| CTRI Number |
CTRI/2025/09/095033 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
The serenity program for teens, reducing phone dependency to improve sleep and school perfomance |
|
Scientific Title of Study
|
Effectiveness of Serenity Program on smart phone addiction and knowledge among adolescents and its impact on sleep quality mental wellbeing and academic performance at selected higher secondary schools in Dindigul District |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jensi Amali R |
| Designation |
Lecturer |
| Affiliation |
College of Nursing |
| Address |
Pediatric Department
Claudine College of Nursing
Chellampatty
Sitharevu Panchayat
Batlagundu, Dindigul Dist.
Dindigul
TAMIL NADU
624211
India |
| Phone |
7402631902 |
| Fax |
|
| Email |
amalirathinam0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anita David |
| Designation |
Professor & HOD |
| Affiliation |
Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pediatrics
Sri Ramachandra Faculty of Nursing
SRIHER (DU)
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444523496 |
| Fax |
|
| Email |
anitadavid@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jensi Amali R |
| Designation |
Lecturer |
| Affiliation |
College of Nursing |
| Address |
Pediatric Department
Claudine College of Nursing
Chellampatty
Chitharevu panchayat
Athur taluka
Dindigul Dist
Dindigul
TAMIL NADU
624211
India |
| Phone |
7402631902 |
| Fax |
|
| Email |
amalirathinam0@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jensi Amali R |
| Address |
Department of Pediatrics
Claudine college of Nursing
Chellampatty
Sitharevu panchayat
Athur Taluka
Dindigul Dist - 624211
Tamil Nadu
|
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jensi Amali R |
Higher secondary schools |
Holy Cross Girls Higher Secondary School, Batlagundu, Dindigul District
Dindigul
TAMIL NADU |
7402631902
amalirathinam0@gmail.com |
| Jensi Amali R |
Higher secondary schools |
Mahalakshmi Girls Higher Secondary School, Batlagundu, Dindigul-Dt
Dindigul
TAMIL NADU |
7402631902
amalirathinam0@gmail.com |
| Jensi Amali R |
Higher secondary schools |
NSVV girls Higher Secondary School, Batlagundu, Dindigul-Dt
Dindigul
TAMIL NADU |
7402631902
amalirathinam0@gmail.com |
| Jensi Amali R |
Higher secondary schools |
NSVV Boys Higher Secondary School, Batlagundu, Dindigul-Dt
Dindigul
TAMIL NADU |
7402631902
amalirathinam0@gmail.com |
| Jensi Amali R |
Higher secondary schools |
CSI Higher Secondary School, Batlagundu, Dindigul-dt
Dindigul
TAMIL NADU |
7402631902
amalirathinam0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| CSI Higher Secondary School |
No Objection Certificate |
| Holy Cross Girls Higher Secondary School |
No Objection Certificate |
| Mahalaxmi Girls Higher Secondary School |
No Objection Certificate |
| NSVV Boys Higher Secondary School |
No Objection Certificate |
| NSVV Girls Higher Secondary School |
No Objection Certificate |
| SRM Institutional Ethics Committee |
Approved |
| Theni Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents Addicted to smartphone |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
| Intervention |
Serenity Program |
1. Breathing Exercise
(7 minutes)
|
| Intervention |
Serenity Program |
2. Meditation (15 minutes) |
| Intervention |
Serenity Program |
3. Video-assisted Teaching (8minutes) |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents
Both boys and girls are studying in the Higher Secondary School
Between 13 to 16 years of age.
who can speak and understand either Tamil or English
who are addicted to Smartphone usage
|
|
| ExclusionCriteria |
| Details |
Adolescents who are
not available during the data collection period
long absentees
on drugs for any psychiatric disorders
not addicted to smartphone usage
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in smartphone addiction |
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in sleep quality |
6months |
| Enhanced mental well-being |
6months |
| Improved academic performance |
6months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
15/10/2025 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amalirathinam0@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study investigates the effectiveness of the serenity program, a mindfulness-based intervention combining breathing exercises, meditation, and video-based education in reducing smartphone addiction and improving sleep quality, mental well-being, and academic performance among adolescents aged 13-16 years in selected higher secondary schools in Dindigul District, Tamil Nadu. Using a cluster randomized controlled trial with 250 participants, the research measures outcome through the Smartphone Addiction Scale Short Version, Pittsburgh Sleep Quality Index, Warwick-Edinburgh Mental Well-being Scale, and Academic Performance Scale with assessments at multiple intervals over six months. The program is delivered four times a week for 30 minutes, aiming to foster healthier smartphone habits, enhance self-regulation, and promote overall well-being, with the expectation of reduced addiction scores, better sleep, improved mental health, and higher academic performance. |