| CTRI Number |
CTRI/2024/09/074524 [Registered on: 30/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An examination of university students who have poor sleep patterns and unhealthful eating habits to determine the prevalence of musculoskeletal discomfort |
|
Scientific Title of Study
|
Prevalence of musculoskeletal pain in university students with unhealthy dietary habits and poor sleep quality - A cross sectional 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 |
Sheeza |
| Designation |
Research student |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, Galgotias University, sector 17 A, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9531883833 |
| Fax |
|
| Email |
sheezaqi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahiba |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, SAHS, Galgotias University, Yamuna expressway, sector 17 a, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7982442137 |
| Fax |
|
| Email |
saifisahiba1993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sheeza |
| Designation |
Research Student |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, SAHS, Galgotias University, Sector 17 a, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9531883833 |
| Fax |
|
| Email |
sheezaqi@gamil.com |
|
|
Source of Monetary or Material Support
|
| Research and developmental cell, Galgotias University, Greater Noida, Uttar Pradesh, 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Room No A315,Research and Development Cell, Galgotias University,
Plot No 2, Sector 17A, Yamuna Expy, opposite Buddha International
circuit, Greater Noida Uttar Pradesh 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 Sheeza |
Galgotias University |
E-005, Department of physiotherapy, Plot no. 2, sector 17 A, Yamuna expressway, Greater Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9531883833
sheezaqi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethics Commitee, Galgotias Univerity N |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
University students |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Male – Female (both)
Age - 18-25 years
University students |
|
| ExclusionCriteria |
| Details |
Consuming anti depressants
PCOD
Heavy smokers
Participants who are unwilling to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nordic musculoskeletal pain questionnaire
Pittsburgh sleep quality index
Healthy eating assessment questionnaire |
1 week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="434"
Sample Size from India="434"
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)
|
05/10/2024 |
| 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="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
|
This cross-sectional study will focus on MSKP, sleeping quality and dietary habits of young adult undergraduate students who are enrolled at Galgotias University, Uttar Pradesh. A total of 434 participants were included in the study. Eligible participants will be aged 18 to 25 of both genders enrolled at Galgotias University and those who agree to participate in the research voluntarily and those who signed the Informed Consent Form. We will exclude participants who are consuming Anti-depressant drugs since last 2 weeks, had Polycystic ovarian disorder (PCOD) in females, who are heavy smokers, or suffering from Thyroid disorders (Hypothyroidism and Hyperthyroidism), they will also be excluded if they had any major surgery in last 1 year. |