| CTRI Number |
CTRI/2021/10/037516 [Registered on: 25/10/2021] Trial Registered Prospectively |
| Last Modified On: |
22/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of specific yoga module to manage covid stress among youths |
|
Scientific Title of Study
|
Adopting specific yoga module to reduce the burden of post COVID stress disorder among unemployed youth and recent graduates: a pilot investigative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kaviraja Udupa |
| Designation |
Additional Professor, Department of Neurophysiology |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
National Institute of Mental Health and Neurosciences, Department of Neurophysiology, I floor, Administrative Block
Hosur Road, Near Bangalore Milk Dairy
Bangalore
KARNATAKA
5600029
India |
| Phone |
|
| Fax |
|
| Email |
kaviudupa1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saumya Subramanian |
| Designation |
Research Associate |
| Affiliation |
Junior Research Fellow/ DST |
| Address |
Dept of Neurophysiology, NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9916127792 |
| Fax |
|
| Email |
saumya.subramanian@ssiar.org |
|
Details of Contact Person
Public Query
|
| Name |
Ashwini K |
| Designation |
Yoga Instructor |
| Affiliation |
Yoga Instructor/ DST |
| Address |
National Institute of Mental Health and Neurosciences, Department of Neurophysiology, Administrative Block
Hosur Road, Near Bangalore Milk Dairy
Bangalore
KARNATAKA
5600029
India |
| Phone |
7996300290 |
| Fax |
|
| Email |
ashwinikeh24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri Institute for Advanced Research
21st Km Kanakpura Road, Udipalya, Bangalore- 560082 |
|
|
Primary Sponsor
|
| Name |
Department of Science Technology Science And Technology of Yoga And Meditation |
| Address |
National Institute of Mental Health and Neurosciences, Department of Neurophysiology, Administrative Block |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kaviraja Udupa |
National Institute of Mental Health and Neurosciences |
National Institute of Mental Health and Neurosciences, Department of Neurophysiology, Administrative Block
Hosur Road, Near Bangalore Milk Dairy, Bengluru, Karnataka - 5600029
Bangalore
KARNATAKA |
9844497111
kaviudupa@gmail.com |
| Dr Kaviraja Udupa |
Sri Sri Institute for Advanced Research |
Sri Sri Institute For Advanced Research
21st Km Kanakapura Rd,
Udayapura, Bengaluru,
Karnataka 560082
Bangalore
KARNATAKA |
9844497111
kaviudupa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics committee |
Approved |
| Sri Sri Institute for Advanced Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Unemployed Youths |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Routine lifestyle |
| Intervention |
Sudarshan Kriya |
Sudarshan Kriya is a technique taught by the Art of Living Foundation in more than 156 countries with more than 6 million practitioners across the globe. It is taught in various modules across various age groups in different parts of the world.
SKY is a cyclic rhythmic breathing technique with its roots in traditional yoga. The 25 minutes process includes three yogic components – pranayama, Om chanting and Sudarshan Kriya. The pranayama is done using the Ujjayi breath. Ujjayi involves experiencing the conscious sensation of the breath touching the throat. This slow breathing technique is performed at a rate of 2–4 breaths per minute (bpm). This technique improves lung capacity, allowing more air to pass through the lungs. ‘Om’ is chanted three times with prolonged exhalation. Lastly, Sudarshan Kriya rhythmic breathing is done in two variations:- long SKY, which is done under Gurudev Sri Sri Ravishankar’s recorded instruction, and short SKY which can be done can be done at home taking slow (20 bpm), medium (40–50 bpm), and fast (60–80 bpm) breaths. The entire technique is done in a seated posture with eyes closed.
The given technique will be administered once every day for 30 minutes till 2 months
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. COVID negative Subjects with history of COVID related stress, job loss/searching a job
2. Severity of anxiety- low to moderate and confirmed by a HAM-A score < 10, requiring no medications
3. Subjects who will consent for and be co-
operative for the study. |
|
| ExclusionCriteria |
| Details |
Subjects with suicidal tendency/thoughts
1. Subjects with other psychotic disorders
2. Subjects having cardiovascular problems
3. Any neurological disorders such as any significant head injury, epilepsy, Parkinson’s disease, neuro-degenerative disorders etc.
4. Subjects of substance use disorders
5. Pregnant and lactating women
6. Any medical conditions that can mimic anxiety disorders like hyperthyroidism |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find the efficacy (if any) of yoga module on vulnerable population (people who lost
their job and unemployed graduates) |
0 Day,
60 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the neurobiological basis of such improvement (if any) in the responders to
this yoga module |
0 Day,
60 Day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2021 |
| Date of Study Completion (India) |
28/01/2022 |
| Date of First Enrollment (Global) |
01/12/2021 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The deadly pandemic of Coronavirus disease (COVID-19) which has taken the lives of thousands and infected millions around the world and in India, is also going to negatively impact the economy, increase social distress, and potentially increase stress related disorders. Early reports coming out illustrate the potential negative long-term impacts of this pandemic. Although there are many yoga and lifestyle modification therapies being offered in this tough situation, there is no specific module including healthy diet, positive lifestyle, asanas that keep one fit, pranayama to increase the lung capacity and immunity, and meditation to calm the mind. Further, there are no studies looking at whether these kinds of interventions will help to effectively tackle the problem of stress induced anxiety and depression. We plan to select two specific and vulnerable populations: young individuals (20-40 yrs) who have lost their job because of COVID pandemic, and young graduates who are facing difficulties due to the effects of this pandemic and who are yet to get a job and settle in their life. Hence, we planned a study with following objectives:
1. To find the efficacy (if any) of yoga module on vulnerable population (people who lost their job and unemployed graduates) 2. To find the neurobiological basis of such improvement (if any) in the responders to this yoga module |