| CTRI Number |
CTRI/2025/07/090526 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [yoga therapy] |
| Study Design |
Other |
|
Public Title of Study
|
How Bhramari pranayama helps to reduce stress and improves sleep quality who works shift |
|
Scientific Title of Study
|
The Impact of Bhramari Pranayama on Stress and Sleep Among People Who Work in Shifts |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayak Das |
| Designation |
Post graduate |
| Affiliation |
S- VYASA Deemed to be University |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana Prasanti Kutiram Vivekandanda Road Kalluballu post Jigani Aneka Taluk Bengaluru 560105 India
MSc in Yoga Therapy
School of Yogic Science, SVYASA
department: School of Yogic Sciences
room no. 6
KARNATAKA
560105
India |
| Phone |
6297225287 |
| Fax |
|
| Email |
sayakdas3001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepsikha Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
S- VYASA Deemed to be University |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana Prasanti Kutiram Vivekandanda Road Kalluballu post Jigani Aneka Taluk Bengaluru 560105 India
Anvesana Research Lab, SVYASA
Department: Molecular Department
room no:3
Bangalore
KARNATAKA
560105
India |
| Phone |
7760732875 |
| Fax |
|
| Email |
drdeepsikha@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepsikha Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
S- VYASA Deemed to be University |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana Prasanti Kutiram Vivekandanda Road Kalluballu post Jigani Aneka Taluk Bengaluru 560105 India
Molecular Biology Department, Anvesana Research Lab, SVYASA
Bangalore
KARNATAKA
560105
India |
| Phone |
7760732875 |
| Fax |
|
| Email |
drdeepsikha@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| S-VYASA Deemed to be University
Swami Vivekananda Yoga Anusandhana Samsthana Prasanti Kutiram Vivekandanda Road Kalluballu post Jigani Aneka Taluk Bengaluru 560105 India
|
|
|
Primary Sponsor
|
| Name |
SAYAK DAS |
| Address |
Aishik simantapally Santiniketan West Bengal India 731235 |
| 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 Deepshikha Srivastava |
S-VYASA UNIVERSITY |
S-VYASA Deemed to be University Swami Vivekananda Yoga Anusandhana Samsthana Prasanti Kutiram Vivekandanda Road Kalluballu post Jigani Aneka Taluk Bengaluru 560105 India
The security guards of this site will be used for the research.
Bangalore Rural
KARNATAKA |
7760732875
drdeepsikha@svyasa.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA INSTITUITIONAL ETHICS COMMITEE(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bhramari pranayama |
1 month |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in research |
|
| ExclusionCriteria |
| Details |
shift workers with any chronic condition
smoking or alcohol intake
any acute disease |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| there will change in sleep quality |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There might be slight change in stress & improved sleep quality |
5 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="30" |
|
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
|
My research topic is Effect of Bhramari pranayama on stress and sleep quality in shift workers. My sample will be shift workers. The intervention is Bhramari Pranayama which will be given to the shift workers for a period of 1 month. It will be pre post study design. The primary outcome will be positive effect of pranayama on stress and sleep quality. |