| CTRI Number |
CTRI/2026/02/104583 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Antenatal Education for Labor Pain and Breast feeding |
|
Scientific Title of Study
|
Enhancing Perinatal Outcomes through Early Antenatal Education and Parentcraft- based Labor Pain Coping Strategies. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivaranjani B |
| Designation |
Research Scholar |
| Affiliation |
School – Health Sciences, Physiotherapy, Garden City University |
| Address |
School – Health Sciences, Physiotherapy, Garden City University, 16th KM, Old Madras Road, Bangalore - 560 049.
Bangalore
KARNATAKA
560049
India |
| Phone |
9677051157 |
| Fax |
|
| Email |
shivasapphire8195@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivaranjani B |
| Designation |
Research Scholar |
| Affiliation |
School – Health Sciences, Physiotherapy, Garden City University |
| Address |
School – Health Sciences, Physiotherapy, Garden City University, 16th KM, Old Madras Road, Bangalore - 560 049.
Bangalore
KARNATAKA
560049
India |
| Phone |
9677051157 |
| Fax |
|
| Email |
shivasapphire8195@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivaranjani B |
| Designation |
Research Scholar |
| Affiliation |
School – Health Sciences, Physiotherapy, Garden City University |
| Address |
School – Health Sciences, Physiotherapy, Garden City University, 16th KM, Old Madras Road, Bangalore - 560 049.
Bangalore
KARNATAKA
560049
India |
| Phone |
9677051157 |
| Fax |
|
| Email |
shivasapphire8195@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panimalar Medical college Hospital and Research institute, Varadharajapuram, Poonamalle, Chennai-600123, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Shivaranjani B |
| Address |
14, Ambethkar st, Melpakkam, Morai, AVadi, Chennai-55 |
| 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 |
| Dr Shivaranjani B |
Panimalar Medical College Hospital and Research Institute |
Women’s Health Physiotherapist
Certified Childbirth Educator,
Certified Lactation Educator,
Pelvic Floor Rehab Specialist and Senior Physiotherapist, Department of Obstetrics & Gynecology.
Chennai
TAMIL NADU |
9677051157
shivasapphire8195@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE (PMCHRI-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY PREGNANT WOMEN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A- Pregnant women receive routine antenatal care and basic physical activity including walking. |
Pregnant women receive routine antenatal care and basic physical activity including walking. |
| Intervention |
Group-B-
1. Early Pregnancy Class
2. Parentcraft Class
3. Labor coping strategies during active labor
|
Begins around 22-32 weeks of gestation
2 session in 10 weeks
Session 1 – Pregnancy physical changes, coping with minor discomforts, fetal development, warning signs, breathing and relaxation exercise
Session 2 – postural awareness, back care, ergonomics, stability and strengthening exercise, defecation dynamics
|
| Intervention |
Group-C
(Early pregnancy and parentcraft classes) |
First stage of labor
Virtual reality with Labor
positions and breathing
Second stage of labor
1.Pelvic Floor relaxation technique
2. Positioning and breathing Technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women volunteers aged 18 – 35 years
Pregnant women after 22 weeks of gestation
Single viable fetus
Primipara with no complications during the antenatal period
|
|
| ExclusionCriteria |
| Details |
Preterm labor
Malpresentation of fetus
Cephalopelvic disproportion
Antepartum hemorrhage
Any medical complications like cardio-pulmonary disease of mother
Fetal abnormalities
Multiple gestations (Twins)
Psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
LABOR OUTCOME
Pain during labor – Rating scale of pain expression during childbirth
Mode of delivery – Rate of Vaginal delivery & C-section
Duration of first and second stage of labor (minutes)
|
22 weeks gestation till 7 days ater delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MATERNAL OUTCOME
Wijma Delivery Expectancy Questionnaire version A (WDEQ-A)
Breastfeeding self-efficacy scale short form (BSES-SF)
Rate of Early initiation of breastfeeding(EIBF) |
22 weeks of gestation & 7 days after delivery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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="1"
Days="2" |
|
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
|
This study explores the impact of structured antenatal education and parentcraft-based interventions on improving perinatal outcomes. It focuses on addressing the psychological distress—particularly fear and anxiety—commonly experienced by expectant mothers, which affects approximately 14% of women of reproductive age globally. These emotional challenges are often linked to increased rates of elective caesarean sections, reliance on epidural analgesia, and difficulties with breastfeeding initiation. By introducing early, culturally sensitive antenatal education and practical labor pain coping strategies, the study aims to empower mothers with knowledge, confidence, and emotional resilience. The intervention is designed to reduce childbirth-related anxiety, promote informed decision-making, and foster positive birth experiences. Ultimately, the research seeks to demonstrate how proactive educational support can lead to healthier outcomes for both mother and infant, while also advocating for the integration of parentcraft programs into routine maternal healthcare. |