| 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
|
|
|
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
|
|
|
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
|
|
|
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. |