| CTRI Number |
CTRI/2024/02/063298 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of volitional yoga breathing on relaxation and and state impulsivity |
|
Scientific Title of Study
|
Effect of devised guided breathing on state impulsivity on students |
| 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 Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building,
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building,
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building,
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar,
Uttrakhand, India, 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation trust |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building,
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India |
| Type of Sponsor |
Research institution |
|
|
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 Shirley Telles |
Patanjali Yogpeeth, Phase1 |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL |
9897963254
office@patanjali.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE OF DEPARTMENT OF YOGA RESEARCH, PATANJALI RESEARCH FOUNDATION (TRUST) HARIDWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alternate nostril yoga breathing (ANYB) |
The intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
| Comparator Agent |
Breath awareness (BAW) |
The intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
| Intervention |
Bumblebee(Bharamri) yoga breathing- non pharmacological
|
The intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
| Comparator Agent |
QUIET SITTING |
Sitting quietly without conscious modification of breathing for 17 minutes |
| Intervention |
Yoga bellow-breathing (Bhastrika) |
The intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
(i) apparent normal health based on a routine clinical exam,
(ii) experience of yoga breathing for at least 6 months, and
(iii) willingness to take part in the study, including all participants’ written signed informed consent.
|
|
| ExclusionCriteria |
| Details |
(i) disturbed sleep routine in the night prior to the assessment, intense physical exercise within 24 hr of the assessment and consumption of alcohol or tobacco (in any form), and breathing difficulties during exertion.
(ii) regular intake of any prescribed or non-prescribed medication or herbal remedies, and
(iii) any history of a learning disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(i)Relaxation state questionnaire (RSQ)
(ii)STATE IMPULSIVITY SCALES(STIMP)
(iii)Global vigor and affect instrument (GVA)
(iv)Blood pressure |
The participants will be assessed at two time points i.e., at baseline and five minute after the intervention or control sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(i)Heart rate variability(HRV)
(ii)Respiration rate |
The participants will be assessed for heart rate variability and respiratory characteristics at three time points (i.e., 5 minute baseline recording prior to the intervention or control sessions; during the intervention or control session and 5 minute after the intervention or control sessions). |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
10/03/2024 |
| 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="6"
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
|
Previous studies reported a decrease in state anxiety following specific yoga breathing techniques. With this background, the study aims to determine the effect of specific yoga breathing techniques on (i) state relaxation and (ii) state impulsivity.
|