| CTRI Number |
CTRI/2024/12/077765 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prevalence |
| Study Design |
Other |
|
Public Title of Study
|
A Study on How Smartphone Use Affects Sleep Problems Among Physiotherapy Students in North Karnataka |
|
Scientific Title of Study
|
Prevalance of sleep disturbances in physiotherapy students in North Karnataka with smartphone usage- An observational 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 |
Dr Priya mohite |
| Designation |
Assistant professor |
| Affiliation |
KLE institute of physiotherapy |
| Address |
Advanced physiotherapy Center, room no.39, Sagar Floor, dr. Prabhakar kore hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8095417027 |
| Fax |
|
| Email |
priyamohite@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya mohite |
| Designation |
Assistant professor |
| Affiliation |
KLE institute of physiotherapy |
| Address |
Advanced physiotherapy Center, room no.39, Sagar Floor, dr. Prabhakar kore hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8095417027 |
| Fax |
|
| Email |
priyamohite@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Yash Kulkarni |
| Designation |
Intern |
| Affiliation |
KLE institute of Physiotherapy |
| Address |
Advanced physiotherapy Center, room no.39, Sagar Floor, dr. Prabhakar kore hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8454080360 |
| Fax |
|
| Email |
yashkulkarni667@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research Institute of Physiotherapy, Medical College Campus J.N., nehru nagar, Belagavi, Karnataka, India- 590010 |
|
|
Primary Sponsor
|
| Name |
Yash Kulkarni |
| Address |
KLE INSTITUTE OF PHYSIOTHERAPY,
nehru nagar,
belagavi-590010 |
| 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 |
| Dr Yash Kulkarni |
KLE institute of physiotherapy |
Advanced physiotherapy Center, room no.39, Sagar Floor, dr. Prabhakar kore hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA
590010
India
Belgaum
KARNATAKA |
8454080360
yashkulkarni667@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
sleep disturbances |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Physiotherapy students using smartphone for more than 5 hours per day |
|
| ExclusionCriteria |
| Details |
Physiotherapy students using smartphone for less than 5 hours per day.
Physiotherapy students with pre existing sleep disturbances.
Physiotherapy students on medications for sleep disturbances or psychiatric illnesses like anxiety, depression, etc. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh sleep quality index |
Score is from 0-3 with 0 being no disturbances and 5 being sleep disturbances present |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="525"
Sample Size from India="525"
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)
|
18/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
In today’s digital age, the usage of smart phones has significantly increased, and research has shown that this can adversely affect health and well-being, leading to issues such as sleep disturbances, anxiety, and depression. Our study focuses on assessing the quality of sleep among physiotherapy students in North Karnataka and the prevalence of sleep disturbances related to smart phone usage. While previous studies have highlighted these negative effects, there is a lack of literature in India specifically addressing the prevalence of sleep disturbances in physiotherapy students in North Karnataka due to increased smart phone usage and time of exposure. The study consists of 525 participants in age group of 18 to 25 years. Outcome measures include PITTSBURGH SLEEP QUALITY INDEX (PSQI), EPWORTH SLEEPINESS SCALE AND SLEEP BANG QUESTIONNAIRE. The study is an observational study and questionnaires will be sent to physiotherapy students in North Karnataka to determine the prevalence of sleep disturbances with smart phone usage.
|