| 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
|
|
|
Primary Sponsor
|
| Name |
Shreya Sharma |
| Address |
Faculty of Physiotherapy Chandu Budhera Village 122505 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |