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CTRI Number  CTRI/2025/04/084229 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of 30 vs. 60 Minutes of Swiss Ball Exercise During Labor: A Randomized Trial 
Scientific Title of Study   Comparing the Efficacy of 30 Minutes to 60 Minutes Swiss Ball Exercise During Labor: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreya Sharma 
Designation  MPT Student 
Affiliation  Faculty of Physiotherapy, SGT University  
Address  Department of faculty of Physiotherapy
SGT University, Badli Road,Chandu,Budhera,Gurugram
Gurgaon
HARYANA
122505
India 
Phone  8250694306  
Fax    
Email  shreya.sharma.ss928@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Renuka Jakhar 
Designation  Assistant Professor 
Affiliation  Faculty of Physiotherapy, SGT University  
Address  Department of Faculty of Physiotherapy,
SGT University,Badli Road,Chandu, Budhera,Gurugram
Gurgaon
HARYANA
122505
India 
Phone  8708330923  
Fax    
Email  renuka_fphy@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Shreya Sharma 
Designation  MPT Student 
Affiliation  Faculty of Physiotherapy, SGT University  
Address  Department of Faculty of Physiotherapy
SGT University, Badli Road,Chandu, Budhera,Gurugram
Gurgaon
HARYANA
122505
India 
Phone  8250694306  
Fax    
Email  shreya.sharma.ss928@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Shreya Sharma 
Address  Faculty of Physiotherapy Chandu Budhera Village 122505 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrShreya Sharma  SGT Hospital  Labour Room,Ground Floor, Department of Obstetric and Gynaecology
Gurgaon
HARYANA 
8250694306

shreya.sharma.ss928@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Ethical Committee,Faculty of Physiotherapy, SGT University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A-Swiss Ball Exercise for 30 minutes  Patients will perform Swiss Ball exercises for 30 minutes which includes 6 different exercises: a)gently bouncing on the ball, b)Rock side to side. c)Pelvic tilt front to back. d)Hip circles e)Rocking front to back or side to side on knees. f)Supported squats. Each exercise will be performed for 4 minutes with 1 minute rest.  
Intervention  Group B-Swiss ball Exercise for 60 minutes  Patients will perform Swiss Ball exercises for 60 minutes which includes 6 different exercises: a)gently bouncing on the ball, b)Rock side to side. c)Pelvic tilt front to back. d)Hip circles e)Rocking front to back or side to side on knees. f)Supported squats Each exercise will be performed for 4 minutes with 1 minute rest with 2 sets.  
Comparator Agent  Group C- Control Group  Patient will be given routine ante-natal practice 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. 18 years or above.
2. Pregnant women.
3. 37-42 weeks pregnant.
4. Cervical dilatation of 1-4cm.  
 
ExclusionCriteria 
Details  1. Any maternal/fetal complication.
2. Getting pregnant via assisted devices.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intensity of pain assessed by Visual Analog Scale
Duration of Labor  
4cm dilatation and 9cm dilatation
After delivery in hours 
 
Secondary Outcome  
Outcome  TimePoints 
Intensity of pain assessed by SF-McGill Pain Questionnaire
Maternal Satisfaction assessed by Satisfaction Visual Analog Scale
APGAR SCORE 
Pre intervention
and
Post intervention
After delivery
After childbirth 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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