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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  
Status 
Not Applicable 
 
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.
 
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