| CTRI Number |
CTRI/2024/09/073893 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Sookshma Meditation on Sleep Quality and Smartphone Usage Among First Year Medical Students A Randomized Controlled Trial |
|
Scientific Title of Study
|
Role of Sookshma Meditation on Quality of Sleep and Smartphone Usage in First-year Medical Students- A Randomized Controlled Study |
| 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 Ashween Bilagi |
| Designation |
Assistant professor and Head |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Integrative Medicine
Tamaka
Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9886666636 |
| Fax |
|
| Email |
ayushashwin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashween Bilagi |
| Designation |
Assistant professor and Head |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Integrative Medicine
Tamaka
Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9886666636 |
| Fax |
|
| Email |
ayushashwin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashween Bilagi |
| Designation |
Assistant professor and Head |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Integrative Medicine
Tamaka
Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9886666636 |
| Fax |
|
| Email |
ayushashwin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and Research
Tamaka
Kolar
Karnataka
PIN-563103 |
|
|
Primary Sponsor
|
| Name |
Dr Ashween Bilagi |
| Address |
Department of Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka
Kolar
Karnataka
PIN-563103 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shobha M V |
Sri Devaraj Urs Medical College |
Department of Physiology
Faculty of Medicine
1st floor SDUMC
Tamaka-563103
Kolar
KARNATAKA |
9448812036
shobha@sduaher.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Quality of Sleep
Smartphone Usage |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
45 min of practice Five days a week for one month. The practice include 20 min walking followed by supine rest with breath awareness. |
| Intervention |
Sookshma Meditation |
45 Min of Sookshma meditation practice Five days a week for one month. Sookshma meditation involves subtle movements and breath control to enhance relaxation and focus. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.First-year medical students
2.Those who are using the smartphone
3.Willing to participate
|
|
| ExclusionCriteria |
| Details |
1.Any physical disability
2.On medication for any psychiatric illness
3.History of substance abuse
4.Practicing Yoga or meditation in the last 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pittsburgh Sleep Quality Index (PSQI)
2. Smartphone addiction Scale
|
Pre data will be collected before intervention and after one month of Yoga intervention post data will be collected |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3. Anthropometric and basic physiological parameters |
Pre data will be collected before intervention and after one month of Yoga intervention post data will be collected |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
First-year medical
students are particularly vulnerable to poor sleep quality and overuse use of smartphone
challenges due to the rigorous academic curriculum, demanding schedules, and
the need to balance academic responsibilities with personal life. These can
adversely affect their academic performance, mental health, and future career
prospects. Meditation as a part of Yoga has shown its efficiency in managing stress, anxiety and depression. Hence present study is designed to evaluate the effect of Sookshma meditation in First-year medical
students. |