| CTRI Number |
CTRI/2023/11/060256 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Overuse of smartphones and its impact on healthy young people mean inspiratory pressure |
|
Scientific Title of Study
|
Effect of smartphone overuse on mean inspiratory pressure in healthy young adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krunali Maru |
| Designation |
PG Student |
| Affiliation |
Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University |
| Address |
PG Classroom, On ground Floor, Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara, Gujarat-391760.
Vadodara
GUJARAT
391760
India |
| Phone |
9409738906 |
| Fax |
|
| Email |
krunalimaru1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Satani |
| Designation |
Proffesor |
| Affiliation |
Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University |
| Address |
Staffroom, On ground Floor, Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara, Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9979483324 |
| Fax |
|
| Email |
kalpesh.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Satani |
| Designation |
Proffesor |
| Affiliation |
Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University |
| Address |
Staffroom, On ground Floor, Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara, Gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9979483324 |
| Fax |
|
| Email |
kalpesh.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Various constituent Institutes of Sumanddep Vidyapeeth Deemed to be University |
|
|
Primary Sponsor
|
| Name |
Krunali Maru |
| Address |
PG Classroom, On ground Floor, Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara, Gujarat-391760 |
| Type of Sponsor |
Other [Other (Self Funded)] |
|
|
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 |
| Krunali Maru |
college of physiotherapy |
Sumandeep Vidyapeeth Deemed to be university, Pipariya,Waghodiya,Vadodara,Gujarat-391760
Vadodara
GUJARAT |
9409738906
krunalimaru1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
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 |
Young adult population who is using smartphone minimum of 3 hours per day.
Self declared healthy young adults.
Both genders.
Age between 18 to 24 years.
Subjects should be able to read as well as write English.
|
|
| ExclusionCriteria |
| Details |
Subjects who is having history of any respiratory disease in previous year.
Subjects who has recently undergone any thoracic or abdominal surgeries.
Subjects who are having neck pain before using the smartphone.
Subjects who are not having cough/cold at present.
Subjects who are having musculoskeletal conditions like Ankylosing Spondylitis, Cervical Radiculopathy, Scoliosis, Kyphosis etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Smartphone Addiction Scale Shorter Version (SAS SV)
Mean Inspiratory Pressure (PImax) |
1:time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "185"
Final Enrollment numbers achieved (India)="185" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2023 |
| Date of Study Completion (India) |
22/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Procedure for measuring Mean Inspiratory Pressure :- Subject will be in comfortable position(Crook lying, Long sitting, High sitting).
- introduce the device (Capsule sensing pressure gauge device).
- Subjects will be allowed to practice once or twice then measurement will be done.
- During measurement subject will be informed to hold the device and close the lips firmly around the mouthpiece.
- A nose clip will be applied to avoid nasal air leak and will be asked to exhale as much as possible and then to inhale maximally for >1 second against the resistance of the device.
- Strong verbal encouragement will be given during the test.
- The best of the three inspiratory efforts will be used for analysis.
- An interval between each effort should be approximately 1 minute and the mean inspiratory pressure will be recorded in the assessment sheet.
|