| CTRI Number |
CTRI/2024/05/067459 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development of Tamil Version of Knowledge, attitude and practice questionnaire about antenatal exercises |
|
Scientific Title of Study
|
Development, validation and psychometric testing of knowledge, attitude and practice (KAP) questionnaire about antenatal exercises among pregnant women: Tamil 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 |
Balamurugan Janakiraman |
| Designation |
Research Associate |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No- PT 29,SRM College of Physiotherapy,SRM Medical College Building, Faculty of Medicine and Health Sciences, SRM Institute of Science and technology, Kattankulathur, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Veeragoudhaman TS |
| Designation |
Dean |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No - PT 01, V Floor,SRM College of Physiotherapy,SRM Medical College Building,Faculty of Medicine and Health Sciences,SRM Institute of Science and technology, Kattankulathur, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
9500375408 |
| Fax |
|
| Email |
eesanan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Veeragoudhaman TS |
| Designation |
Dean |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No- PT 01, V floor, SRM College of Physiotherapy,SRM Medical College Building, Faculty of Medicine and Health Sciences, SRM Institute of Science and technology, Kattankulathur, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
9500375408 |
| Fax |
|
| Email |
eesanan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRM Medical College Building,SRM Institute of Science and technology, Kattankulathur,Tamil Nadu,India. Pin Code -603 203 |
|
|
Primary Sponsor
|
| Name |
Balamurugan Janakiraman |
| Address |
Room No- PT 29, IV Floor,SRM College of Physiotherapy,SRM Medical College Building, Faculty of Medicine and Health Sciences, SRM Institute of Science and technology, Kattankulathur, Tamil Nadu, India |
| 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 |
| DrBalamurugan Janakiraman |
SRM Medical College Hospital and Research Centre,,SRM IST |
Ground Floor, C Block, Obstetrics and Gynaecology Outpatient Department,SRM Medical College Hospital and Research Centre,SRM IST -603 203
Kancheepuram
TAMIL NADU |
9941215503
bala77physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women of Indian nationality who are able to read and understand Tamil language. |
|
| ExclusionCriteria |
| Details |
Mothers who cannot speak Tamil language, cognitive impairment, and mother diagnosed as high risk pregnancy and advised to avoid physical activity or exercise, Mothers with communication impairment and visual impairments and physical impairments
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tamil version of KAP Antenatal questionnaire |
Baseline (Test), Post 48 hours (Re-test) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Level of antenatal exercise |
Baseline (Test) |
|
|
Target Sample Size
|
Total Sample Size="461"
Sample Size from India="461"
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)
|
15/06/2024 |
| 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="5"
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
|
Background : Antenatal exercises are a set of unique exercise protocol that is designed specific to the mother and fetus. The antenatal exercises are proven to reduce the risks of systemic illnesses during pregnancy. It benefits the mother by assisting in maintenance of healthy weight and positively contributing to the physiological health, psychological health and overall wellbeing of the mother. The benefits of antenatal exercises broadly cover the healthy development of the fetus and a safe baby birth. The reduced physical activities among women globally due to the modern lifestyle adaptations have proven to have negative impact in their gestational phase. Approximately 1.3 million maternal deaths were estimated among Indian women in the last two decades. A lack of physical activity and exercise is associated with maternal and fetal adverse outcomes. These include pregnancy complications such as gestational diabetes mellitus (GDM), preeclampsia, gestational hypertension and fetal macrosomia due to rising maternal obesity.Methodology : It is a prospective cross sectional observational study with the sample size of 461 pregnant women’s. Sample size was calculated using single population proportion formula; the following assumptions were used ,the margin of error 5%,confidence interval 95%,proportion or prevalence -50%
Procedure :
Questionnaire item generation
Step 1: An extensive literature review was conducted to identify suitable items for the questionnaire. In addition, existing guidelines and recommendations of recognized bodies like ACOG and FOSGI, India will be used. Step 2: A focal group will be setup including OBS Physicians ,OBG Nurses, OBG Physiotherapists and Graduate Pregnant mother Questionnaire item reduction/selection Step 3: Selection and organization of Questionnaire items Step 4: Pilot testing of Questionnaire Step 5: Test, re-test reliability Step 6: Psychometric analysis
Discussion:
This study will develop a new self- reported, contextual based outcome measure which assess the understanding, believes, doing (good practice) of antenatal exercise among pregnant mothers in Tamil Nadu. We strongly believe that the proposed study design and methods will generate a three dimensional KAP Antenatal questionnaire which will be easy, reliable and accurate.
|