| CTRI Number |
CTRI/2024/08/071929 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Impact of fear staying without mobile because of usage Social Media and affection of sleep in Young Adults and find effects Physiotherapy treatment on nomophobia |
|
Scientific Title of Study
|
A longitudinal study on nomophobia, use of social media and level of insomnia among young adults & its physiotherapy management |
| 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 Niyatiben Nileshbhai Patel |
| Designation |
Ph.D Scholar, Assistant Professor |
| Affiliation |
Veer Narmad South Gujarat University |
| Address |
Government Physiotherapy College, Medical Campus, Majura Gate, Surat
Vidhyadeep institute of physiotherapy, vidhyadeep university, anita, kim, olpad, surat
Surat
GUJARAT
395001
India |
| Phone |
09974645381 |
| Fax |
|
| Email |
drniyatipatel24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niyatiben Nileshbhai Patel |
| Designation |
Ph.D Scholar, Assistant Professor |
| Affiliation |
Veer Narmad South Gujarat University |
| Address |
Government Physiotherapy College, Medical Campus, Majura Gate, Surat
Vidhyadeep institute of physiotherapy, vidhyadeep university, anita, kim, olpad, surat
Surat
GUJARAT
395001
India |
| Phone |
09974645381 |
| Fax |
|
| Email |
drniyatipatel24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niyatiben Nileshbhai Patel |
| Designation |
Ph.D Scholar, Assistant Professor |
| Affiliation |
Veer Narmad South Gujarat University |
| Address |
Government Physiotherapy College, Medical Campus, Majura Gate, Surat
Vidhyadeep institute of physiotherapy, vidhyadeep university, anita, kim, olpad, surat
Surat
GUJARAT
395001
India |
| Phone |
09974645381 |
| Fax |
|
| Email |
drniyatipatel24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No-104, Physiotherapy Dept, Vidhyadeep Institute Of Physiotherapy, Vidhyadeep University, Anita,Kim,Surat,304110 |
|
|
Primary Sponsor
|
| Name |
Government Physiotherapy College |
| Address |
Medical Campus, Majura Gate, Surat |
| Type of Sponsor |
Other [No] |
|
|
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 Niyatiben Nileshbhai Patel |
Government Physiotherapy Department & Physiotherapy Department at VDU |
Government Physiotherapy College, Medical Campus, Majura Gate,Vnsgu, Surat,
Vidhyadeep Institute Of Physiotherapy, Vidhyadeep Campus, Anita, Kim, Surat
Surat
GUJARAT |
9974645381
drniyatipatel24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NOMOPHOBIA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Spot Marching,
Hook Ups,
Positive Point,
The Active Arms,
Earth Buttons,
The Energy Yawn,
A Lazy 8’s,
Gravity Glider,
Foot Flex,
The Energizer,
Relaxation |
5 days per week for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
3. Own at least one smart phone device/ mobile
4. Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. A history of any psychiatric disorders
2. Chronic medical conditions
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Nomophobia Questionnaire
|
Baseline, after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Social media addiction scale student form
Insomnia severity index
|
baseline, after 4 weeks
baseline, after 4weeks |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 present study seeks to address the insufficient evidence regarding the interrelationships between nomophobia, social media use, and insomnia by employing a longitudinal design to explore these temporal dynamics among adults. Specifically, it hypothesizes that variations in nomophobia levels are correlated with changes in insomnia severity, positing that heightened nomophobia exacerbates insomnia symptoms. Additionally, it hypothesizes that increased addictive use of social media is linked to greater insomnia severity. The primary objectives of this research are to elucidate the correlations between nomophobia, social media usage, and insomnia levels in young adults and to examine the potential mitigating effects of brain gym exercises on nomophobia. Through these investigations, the study aims to provide a comprehensive understanding of how digital behaviors influence sleep health and to explore potential interventions for reducing nomophobia and its associated sleep disturbances. |