| CTRI Number |
CTRI/2024/09/073998 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Designing a questionnaire for understanding the believes and practice of the exercises for women during their pregnancy. |
|
Scientific Title of Study
|
Development, validation and psychometric testing of knowledge, attitude and practice (KAP) questionnaire about antenatal exercises among pregnant women: Marathi Language. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajakta Patwe |
| Designation |
Student of Masters of Physiotherapy (MPT) |
| Affiliation |
SRM College of Physiotherapy, Kattankulathur, Chennai. |
| Address |
Room number: 505, Department of Physiotherapy, SRM college of
Physiotherapy, Pillayar Koil st.,Potheri, SRM Nagar, Kattankulathur,
Tamil Nadu. India.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8793733770 |
| Fax |
|
| Email |
patweprajakta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prajakta Patwe |
| Designation |
Student of Masters of Physiotherapy (MPT) |
| Affiliation |
SRM College of Physiotherapy, Kattankulathur, Chennai. |
| Address |
Room number: 505, Department of Physiotherapy, SRM college of
Physiotherapy, Pillayar Koil st.,Potheri, SRM Nagar, Kattankulathur,
Tamil Nadu. India.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8793733770 |
| Fax |
|
| Email |
patweprajakta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prajakta Patwe |
| Designation |
Student of Masters of Physiotherapy (MPT) |
| Affiliation |
SRM College of Physiotherapy, Kattankulathur, Chennai. |
| Address |
Room number: 505, Department of Physiotherapy, SRM college of
Physiotherapy, Pillayar Koil st.,Potheri, SRM Nagar, Kattankulathur,
Tamil Nadu. India.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8793733770 |
| Fax |
|
| Email |
patweprajakta@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRM institute of Science and Technology, Potheri,
SRM Nagar,
Kattankulathur, Tamil
Nadu 603203.
|
|
|
Primary Sponsor
|
| Name |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy, SRM institute of Science and Technology, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203. |
| 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 |
| Mr Balamurugan Janakiraman |
SRM Medical college and research center. |
SRM Institute of
Science and
Technology, College of
Physiotherapy,
Department of
Physiotherapy, Pillayar
Koil street, Potheri,
SRM Nagar,
Kattankulathur, Tamil
Nadu 603203.India.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9941215503
balamurj1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRM Medical college hospital and research centre. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women of Indian Nationality.
Women who are able to read and write Marathi language.
Women with close association with Marathi culture.
|
|
| ExclusionCriteria |
| Details |
Women who cannot answer the questionnaire due to illiteracy.
Pregnant women with psychological disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Awareness and Knowledge about Antenatal exercises among pregnant Marathi speaking women will be assessed as primary outcome. |
Baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="345"
Sample Size from India="345"
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)
|
23/09/2024 |
| 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="6"
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
|
This tool development and validation study will be conducted in 3 phases; item Construction, pilot testing, and psychometric testing. A KAP model questionnaire will be developed based on expert consultation and literature review. The questions specific to each domain; knowledge, attitude and practice (KAP) will be framed giving appropriate weightage to each. The item KAP-Antenatal questionnaire will be assessed for content validity, reliability, and construct validity by a team of 11 experts. It will be assessed on the basis of clarity appropriateness and the adequateness of the questions. The face validity and construct validity will be done. The inclusion and exclusion criteria will be specified. The participants will be selected through snowball sampling strictly adhering to the inclusion and exclusion criteria. The questionnaire will then be converted to online google form format. The survey is planned to be in the online mode to overcome the geographical barriers and to conserve paper. Pregnant women in Maharashtra will be approached and the questionnaire will be circulated to them. The instruction about the questionnaire used in the project will be given in the online mode and consent will be taken from the participants. A facilitator to assist the participants with their doubts regarding the study will be appointed for each cluster. Total 500 women from Maharashtra state will be approached. Total responses will be obtained. The data of the participants who did not answer the attention question satisfactorily will be removed from the study, thus, the total responses will be collected for the study. Data cleaning and coding will be done. Data will be analyzed using the SPSS software. We respect the privacy of the participants and we assure you that all the information shared by the participants will strictly be used for the research enhancement purpose, none of the data will be shared to any third party without the participant’s consent. |