| CTRI Number |
CTRI/2026/02/103919 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Brain-Focused Exercise Therapy and Guided Meditation in Reducing Burnout and Improving Sleep, Thinking Ability, and Stress Levels in Healthcare Professionals |
|
Scientific Title of Study
|
Effect of Cognition-Targeted Exercise Therapy versus Guided Meditation on Burnout, Cognitive Function, Sleep Quality, and Oxidative Stress- Biomarker in Healthcare Professionals with Burnout Syndrome: A Randomized Clinical 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 |
Jessica Rochelle Dsouza |
| Designation |
Post Graduated Student (Orthopaedic Physiotherapy) |
| Affiliation |
KAHER Institute Of Physiotherapy ,Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010
Belgaum KARNATAKA 590010 India |
| Phone |
8879006716 |
| Fax |
|
| Email |
dsouzajessica186@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aarti Welling |
| Designation |
Associate Professor, Department of Orthopaedic Physiotherapy |
| Affiliation |
KAHER Institute Of Physiotherapy ,Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010
Belgaum KARNATAKA 590010 India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aarti Welling |
| Designation |
Associate Professor, Department of Orthopaedic Physiotherapy |
| Affiliation |
KAHER Institute Of Physiotherapy ,Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010
Belgaum KARNATAKA 590010 India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy, Belagavi |
|
|
Primary Sponsor
|
| Name |
Jessica Rochelle Dsouza |
| Address |
KLES Dr Prabhakar Kore Hospital and MRC, Advance Physiotherapy Centre Orthopaedic Physiotherapy Room Number 18, Nehru Nagar, Belagavi, Karnataka, India, 590010 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aarti Welling |
KAHER Institute Of Physiotherapy, Nehru Nagar Belagavi, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aarti Welling |
KLES Dr. Prabhakar Kore Hospital and MRC |
Advanced Physiotherapy Centre Department of Orthopaedic Physiotherapy Room Number 18, Nehru Nagar, Belagavi, Karnataka, India, 590010 Belgaum KARNATAKA |
9448814569
aartiwell88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committe, KLEU Institute of Physiotherapy, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z730||Burn-out, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Targeted Exercise therapy |
Cognitive Targeted Exercise therapy will include body awareness & attentional control ,executive function & emotional regulation and stress adaptation & cognitive flexibility.All intervention will b administered under physiotherapist supervision.3 session per week admistered for 3weeks by a trained Physiotherapist.
|
| Comparator Agent |
Guided meditation. |
Guided meditation will include Relaxation and breathing awareness ,emotional regulation and mindful awareness and compassion,resilience and stress coping.All intervention will b administered under physiotherapist supervision.3 session per week admistered for 3weeks by a trained Physiotherapist. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthcare professionals (doctors, nurses, and allied health staff)
2. Aged 25–45 years.
3.Individuals with Low, Moderate, High Burnout score as per Maslach Burnout Inventory (MBI) .
4.Participants experiencing sleep disturbances as indicated by Pittsburgh Sleep Quality Index (PSQI)more than 5.
5.Those willing to participate and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Secondary or other primary headache disorders.
2.Neurological or psychiatric Condition.
3.Ongoing physiotherapy or relaxation training.
4.Pregnancy or systemic illness.
5.Recent head or neck injury. |
|
|
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 |
1.Assessing Burnout Using Maslach Burnout InventoryAssessing Burnout Using Maslach Burnout Inventory
2.Oxidative stress (Biomarker) Using Malondialdehyde test |
1.Burnout will be assessed pre-intervention and post-intervention over 3 weeks
2.Oxidative stress (Biomarker) will be assessed pre-intervention and post-intervention over 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessing Sleep Quality Using Pittsburgh Sleep Quality Index.
2.Assessing Cognition Using Montreal Cognitive Assessment. |
1.Sleep Quality will be assessed pre-intervention and post-intervention over 3 weeks.
2.Cognitionwill be assessed pre-intervention and post-intervention over 3 weeks. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
25/02/2026 |
| 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="1" 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
|
Burnout syndrome is a prevalent occupational health problem among healthcare professionals, characterized by emotional exhaustion, depersonalization, and reduced personal accomplishment. Prolonged exposure to occupational stress not only affects psychological well-being but also leads to impaired cognitive function, poor sleep quality, and increased physiological stress responses, including oxidative stress. These consequences negatively impact professional performance, patient care, and overall quality of life. The present study proposes a randomized clinical trial to compare the effectiveness of Cognition-Targeted Exercise Therapy (CTET) and Guided Meditation (GM) in healthcare professionals diagnosed with burnout syndrome. CTET integrates physical exercise with cognitive engagement to address maladaptive thoughts, enhance attention, executive function, and stress resilience. Guided Meditation, a mind–body intervention, emphasizes breathing awareness, mindfulness, and emotional regulation to activate parasympathetic responses, improve sleep, and reduce stress-related biochemical alterations. A total of 40 healthcare professionals aged 25–45 years with burnout syndrome will be randomly allocated into two groups. Group A will receive Cognition-Targeted Exercise Therapy, and Group B will receive Guided Meditation. Both interventions will be administered for three weeks, with sessions conducted three times per week for 30 minutes. Outcome measures will be assessed before and after the intervention using validated tools: Maslach Burnout Inventory for burnout, Montreal Cognitive Assessment for cognitive function, Pittsburgh Sleep Quality Index for sleep quality, and Malondialdehyde (MDA) levels as a biomarker of oxidative stress. The study aims to determine and compare the effects of these two non-pharmacological interventions on both subjective and objective outcomes related to burnout. By incorporating psychological, cognitive, and biochemical parameters, this research seeks to provide a comprehensive understanding of intervention efficacy. The findings are expected to contribute evidence-based guidance for integrative physiotherapy and mind–body approaches in managing burnout among healthcare professionals. |