| CTRI Number |
CTRI/2024/11/077224 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Work related musculoskeletal disorders in women |
|
Scientific Title of Study
|
Prevelance of Work Related Musculoskeletal Disorders among House Keepers & Corporate Females – A Comparative Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dinesh |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
B-316 Galgotias University Yamuna Express way opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh pin code 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8130625905 |
| Fax |
|
| Email |
dineshudiyar12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
B-316 Galgotias University Yamuna Express way opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh pin code 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8130625905 |
| Fax |
|
| Email |
dineshudiyar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
B-316 Galgotias University Yamuna Express way opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh pin code 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8130625905 |
| Fax |
|
| Email |
dineshudiyar12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Room no.C 114 Galgotias University Yamuna Express way opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh pin code 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Prof Nidhi Singh |
Galgotias University |
B-316 Galgotias University Yamuna Express way opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh pin code 203201
Gautam Buddha Nagar
UTTAR PRADESH |
7042627025
Nidhi.file.assign@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Only Women either working as housekeepers or in the corporate sector will be selected for the research-
2. Occupation: Employed as a full-time or part-time housekeeper in private households or women in the corporate sector -
3. Age – 20-30/ 30-40/ 40-50
4. Work Experience of at least 1 year in both cases
5. Consent: To take part in the study, participants must give their informed consent.
6. Ability to communicate effectively: Must be able to understand and respond to questions
|
|
| ExclusionCriteria |
| Details |
1. Women with severe health conditions unrelated to musculoskeletal disorders
2. No pregnancy and breastfeeding at the time of Data collection
3. Individuals who are unable to provide informed consent
4. Age Restrictions: To minimize confounding variables associated with aging, older people—especially those over a specific age (more than 50) and also younger age below 20— may be omitted.
5. Women not employed in the corporate sector or as housekeepers
6. Individuals having Musculoskeletal chronic pain due to any reason which is not work-related
7. Current or recent diagnosis of a musculoskeletal disorder that is not work-related
8. Neurological Conditions: Disorders like neuropathy and multiple sclerosis can impair sensation and control of the muscles, which may result in pain that is not directly caused by problems with the musculoskeletal system but rather by damage to the nerves.
9. Mental Health Conditions (like Depression and Anxiety) can influence pain perception
10. Working experience of less than 1 year
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nordic scale |
baseline to 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NPRS ( Numerous Pain rating scale) |
0 to 10
0 means no pain
10 means severe pain |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
15/12/2024 |
| 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="1"
Months="0"
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
|
Comparing the prevalence and severity of musculoskeletal disorders (MSDs) among Indian housekeepers and corporate working women is the goal of this study. The research will look into the particular MSDs, risk factors, and how work-related factors affect these illnesses in both groups. The results will shed light on the particular difficulties that each group faces and guide the creation of focused interventions for the management and prevention of MSDs. The study intends to enhance the health of working women in both industries by tackling this important public health concern.
Google forms and a demographic form are being used for this study; one is being used to gauge the degree of pain, and the other is being used to gauge various musculoskeletal disorders. |