跳至主要内容
临床试验/CTRI/2025/05/087646
CTRI/2025/05/087646尚未招募不适用

The effect of exercises performed on birthing ball on labor pain and duration of labor- A Randomised controlled trial

Akanksha Singh1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
1)To compare intensity of labor pain during active stage of labor at 5cm and at 9cm using Visual Analog Scale (VAS) among the two groups ( one whom intervention will be used and one without intervention.)

研究概览

简要总结

This study is a non randomised control trial to find out the effect ofexercises performed on birthing ball on labor pain and duration of labor inactive phase of labor among primiparous anternatal women at term, who will beadmit in AIIMS PATNA labor ward. Labour pain can be extremely intense andprolonged, making them challenging for many women to endure without medicalintervention or support. Birthing ball can be a effective nonpharmacological method of pain relief during labor without side effect and would have better outcomes for both mother and baby. Birthing ballexercises by its impact on pelvic structure/dimension may help in fetal descentand cervical dilatation, and will significantly reduce maternal pain in laborand reduce labor duration. Informed consent will be obtained from antenatalwomen before conduction of study. This study will be done in 74 primiparousantenatal women at term (37-42week POG) with singelton pgegnancy with cephalicpresentation in active stage of labor. patient will be randomised between 2group intervention and control group.Intervention group recieve birthingball exercise (4cycle of 15 min exercise at an interval of 45 min) as wellas routine care and control group will recieve only routine care. Exercisesinclude- 3 Simple exercises  – bouncing on ball, rocking left toright , hip circles. Outcome will be measured by visual analogue scale (VAS)  for pain duringlabor at 2 time points (at 5cm, and 9 cm cervical dilatation ) as primaryoutcome, determining the length of labor by measuring cervical dilatationusing  partograph (WHO labor care guide)and measuresubjective outcome of childbirthsatisfaction  using  childbirth experience questionnaire(CEQ2) as secondary outcome.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • •1.primigravida antenatal women at term POG(37-42week) singleton pregnancy with cephalic presentation.
  • •2.primigravida at term who are in active stage of labor.
  • •undergone labor spontaneously / by induction.
  • •3.willing to participate in study.

排除标准

  • •1.Patient not giving consent 2.Maternal complications (Oligohydramnios, Polyhydramnios, Placenta previa, Preeclampsia, PROM, Inadequate pelvis, physical abnormality, chronic pelvic pain).
  • •3.Fetal complication ( Malpresentation, IUGR, fetal anomaly, intrauterine death, fetal macrosomia, fetal distress) 4.Elective and Emergency cesarean section in 1st stage of labor 5.Having any complications that prevent vaginal delivery, having any extremity problems for using the birth ball and performing activities.

结局指标

主要结局

1)To compare intensity of labor pain during active stage of labor at 5cm and at 9cm using Visual Analog Scale (VAS) among the two groups ( one whom intervention will be used and one without intervention.)

时间窗: during active stage of labor at 5cm and at 9cm using Visual Analog Scale (VAS)

次要结局

  • To compare subjective outcomes of childbirth experience using Childbirth Experience Questionaire 2( CEQ-2 ) between the two groups(after delivery of baby)
  • To determine the duration of the active stage of labor using labor care guide in both group of patient(duration of active stage of labor (from 5cm to 10cm cervical dialatation ))

研究者

发起方
Akanksha Singh
申办方类型
Other [self]

研究点 (1)

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