| CTRI Number |
CTRI/2026/03/106398 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Music therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of effect of Indian Clasical Music on Cognition in children with learning difficulties |
|
Scientific Title of Study
|
Investigating the influence of Indian Classical Instrumental Music listening on Cognitive abilities in Children with Learning Difficulties |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavana B I |
| Designation |
Ph.D. Scholar |
| Affiliation |
Manipal Institute of Technology, MAHE |
| Address |
Room No 34, Research lab, Department of Mechatronics, School of Mechanical Engineering, Academic Block 1, Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7349190325 |
| Fax |
|
| Email |
kavana.mitmpl2024@learner.manipal,edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramya S |
| Designation |
Associate Professor |
| Affiliation |
Manipal Institute of Technology, MAHE |
| Address |
E&C Faculty Chamber 3, Room no 49, Department of Electronics and Communication, School of Electrical Engineering, Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9980947240 |
| Fax |
|
| Email |
ramya.lokesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramya S |
| Designation |
Associate Professor |
| Affiliation |
Manipal Institute of Technology, MAHE |
| Address |
E&C Faculty Chamber 3, Room no 49, Department of Electronics and Communication, School of Electrical Engineering, Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9980947240 |
| Fax |
|
| Email |
ramya.lokesh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
School of Mechanical Engineering, Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kavana B I |
PhD Scholar, School of Mechanical Engineering, Manipal Institute of Technology, Manipal Academy of Higher Education, Manipal 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kavana B I |
Government Higher Primary School |
Saralebettu, Udupi - 576104
Udupi
KARNATAKA |
7349190325
kavana.mitmpl2024@learner.manipal.edu |
| Kavana B I |
Government Higher Primary School |
Athradi, Udupi - 576104
Udupi
KARNATAKA |
7349190325
kavana.mitmpl2024@learner.manipal.edu |
| Kavana B I |
Government Higher Primary School |
Doddanagudde,Udupi - 576104
Udupi
KARNATAKA |
7349190325
kavana.mitmpl2024@learner.manipal.edu |
| Kavana B I |
Gundibail English Medium School |
Gundibail, Udupi - 576104
Udupi
KARNATAKA |
7349190325
kavana.mitmpl2024@learner.manipal.edu |
| Kavana B I |
Hiriyadka Government School |
Hiriyadka, Ududpi - 576104
Udupi
KARNATAKA |
7349190325
kavana.mitmpl2024@learner.manipal.edu |
| Kavana B I |
Kadiyali Aided School |
Kadiyali, Udupi - 576104
Udupi
KARNATAKA |
7349190325
kavana.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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Learning difficulties |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music therapy |
Indian Classical Instrumental Music. Both active and passive approach is employed. The intervention consists of 36 sessions, each lasting 20 minutes, administered three times per week over a three month period. This is followed by a two month follow up assessment. To be included in the final data analysis, participants are required to maintain a minimum attendance rate of two sessions per week. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Students of age range 8 – 12 years
Gender: male and female
Score 40 and above on LD checklist
|
|
| ExclusionCriteria |
| Details |
Child with vision and hearing problem
Child who are undergoing specific speech language intervention/therapy
Child with documented history of psychiatric disorders or ongoing pharmacological treatment
Below 40 on LD checklist
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cognitive abilities |
2.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Academic performance |
2.5 years |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 study is a single arm interventional study, assessing the effectiveness of Indian Classical Instrumental music on cognitive abilities in children with learning difficulties. Children aged 8 to 12 years will be screened using the Checklist for Identifying Children with Specific Learning Disorders, with scores more than 40 categorized as at risk. Children identified with confirmed learning disability will be referred for appropriate services and excluded from the intervention. Eligible participants will be allocated to a music intervention. Music intervention is provided 3 times a week for 3 months. The 20-minute sessions will integrate active and receptive music therapy components, delivered in groups using studio-recorded instrumental music. Baseline and post-intervention assessments with 8 week follow-up will evaluate attention, memory, and emotional regulation using standardized tools. |