| CTRI Number |
CTRI/2023/11/059967 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which is Better for New Moms: Hands-on Simulation or Video Training for Breastfeeding? A Study |
|
Scientific Title of Study
|
Simulation-based versus video-based training of primiparous mothers for effective breastfeeding: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti |
| Designation |
Paediatrics Resident |
| Affiliation |
Maharaja Agrasen Medical College, Agroha |
| Address |
New Campus, Maharaja Agrasen Medical College,Agroha
Jind
HARYANA
125047
India |
| Phone |
7988219200 |
| Fax |
|
| Email |
jyotigarg2496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
Professor and HOD |
| Affiliation |
Maharaja Agrasen Medical College, Agroha |
| Address |
Maharaja agrasen medical college, dept of paediatrics.
Hisar
HARYANA
125047
India
Hisar
HARYANA
125047
India |
| Phone |
8930200825 |
| Fax |
|
| Email |
paediatrics@mamc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti |
| Designation |
Paediatrics Resident |
| Affiliation |
Maharaja Agrasen Medical College, Agroha |
| Address |
New Campus, Maharaja Agrasen Medical College,Agroha
Jind
HARYANA
125047
India |
| Phone |
7988219200 |
| Fax |
|
| Email |
jyotigarg2496@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agrasen Medical College,Agroha |
|
|
Primary Sponsor
|
| Name |
Dr Jyoti |
| Address |
New Campus, Maharaja Agrasen Medical College, Agroha |
| 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 Jyoti |
Maharaja Agrasen Medical College,Agroha |
Department of Paediatrics and Obstetrics
Hisar
HARYANA |
7988219200
jyotigarg2496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research , Maharaja Agrasen Medical College, Agroha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z391||Encounter for care and examinationof lactating mother, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Simulation based training |
The simulation-based training will be for 30 minutes and the same simulation equipment will be used for all the participants of the group |
| Comparator Agent |
Standardized video based training |
The standard video will be displayed on a 56-inch television for training the mother in the demonstration room. Any query of the mother will be addressed by the trainer within 30 minutes of session. The same video will also be shared by multimedia/social media on the mothers phone. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primiparous mothers whose babies are term (37 0/7 to 41 6/7 weeks) and physiologically stable |
|
| ExclusionCriteria |
| Details |
1. Primiparous mothers whose babies are preterm (<37 weeks) 2. Primiparous mothers whose babies are admitted in Neonatal Intensive Care Unit (NICU)
3. Primiparous mothers admitted in Intensive Care Unit (ICU)
4. Mothers who refused to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre and post-training LATCH score |
Two Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
23/11/2023 |
| 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="1"
Days="6" |
|
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
|
Breast milk is the natural and ideal food for healthy growth and development of newborn. Exclusive breast feeding for 6 months of life is the optimal way of feeding infants.Considering the importance of breastfeeding, we designed this study to improve breastfeeding by training mothers and to find out the better method of breastfeeding training out of two methods i.e. video based or simulation based training. We have chosen the LATCH scoring system for this study which is a simple breastfeeding assessment tool that has been used to assess breastfeeding practices. A trained person will be assigned to do LATCH scoring in these mothers within 24 hours of delivery. After pre-training LATCH scoring, the mothers will be randomly allocated to one of the two training groups by an online generated random number table. Group A will be trained in breastfeeding through Lactation Simulation Model while group B will be trained using standardized video. Allocation concealment will be done by Sequentially numbered opaque sealed envelopes (SNOSE) method. Again, LATCH scoring will be done at 48 hours of delivery by the same person who assessed LATCH scoring earlier. LATCH score improvement in both groups will be compared and data will be assessed for the result by a data analyst who will be blinded for the type of groups. |