| CTRI Number |
CTRI/2023/05/052922 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of excessive use of smartphone on lung functions in young population |
|
Scientific Title of Study
|
Effect Of Smartphone Addiction On Pulmonary Function In Young Adults. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mirza Minal Fatima |
| Designation |
PG Student |
| Affiliation |
College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University |
| Address |
PG Classroom,Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At and Post Pipariya, Taluka - Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7021585964 |
| Fax |
|
| Email |
mirzaminal940@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mirza Minal Fatima |
| Designation |
PG Student |
| Affiliation |
College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University |
| Address |
PG Classroom,Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At and Post Pipariya, Taluka - Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7021585964 |
| Fax |
|
| Email |
mirzaminal940@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kalpesh satani |
| Designation |
Professor and guide |
| Affiliation |
College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University |
| Address |
Staffroom,Ground Floor, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At and Post Pipariya, Taluka - Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9979483324 |
| Fax |
|
| Email |
kalpesh.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Sumandeep Vidyapeeth |
|
|
Primary Sponsor
|
| Name |
Mirza Minal Fatima |
| Address |
College Of Physiotherapy, Sumandeep Vidyapeeth (Declared as Deemed To Be University u/s 3 of UGC act 1956) ,Pipariya, Taluka - Waghodia, Dist - Vadodara, Gujarat - 391760 |
| 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 |
| Mirza Minal Fatima |
College Of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
Ground floor, PG Classroom, College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At and Post Pipariya, Taluka - Waghodia, Vadodara
Vadodara
GUJARAT |
7021585964
mirzaminal940@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pulmonary Function |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Self-declared healthy young adult people.
Both genders.
Young Adult of age between 18 to 25 years age group.
Young adult population who is using smartphones since atleast of 2 years. |
|
| ExclusionCriteria |
| Details |
Any neurological/cardiorespiratory/musculoskeletal problems that hinders with the
performance of the individual.
Individuals with onset of neck pain before starting to use smartphone
The one who is a known case of any chronic respiratory diseases such as Tuberculosis,
Lungcancer etc.
The one who has recently undergone any thoracic or abdominal surgeries.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Smartphone Addiction Scale – Shorter Version (SAS-SV).
|
single time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak Expiratory Flow Rate (PEFR) |
single time study |
|
|
Target Sample Size
|
Total Sample Size="203"
Sample Size from India="203"
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)
|
08/08/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After obtaining the permission, the young adult population
considered will be explained about the study. Those who are willing to participate in the study,
written informed consent form (annexure â… ) will be obtained from them. Participation
information sheet (annexure â…¡) will be given to them explaining the details of the study.
Subjects will be screened and assessed (Annexure III) and those fulfilling the inclusion and
exclusion criteria will be recruited for the study.
Those subjects who are recruited for the study, first their demographic details including the
amount of time they are using the smartphone will be recorded. Then depending upon the time
of usage of smartphone they will be divided into 3 groups; usage time less than 2 hours, usage
time more than 2 hours but less than 4 hours, and usage time more than 4 hours. Then they will
be handed over the Smartphone Addiction Scale- Shorter Version SAS-SV. It will be collected
back once participants completes the questionnaire. After collecting the questionnaire, Peak
Expiratory Flow Rate (PEFR) of all participants will be measured using Mini wright’s peak flow meter. |