| CTRI Number |
CTRI/2025/07/090601 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative |
| Study Design |
Other |
|
Public Title of Study
|
Feeling of physical and mental tiredness in people with excessive mobile phone use and in people with mobile phone use in moderation in the age group of 18-25 years |
|
Scientific Title of Study
|
Physical and mental fatigue in problematic and non-problematic smartphone users in the age group of 18 to 25 years: A semi structured interview |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shlok Rathod |
| Designation |
Postgraduate Student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy, Pune. |
| Address |
DES Brijlal Jindal College of Physiotherapy, Musculoskeletal Sciences Department, Division 1, Room number 2, Fergusson College Campus, Shivaji Nagar, Pune. Pune MAHARASHTRA 411004 India
Pune
MAHARASHTRA
411004
India |
| Phone |
9987585518 |
| Fax |
|
| Email |
matterskill@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namrata Bhadbhade |
| Designation |
Assistant Professor |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy, Pune. |
| Address |
DES Brijlal Jindal College of Physiotherapy, Musculoskeletal Sciences Department, Division 1,Room number 2, Fergusson College Campus, Shivaji Nagar, Pune. Pune MAHARASHTRA 411004 India
Pune
MAHARASHTRA
411004
India |
| Phone |
7709404336 |
| Fax |
|
| Email |
namratasidhaye.physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namrata Bhadbhade |
| Designation |
Assistant Professor |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy, Pune. |
| Address |
DES Brijlal Jindal College of Physiotherapy, Musculoskeletal Sciences Department, Division 1,Room number 2, Fergusson College Campus, Shivaji Nagar, Pune. Pune MAHARASHTRA 411004 India
Pune
MAHARASHTRA
411004
India |
| Phone |
7709404336 |
| Fax |
|
| Email |
namratasidhaye.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.E.S Brijlal Jindal College of Physiotherapy, Musculoskeletal sciences department, division 1, room number 2, Fergusson college campus, shivaji nagar, Pune-411004 |
|
|
Primary Sponsor
|
| Name |
Shlok Rathod |
| Address |
A/303, Banjara Hills, Nahur road, Mulund west, Mumbai 400080 |
| 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 Shlok Rathod |
Seth Tarachand Ramnath Dharmarth Ayurvedic Hospital, Rasta Peth, Pune. |
Physiotherapy OPD, Division- 2, Room no- 22, Rasta Peth, Pune, Maharashtra- 411011.
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9987585518
matterskill@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DES Brijlal Jindal College of Physiotherapy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Problematic Smartphone Users |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 25 years
Gender Both male and female equal in number.
Individuals who read, write and understand English language.
Problematic Smartphone Users with SAS SV score more than 33 for females and more than 31 for males
Non problematic smartphone users with SAS SV score ranging from 10 to 30 for men and 10 to 32 for females |
|
| ExclusionCriteria |
| Details |
Individuals who are
Having a poor diet
Having addictions like smoking, tobacco use
History of substance abuse like opiods
diagnosed with sleep disorders like insomnia, sleep apnea
Lack of physical activity
Diagnosed with chronic infections like influenza, hepatits, tuberculosis
Currently on prescription medications like benzodiazepines, anticonvulsants
Currently experiencing symptoms of premenstrual syndrome
Diagnosed with autoimmune disorders like multiple sclerosis, rheumatoid arthritis, Type 1 diabetes mellitus, chronic kidney disease
Diagnosed with mental health disorders
Diagnosed with dietary deficiencies
Diagnosed with eating disorders
Diagnosed with chronic pain anywhere in the body |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Smartphone Addiction Scale- short version (SAS-SV) |
At the time of evaluation - one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
25/09/2025 |
| 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="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
|
The pervasive use of smartphones among young adults has raised concerns about its impact on physical and mental well-being. This qualitative study explores the experiences of physical and mental fatigue among problematic and non-problematic smartphone users aged 18 to 25 years through semi-structured interviews. Participants will be screened according to inclusion and exclusion criteria. Procedure will be explained and written consent will be taken from the participants. Participants will be categorised into 2 groups namely problematic smartphone users and non-problematic smartphone users. Then the participants will be screened according to the self prepared screening tool used in the exclusion criteria. After which both the groups will be asked a featured set of questions to determine their opinions and perspective about smartphone use. Then the themes will be generated and discussed in detail. |