| 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
|
|
|
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
|
|
|
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. |