| CTRI Number |
CTRI/2023/05/052296 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
USE OF C SHAPED PILLOW TO GIVE COMFORT,IMPROVE FEEDING AND SATISFACTION AMONG
POSTCAESAREAN MOTHERS
|
|
Scientific Title of Study
|
EFFECTIVENESS OF BREASTFEEDING
C-PILLOW ON COMFORT, LATCH ON AND MATERNAL SATISFACTION AMONG POSTCAESAREAN MOTHERS
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Clerita Joylen lobo |
| Designation |
Post graduate student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller road
Kankanady
Managulu -575002
Father Muller College of Nursing
Father Muller road
Kankanady
Managulu -575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8050445437 |
| Fax |
|
| Email |
cleritamuller1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Precilla Dsilva |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller road
Kankanady
Managulu -575002
Father Muller College of Nursing
Father Muller road
Kankanady
Managulu -575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
precilladsilva25@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Precilla Dsilva |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller road
Kankanady
Managulu -575002
Father Muller College of Nursing
Father Muller road
Kankanady
Managulu -575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
precilladsilva25@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College and research Center.
|
|
|
Primary Sponsor
|
| Name |
Father Muller Research Center |
| Address |
Father Muller College of Nursing
Father Muller road
Kankanady
Managulu -575002
MANGALURU- 575002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Clerita Joylen Lobo |
father Muller Medical college Hospital |
Father Muller College of Nursing
Father Muller road
Kankanady
Managulu -575002
Dakshina Kannada
KARNATAKA |
8050445437
cleritamuller1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women who are undergoing first time caesarean section |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
standard treatment |
1. Baseline data will be assessed among control group.
2. Standard routine care will be followed for mothers in control group
3. Posttest will be taken on comfort, latch on and maternal satisfaction will be assessed each day for a period of three days
|
| Intervention |
Use of breast feeding pillow |
1.An informed written consent will be obtained from the mothers who fulfill the inclusion criteria.
2.Based on inclusion criteria mothers were assigned to Intervention group
3. Baseline data and pretest on Comfort, maternal satisfaction will be collected from intervention group. 4. LATCH ON score assemment will be done by the investigator Demonstration on use of breastfeeding pillow and instructions are given to mother to use pillow while feeding
5. Mother is advised to sit comfortably (fowlers/ leaning back) with her legs crossed. 6. Keep breast feeding pillow on the lap while supporting the surgical wound site.
Using cradle or cross cradle method baby is supported on the pillow
7. Feed the baby and repeat it on opposite breast also.
8. Each side breastfeeding will be given for 15-20 minutes.
9. The pillows are covered with rexine material to maintain hygiene.
10. To maintain compliance with the use of pillow, a dairy and pen will be provided for mothers and asked to put a tick mark against the number of breast feeds and use of pillow during each feed
11. Posttest will be taken from mothers on comfort, and maternal satisfaction will be assessed each day for a period of three days
12. Posttest LATCH ON assessment will be done by the investigator on all three days
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Mothers aged between 21to 40 years.
2. Women with first time caesarean section
3. Mothers with Inverted or cracked nipples.
|
|
| ExclusionCriteria |
| Details |
1. Mothers with breast complications like breast abscess, mastitis, Breast cancer etc.
2. Mothers with present history of postpartum psychosis and depression
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Latch score , comfort level and maternal satisfaction score |
Improvement in Latch score in 5 days , comfort level attained after using pillow and maternal satisfaction score will improve in 3 days of using C pillow. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| association of LATCh on method, comfort level and maternal satisfaction based on baseline variables |
one month |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/08/2023 |
| 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="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
will be completed after the completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [cleritamuller1@gmail.com].
- For how long will this data be available start date provided 05-11-2024 and end date provided 31-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Breast feeding pillow will help the ceaserean section mothers to improve breast feeding by providing a comfortable position. this improves latch on with baby and maternal satisfaction with breast feeding . |