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CTRI Number  CTRI/2024/10/074735 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To understand the knowledge of breastfeeding among mothers 
Scientific Title of Study   Development and validation of questionnaire for assessing knowledge, Attitude and Practice of breastfeeding 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Blessline Nibisha B V 
Designation  Post Graduate student pursuing M.SC in Speech Language Pathology 
Affiliation  Manipal College of Health Professions (MCHP) Manipal Academy of Higher Education 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9486325400  
Fax    
Email  blessline.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena K D 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions (MCHP) Manipal Academy of Higher Education 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448824346  
Fax    
Email  r.veena@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Veena K D 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions (MCHP) Manipal Academy of Higher Education 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448824346  
Fax    
Email  r.veena@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal Udupi Karnataka India 576104 
 
Primary Sponsor  
Name  Blessline Nibisha B V 
Address  Department of Speech and Hearing Manipal College of Health Professions, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashikala K Bhat   Dr TMA Pai Hospital   Obstetrics and Gynecology OPD First floor Dr TMA Pai Hospital (A unit of MAHE Manipal) Opposite to old Taluk office, Udupi 576101
Udupi
KARNATAKA 		 9611362119

shashikala.bhat@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O992||Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All first-time pregnant women (Primigravida) and women who are giving birth for the first time (Primipara) and who reside or native of Udupi taluk are included. 
 
ExclusionCriteria 
Details  Women who are pregnant for a second time (Multigravida) or giving birth for a second time (Multipara) are excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know in which breastfeeding-related domain the newly delivered mothers are lacking and the difficulties they are facing during breastfeeding and it will be useful in counseling the first time pregnant women and newly delivered mothers related to breastfeeding.
at the end of this study, comparisons will be made between two groups and within the groups. 		 13 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   21/10/2024 
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="0"
Months="10"
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  

1. Title of the project:  Development and Validation of Questionnaire for Assessing Knowledge, Attitude, and Practice of Breastfeeding

2. Type of Study: Prospective study cross-sectional study

3. Aims & objectives: To develop and validate a questionnaire for assessing breastfeeding knowledge, attitude, and practice and to assess knowledge, attitude, and practice of breastfeeding among primipara and primigravida women.

4. Justification for study (whether of national significance with rationale): Most of the studies included only one group of population that either included postnatal, antenatal or primigravida mothers. In addition, most studies focused only on the knowledge component, unlike the attitude and practices of breastfeeding. The studies were widely done across the population that included distinct locations (rural or urban), different socio-economic backgrounds people (low or high), and different strata of literacy. There is absence of literature investigating the effect of any of these variables on breastfeeding practices in India. Speech Language Pathologists are responsible for assessing and managing infants with feeding and swallowing difficulties and hence could impact breastfeeding practices. Exclusive breastfeeding practices benefit both the woman and the child. Literature has evidenced a high mortality rate in children aged less than 5 years due to inadequate EBF practices. Hence the present study focuses on this direction.

5. Departments involved: Departments involved in the study is the Department of Obstetrics and Gynaecology, Dr TMA Pai Hospital, Udupi.

6. Sample size:

 For validation of questionnaire (n) = 16 in each group (20%) (Primipara and Primigravida) - primary objective

 Sample Size for administering on large population after validation of the questionnaire (n) = 84 in each group (Primipara and Primigravida) - secondary objective.

7. Materials and methods: The primary aim of the study is to develop a questionnaire in three domains- Knowledge, attitude, and practice of breastfeeding and validate the content of the questionnaire using content validity by the Delphi method. The validation will be performed by one Speech Language Pathologist, one OBG specialist, and one Lactation consultant. It will be rated using I-CVI and pretested among 16 participants from primipara (antenatal hospital visit between the month of 5th to 8th month of gestational period) and primigravida women (hospitalization of post-delivery) for questionnaire validation. The secondary aim of the study is to administer the validated questionnaire on the large population of primipara and primigravida women (n = 84 in each group).

Inclusion criteria: All first-time pregnant women (primigravida) and women who giving birth for the first time (primipara) between the age range of 21 years to 40 years and who reside or are native of Udupi taluk are included.

 Exclusion criteria: Women who are pregnant for a second time or giving birth to a second baby are excluded

b) Biological materials required: No

c) Statistical methods: Descriptive statistics measures including mean, median, and standard deviation will be used to report the study outcomes using Jamovi version 2.4.11 and Inferential statistics, the independent test or Mann – Whitney U test will be used for hypothesis testing will used for data analysis.

The developed questionnaire will be subjected to content validation.

8. Detailed description of procedure/processes:

This study would commence only after obtaining the approval from Institutional Research Committee (IRC) and Institutional Ethics Committee (IEC), followed by CTRI registration.

Phase 1: Item Pooling and Validation

The questionnaire will be developed under three sections, knowledge, attitude, and practice.  The items will be generated based on the deductive method. This method includes item pooling based on an extensive literature review through assessing different databases (Scopus, PubMed, Google Scholar). The developed questionnaire will be subjected to review for possible modifications with the help of a speech pathologist working in dysphagia more than two years of experience will be considered.

The modified questionnaire will be subjected to content validity. The Delphi method will be adapted to determine the consensus from the experts on the domains. The validation will be performed by one speech language pathologist, one OBG’s and one Lactation consultant. The items will be subjected to clarity and its relevancy on a 3-point ordinal scale (1-non relevant, 2-somewhat relevant, 3-highly relevant). The items rated as 2 and 3 will be considered. The items selected will be quantified using Item Content Validity Index (I-CVI) to measure the agreement on the relevancy of each item between the experts. The cut off I-CVI will be considered as 0.75.

Phase 2: Development of Questionnaire

The modified version will be considered as the final questionnaire to assess the knowledge practice and attitude of breastfeeding practices. The finalized items will be organized in appropriate format and will be validated by administering to the 32 participants through interviews and ask them to respond the questionnaire by ticking their responses. This will be done on their antenatal hospital visit during their 5th to 8th month of gestational period for the primipara group and during the postpartum hospitalized period for primigravida group for validation of the questionnaire. The questionnaire will take 20 minutes.

After Validating the questionnaire, if time permits use this questionnaire in a large population of primipara women group and primigravida women group and compare the knowledge, Attitude and practice of breastfeeding among and within groups. Administering the questionnaire on the participants through interview and ask them to respond the questionnaire by ticking their responses. This will be done on their antenatal hospital visit during their 5th to 8th month of gestational period for primipara group and during postpartum hospitalized period for primigravida group. The questionnaire will take 20 minutes.

9. Outcome measures: Develop and validate a questionnaire on three domains – knowledge, attitude, and practice of breastfeeding. It will give To know in which breastfeeding-related domain the newly delivered mothers are lacking and the difficulties they are facing during breastfeeding and it will be useful in counseling the first-time pregnant women and newly delivered mothers related to breastfeeding, at the end of this study, comparisons will be made between two groups and within the groups.

10. Potential risks and benefits:

Risks: The study has a minor increase over minimal risk as the study is interview and responding to a questionnaire. Duration to respond to the questionnaire can cause some discomfort in pregnant and newly delivered women.   

Benefits: This study will give you information regarding breastfeeding, you will know how much you are lacking in breastfeeding knowledge, so that you can gain more knowledge regarding breastfeeding. It will also give you information related to attitude towards breastfeeding and practice of breastfeeding, what you are not supposed to do and what you must do.

11. Ethical considerations: Participants fulfilling the inclusion criteria will be chosen for the study and written informed consent will be taken from the participants, before the commencement of data collection. Only participants willing to take part in the study shall be included among the selected participants.

12. Budget and proposed funding source: Not Applicable

13. Review of literature: Approximately one-third of pregnant women did not know the proper way to breastfeed. Only 25% of prenatal and postpartum mothers knew sufficiently about the advantages and techniques of breastfeeding. Reducing infant mortality can be achieved by breastfeeding and immunization. Cultural policies and designing for breastfeeding intervention in resource-limited settings. It provides education and counseling, to improve attitudes and knowledge toward breastfeeding practices. 

            Most of the studies included only one group of population that either included postnatal or antenatal or primigravida mothers. majority of the studies focused only on the knowledge component, unlike the attitude and practices of breastfeeding. The studies were widely done across the population that included different locations (rural or urban), different socio-economic backgrounds people (low or high) and across different strata of literacy. There is absence of literature investigating the effect of any of these variables on breastfeeding practices in India.

 
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