| CTRI Number |
CTRI/2024/02/063346 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [group education intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A group educational intervention study to test how well a specific teaching method or program works by comparing it with other group provided with no intervention. |
|
Scientific Title of Study
|
Effectiveness Of Prenatal Group Education Intervention In Establishing Successful Breastfeeding Among Primiparous Mothers : intervention study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha |
| Designation |
MPH Scholar |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Community & Family Medicine
School of Public Health, MPH Wing
All India Institute Of Medical Sciences , Rishikesh
Veerbhadra road
Uttarakhand
249203
Department of Community & Family Medicine
School of Public Health, MPH Wing
All India Institute Of Medical Sciences , Rishikesh
Veerbhadra road
Uttarakhand
249203
Dehradun
UTTARANCHAL
-249203
India |
| Phone |
9654410639 |
| Fax |
|
| Email |
1215diksha.ds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenakshi Khapre |
| Designation |
Additional professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
All India Institute Of Medical Sciences , Rishikesh
Veerbhadra road
Uttarakhand
All India Institute Of Medical Sciences , Rishikesh
Veerbhadra road
249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8275395006 |
| Fax |
|
| Email |
drmeenaxi15@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Diksha |
| Designation |
MPH Scholar |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Community & Family Medicine
School of Public Health-MPH Wing
All India Institute Of Medical Sciences , Rishikesh
Veerbhadra road
Uttarakhand
Department of Community & Family Medicine
School of Public Health-MPH Wing
All India Institute Of Medical Sciences , Rishikesh
Veerbhadra road
Uttarakhand
249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9654410639 |
| Fax |
|
| Email |
1215diksha.ds@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Diksha |
AIIMS & SPS hospital |
1. OBYGN OPD of All India Institute Of Medical Sciences, Level 2 , ANC room
Veerbhadra road
2.OBYGN OPD of Shanti Prasann Sharma hospital,Ground floor, ANC room, Manvendera Nagar, Doiwala, District Dehradun, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL |
9654410639
1215diksha.ds@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 |
Primiparous pregnant females coming to OBGYN OPD during 8th & 9th months for ANC with no history of chronic disease, and are in apparently healthy condition. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group Education intervention |
In the experimental arm, a skill-based group intervention will be provided to the mothers in addition to the routine basic education in Hindi. This group intervention will consist of structured 1 hour face to face educational sessions conducted by the researcher. For breast feeding techniques we will provide them dummy doll and breast to practice breast feeding techniques at the end of session.
Lesson Plan
Breakdown of the 1-hour face-to-face session for providing group education on successful breastfeeding to primiparous mothers:
a.5 minutes division :
1.Introduction & briefing about the session and to know about their knowledge and experience about breastfeeding.
b.10 minutes division :
1.Benefits of breastfeeding for baby and mother.
2.Common challenges faced in breastfeeding.
3.Addressing common myths about breastfeeding.
c.30 minutes division:
1.Breastfeeding techniques.
2.Demonstrate the proper technique for breastfeeding using baby dolls or models.
3.Discuss the importance of a proper latch and positioning.
4.Explain how to recognize when the baby is getting enough milk.
5.Demonstrate the use of a breast pump and how to store breast milk.
d.15 minutes division :
1.Feedback about the session.
2.Question and answer session.
e.Follow-ups:
1.Weekly tailored messages via WhatsApp on a fixed day to provide additional information and support.
2.Consultation availability if needed for individual assistance or clarification.
1st contact - during ANC visit in last trimester
2nd contact - post delivery within 24-72 hours of delivery
|
| Comparator Agent |
Standard knowledge given during their ANC visit |
1st contact - during ANC visit in last trimester
2nd contact - post delivery within 24-72 hours of delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
females becoming mothers for the first time with no previous experience of breastfeeding |
|
| ExclusionCriteria |
| Details |
Females becoming mothers for the first time with history of current chronic illness
Females denying to participate in the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantitative analysis of early initiation of breastfeeding among primiparous females |
last trimester ANC visit to provide with the intervention, followed up post delivery within 24-72 hours of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing early initiation of breastfeeding among primiparous females in intervention & control arm |
3rd trimester ANC visit & post delivery within 24-72 hours of delivery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
03/03/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
Breastfeeding self-efficacy is a modifiable factor that can be improved by educational interventions and support from health professionals. Therefore, it is important for health professionals to provide mothers with adequate information and support to improve their self-efficacy and encourage them to initiate breastfeeding early. This can have positive impacts on the health and well-being of both mothers and infants. Demonstrations and group education are two effective tools that can be used to improve self-efficacy. |