| CTRI Number |
CTRI/2023/02/050048 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Mobile phone Dependency on Neck position, Hand holding power and Breathing function among high school students of Delhi. |
|
Scientific Title of Study
|
Effect of Smartphone Addiction on Cervical Posture, Hand Grip Strength and Respiratory Function among Secondary school students of Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Dubey |
| Designation |
MPT 1st year |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy, Indraprastha University |
| Address |
FLAT NO. 112, ROSE APARTMENT, DWARKA SECTOR -18B
Chandiwala estate, Maa Anandmai marg, Kalkaji
South West
DELHI
110075
India |
| Phone |
08700720231 |
| Fax |
|
| Email |
jyotiminidubey98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Kalra |
| Designation |
Associate Professor |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy, Indraprastha University |
| Address |
Banarsidas Chandiwala Institue of Physiotherapy, Chandiwala estate, Maa Anandmai marg, Kalkaji
Chandiwala estate, Maa Anandmai marg, Kalkaji
South West
DELHI
110019
India |
| Phone |
9910876386 |
| Fax |
|
| Email |
nidhiskalra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Dubey |
| Designation |
MPT 1st year |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy, Indraprastha University |
| Address |
FLAT NO.112 ROSE APARTMENT, DWARKA, SECTOR 18B
Chandiwala estate, Maa Anandmai marg, Kalkaji
South West
DELHI
110075
India |
| Phone |
08700720231 |
| Fax |
|
| Email |
jyotiminidubey98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banarsidas Chandiwala Institue of Physiotherapy. |
|
|
Primary Sponsor
|
| Name |
Jyoti Dubey |
| Address |
Flat no. 112, Rose Apartment, Dwarka Sector 18B,Dwarka
New Delhi
110075 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nidhi Kalra |
Banarsidas Chandiwala Institute of Physiotherapy,Maa Anandamai Marg ,Kalkaji, New Delhi - 110019 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jyoti Dubey |
J.N. INTERNATIONAL SCHOOL |
BIOLOGY LAB, 1st FLOOR, SENIOR WING, J.N. INTERNATIONAL SCHOOL, JAGADAMBA COLONY, AALI VIHAR, SARITA VIHAR, NEW DELHI - 110076
South
DELHI |
8700720231
jyotiminidubey98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Banarsidas Chandiwala Institute of Physiotherapy Ethical Committee (BCIPEC) |
Approved |
| J.N INTERNATIONAL SCHOOL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Students having smartphone addicted (defined by SAS-SV Questionnaire).
2. The students having Body Mass Index (BMI) in the normal range that is 18.5 to 24.9 kgm-2.
3. Students having adequate understanding of English.
4. Those who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
1. Students suffering from musculoskeletal disorder, neurological disorder, respiratory disorders and congenital defects.
2. Recent history of fracture and injury of the upper limb and spine.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Craniovertebral angle
Hand grip strength
FEV1
FVC
FEV1/FVC
FEF 25-75%
MVV
|
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| smartphone usage per day (in hours) |
1 year |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
01/03/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an observational cross-sectional study. The aim of the study is to check the effect of smartphone addiction on cervical posture, hand
grip strength and respiratory function among secondary school students of Delhi. A total of 246 students each will be taken by random method sampling
on the basis of the inclusion and exclusion criterion. Procedure includes secondary school students having Smartphone Addiction (defined by SAS-SV Questionnaire) and Body mass index (BMI) in the normal range (18.5 to 24.9 kg/m2), measurement of Craniovertebral angle
(CVA) using ON PROTRACTOR app, hand grip strength through Jamar grip dynamometer, Respiratory function testing using Clarity
Spiro Tech CMPS – 01. Primary outcome includes Craniovertebral angle (CVA), Hand grip strength and Respiratory function (FEV1, FVC, FEV1/FVC, FEF
25-75%, MVV, Breathing
inspiration hold time, Breathing
inspiration hold time). Statistical
analyses will be performed by using SPSS software. (Version 28.0.1.1). Mean ± SD will be
calculated for the quantitative variables and frequency along with the
percentage will be calculated for categorical data. Appropriate statistical
analysis will be done after collecting data.
|