FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077052 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   "Effectiveness of Videos in Teaching Antenatal Mothers About Using a Birthing Ball During Labor" 
Scientific Title of Study   Assess the effectiveness of video assisted teaching on knowledge regarding use of birthing ball in labor among antenatal mothers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Achal Gulghane 
Designation  Post Graduate Student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Obstetrics and Gynecology, Antenatal ward no 11, first floor A.V.B.R. Hospital Sawangi Meghe

Wardha
MAHARASHTRA
442102
India 
Phone  8975112094  
Fax    
Email  achalgulghane4760@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Vaishali Taksande 
Designation  Professor cum Principal 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Obstetrics and Gynecology, Antenatal ward no 11, first floor A.V.B.R. Hospital Sawangi Meghe

Wardha
MAHARASHTRA
442102
India 
Phone  9970423710  
Fax    
Email  vtaksande@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Vaishali Taksande 
Designation  Professor cum Principal 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Obstetrics and Gynecology, Antenatal ward no 11, first floor A.V.B.R. Hospital Sawangi Meghe


MAHARASHTRA
442102
India 
Phone  9970423710  
Fax    
Email  vtaksande@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research  
Address  Sawangi Meghe Wardha 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishali Taksande  Acharya Vinobha Bhave Rural Hospital Sawangi Meghe Wardha  Department of Obstetrics and Gynecolgy Antenatal ward no 11 First floor A.V.B.R. Hospital Sawangi Meghe
Wardha
MAHARASHTRA 
9970423710

vtaksande@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NA 
Intervention  Video assisted teaching program  The video-assisted teaching program on using a birthing ball in labor for antenatal mothers provides essential guidance on the benefits, techniques, and safety of birthing balls. The program includes an introduction to the birthing ball, explanations of its benefits in easing labor pain and promoting fetal positioning, and demonstrations of various exercises and positions. It also covers safety measures, such as selecting the right ball size and ensuring proper use. The program concludes with a Q&A session and the distribution of educational materials to reinforce learning, helping mothers confidently incorporate the birthing ball into their labor plans. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Those are willing to participate in this study.
2. Mother those who are admitted for safe confinement.

 
 
ExclusionCriteria 
Details  1. Antenatal mother those who are in high-risk pregnancy. (Like Placenta previa, Placenta abruption, Pregnancy induced hypertension, Pre-eclampsia, Eclampsia).
2. Those who are having a planned in caesarean section.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Demographic variable: - Age of mothers, Gravida, Para, and sociodemographic status.
Assessment variable- Knowledge, Pain assessment by numerical pain rating scale (NPRS), Rate of vaginal delivery.
 
The ideal time to start video-assisted teaching on birthing ball use is during the third trimester (28-32 weeks) of pregnancy. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/12/2024 
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 Yet Recruiting 
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  

Abstract

Introduction: Pregnancy and childbirth are important life events for women. A woman’s body is ready for pregnancy and childbirth, two physiological processes, when she is ready to conceive, bear, and give birth to a child. Despite being physiological, labor pain can be extremely difficult for women to endure. Every woman deserves compassionate care during childbirth which addresses pain management and allows her the flexibility to design a one-of-a-kind, wonderful experience. Need of the study: - Motherhood - a safe experience where, Pain and joy are one at this moment to live. The main thing that deters women from enjoying Pain constitutes what labor and delivery are all about. When giving birth, images of pregnant women in agony, which they have seen in countless movies, pass through their minds, making them feel sick. Although they cannot be completely avoided, labor pains can be somewhat lessened by using both pharmaceutical and non-pharmacological methods. Aim: - Aim of the study to assess the efficacy of video assisted teaching on knowledge regarding use of birthing ball in labor among antenatal mothers. Material & method: - A set of systematic, disciplined procedures used in the deliberate gathering, analysing, and interpreting of the research approach is called data. The methodology employed for this investigation is explained in this chapter research design, target population classification, and accessible population. Planning the selection approach, the number of samples, included and excludes criterion (sample), tool preparation, research feasibility, validity, dependability, pilot research, and gathering of data and method of gathering information, and data analysis plan are all made easier by excellent research design. Additionally, it includes the subject selection process, experimental variable manipulation. Keywords:  Pregnancy in the Third Trimester, Pain, Labor, Birthing Ball, Birth ball exercise, Pain management, Childbirth.

 
Close