| CTRI Number |
CTRI/2024/04/065360 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
To study the Effect of Bhramari Pranayama on Reaction Time, Heart Rate Variability and Mindfulness Among Nurses. |
|
Scientific Title of Study
|
Effect of Bhramari Pranayama on Reaction Time, Heart Rate Variability and Mindfulness Among Nurses. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sivanibairavi Tamilselvan |
| Designation |
PG student |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Mind Body Medicine and Lifestyle Sciences, SRFAHS, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9361204853 |
| Fax |
|
| Email |
a3922003@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D C Mathangi |
| Designation |
Professor and Head |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Mind Body Medicine and Lifestyle Sciences, SRFAHS, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116
DEPARTMENT OF MIND BODY MEDICINE AND LIFESTYLE SCIENCES,SRFAHS,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,PORUR,CHENNAI-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr D C Mathangi |
| Designation |
Professor and Head |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Mind Body Medicine and Lifestyle Science, SRFAHS, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| SIVANIBAIRAVI TAMILSELVAN |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,NO 1 RAMACHANDRA NAGAR,PORUR,CHENNAI-600116
Kancheepuram
TAMIL NADU |
9361204853
a3922003@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
21-40 YEARS OF AGE, NURSES
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bhramari Pranayama |
Effect of Bhramari Pranayama on Reaction Time, Heart Rate Variability and Mindfulness.
Total Duration is two weeks conducted by Principal Investigator. |
| Comparator Agent |
No intervention |
Pre and Post Assessment Intervention |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Nurses working at Sri Ramachandra Medical Centre
Individuals who don’t practice any form of yoga or pranayama.
Age group: 21-40
Nurses with experience above 2 years
Female
|
|
| ExclusionCriteria |
| Details |
Yoga practitioner
Individuals with comorbidities
Male
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability |
Baseline and after 2 weeks of practice |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reaction Time |
Baseline & after 2 weeks of practice |
| Mindfulness |
Baseline & after 2 weeks of practice |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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 2 |
|
Date of First Enrollment (India)
|
17/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Studies have shown that there is a high prevalence of job stress among medical professionals and healthcare workers, particularly among nurses. To combat this , one has to redirect his/her efforts in improving their physical and mental well-being. Yoga is a scientifically proven practice which brings a holistic effect on an individual striking balance between the body and mind. Pranayama, being one of the components of yoga, had the potential to regulate the psycho-neuroimmune system of an individual thereby contributing to their physical and mental well-being. this research is proposed to study the effect of two-week Bhramari Pranayama on autonomic dysfunction, reaction time and mindfulness among nurses. The study outcome will be published once all data are collected and analyzed. |