| CTRI Number |
CTRI/2025/03/081675 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Developing and testing a questionnaire for Musculoskeletal disorders in Construction Workers |
|
Scientific Title of Study
|
Development and Validation of a Questionnaire to assess Knowledge Attitude and Awareness on Work Related Musculoskeletal Disorders among Construction Workers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjiv Kumar |
| Designation |
Principal and Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
room no 39, Advanced Physiotherapy center, sagar floor KLE PBK Hospital Nehrunagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
08867480565 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjiv Kumar |
| Designation |
Principal and Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
room no 39, Advanced Physiotherapy center, sagar floor KLE PBK Hospital Nehrunagar Belagavi
KARNATAKA
590010
India |
| Phone |
08867480565 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalaxmi Kanabur |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
room no 39, Advanced Physiotherapy center, sagar floor KLE PBK Hospital Nehrunagar Belagavi Karnataka India
Belgaum
KARNATAKA
590010
India |
| Phone |
08867480565 |
| Fax |
|
| Email |
vvkdeeksha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 39, Advanced Physiotherapy center, sagar floor KLE Prabhakar Kore Hospital Nehrunagar Belagavi Karnataka India- 590010 |
|
|
Primary Sponsor
|
| Name |
Akanksha Suresh Desai |
| Address |
Room no 39, Advanced Physiotherapy center, sagar floor KLE Prabhakar Kore Hospital Nehrunagar Belagavi Karnataka India-590010 |
| 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 |
| Akanksha Suresh Desai |
CONSTRUCTION SITES OF BELAGAVI |
BELAGAVI
Belgaum
KARNATAKA |
7820914380
dessaiakanksha09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICAL COMMITTE, KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Construction workers(mason, carpenter, plumber, painter) working at the construction sites in Belagavi city
Construction workers of age 19-55years
Construction workers having work experience of more than a year
Construction workers working for 7-8 hours a day |
|
| ExclusionCriteria |
| Details |
Construction workers unwilling to participate
Subcontractor and supplier employees. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| questionnaire |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
12/03/2025 |
| 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
|
Development and Validation of a Questionnaire to assess Knowledge, Attitude, and Awareness of Work-Related Musculoskeletal Disorders among Construction Workers
Aim: To
develop and validate a questionnaire to assess knowledge, attitude and
awareness on work related musculoskeletal disorders in construction workers . Objective: To determine the knowledge, attitude and awareness on
work related musculoskeletal disorders
among construction workers using a noval questionnaire
Research Question : What is extent of Knowledge, Attitude,
and Awareness about Work Related Musculoskeletal Disorders among the
construction workers? Inclusion criteria: Construction
workers (mason, carpenter, plumber, painter) working at the construction site
in Belagavi city Construction
workers of age group 19-55 years . Construction workers having work experience of more than
year Construction
workers working for 7-8 hours a day
Exclusion criteria : Construction
workers unwilling to participate.
Subcontractor and supplier employees
Procedure: The study will be done in two stages:
Stage 1: Development of Questionnaire
The questionnaire will contain 4 domains that are
demographic data, knowledge, attitude and awareness
Items will be generated for the above mentioned
domains
Questionnaire will be made and subjected to content
validity
Stage 2 : Validation of questionnaire
Assessing the
items adequate measures of the domain interest by evaluating each item for
content relevance representatives and technical quality will be done
Critical review and all expert comments will be
taken into consideration
A pilot study will be conducted for the validity of
the questionnaire
Stage3: Survey procedure
After obtaining Ethical Clearance from Institution
ethical committee the study will be registered under CTRI prospectively.
Permission to conduct the study will be obtained
from onsite construction supervisor and the subjects meeting the inclusion
criteria will be provided with the informed consent
After explaining procedure those subjects consenting
and willing to participate will be included into the study.
The self structured questionnaire will be
administered by the investigator and their responses will be recorded.
The administration of questionnaire would last for 30minutes for each
subject and the responses recorded will be subjected to statistical analysis |