of this stage Given that labor pain is a physiological phenomena, giving birth will always involve some degree of discomfort. However, under certain conditions, the invasive techniques employed in medicalized labor and delivery may make this agony worse.Numerous studies have shown that mothers’ fear of labor pains leads them to want caesarian sections (C/S), which has raised the number of C/S cases.3,4 In Iran, the C/S rate in public hospitals has increased to 40–50%. In order to feel less discomfort, up to 60% of Iranian women are interested in C/S.5. Even though the death rate from C/S is reportedly five times higher than that of a typical vaginal delivery, experiencing excruciating pain may influence a woman’s choice for delivery method in subsequent pregnancies.There are three local observational studies found that Chinese women using birth balls in public hospitals in Hong Kong expressed strong acceptability and high satisfaction (over 90%) with the procedure. There is inadequate data to support the use of birth balls by expectant mothers and the associated consequences of childbirth. So far, four randomised controlled trials (RCTs) throughout Spain, Taiwan, Iran, and Brazil have been carried out, along with one systematic review with a meta-analysis. Due to chance and bias, it would be challenging to determine the true effect size of a birth ball on pain control because these RCTs have been tiny, with just 220 participants.The three main benefits of birth ball exercise during pregnancy are improved posture, relaxation, and strengthened and stretched muscles. According to Sekendiz et al., (2012), birth ball exercises improve the trunk, lower back, and quadriceps’ strength, resistance, flexibility, and balance. A clinical trial was carried out by Chang et al., (2011) to ascertain the impact of birth ball exercises in the latter stages of pregnancy. The intervention group had a lower rate of cesarean sections than the control group, which did not engage in any physical activity.Perez and Simkin (2018) were the first to employ the birth ball as a labor aid. According to Perez, birth balls are helpful during pregnancy and childbirth, and in recent times, they have also been employed as a labor support device. Midwives were the ones who initially employed the birth ball to quicken the labor’s progression and lessen contraction pain. Benefits of the birth ball have reportedly included lowering anxiety levels, lessening the perception of labor pain, reducing the length of the initial stage of labor, enhancing the satisfaction of giving birth, and assisting the fetal head’s fall. In the studies, it has been suggested that the birth ball can be used actively to assist labor as it shortens the labor time and supports the pelvic floor muscles.Birth ball exercises are also suggested to have other benefits for pregnant women, such as lowering anxiety in laboring women, reducing the frequency of opiate use, facilitating fetal head rotation and descent, shortening labor duration, and improving women’s satisfaction and well-being**.**This research focuses on exploring the effectiveness of active pelvic exercises on a Swiss ball during labor, a topic that has received limited attention in existing literature. It aims to provide novel insights into the benefits of this specific modality, comprehensively evaluating labor progression and pain perception through standardized assessments. Additionally, the research highlights the potential cost-effectiveness and accessibility of Swiss balls, suggesting them as a valuable tool for promoting efficient labor and pain relief, particularly in resource-constrained settings. The aim of this study is to evaluate the effectiveness of active pelvic exercises on a Swiss ball in promoting efficient labor and alleviating pain during childbirth.

Null Hypothesis

N

H (0 1): There will be no significant difference in pain perception, satisfaction and APGAR Score during labor between women who perform active pelvic exercises on a Swiss ball for 30 minutes and 60minutes.

H (0 2): There will be no significant difference in pain perception, satisfaction and APGAR Score during labor between women who perform active pelvic exercises on a Swiss ball for 30 minutes and control group.

H (03): There will be no significant difference in pain perception, satisfaction and APGAR Score during labor between women who perform active pelvic exercises on a Swiss ball for 60 minutes and control group.

Alternate Hypothesis

H(#1): There will be a significant difference in and pain perception, satisfaction and APGAR Score during labor between women who perform active pelvic exercises on a Swiss ball for 30 minutes and 60 minutes.

H(#2): There will be a significant difference in and pain perception, satisfaction and APGAR Score during labor between women who perform active pelvic exercises on a Swiss ball for 30 minutes and control group.

H(#3): There will be a significant difference in and pain perception, satisfaction and APGAR Score during labor between women who perform active pelvic exercises on a Swiss ball for 60 minutes and control group.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 18 years or above.
  • Pregnant women.
  • 37-42 weeks pregnant.
  • Cervical dilatation of 1-4cm.

排除标准

  • Any maternal/fetal complication.
  • Getting pregnant via assisted devices.

结局指标

主要结局

Intensity of pain assessed by Visual Analog Scale

时间窗: 4cm dilatation and 9cm dilatation | After delivery in hours

Duration of Labor

时间窗: 4cm dilatation and 9cm dilatation | After delivery in hours

次要结局

  • Intensity of pain assessed by SF-McGill Pain Questionnaire(Maternal Satisfaction assessed by Satisfaction Visual Analog Scale)

研究者

发起方
Shreya Sharma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shreya Sharma

Faculty of Physiotherapy, SGT University

研究点 (1)

Loading locations...

相似试验