| CTRI Number |
CTRI/2024/06/069533 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of meditation on adults with internet addiction. |
|
Scientific Title of Study
|
Role of meditation on Cognitive functions and subjective well-being in Adults with Internet addiction |
| 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 Sudesh Kumar |
| Designation |
Junior Resident (PG) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology
Maulana Azad Medical college
New Delhi
Central
DELHI
110002
India |
| Phone |
7982392640 |
| Fax |
|
| Email |
sudeshmamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Jain |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology
Maulana Azad Medical college
New Delhi
Central
DELHI
110002
India |
| Phone |
996860434 |
| Fax |
|
| Email |
drpreetijain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Jain |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology
Maulana Azad Medical college
New Delhi
DELHI
110002
India |
| Phone |
996860434 |
| Fax |
|
| Email |
drpreetijain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical college
New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadurshah Zafar Marg
New Delhi- 110002 |
| Type of Sponsor |
Government 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 Sudesh Kumar |
Maulana Azad Medical College |
Department of Physiology,
MAMC
Central
DELHI |
7982392640
sudeshmamc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y93C||Activities involving computer technology and electronic devices, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Meditation |
20 minutes/day for 6weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with internet addiction based on Youngs internet addiction test |
|
| ExclusionCriteria |
| Details |
1.subjects regularly practising meditation.
2. subjects suffering from acutephysical and mental illness.
3.Subjects with history of any auditory-visual impairment, neurological disorder or musculoskeletal disorder.
4. those on medications likely to affect cognition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in scores of Positive and Negative affect scale and Satisfaction with life scale after Raj yog meditation. |
Baseline,2 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. change in scores of Cognitive function test and percieved stress scale.
2. Change in serum cortisol level and BDNF levels.
|
Baseline, 2 weeks and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2024 |
| 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="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 - NO
|
|
Brief Summary
|
This study will be conducted in the Department of Physiology, MAMC New Delhi. The present study is designed to assess the influence of Meditation on Cognitive functions, subjective well being and biochemical markers in internet addicts. |