| CTRI Number |
CTRI/2024/03/063400 [Registered on: 01/03/2024] 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, Parallel Group Trial |
|
Public Title of Study
|
Can yoga breathing improve sustained attention in problematic users of smartphone? |
|
Scientific Title of Study
|
Effect of yoga breathing on sustained attention in problematic users of smart phone |
| 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 |
Director of Research |
| 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 |
Director of Research |
| 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
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Telles |
| Designation |
Director of Research |
| 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
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
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
9897963254
office@patanjali.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Department of Yoga Research, Patanjali Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Quiet sitting |
Sitting quietly without conscious modification of breathing for 17 minutes control session |
| Intervention |
Breath awareness |
The intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
| Intervention |
Bumblebee breathing (Bhramari) |
The intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
| Intervention |
High frequency yoga breathing (kapalbhati) |
The intervention session will be for 17 minutes which includes two minutes of rest after every five minutes of practice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Problematic users of smartphone
2. Aged 18-45 years |
|
| ExclusionCriteria |
| Details |
(i) consumption of alcohol or tobacco (in any form), (ii) use of medication, (iii) presence of physical or neurological illness which prevents participants practicing any of the four yoga breathing techniques (e,g., deviated nasal septum in case of alternate nostril yoga breathing and epilepsy for high frequency yoga breathing) and (v) extra systole in the EKG (to avoid abnormal HRV recordings) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. P300
2. Digit vigilance test
|
Before and after 15 minute of yoga breathing practices
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| STAI |
Before and after 15 minute of yoga breathing practices |
| heart rate variability |
Before, during and after 15 minute of yoga breathing practices |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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="1"
Months="0"
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
|
Improved sustained attention have been reported following specific yoga breathing techiques in normal healthy volunteers. However, this has not been tested in problematic users of smartphone. With this, this study aims to determine the effects of specific yoga breathing techniques on sustained attention in problematic users of smart phone |