| CTRI Number |
CTRI/2024/10/075146 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Smartphone Usage Duration and Hand Posture on The Prevalence of Hand Pain, Vision Problems and Sleep Disturbance among Students |
|
Scientific Title of Study
|
The Impact of smartphone use duration and hand posture on the prevalence of hand pain vision problems and sleep disturbance among college students |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shambhavi Raj, Chandan Kumar |
| Designation |
Student, Professor |
| Affiliation |
Department of Physiotherapy, Galgotias University |
| Address |
Department of Physiotherapy,
School of allied health sciences,
Plot No. 2, Sector 17-A Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida, Gautam Buddh Nagar,
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
shambhaviraj0804@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandan Kumar |
| Designation |
Professor |
| Affiliation |
Department of Physiotherapy, Galgotias University |
| Address |
3rd Floor staff room, Block- B, Plot No. 2, Yamuna Expressways, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
ptchandan221@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof. (Dr.)Chandan Kumar |
| Designation |
Professor |
| Affiliation |
Department of Physiotherapy, Galgotias University |
| Address |
Plot No. 2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
chandankumar@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Allied Heath Sciences,
Galgotias University,
Plot No. 2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy School of Allied Health Sciences Galgotias University |
| Address |
Plot No. 2, Sector 17A Yamuna Expressway, Greater Noida, Gautam, Buddh Nagar, Uttar Pradesh, India |
| Type of Sponsor |
Other [Educational University] |
|
|
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 |
| Prof Dr Chandan Kumar |
School of Allied Health Sciences |
Department of Physiotherapy Staff Room B-309 School of Allied Health Sciences Plot No. 2 Yamuna Expressways opposite Buddha International Circuit Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
7773923831
chandankumar@galgotiasuniversity.edu.in |
|
|
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 |
Healthy college students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1. Owning a smartphone [32],
2. Using a smartphone for at least two hours per day
|
|
| ExclusionCriteria |
| Details |
1. Having congenital or acquired musculoskeletal abnormalities and
2. History of wrist fractures, injuries, or trauma within the past six months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cornell Hand Discomfort Questionnaire
Computer Vision Syndrome Questionnaire
Pittsburgh Sleep Quality Index |
Baseline- Once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh Sleep Quality Index |
Baseline- Once |
|
|
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)
|
24/10/2024 |
| 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="6"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
From this study, we can learn about the vision problems students face from prolonged smartphone usage.
Many college students are unaware of the side effects of using smartphones at
bedtime; they incorrectly imagine that these media might help them sleep, and
their phone use becomes part of their sleep routine [28]. This study will help understand the
combined effect of hand pain, vision problems, and sleep disturbances due to prolonged smartphone usage, duration, and posture. |