| CTRI Number |
CTRI/2025/08/093031 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Effectiveness of Nurse led self efficacy based module ] |
| Study Design |
Other |
|
Public Title of Study
|
A study to help first time mothers breastfeed better with support from Nurse |
|
Scientific Title of Study
|
A mixed method study to assess the effectiveness of a nurse led self efficacy based module on lactational health-promoting behavior and explore lactation satisfaction among primimothers. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seethi Suseela |
| Designation |
Associate Professor/PhD Scholar |
| Affiliation |
College of Nursing Sciences, Dayananda Sagar University |
| Address |
Room No HS014, College of Nursing Sciences, Dayananda Sagar University, Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South
Bangalore
KARNATAKA
562112
India |
| Phone |
9035120225 |
| Fax |
|
| Email |
susireddyrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jamuna PP |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing Sciences, Dayananda Sagar University |
| Address |
Room No HS014,College of Nursing Sciences, Dayananda Sagar University, Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South
Bangalore
KARNATAKA
562112
India |
| Phone |
9901600987 |
| Fax |
|
| Email |
drjamuna-nsg@dsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Seethi Suseela |
| Designation |
Associate Professor/PhD Scholar |
| Affiliation |
College of Nursing Sciences, Dayananda Sagar University |
| Address |
Room No HS014, College of Nursing Sciences, Dayananda Sagar University, Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South
Bangalore
KARNATAKA
562112
India |
| Phone |
9035120225 |
| Fax |
|
| Email |
susireddyrs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research Hospital, Devarakaggalahalli, Harohalli, Kanakapura Road, Begaluru South- 562112. It provides infrastructural support, access to antenatal and postnatal mothers and their records, and clinical facilities. |
|
|
Primary Sponsor
|
| Name |
Seethi Suseela |
| Address |
Room No HS014, College of Nursing Sciences, Dayananda Sagar University, Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South Dist-562112 |
| 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 Raksha SK |
Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research Hospital |
Room No 7,8 and ward No 2,3, Department of OBG and Department of paediatrics, Devarakaggalahalli, Harohalli, Kanakapura Road, Bengaluru South-562112.
Bangalore
KARNATAKA |
09880857270
raksharaosk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Antenatal and postnatal mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nurse led self efficacy based module |
Nurse led self efficacy based module which includes teaching on breastfeeding, demonstration of breastfeeding techniques, videos, information guide handouts, and deep breathing exercises. This module will be given 2 times between 32-40 weeks of gestation. Post test will be conducted on postnatal day 3 and week 6. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Antenatal mothers who are able to use android mobile.
2)Antenatal mothers who are in 32-40 weeks of gestation.
3)Antenatal mothers who are Willing to participate
4)First-time mothers (no prior childbirth experience)
|
|
| ExclusionCriteria |
| Details |
1)Antenatal mothers having medical conditions contraindicating breastfeeding.
2)Antenatal mothers with fetal demise.
3)High-risk pregnancies with severe obstetric complications
4)Antenatal mothers taking medications that interfere with breastfeeding (e.g., chemotherapy, antipsychotic drugs)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in lactational health-promoting behavior |
Postpartum day 3 and week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Increase in self-efficacy related to breastfeeding
2.Improves knowledge on breastfeeding.
3. Lactation satisfaction |
Postpartum day 3 and week 6 |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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 2 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
This mixed-method research aims to assess the effectiveness of a nurse-led self-efficacy-based module on lactational health-promoting behavior and to explore lactation satisfaction among primiparous mothers. The intervention will be given 2 times between 32-40 weeks of gestation. The quantitative phase will involve assessing changes in self-efficacy, lactational behavior, and knowledge before and after the intervention on postpartum day 3 and week 6. The qualitative phase will explore mothers’ experiences and satisfaction with lactation. The study intends to empower new mothers by enhancing their confidence and promoting positive breastfeeding practices.
|