| CTRI Number |
CTRI/2026/01/102557 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see whether taking a break from mobile phones improves sleep and mental health among B.Sc. nursing students of Shrimati Radhikabai Meghe Memorial College of Nursing Wardha. |
|
Scientific Title of Study
|
Assess the effectiveness of a digital detox intervention on sleep quality and mental well-being among B.sc nursing students of Shrimati Radhikabai Meghe Memorial College of Nursing Wardha |
| 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 Sonali Khade |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Department of Mental Health Nursing Ground Floor SRMMCON Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8871912755 |
| Fax |
|
| Email |
sonukhade331@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Meshram |
| Designation |
Clinical Instructor |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Department of Mental Health Nursing Ground Floor SRMMCON Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8600289201 |
| Fax |
|
| Email |
priyankameshramganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Meshram |
| Designation |
Clinical Instructor |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Department of Mental Health Nursing Ground Floor SRMMCON Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8600289201 |
| Fax |
|
| Email |
priyankameshramganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe , Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe , Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Priyanka Meshram |
Shrimati Radhikabai Meghe Memorial College Of Nursing |
Department of Mental Health Nursing Ground Floor SRMMCON Sawangi Meghe
Wardha
MAHARASHTRA |
8600289201
priyankameshramganvir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Digital detox intervention on improving sleep quality and mental well-being among b.sc nursing students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Planned teaching intervention |
To educate college students about the negative consequences of excessive digital device use on sleep quality and mental well-being and to motivate them to adopt healthier screen habits |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. College students aged 18–25 years.
2. Using digital devices for more than 4 hours per day.
3. Willing to participate and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Students with diagnosed psychiatric or sleep disorders.
2.Students on medications affecting sleep.
3.Students not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sleep quality and mental well being among students after the digital detox intervention. |
Assessment will be done at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2026 |
| 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 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
21st century is marked by rapid technological advancement and the widespread
availability of digital devices. Digital
addiction is the phrase used to describe obsessive and uncontrollable usage of
digital gadgets, which is frequently accompanied by restlessness, anxiety, and
anger when disconnected. The study focuses on assessing the effectiveness of a structured digital
detox intervention in improving sleep quality and mental well-being among
college students. |