| 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
|
|
|
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
|
|
|
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.
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