FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080493 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 07/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [pranayama, kapalbhati and om chanting ]  
Study Design  Single Arm Study 
Public Title of Study   A Study to Assess the Impact of Pranayama and Meditation on mental and physical wellbeing of Paramedical and Nursing Staff. 
Scientific Title of Study   A Prospective, Single-Centre Interventional Study to Assess the Impact of Pranayama and Meditation on psychological and physiological wellbeing of Paramedical and Nursing Staff. 
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 Jyotsana Karande 
Designation  Consultant Anaesthesiologist and Certified Yoga Instructor 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  B wing, Second Floor, OPD No 2, Department of Anesthesiology, Bhaktivedanta Swami Marg, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107

Thane
MAHARASHTRA
401107
India 
Phone  9892056189  
Fax    
Email  karandejyotsna9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyotsana Karande 
Designation  Consultant Anaesthesiologist and Certified Yoga Instructor 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  B wing, Second Floor, OPD No 2, Department of Anesthesiology, Bhaktivedanta Swami Marg, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107

Thane
MAHARASHTRA
401107
India 
Phone  9892056189  
Fax    
Email  karandejyotsna9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyotsana Karande 
Designation  Consultant Anaesthesiologist and Certified Yoga Instructor 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  B wing, Second Floor, OPD No 2, Department of Anesthesiology, Bhaktivedanta Swami Marg, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107

Thane
MAHARASHTRA
401107
India 
Phone  9892056189  
Fax    
Email  karandejyotsna9@gmail.com  
 
Source of Monetary or Material Support  
Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Bhaktivedanta Swami Marg, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyotsana Karande  Bhaktivedanta Hospital and Research Institute  Second Floor, Department of Anesthesiology, Bhaktivedanta Swami Marg, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA 
9892056189

karandejyotsna9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Paramedical and Nursing Staff 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Yoga and Meditation   The paramedical staff will undergo pranayama, kapalbhati and om chanting training from a certified yoga instructor. Further, the paramedical staff will be instructed to follow these practices consistently for a duration of three weeks for 20 minutes per day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Participants who are 18 years of age and above
Paramedical Staffs (e.g., nurses, OT technicians (Surgical and Anaesthesia)
Participants who are willing to participate in pranayama and meditation sessions
 
 
ExclusionCriteria 
Details  Individuals with severe cardiovascular conditions, uncontrolled hypertension, or chronic respiratory illnesses that may interfere with their ability to participate in breathing exercises or meditation
Participants who have been regularly practicing pranayama or meditation for more than six months prior to the study will be excluded to ensure that the intervention’s effects are not confounded by pre-existing habits
Participants who are not willing to participate.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the changes in stress, anxiety, depression and burnout parameters pre and post intervention  Pre Intervention: baseline (Day 0). Post Intervention: at the time point 3rd week 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the changes in HRV as measured by ECG before and after the intervention to evaluate improvements in autonomic nervous system balance and physiological well-being  Pre Intervention: baseline (Day 0). Post Intervention: at the time point 3rd week 
 
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)   12/01/2026 
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="3"
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  
Paramedical staff, including nurses and OT technicians, often experience high levels of stress, anxiety, and depression due to demanding workloads, long hours, and emotionally challenging situations. These factors increase the risk of burnout and negatively impact mental health, job performance, and overall well-being. Holistic practices like pranayama and meditation offer effective, non-invasive solutions. Pranayama promotes relaxation by reducing cortisol levels and enhancing cardiovascular health, while meditation improves mindfulness, emotional regulation, and resilience.

The aim of this study is to evaluate the effects of pranayama and meditation in stress, anxiety, depression, and burnout and Heart Rate Variability (HRV) in paramedical staff. Stress, anxiety, and depression will be assessed using the DASS 21 Scale, burnout will be measured using the Maslach Burnout Inventory Scale, and HRV will be monitored through ECG.

The inclusion criteria for the study paramedical staff aged 18 years and above, paramedical staff (e.g., nurses, OT technicians specializing in surgical and anesthesia care), and individuals willing to participate in pranayama and meditation sessions.

The exclusion criteria for the study are individuals with severe cardiovascular conditions, uncontrolled hypertension, or chronic respiratory illnesses that may interfere with their ability to participate in breathing exercises or meditation. Participants who have been regularly practicing pranayama or meditation for more than six months prior to the study will also be excluded to avoid confounding the intervention’s effects with pre-existing habits. Additionally, individuals unwilling to participate will not be included.

Participants will be evaluated based on DASS-21 scale, Maslach Burnout Inventory, and ECG.

Participants will undergo the above mentioned evaluations at the following time points: Visit 1 (Day 0) and Visit 2 (End of Treatment, 3rd week).

The patient recruitment duration of the study is 3 months. 

The endpoint of the study is to evaluate changes in stress, anxiety, depression, and burnout parameters before and after the intervention. It will also assess changes in Heart Rate Variability (HRV) as measured by ECG, to evaluate improvements in autonomic nervous system balance and physiological well-being.



 
Close