| CTRI Number |
CTRI/2025/07/091560 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mindfulness Based Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mindfulness based intervention on levels of stress and burnout in ICU staff |
|
Scientific Title of Study
|
The efficacy of a mindfulness based intervention on levels of stress and burnout in ICU nurses and physicians: A Randomized Controlled Study |
| Trial Acronym |
The SMILE study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutula Sonawane |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be University Medical College |
| Address |
Room no. 415, fourth floor, super specialty building, Bharati Hospital and Research Centre, Pune-Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8149990072 |
| Fax |
|
| Email |
drrutula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rutula Sonawane |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be University Medical College |
| Address |
Room no. 415, fourth floor, super specialty building, Bharati Hospital and Research Centre, Pune-Satara Road Pune
MAHARASHTRA
411043
India |
| Phone |
8149990072 |
| Fax |
|
| Email |
drrutula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutula Sonawane |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be University Medical College |
| Address |
Room no. 415, fourth floor, super specialty building, Bharati Hospital and Research Centre, Pune-Satara Road Pune
MAHARASHTRA
411043
India |
| Phone |
8149990072 |
| Fax |
|
| Email |
drrutula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Research Publication Unit, Bharati Hospital and Research Centre, Pune - Satara Rd, Bharati Vidyapeeth Campus, Dhankawadi, Pune, Maharashtra, India 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research Centre |
| Address |
Bharati Hospital and Research Centre, Pune - Satara Rd, Bharati Vidyapeeth Campus, Dhankawadi, Pune, Maharashtra, India 411043 |
| 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 Rutula Sonawane |
Bharati Hospital and Research Centre |
Room no. 415, Department of Critical Care Medicine,
Bharati Vidyapeeth Campus
Pune - Satara Rd, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA |
8149990072
drrutula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness Based Intervention |
Mindfulness-Based Intervention for ICU Nurses and Physicians
The intervention will be carried out by mindfulness experts
Dr Rohi Shetty
Dr Manjula Bhosale
Core Components are:
Smiling Meditation
Week 1: SMILE
Week 2: RELAX
a. Breath
b. Body scan
Week 3: SHARE YOUR METTA (Unconditional Goodwill)
a. Metta to Yourself
b. Metta to Spiritual Friend
Week 4: MINDFULNESS
Week 5: LET GO
Week 6: DON’T TAKE ANYTHING PERSONALLY
Week 1
Smiling Meditation
Walking Meditation
Journaling
Tiny Habits
Applied Meditation
Week 2
Smiling Meditation
Walking Meditation
Forgiveness Meditation
Applied Meditation
Week 3
Smiling Meditation
Walking Meditation
Gratitude Meditation
Applied Meditation
Week 4
Smiling Meditation
Walking Meditation
Breath Meditation
Applied Meditation
Week 5
Smiling Meditation
Walking Meditation
Body Scan Meditation
Applied Meditation
Week 6
Smiling Meditation
Walking Meditation
Applied Meditation
Review and Next Steps
|
| Comparator Agent |
Participants without intervention |
Study participants will be assessed at 0, 6 weeks and 12 weeks of starting the study for stress, burnout and mindfulness. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Staff Nurse working in ICU with more than 6 months of experience.
Senior residents with more than 6 months of experience of working in ICU
|
|
| ExclusionCriteria |
| Details |
Refusal of consent |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean and proportions of
Levels of Stress
Levels of Burnout
Levels of Mindfulness
|
0 6 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Quality of Life |
at 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
20/08/2025 |
| 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 Yet Recruiting |
| 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
|
Healthcare
professionals, particularly those working in Intensive Care Units, experience
high levels of stress, burnout, and compassion fatigue due to the demanding
nature of their work.
These
factors can negatively impact their mental health, job satisfaction, and the quality
of
patient care
provided. Mindfulness-based
interventions (MBI) have emerged as a promising approach to mitigate stress and
burnout.
MBIs
cultivate present moment awareness and emotional regulation, potentially
fostering resilience and
reducing
stress. We
could
not find any studies reported from India on MBIs in healthcare professionals. A
recent editorial suggest the urgent need for studies on reducing stress and
burnout in healthcare professionals working in Indian ICUs. We
plan to assess the effectiveness of a MBI in improving mindfulness and reducing
stress and burnout for ICU physicians and nurses.
|