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CTRI Number  CTRI/2025/10/096194 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Other 
Public Title of Study   Effectiveness of parenting skill empowerment program on knowledge, attitude and expressed practice among primigravida mothers. 
Scientific Title of Study   A study to assess the effectiveness of parenting skill empowerment program on knowledge, attitude and expressed practice among primigravida mothers at Obstetrics & Gynecology OPD of the tertiary care hospital in Andhra Pradesh. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kusumlata Kumari 
Designation  MSc Nursing Student 
Affiliation  AIIMS Mangalagiri 
Address  Room no.-103, College of Nursing, AIIMS Manglagiri, Guntur, Andhra Pradesh, 522503.

Guntur
ANDHRA PRADESH
522503
India 
Phone  7294153349  
Fax    
Email  kusumrmch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Danasu R 
Designation  Professor cum Principal 
Affiliation  AIIMS Mangalagiri 
Address  Room no.-414,fourth floor, College of Nursing, AIIMS Mangalagiri, Guntur, Andhra Pradesh, 522503.

Guntur
ANDHRA PRADESH
522503
India 
Phone  8946093068  
Fax    
Email  drdanasu@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query
 
Name  Kusumlata Kumari 
Designation  MSc Nursing Student 
Affiliation  AIIMS Mangalagiri 
Address  Room no.-103, College of Nursing, AIIMS Manglagiri, Guntur, Andhra Pradesh, 522503.

Guntur
ANDHRA PRADESH
522503
India 
Phone  7294153349  
Fax    
Email  kusumrmch@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Kusumlata Kumari 
Address  Room No.-007, pg female hostel, AIIMS Mangalagiri, Guntur, Andhra Pradesh, 522503. 
Type of Sponsor  Other [Self] 
 
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 
Kusumlata Kumari  AIIMS, Mangalagiri  Room no-103, First Floor, College of Nursing building, All India Institute of Medical Sciences, Mangalagiri
Guntur
ANDHRA PRADESH 
7294153349

kusumrmch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Mangalagiri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Parenting Skill Empowerment Program   Administration of systematically designed, structured three interventional sessions of which session one will be an educational session for 30 minutes to provide knowledge about Parenting skill regarding newborn care including breastfeeding & positioning, burping, swaddling, eye care, cord care, bathing, safe hygienic practices, safe sleep practices, console crying, immunization, maintenance of body temperature, identification of warning signs . It will be delivered through interactive lecture cum discussion with the help of audio-visual aids. Session two will be demonstration of selected components of parenting skill including breastfeeding positions, and burping positions for 20 minutes. Session three will be an interactive Question-answer & re-demonstration session for 10 minutes. Also, the participants will be provided an information leaflet for further reinforcement of the study.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Primigravida mothers who are:
1.In 3rd trimester (28 weeks onwards).
2.Visiting OPD of selected tertiary care hospital of AP.
3.Understanding Telugu & English.
4.Willing to participate.
 
 
ExclusionCriteria 
Details  Primigravida mothers-
1.With high-risk pregnancy (GDM, PIH, Oligohydramnios).
2.With fetal abnormalities (Down Syndrome, IUGR, Renal Agenesis).
3.Who are previously exposed to similar parenting programs.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge, Attitude and Expressed Practice.  Baseline Day, Day 30. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   11/11/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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
Modification(s)  

Primigravida mothers often face numerous challenges during the transition to motherhood, including anxiety, stress, and uncertainty due to their lack of experience in newborn care. These challenges, if not addressed, can negatively impact both maternal confidence and neonatal outcomes. Empowering first-time mothers with appropriate parenting knowledge, attitude, and skills is essential for improving maternal preparedness and ensuring the health and well-being of the newborn. The present study aims to assess the effectiveness of a Parenting Skill Empowerment Program (PSEP) on knowledge, attitude, and expressed practice among primigravida mothers attending the Obstetrics and Gynecology OPD of a tertiary care hospital in Andhra Pradesh. A quantitative quasi-experimental one group pre-test post-test design will be adopted, involving 60 primigravida mothers selected through convenience sampling. The intervention will include structured educational sessions focusing on essential newborn care practices such as breastfeeding, bathing, immunization, cord care, positioning, burping, and identification of warning signs. Data will be collected using self-structured tools and analyzed using descriptive and inferential statistics to assess the effectiveness of the intervention and the association of demographic variables with the outcomes. The conceptual framework of the study is based on Pender’s Health Promotion Model, emphasizing empowerment, self-efficacy, and behavior change. The study is expected to show significant improvement in the knowledge, attitude, and practices of primigravida mothers post-intervention. Findings may help in promoting parenting education as a part of routine antenatal care, particularly in tertiary care settings, and may contribute to the reduction of maternal and neonatal complications. This study highlights the importance of culturally relevant, empowerment-focused programs in strengthening maternal and child health strategies in Andhra Pradesh.

 

 
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