| CTRI Number |
CTRI/2024/07/071632 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NURSE LED LACTATION MANAGEMENT TRAINING] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of breastfeeding management training programme to improve knowledge and practice about breast feeding among antenatal and postnatal mothers. |
|
Scientific Title of Study
|
Effect of Nurse Led Lactation management training on practice of Exclusive breast feeding ,Growth of child and maternal outcome among primi mothers in IMS &SUM Hospital of Bhubaneswar |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rubi Pradhan |
| Designation |
Associate Professor |
| Affiliation |
SUM Nursing College, Siksha O Anusandhan University,Bhubaneswar. |
| Address |
SUM Nursing College, Room no 4,2nd floor,Faculty of Nursing, Siksha O Anusandhan University Campus-2, Kalinga Nagar, Ghatikia, Bhubaneswar. Odisha.
Khordha
ORISSA
751003
India |
| Phone |
9338936472 |
| Fax |
|
| Email |
rubipradhan@soa.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rubi Pradhan |
| Designation |
Associate Professor |
| Affiliation |
SUM Nursing College, Siksha O Anusandhan University,Bhubaneswar. |
| Address |
SUM Nursing College, room no 4,2nd floor, Siksha O Anusandhan University Campus-2, Kalinga Nagar, Ghatikia, Bhubaneswar. Odisha.751003
Khordha
ORISSA
751003
India |
| Phone |
9338936472 |
| Fax |
|
| Email |
rubipradhan@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof, Dr. Pravati Tripathy |
| Designation |
Dean |
| Affiliation |
SUM Nursing College, Siksha O Anusandhan University,Bhubaneswar. |
| Address |
SUM Nursing College, Ground floor, Dean room, Siksha O Anusandhan University Campus-2, Kalinga Nagar, Ghatikia, Bhubaneswar. Odisha.751003
Khordha
ORISSA
751003
India |
| Phone |
7008578880 |
| Fax |
|
| Email |
pravati.tripathy@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUM Nursing College, Siksha O Anusandhan University. Kalinga Nagar, Ghatikia, Bhubaneswar, Odisha, India. 751003 |
|
|
Primary Sponsor
|
| Name |
Rubi Pradhan |
| Address |
SUM Nursing College,Room no 4, 2nd floor,Siksha O
Anusandhan University, Bhubaneswar. Odisha. |
| 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 |
| DrPravati Tripathy |
Institute of Medical Sciences, SUM Hospital |
Gynaecology OPD,Room no-4 IMS &
SUM Hospital, K-8,
Kalinga Nagar,
Bhubaneswar,
751003
Khordha
ORISSA
Khordha
ORISSA |
9437035927
pravati.tripathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IMS & SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, (3) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
controlgroup |
The control group will only receive the standard treatment and general counselling |
| Intervention |
NURSE LED LACTATION MANAGEMENT TRAINING |
Session 1 (Antenatal counseling from 3rd trimester)
Introducing the researcher, the objectives, breast feeding attrition prediction tool to understand and analyze the problems of breast feeding knowledge of subjects, on the basis of the results, the researcher will provide individualized intervention by face to face.
Session 2(Immediately after delivery upto discharge) Assess the breast feeding by practice check list,then promoting knowledge by understanding the worries or concerns, support from other family members, early positioning and attachment of the baby at the breast and the importance of colostrum for the infant(ppt, demonstration).
Session 3(On day-7 during Routine check-up)
Assess the breast feeding, counselling the mothersabout appropriate breast feeding practices, teaching the mother about importance of rest, good positioning and attachment, frequent breast feeding, balanced diet and preparation of breast before feeding.(ppt,demonstration)
Session 4(On day 15)
Researcher asked for details of breast feeding situation, assess the breast feeding, teach the mother about the importance of exclusive breast feeding for both mother and infant, regarding adequacy of breast milk, helping mother to increase her milk supply by increasing mother’s confidence,and relaxation technique to be used by mothers.(leaflets)Session 5(On 6th weeks During routine immunization)
Researcher asses the breast feeding status, counselling mothers about appropriate breast feeding practices, demonstrate in managing selected breast problems (eg mastitis ,engorged breast and breast abscess) (health education)
Session 6(on 10th week during routine immunization)
Assess the breast feeding and provide support accordingly.
Session 7(on 14th week during routine immunization)
Assess the breast feeding and need based counselling will be provided.
Session 8(on 4and half month )
Researcher assess the breast feeding status, counselling mothers about appropriate breast feeding practices, discuss options for working mothers to continue exclusive breast feeding, methods of expressing, storing and feeding expressed breast milk to their babies.
Session 9(on 6 month)
A review of the discussed points, receiving feedback from the members regarding the discussed points, question and answer, group discussion, and completing the knowledge questionnaire, practice check list and maternal satisfaction evaluation tool.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age of 18 years or more,more than 34 gestational week and had no complications that prevent from breast feeding |
|
| ExclusionCriteria |
| Details |
contraindications to breast feed due to medical conditions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exclusive breast feeding practices . |
3rd trimester of pregnancy to 6 months post partum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
growth of infants
maternal outcome |
delivery to 6 months post partum |
|
|
Target Sample Size
|
Total Sample Size="285"
Sample Size from India="285"
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)
|
16/08/2024 |
| 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="1"
Months="0"
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
|
primary purpose of the protocol: Evidence supports that breastfeeding support offered to women increases both duration and exclusivity of breastfeeding before four to six weeks and after six months of age. Among the wide range of interventions, greater effect for exclusive breastfeeding is associated with face-to-face support.Hence the investigator found this topic as the demand of the situation and is the Novelty of the study to investigate the same.
Hypothesis: HO1: There is no significant difference between post test score of experimental and control group in terms of Exclusive breast feeding practices. HO2: There is no significant difference between post test score of experimental and control group in terms of maternal role competence. HO3: There is no significant difference between post test score of experimental and control group in terms of growth. HO4: There is no significant association between growth and maternal out come with selected socio-demographic variables. |