| CTRI Number |
CTRI/2025/06/088428 [Registered on: 09/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Instrument development study |
| Study Design |
Other |
|
Public Title of Study
|
Development Of A Questionnaire, To Assess The Awareness Of Pregnancy Induced Postural Changes And Musculoskeletal pain Among Women; Validation And Reliability Check |
|
Scientific Title of Study
|
Development Of A Questionnaire, To Assess The Awareness Of Pregnancy Induced Postural Changes And Musculoskeletal Issues Among Women; Validation And Reliability Check |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abirami S |
| Designation |
Undergraduate Student |
| Affiliation |
SRM Institute of science and technology |
| Address |
SRM College Of Physiotherapy,Kattankulathur Campus,Chengalpattu,Tamilnadu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8438522638 |
| Fax |
|
| Email |
pademsfam74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbu Priya M |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of science & technology |
| Address |
SRM College of Physiotherapy,Kattankulathur Campus,Chengalpattu,Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anbu Priya M |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of science & technology |
| Address |
SRM College of Physiotherapy,Kattankulathur Campus,Chengalpattu,Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRM Institute of science and technology |
| Address |
SRM College Of Physiotherapy,Kattankulathur Campus,Chengalpattu,Tamilnadu 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 |
| Dr Anbupriya M |
SRM Medical College and Research centre |
SRM College of physiotherapy,
SRM Institute of Science and Technology,
Kancheepuram
TAMIL NADU |
9841549219
anbuprim@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital & Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nulligravidal, primigravidal women in first trimester |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Women in the age group of 18-40 ,nulligravida.
2)Women in their primipara [1st trimester].
3)Collegiates, working women, house wives, any women who comes under the above category.
|
|
| ExclusionCriteria |
| Details |
1)Multigravida
2)Any history of Musculoskeletal condition/disease with management.
3)Any cognitive impairment/Psychological disorder
4)Any communication impairment.
5)History of postural deformities (acquired or congenital) with management.
6)History of Neurological conditions/ Neuromuscular conditions with management.
7)Medical students are avoided since they may have prior knowledge about posture and its importance ,which could influence their responses and introduce bias.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Quality ( clarity, comprehensibility, relevance, usefulness) will be verified.
2)Validity ( content, face) of the tool will be analyzed.
3)Reliability of the tool will be checked. |
4 weeks for validity and reliability. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
17/06/2025 |
| 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="3"
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: Posture refers to the body’s alignment in both static and dynamic positions, maintained by coordinated muscle actions. Any misalignment can lead to nerve compression, stress on ligaments and joints, and musculoskeletal discomfort. Pregnancy brings significant biological changes, including shifts in body mass, alterations in the centre of gravity, and muscle stretching or weakening. While some studies have explored pregnant women’s perception of physiotherapy and postural changes, no comprehensive research or assessment tool exists to evaluate their knowledge. This study aims to develop a reliable questionnaire to assess women’s awareness of postural changes and related musculoskeletal issues during pregnancy. OBJECTIVE: This study aims to develop a self-report questionnaire to assess women’s awareness of pregnancy-related postural changes and musculoskeletal issues. Since no existing tool measures subjective postural awareness, the research will create and validate a new scale, ensuring its reliability and psychometric accuracy. The goal is to establish a useful clinical and research tool that enables timely interventions, preventing postural defects and reducing musculoskeletal pain. METHODOLOGY: This study will conduct a literature review on postural changes and musculoskeletal issues during pregnancy, including evaluation tools and existing questionnaires. A close-ended questionnaire with figures will be developed and validated in multiple phases. An expert panel, consisting of professionals from various fields, will review the initial version for validity. After incorporating their feedback, a revised version will undergo qualitative pre-testing with 15 participants. The final questionnaire will be tested for reliability using a test-retest method with 30 participants over a one-week gap, ensuring internal consistency. Participants will be selected based on specific criteria, with informed consent obtained before participation. RESULT: A new self-report questionnaire will be created to assess women’s awareness of pregnancy-related postural changes and musculoskeletal issues. The questionnaire will undergo validation and reliability testing, with results analysed and discussed later.
KEYWORDS: Pregnancy awareness, Postural changes, Musculoskeletal issues, Self-report questionnaire, Validation and reliability, Psychometric properties, Qualitative analysis, Expert panel review, Test-retest method, Internal consistency, Postural habits evaluation, Pretesting and finalization .
|