| CTRI Number |
CTRI/2024/03/063463 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Nurse-led lactation management counseling on Awareness perception regarding breast milk donation and skill in breast milk expression among lactating mothers in comprehensive lactation management center at tertiary Level health care Center: A Quasi-experimental study |
|
Scientific Title of Study
|
Structured nurse–led lactation management counseling on awareness, perception regarding breast milk donation and skill in breast milk expression among lactating mother in comprehensive lactation management center at tertiary level health care center: A Quasi-experimental 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 |
Darade priyanka |
| Designation |
PG STUDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department of Pediatric Nursing
Room. no.116 College of Nursing AIIMS, Jodhpur 342005
INDIA.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7020337094 |
| Fax |
|
| Email |
dardepriya94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Darade priyanka |
| Designation |
PG STUDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department of Pediatric Nursing, Room no.116 College of Nursing AIIMS, Jodhpur. Rajasthan 342005
INDIA
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9779534307 |
| Fax |
|
| Email |
dardepriya94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Chandra Sharma |
| Designation |
Associate professore |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department of Pediatric Nursing, Room. no,110 College of Nursing AIIMS, Jodhpur. Rajasthan 342005.
INDIA
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9779534307 |
| Fax |
|
| Email |
sharmamukeshchandra0704@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur College of Nursing and Hospital, department of pediatric |
|
|
Primary Sponsor
|
| Name |
Non sponsored |
| Address |
Non sponsored |
| Type of Sponsor |
Other [NIL] |
|
|
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 Mukesh Chandra Sharma |
Third Floor in Comprehensive lactation management center (CLMC ) at AIIMS JODHPUR |
Department of Neonatology ,Third floor in comprehensive lactation management center (CLMC) at AIIMS, JODHPUR 342005
Jodhpur
RAJASTHAN |
9779534307
sharmamukeshchandra704@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS JODHPUR INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy lactating mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Structured Nurse-led Lactation Management Counselling (SNLLMC)after informed consent pretest data collection and intervention given for 30 to mother and posttest done on 8th day intervention . |
STEP 1: RECRUITMENT OF LACTATING MOTHERS
The formal permission was obtained to conduct the study from concerned authorities of the institute. Initially, all the eligible lactating mothers who were visiting in CLMC, AIIMS Jodhpur were recruited. The first 30 were assigned to the control group by nonprobability convenient sampling and informed written consent was obtained after explaining the purpose of the study. Confidentiality of data was ensured to all participants. One week after the allocation of the sample into the control group, 30 samples were recruited into the experimental group to prevent contamination.
STEP 2: COLLECTION OF SOCIO DEMOGRAPHIC DATA
Data related to socio-demographic variables, assessment of awareness, perception level and skill in milk expression among lactating mothers was collected by interview technique both in control group and experimental group before starting the routine care and intervention.
STEP 3: After one week of receiving the usual routine counselling, post-test data were collected to assess awareness, perception and skill in milk expression among lactating mothers in control group.
STEP 4: Initially, the rapport was established with intervention group participants for 5-10 minutes after the pre-assessment of awareness, perception, and skill in milk expression.
STEP 5: INTERVENTION
Structured Nurse-Led Lactation Management Counselling was administered to the experimental group for 30 minutes during directive counselling sessions. SNLLMC involve Nurse-mother Interaction Session last for 30 minutes.
I) (First 10 minutes) Covering the importance of breast milk and breast milk donation, including a question-and-answer session for lactating mothers to discuss and stimulate awareness.
II) After a 1–2-minute gap: The next 10-minute interaction focused on milk banks and skills in expressing breast milk
III) For the final 10 minutes: Lactation management and nutrition were discussed.
STEP 6: After a one-week gap, post-test data were collected to assess the awareness, and perception regarding breast milk donation and skill in breast milk donation. Data was compiled and analyzed using inferential statistics to determine the effectiveness of SNLLMC on awareness, perception regarding breast milk donation, and skill in breast milk expression among lactating mothers in the CLMC.
|
| Comparator Agent |
Usual counselling by health professional to control group 30 lactating mothers .pretest taken Frist day and posttest data collected after 1 week gap respectively following usual counselling . |
Usual counseling by health professionals to control group of 30 lactating mothers. pretest taken after informed consent and post-test after 1 week duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Lactating mothers whose babies were born and admitted at AIIMS Jodhpur.
A lactating mother will be available at the time of data collection.
The lactating mother will be willing to give consent to participate in the study.
A lactating mother who can understand Hindi or English.
Lactating mother free from chronic illness.
|
|
| ExclusionCriteria |
| Details |
Mother suffering from any infection (HbS, HIV) or chronic illness.
Mothers taking psychotropic drugs.
Mothers who smoke or consume alcohol.
Mothers having tattoos.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess and Compare Awareness level perception level regarding breast milk donation and skill in breast milk expression among lactating mothers. |
The Pre-test data is collected on the first day obtaining informed consent after giving intervention for 30 minutes s counseling to mothers and the post-test is done on the 8th-day implementation of counseling by the researcher and from mothers respectively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of SNLLMC on awareness ,perception regarding breast milk donation & skill in breast milk expression .
find out the association between sociodemographic variables with awareness level, perception level regarding breast milk donation, & skill in breast milk expression. |
1 week of gap after that on the 8th day assessing the effectiveness of the intervention. |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/03/2024 |
| 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="1"
Months="0"
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
|
1. Lactating mothers were selected through a non-probability purposive sampling technique. Those fulfilling the inclusion criteria. The first 30 were assigned to the control group and the next 30 to the experimental group mothers visiting the CLMC. 2. First data were obtained from the control group who did receive the usual counseling about breast milk donation by health care professionals. Control Group 1. The researcher explained the study and formed a good rapport with the lactating mothers. and informed consent was taken after a proper explanation by the researcher. 2. The lactating mothers were given a comfortable environment and then obtained sociodemographic data and recorded in a sociodemographic data sheet. 3. Data were collected through the interview technique to fill the pre-test datasheet of respective tools. It took around 15 minutes to complete the information. follow-up date was recorded to keep track of lactating mothers 4. After 1 week of usual counseling, form the lactating mother’s post-test data was collected. 5. After the collection of data, information about structured nurse-led lactation management counseling was given with a short briefing about it. Experimental Group 1. The researcher explained the study and formed a good rapport with the lactating mothers. and informed consent was taken after a proper explanation by the researcher. 2. The lactating mothers were given a comfortable environment and then obtained sociodemographic data and recorded in a sociodemographic data sheet. 3. Data were collected through the interview technique to fill the pre-test datasheet of respective tools. It took around 15 minutes to complete the information. follow-up date was recorded to keep track of lactating mothers one week gap. 4. Intervention given through for 30 minutes which is structured nurse-led lactation management counseling (SNLLMC). It was non-direct counseling to an experimental group of lactating mothers. consists of a nurse-mother interaction session using a structured format. the first session includes information about the importance of breast milk, breast milk donation The second session was related to milk bank, skills in breast milk expression and The third session was lactation management respectively to lactating mothers in CLMC. 5. After 1 week gap of structured nurse-led lactation management counseling, from lactating mother’s post-test data was collected. A comparison between the two groups was done to determine the awareness and perception regarding breast milk donation and skill in breast milk expression among lactating mothers in CLMC (comprehensive lactation management center) at the tertiary care health center. |