| CTRI Number |
CTRI/2024/05/066708 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Work-related musculoskeletal disorder among students impacting their stress and sleep quality |
|
Scientific Title of Study
|
"Prevalence of work-related musculoskeletal disorders on stress and sleep quality among students of Galgotias University." |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivanshi Goel |
| Designation |
BPT Scholar |
| Affiliation |
Galgotias University |
| Address |
Room no B-304, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot no 2,Sector 17A, Yamuna Expressway opposite Buddha International Circuit,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
|
| Fax |
|
| Email |
shivanshigoel15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanya Gujral |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B-315,Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09311020220 |
| Fax |
|
| Email |
tanya.gujral@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Tanya Gujral |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B-315,Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09311020220 |
| Fax |
|
| Email |
tanya.gujral@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Research and Development cell, Room No B-316, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar
|
|
|
Primary Sponsor
|
| Name |
Research and Developmental cell Galgotias University |
| Address |
Room No B-316, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar |
| 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 Shivanshi Goel |
Galgotias University |
Room No B 304, Dept Of Physiotherapy, School of Allied Health Sciences, Plot No2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
8445634188
shivanshigoel15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Work Related Musculoskeletal Disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1. The study will include students of
physiotherapy course.
2. The study will include students who
consistently sits for five to six hours
throughout the day.
3. The study will include students who do not
engage in regular physical activity.
|
|
| ExclusionCriteria |
| Details |
1.The study will not include students who had
chronic systemic illness.
2. Any previous history of injury to hand, cervical
spine due to Road Traffic Accident (Traumatic
Injury), Non-Traumatic Injury. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The Nordic Pain Questionnaire
2.Perceived Stress Scale 3.Pittsburgh Sleep Quality
Index (PSQI) |
Baseline only as it is a one time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="377"
Sample Size from India="377"
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)
|
13/05/2024 |
| 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="2"
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
|
A cross-sectional study involving a self-administered questionnaire. The Nordic Pain Questionnaire, Perceived Stress Scale and Pittsburgh Sleep Quality Index (PSQI) will be distributed to all the students. Inquiring about their voluntary participation in the study along with the online survey, each participant will receive an email with a letter outlining the goal of the study. Every participant will be given a description of the questionnaire by the researchers along with a contact number in case any more explanation is needed. Through their questionnaire responses, each subject will grant permission to take part in this study. All the participants will receive a gentle reminder from the researcher to complete the questionnaire. The study will not include any questionnaires that will incomplete. All participants will read and sign the informed consent. The data collected will be handled confidentially. |