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CTRI Number  CTRI/2026/03/106177 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Other (Specify) [Raga intervention (Music intervention ) through a developed mobile application]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Music intervention for breast cancer patients through a developed self-care mobile application which helps their psychological wellbeing.  
Scientific Title of Study   Design and Development of Mobile Based Self-Care Application Using Indian Ragas on Mental Health of Breast Cancer Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nisarga SM 
Designation  PhD Scholar  
Affiliation  MAHE, Manipal AB 5 
Address  School of Electrical Engineering MIT, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9972331003  
Fax    
Email  nisarga2.mitmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Surekha Kamath  
Designation  Professor  
Affiliation  MAHE, Manipal AB 5 
Address  School of Electrical Engineering MIT, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9964583262  
Fax    
Email  surekha.kamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Surekha Kamath  
Designation  Professor  
Affiliation  MAHE, Manipal AB 5 
Address  School of Electrical Engineering MIT, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9964583262  
Fax    
Email  surekha.kamath@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, MIT, MAHE, Manipal 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education, ,MAHE 
Address  MAHE, Manipal , Udupi , 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nisarga SM  PhD Scholar , School of Electrical Engineering, MIT, MAHE, Manipal 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nisarga SM  KMC, Manipal   Department of Medical Oncology, KMC, 4TH FLOOR, Shirdi block, MAHE, Manipal
Udupi
KARNATAKA 		 9972331003

nisarga2.mitmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Raga intervention (music intervention) with standard   Raga intervention will be provided from a developed mobile based self-care application for about 2 months, 15 minutes everyday, Psychological wellbeing will be assessed with DASS 21 and FAS questionnaires 
Comparator Agent  Standard care only   Standard care only will be provided without any intervention, psychological wellbeing will be assessed with DASS 21 and FAS scales 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1.Patients diagnosed with 1st, 2nd and 3rd stages of breast cancer [from Department of Medical Oncology, Kasturba Hospital].
2.Patients who are willing to take Raga intervention through mobile application.
3.Patients who have access to a smartphone.
 
 
ExclusionCriteria 
Details  1.Diagnosis of other primary cancers.
2.Pre-existing severe psychiatric disorders.
3.Severe hearing impairment.
4.Unstable medical condition.
5.Participants who score very high on the depression (severe – 21 to 27 and extremely severe - 28+), anxiety (severe – 15 to 19 and extremely severe 20+), stress (severe – 26 to 33 and extremely severe – 34+) who will be referred to mental health professionals.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Psychological Wellbeing   2.5 Years 
 
Secondary Outcome  
Outcome  TimePoints 
Fatigue  2.5 Years 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   01/06/2026 
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="5"
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 interventional study aims to design and evaluate a mobile-based self-care application utilizing Indian Ragas to improve the psychological well-being of breast cancer patients. Researchers will specifically investigate the impact of five selected Carnatic Ragas on reducing depression, anxiety, stress, and fatigue during chemotherapy. Participants with 1st, 2nd and 3rd stage of breast cancer will be involved. After seeing if the participants meets the eligiblity criteria they will be segregated into interventional and control group through sealed envelope method. Control group will only receive standard care only. Participants who are seen suffering from severe psychological distress are excluded from the study and referred for psychological and psychiatric care in the hospital (this will be considered at any point of the study). To check the psychological wellbeing DASS 21 (Depression, anxiety and stress) and FAS (Fatigue assessment scale) will be assessed. Intervention will be for 2 month for 15 minutes each day (participants are free to choose the tracks in the  developed mobile application). Participants will be assessed with the psychological questionnaires when they come for chemotherapy to the hospital for every 15days for 2 months. After the completion of intervention a follow will be held. Data gathered from the questionnaires will be assessed statistically to check the effectiveness of the Raga intervention.  
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