| CTRI Number |
CTRI/2024/12/078521 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [counselling] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Focused breastfeeding counselling to improve nighttime breastfeeding challenges and self efficacy among primiparous lactating mothers |
|
Scientific Title of Study
|
Impact of Focused Breastfeeding Counseling on Nighttime Breastfeeding Challenges and Maternal self-efficacy on Breastfeeding among primiparous lactating mothers at tertiary care hospital, Gorakhpur: A Randomized Control 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 |
Km Sabita Jaysawal |
| Designation |
M.Sc. Nursing student |
| Affiliation |
AIIMS Gorakhpur |
| Address |
College of nursing, AIIMS GORAKHPUR
College of nursing, AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8795096029 |
| Fax |
|
| Email |
sabita.jaiswal.2722@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deviga T |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Faculty room no. 4, 4th floor MNC building, college of nursing, AIIMS GORAKHPUR
Faculty room no. 4, 4th floor MNC building, college of nursing, AIIMS GORAKHPUR
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8003991332 |
| Fax |
|
| Email |
deviga.thirush@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Km Sabita Jaysawal |
| Designation |
M.Sc. Nursing student |
| Affiliation |
AIIMS Gorakhpur |
| Address |
College of nursing, AIIMS GORAKHPUR
College of nursing, AIIMS GORAKHPUR
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8795096029 |
| Fax |
|
| Email |
sabita.jaiswal.2722@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of nursing, All India Institute of Medical Sciences, Gorakhpur, Kuranghat, Uttar Pradesh, 273008 |
|
|
Primary Sponsor
|
| Name |
Km Sabita Jaysawal |
| Address |
College of Nursing, AIIMS Gorakhpur, Uttar Pradesh
pin code- 273008 |
| 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 Deviga T |
All India Institute of Medical Sciences, Gorakhpur |
3rd floor, Obstetrics and gynecology ward, All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH |
8003991332
deviga.thirush@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Commitee All India Institute of Medical Sciences, Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
focused breastfeeding counselling |
phase 1: one room will be allocated near to postnatal ward for counselling session. postnatal lactating mother will be recruited for breastfeeding counselling for research study
phase 2: pre test will be dine on 2nd postnatal day, following pretest focused breastfeeding counselling session will be conducted
phase 3: mother will be called for 2nd counselling after 24 hours, if needed mother will be call further counselling sessions
Phase 4:5th day of postnatal period post test will be conducted with self structured nighttime breastfeeding assessment tool and Breastfeeding self-efficacy scale-short form (BSES-SF)
Phase 5: Follow up test will be done on the postnatal day of 7th and 14th |
| Comparator Agent |
routine standard care |
In this group the mothers will take routine standard care given by doctors and nurses, as all mother will receive same care according institutional policy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Postnatal primiparous lactating mothers (both cesarian section and normal vaginal delivery) who is admitted in Obstetrics and Gynecology ward, AIIMS Gorakhpur at the time of data collection.
2. Mothers who know Hindi, English and Bhojpuri language.
3. Mothers who is willing to participate series of counselling sessions.
|
|
| ExclusionCriteria |
| Details |
1. Mother age group less than 18 years
2. Baby is sick/admitted in NICU
3. Mother is in major/emergency medical, surgical and obstetric health issue such as PPH, shock, severe hypertension etc.
4. Mother is having psychiatric issue
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| focused breastfeeding counselling will reduce the breastfeeding challenges and improve the self efficacy of the postnatal lactating mothers |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Giving focused breastfeeding counselling will be able to find out the association between night time breastfeeding challenges & selected demographic data & also find out the association between self efficacy on breastfeeding & selected demographic data |
4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
26/12/2023 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is one of the most important interfering factors in infants health. Monitoring mothers performance and providing them with the feedback helps to increase their self-efficacy, interest in learning, and level of performance. The present research evaluate the effect of counselling on the breastfeeding self-efficacy and frequency of breastfeeding problems in primiparous lactating mothers.breastfeeding is recommended as the primary source of infant nutrition until 6 months when complementary foods are introduced, and sustained for longer-up to 2 years and beyond according to maternal preference.The postpartum period is a vulnerable time for women. If the are given too much information about all the possible obstacles to breastfeeding, by the time the discussion centers on what truly matters to them, their attention may have already been lost. Other studies have shown the effectiveness of doing counselling focused on womens needs. |