| CTRI Number |
CTRI/2025/01/079452 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Impact of Short-Term Yoga on Mental Health, Sleep, and Well-being in Medical Interns |
|
Scientific Title of Study
|
Effect of a Short-Term Yoga on Mental Health, Mobile Addiction, Cardio-Autonomic Function, and Sleep in Medical Interns |
| 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 |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
2nd floor, PG Building, Department of Integrative Medicine
Sri Devaraj Urs Academy of
Higher Education and Research 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 |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
2nd floor, PG Building, Department of Integrative Medicine
Sri Devaraj Urs Academy of
Higher Education and Research 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 |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
2nd floor, PG Building, Department of Integrative Medicine
Sri Devaraj Urs Academy of
Higher Education and Research 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- 563103
India |
|
|
Primary Sponsor
|
| Name |
Dr Ashween Bilagi |
| Address |
2nd Floor
PG Building
Department of Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka
Kolar
Karnataka- 563103
India |
| 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 Ashween Bilagi |
Sri Devaraj Urs Academy of Higher Education and Research |
2nd Floor
PG Building
Department of Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research
Kolar
KARNATAKA |
9886666636
ayushashwin@gmail.com |
|
|
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 |
healthy medical interns |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Self as control group |
Sri Devaraj Urs Medical College interns attending compulsory training in the other departments one week before the AYUSH posting. The duration is 6days |
| Intervention |
Yoga |
Sri Devaraj Urs Medical College interns attending one-week compulsory AYUSH training in the Integrative Medicine Department will attend 90 minutes per session for 6 days under the supervision of a trained Yoga instructor. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Practiced Yoga (in last 3 months)
2. On medication for psychiatric diagnosis
3. Physically challenged
4. Recent surgery or injury
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of short-term yoga on mental health in medical interns.
2. To assess the effect of short-term yoga on heart-rate variability in medical interns. |
1. Control baseline data collection on 1st day
2. Control Post-data/ Yoga pre-data collection on 7th day.
3. Yoga post-data collection on 14th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of short-term yoga on mobile addiction in medical interns.
2. To assess the effect of short-term yoga on sleep in medical interns. |
1. Control baseline data collection on 1st day
2. Control Post-data/ Yoga pre-data collection on 7th day.
3. Yoga post-data collection on 14th day. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
27/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Mobile addiction has emerged as a growing concern in today’s digital
age, particularly among young adults, including medical students and resident
interns. The excessive use
of smartphones, often characterised by compulsive checking, prolonged screen
time, and difficulty in disconnecting, is now recognized as a form of behavioural
addiction. Smartphone addiction, also known as problematic smartphone use or
mobile phone dependency, has emerged as a significant public health concern
worldwide. Characterised by
excessive, uncontrollable use of smartphones, this addiction impacts various
aspects of daily life, including social relationships, mental health, and
physical well-being. The ubiquity of
smartphones and their multifunctionality—providing instant access to social
media, games, and information—have contributed to their addictive potential.
Research indicates that smartphone addiction can lead to negative outcomes such
as sleep disturbances, increased anxiety, and impaired academic and
professional performance, particularly among students and young adults. The addictive
nature of smartphones is often linked to their ability to offer immediate
gratification and continuous stimulation, which can disrupt time management,
cognitive focus, and emotional regulation. Excessive
smartphone use, or smartphone addiction, has been found to significantly impair
sleep quality across various populations. Prolonged screen exposure, especially
before bedtime, disrupts the circadian rhythm, delays sleep onset, and leads to
poorer sleep quality and shorter sleep duration. Research shows that
individuals with higher smartphone usage often report increased instances of
insomnia and daytime sleepiness. Factors such as
bedtime procrastination and the stimulating nature of smartphone content also
exacerbate these sleep disturbances. Smartphone
addiction is highly prevalent among Asian medical students. Smartphone
addiction may adversely affect mental health, resulting in sleep disturbance,
stress, anxiety, depression, and neuroticism. It is necessary to
take appropriate preventive actions and interventions to prevent smartphone
overuse among medical students . As smartphone use
continues to grow, understanding the underlying mechanisms of addiction and
developing strategies for prevention and intervention becomes crucial. |