| CTRI Number |
CTRI/2025/05/087925 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Musculoskeletal pain, sleep problems, and quality of life are all linked among Food delivery workers. |
|
Scientific Title of Study
|
"Association Of Musculoskeletal Pain, Sleep Disturbances, Quality of Life Among Food Delivery 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 |
Bhuvaneshwari L |
| Designation |
Student |
| Affiliation |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy
SRM Institute of Science and Technology
Kattankulathur
Kancheepuram
603203
SRM College of Physiotherapy
SRM Institute of Science and Technology
Kattankulathur
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6374729825 |
| Fax |
|
| Email |
bl7781@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajkumar M |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy
SRM Institute of Science and Technology
Kattankulathur
Kancheepuram
603203
SRM Institute of Science and Technology SRM College of Physiotherapy
Kattankulathur
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7092022034 |
| Fax |
|
| Email |
rajkumam2@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhuvaneshwari L |
| Designation |
Student |
| Affiliation |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy
SRM Institute of Science and Technology
Kattankulathur
Kancheepuram
603203
SRM Institute of Science and Technology SRM College of Physiotherapy
Kattankulathur
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6374729825 |
| Fax |
|
| Email |
bl7781@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhuvaneshwari L |
| Address |
SRM Institute of Science and Technology
Kattankulathur
Tamilnadu
India
603203 |
| 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 |
| Bhuvaneshwari L |
Chengalpattu |
In and Around Chengalpattu
Kancheepuram
TAMIL NADU |
6374729825
bl7781@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SRM Medical College Hospital And Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Musculoskeletal Pain, Sleep Disturbances, Quality Of Life |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Working duration more then 5 hours per day
Food delivery workers
Working experiance; At least 6 months of long duration riding
Riding experience;3 days/week with minimum of 4 hours
Type of vehicle;Ride a motorcycle,scooter or bicycle for food delivery
Work schedule; Full time or part time food delivery workers who regularly ride and deliver on weekdays or weekends (e.g at least 3 to 5 days per week) |
|
| ExclusionCriteria |
| Details |
Night shift food delivery workers
Preexisting musculoskeletal conditions
Recent injuries or surgeries
Non-occupational factors that may influence MSK pain
Presence of medical conditions like Diabetes, hypertension, sleep apnea .
Part time or occasional riders
Nonfood delivery workers
Participants with cognitive impairment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Musculoskeletal Pain Measured By Using Nordic Musculoskeletal Scale |
Single |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sleep Disturbances Measured By Using Sleep Quality Scale |
Single 1 |
| Quality of Life Measured By Using SF 12 Health Survey |
Single 1 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/06/2025 |
| 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)
|
Completed |
| 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
|
The Study Was Approved by the Institutional Ethical Committee (IEC)- Ethical Clearance Number: SRMIEC-ST0125-2092 of SRM Medical College Hospital and Research Centre.This is a cross-sectional observational study designed to assess the association of musculoskeletal pain, sleep disturbances, and quality of life among food delivery workers. Musculoskeletal pain will be evaluated using the Standardized Nordic Musculoskeletal Questionnaire (NMQ), sleep disturbances will be assessed using the Sleep Quality Scale (SQS), and quality of life will be measured using the SF-12 Health Survey. Data will be collected at a single time point from participants working in the food delivery sector. The study aims to identify the prevalence of these conditions and their interrelationships, thereby contributing to better understanding and management of occupational health risks in this population.
|