| CTRI Number |
CTRI/2024/06/069329 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Yogic Breathing on Depression, Anxiety, Stress and Sleep Quality among School going Adolescents . |
|
Scientific Title of Study
|
Effect of Yogic Breathing on Depression, Anxiety, Stress and Sleep Quality among School going Adolescents in Rural Jodhpur. |
| 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 Naveen K H |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Science Jodhpur |
| Address |
Room No 212 Department of Community Medicine and Family Medicine 2nd Floor Medical College Building All India Institute of Medical Science (AIIMS) Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9036773746 |
| Fax |
|
| Email |
naveenkhdoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Twinkle Mourya |
| Designation |
PG Resident |
| Affiliation |
All India Institute of Medical Science Jodhpur |
| Address |
Room No 210 Department of Community Medicine and Family Medicine 2nd Floor Medical College Building All India Institute of Medical Science (AIIMS) Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9425735674 |
| Fax |
|
| Email |
twinklemourya18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Twinkle Mourya |
| Designation |
PG Resident |
| Affiliation |
All India Institute of Medical Science Jodhpur |
| Address |
Room No 210 Department of Community Medicine and Family Medicine 2nd Floor Medical College Building All India Institute of Medical Science (AIIMS) Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9425735674 |
| Fax |
|
| Email |
twinklemourya18@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science, Jodhpur, Rajasthan, Pincode-342005, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science jodhpur |
| Address |
All India Institute of Medical Science jodhpur Industrial Area Basni Phase 2 pin code 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Naveen K H |
All India Institute of Medical Science, Jodhpur, pin code 342005, Rajasthan, India |
Room no. 202, Department of Community Medicine and Family Medicine, 2nd Floor, Medical College Building, AIIMS Jodhpur, Pin code-342005, Rajasthan, India
Jodhpur
RAJASTHAN |
9036773746
naveenkhdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Intervention for Prevention of mild, moderate and Normal Depression, Anxiety and Stress |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
No intervention will be given in this group, Telephonic call will be made once in 15 days for any health issue and appropriate help will be provided |
| Intervention |
Yogic Breathing |
Intervention of Yogic breathing for 8 weeks will be given in participants to see its effect on participant with mild moderate depression, anxiety and stress |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
School-going Adolescents studying in classes 9th to 12th who are non-symptomatic or with mild
to moderate levels of depression, anxiety, and stress. |
|
| ExclusionCriteria |
| Details |
Those who are having any contraindications for the practice of yogic breathing. (e.g., any surgeries
within last 6 months) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Depression, anxiety and stress levels as measured by DASS-21 Y scale
Sleep quality as measured by PSQI.
|
Baseline assessment will be done followed by giving 8 weeks of intervention , Followed by Endline assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure Pulse rate oxygen saturation & Body Mass Index (BMI) |
Baseline Assessment followed by giving 8 weeks of Intervention following this endline assessment will be done |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/07/2024 |
| 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="0"
Months="11"
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
|
In conclusion, the prevalence of mental health challenges among adolescents is a global concern that requires attention and intervention. Yoga offers a holistic approach to alleviate these challenges, and ongoing research aims to refine its application, particularly in underserved rural contexts. By addressing gaps in existing research, this study strives to provide insights and solutions to enhance adolescent mental well-being. |