| CTRI Number |
CTRI/2026/04/108489 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can a Nurse-Led Wellness Program(yoga & counselling) Reduce Burnout Among Nursing Staff |
|
Scientific Title of Study
|
Effect of Nurse-led Integrative Intervention On Burnout, Stress And Psychological Well-being Among Nurses Working In a Tertiary Care Centre: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansingh jat |
| Designation |
sr nursing officer |
| Affiliation |
AIIMS new delhi |
| Address |
room no 7004, conversion block 7th floor aiims new delhi
New Delhi
DELHI
110047
India |
| Phone |
9968407284 |
| Fax |
|
| Email |
mansingh.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor In Charge |
| Affiliation |
AIIMS new delhi |
| Address |
CIMR room no 7004, conversion block 7th floor aiims new delhi
New Delhi
DELHI
110047
India |
| Phone |
01126549425 |
| Fax |
|
| Email |
cimrdelhi@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mansingh jat |
| Designation |
sr nursing officer |
| Affiliation |
AIIMS new delhi |
| Address |
room no 7004, conversion block 7th floor aiims new delhi
New Delhi
DELHI
110047
India |
| Phone |
9968407284 |
| Fax |
|
| Email |
mansingh.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CIMR AIIMS NEW DELHI |
| Address |
7004 CONVERSION BLOCK, AIIMS New Delhi pin 110029 |
| Type of Sponsor |
Government 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 |
| Dr gautam sharma |
AIIMS NEW DELHI |
room no 7004, convesrion block ansari nagar AIIMS NEW DELHI 110029
South
DELHI |
9968407284
mansingh.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
BURNOUT |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COUNSELLING |
The active control group will receive 10-minute brief counseling sessions only, without any yoga intervention. This consists of four short offline counseling sessions conducted during the initial phase of the 6-week study period |
| Intervention |
YOGA & COUSELLING |
Participants will undergo a structured 6-week Nurse-Led Integrative Intervention (NLII) comprising 40 minutes of yoga therapy and 10 minutes of brief counseling per session. The protocol includes 24 supervised yoga sessions in total: four offline sessions in the first week, followed by one offline and three online sessions per week for the remaining five weeks, supplemented by twice-weekly self-practice |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Registered Direct Care Giving Nurses
Moderate burnout in any two domains of the MBI HSS(MP) scale
Who are willing and able to participate
Both sex
Age ranging between 25-50 years
Who are able to speak and read English
|
|
| ExclusionCriteria |
| Details |
1.NOs and SNOs who are diagnosed with severe musculoskeletal, neurological or psychiatric illness.
2.Subjects with recent surgical intervention which not allow to perform yoga
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Nurse-led Integrative Intervention(NLII) on Burnout among nurses |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Evaluate the effect of Nurse-Led Integrative Intervention(NLII) among nurses on
• Burnout
• stress
• psychological well-being
• Nursing work quality of life
• sleep quality among nurses
• Anthropometric parameters
• cortisol level
|
6 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
24/04/2026 |
| 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="2"
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
|
This study titled “Effect of Nurse-Led Integrative Intervention on Burnout, Stress and Psychological Well-being among Nurses Working in a Tertiary Care Center: A Randomized Controlled Trial” aims to evaluate the effectiveness of a structured Nurse-Led Integrative Intervention (NLII) in reducing burnout and improving psychological outcomes among nursing professionals.
An open-label randomized controlled trial design will be used. A total of 170 registered nursing officers (85 per group), aged 25–50 years, with moderate burnout in at least two domains of the MBI-HSS(MP) scale will be recruited from a tertiary care center. Participants will be randomly allocated to either the intervention group receiving NLII or a comparison group receiving routine care.
The NLII comprises integrative components including yoga-based practices and counselling strategies delivered by trained nurses. The primary outcome is burnout level. Secondary outcomes include stress, psychological well-being, quality of nursing work life, sleep quality, anthropometric parameters, and serum cortisol levels.
The study seeks to address the high burden of burnout among nurses by implementing a holistic, culturally acceptable, and sustainable nurse-led model. Data confidentiality will be maintained using coded identifiers, and all procedures comply with ethical standards. No financial burden will be placed on participants. The findings are expected to provide evidence for scalable workplace wellness interventions to enhance mental health and professional quality of life among nurses. |