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CTRI Number  CTRI/2025/08/093812 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 27/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Childbirth preparedness and Parenting educational intervention 
Scientific Title of Study   The effect of childbirth preparedness and parenting educational intervention on maternal stress and childbirth experience among primigravida women in a selected hospital, Odisha. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharitri Swain 
Designation  Assistant Professor 
Affiliation  AIIMS BHUBANESWAR, ODISHA 
Address  College of Nursing, Room No-102, All India Institute of Medical Sciences(AIIMS),Bhubaneswar, Odisha Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  9438884272  
Fax    
Email  dhari79@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dharitri Swain 
Designation  Assistant Professor 
Affiliation  AIIMS BHUBANESWAR, ODISHA 
Address  College of Nursing, Room No-102, All India Institute of Medical Sciences(AIIMS),Bhubaneswar, Odisha Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  9438884272  
Fax    
Email  dhari79@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Sayantika Dutta 
Designation  Msc Nursing student 
Affiliation  AIIMS BHUBANESWAR, ODISHA 
Address  College of Nursing, Room No-LT 5, All India Institute of Medical Sciences(AIIMS),Bhubaneswar, Odisha Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  8918738619  
Fax    
Email  sduttakandi742137@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of medical sciences, Bhubaneswar, Odisha  
 
Primary Sponsor  
Name  AIIMS BHUBANESWAR 
Address  SIJUA, BHUBANESWAR,KHURDHA ODISHA  
Type of Sponsor  Research institution and hospital 
 
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 
Dr Arati Satapathy  Khordha district hospital   Labour room, Maternity and labor ward and OPD. Khordha Obstetric and gynecological department. Room no-3 ORISSA
Khordha
ORISSA 		 9437111323

aratisatapathy123@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
All India Institute of Medical Sciences   Approved 
OFFICE OF THE CHEIF DISTRICT MEDICAL AND PUBLIC HEALTH OFFICER KHORDHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  O26.9: Pregnancy-related condition, unspecified Z34.0: Supervision of normal first pregnancy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Childbirth preparedness and parenting educational intervention  3-session structured educational program from 36–39 weeks gestation: Progressive Muscle Relaxation and Breathing Exercises Childbirth Preparation (stages, positions, non-pharmacological pain relief, support person training) Parenting Education (infant care, breastfeeding, parenting strategies) Mode: Video-Assisted Training (VAT), teaching aids, home practice with WhatsApp reminders and weekly follow-up 
Comparator Agent  Routine antenatal care after 36 weeks as per hospital protocol  Routine antenatal care will be provided by midwives as per the hospital guidelines. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Primigravida women attending ANC at Khordha District Hospital

Gestational age 36 weeks and above

Willing to participate and provide informed consent 
 
ExclusionCriteria 
Details  Diagnosed psychological disorders (depression, anxiety)

Diagnosed fetal anomalies (neural tube defects, congenital heart disease, cleft lip/palate, Down syndrome, chromosomal abnormalities)

Participation in other antenatal educational programs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in maternal stress
2.Childbirth experience 		 After 3 interventional session 
 
Secondary Outcome  
Outcome  TimePoints 
Breastfeeding Self-Efficacy  Postpartum Day 3 
 
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 3 
Date of First Enrollment (India)   13/10/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dhari79@yahoo.co.in].

  6. For how long will this data be available start date provided 12-08-2026 and end date provided 12-08-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to evaluate whether providing structured childbirth preparedness and parenting education can reduce stress and improve childbirth experiences for first-time mothers. Many women experience fear, anxiety, and uncertainty about labor and parenting, which can negatively impact both mother and baby. The intervention includes relaxation exercises, guidance on labor and delivery, non-drug pain relief methods, and parenting education (including breastfeeding and newborn care). Participants in the experimental group will receive three sessions of video-assisted education with follow-up support, while the control group will receive routine hospital care. The study will measure changes in stress, childbirth experience, and breastfeeding confidence. Findings may help improve antenatal education programs in India and contribute to better maternal and neonatal outcomes. 
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