| CTRI Number |
CTRI/2026/04/107429 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Music therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Skitii Adaptive Music therapy to help head and neck cancer patients feel better during treatment |
|
Scientific Title of Study
|
Effectiveness of RMSSD-Based Adaptive Music Therapy (Skitii) in Reducing Treatment-Related
Distress in Head and Neck Cancer Patients: 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 |
Dr Prabha Adhikari MR |
| Designation |
Professor and HOD |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Geriatric MedicineYenepoya Medical College Hospital Deralakatte University Road Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9880991290 |
| Fax |
08242204664 |
| Email |
prabha.raghuveer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha Adhikari MR |
| Designation |
Professor and HOD |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Geriatric MedicineYenepoya Medical College Hospital Deralakatte University Road Mangalore
KARNATAKA
575018
India |
| Phone |
9880991290 |
| Fax |
08242204664 |
| Email |
prabha.raghuveer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabha Adhikari MR |
| Designation |
Professor and HOD |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Geriatric MedicineYenepoya Medical College Hospital Deralakatte University Road Mangalore
KARNATAKA
575018
India |
| Phone |
9880991290 |
| Fax |
08242204664 |
| Email |
prabha.raghuveer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital, Deralakatte, Mangalore, Karnataka, India. 575018 |
|
|
Primary Sponsor
|
| Name |
Chirag Jain |
| Address |
Mindful Gurukul Private Limited, 707, 7th Floor, Prasad Chambers, Charni Road, Mumbai India - 400004. |
| Type of Sponsor |
Other [Device Manufacturer ] |
|
|
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 Prabha Adhikari MR |
Yenepoya Medical College Hospital |
Department of Geriatric MedicineYenepoya Medical College Hospital Deralakatte University Road Mangalore
Dakshina Kannada
KARNATAKA |
09880991290
08242204664
prabha.raghuveer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Demographic:
More than 18 years and less than 75 years
Able to provide written informed consent
Able to understand and communicate in Kannada, English, Hindi, or Malayalam
Willing to participate for full study duration 3-6 weeks
Medical:
Confirmed diagnosis of head and neck cancer any subsite: oral cavity, oropharynx, hypopharynx, larynx, nasopharynx
Any cancer stage I to IV
Treatment status any of the following
Newly diagnosed starting radiotherapy or chemotherapy
Currently undergoing radiotherapy and or chemotherapy
Pre-operative with neoadjuvant treatment
Post-operative undergoing adjuvant therapy
Scheduled for minimum 3 weeks of continuous treatment
ECOG Performance Status 0 to 2
Life expectancy more than 3 months
Baseline distress score more than or equal to 4 on NCCN Distress Thermometer OR HADS anxiety or depression subscale score more than 8
Technical:
Able to use smartphone or tablet with assistance
No severe hearing impairment preventing headphone use
Willing to wear heart rate monitoring device chest strap
No known allergy to device materials silicone, fabric, plastic
Access to reliable mobile phone for authentication
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1 Medical
Cardiac conditions:
Active arrhythmias requiring medication
Recent myocardial infarction less than 3 months
Severe heart failure NYHA Class III-IV
Implanted cardiac pacemaker or defibrillator
Atrial fibrillation affecting HRV measurement
2 Neurological/Psychiatric:
Severe cognitive impairment MMSE less than 20
Active psychotic disorder requiring hospitalization
Severe depression with suicidal ideation HADS more than 15
Uncontrolled epilepsy
3 Treatment-related:
Concurrent enrollment in other interventional trials
Palliative care without curative-intent treatment
4 Contraindications to HRV monitoring
Conditions causing unreliable heart rate monitoring
Pregnancy physiological HRV changes
Technical:
Severe bilateral hearing loss preventing headphone use
Documented allergies to device materials
Skin conditions at monitoring site preventing device placement
Severe chest wall deformities preventing electrode contact
Inability to maintain device connection
Logistical
Geographic inaccessibility preventing regular visits
Planned treatment transfer within study period
Inability to attend scheduled assessments
Language barriers preventing proper consent
Unwillingness to comply with daily sessions 3 times per day
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hospital Anxiety and Depression Scale
14 item selfreport questionnaire
Two subscales Anxiety 7 items Depression 7 items
4-point Likert scale 0 to -3 per item
Score range 0 to 21 per subscale
Takes 2 to 3 minutes to complete
Available in Kannada English Hindi Malayalam
|
4 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NCCN Distress Thermometer
Single item visual analog scale 0 to 10
39 item problem checklist 5 domains
Takes 2 to 3 minutes
EORTC QLQ-C30 Quality of Life - Core
30 item cancer specific questionnaire
Functional scales symptom scales global health
Takes 10 15 minutes
EORTC QLQ-H&N35 Head & Neck Module
35 item HNC specific supplement
Pain swallowing speech social eating scales
Takes 10 minutes
Visual Analog Scales
Current stress level 0 to 10
Sleep quality 0 to 10
Overall well being 0 to 10
Treatmentrelated anxiety 0 to 10
Patient Satisfaction Questionnaire Custom
10 items 5 point Likert scale
Music therapy satisfaction helpfulness comfort
Open ended feedback section
|
4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prabha.raghuveer@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This randomized controlled trial evaluates the effectiveness of Skitii adaptive music therapy in reducing treatment related distress among head and neck cancer HNC patients undergoing radiotherapy and or chemotherapy. The study will enroll 70 patients 35 intervention 35 control at Yenepoya Medical College Hospital over 4 to 5 months. The intervention uses real time heart rate variability monitoring RMSSD Root Mean Square of Successive Differences to personalize music selection during treatment. The system employs a novel two phase algorithm Phase 1 to 2.5 minutes uses heart rate to predict initial stress state and select appropriate music while RMSSD values are calculated Phase 2 2 5 to 20 minutes uses RMSSD based real time adaptation. The adaptive algorithm learns individual patient responses and excludes ineffective music tracks maintaining RMSSD more than or equal 30ms indicating reduced stress . The control group receives static music therapy without real time adaptation. The primary outcome is reduction in anxiety measured by Hospital Anxiety and Depression Scale HADS at 3 weeks. Secondary outcomes include depression quality of life treatment adherence HRV parameters and blood cortisol levels. This minimal risk intervention addresses a critical gap in supportive cancer care with 65 to 85 percentage of HNC patients experiencing significant treatment related distress.
|