| CTRI Number |
CTRI/2026/04/107356 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Raag chikitsa in pediatrics dentistry |
|
Scientific Title of Study
|
Music for mind and soul Comparison of effectiveness of
various music as a calming effect during dental treatment |
| 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 Rutuja Lakhotiya |
| Designation |
post Graduate |
| Affiliation |
Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
| Address |
D. Y. Patil University School of Dentistry department of pediatric and preventive dentistry Basement room no 1
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
08329988291 |
| Fax |
|
| Email |
rutujalakhotiya14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Gandhy Baviskar |
| Designation |
Professor |
| Affiliation |
Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
| Address |
D. Y. Patil University School of Dentistry department of pediatric and preventive dentistry Basement room no 1
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
09970271280 |
| Fax |
|
| Email |
mansi.baviskar@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutuja Lakhotiya |
| Designation |
post Graduate |
| Affiliation |
Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
| Address |
D. Y. Patil University School of Dentistry department of pediatric and preventive dentistry Basement room no 1
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
08329988291 |
| Fax |
|
| Email |
rutujalakhotiya14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
D. Y. Patil University School of Dentistry department of pediatric and preventive dentistry Basement room no 1., Nerul ,navi mumbai ,400706 |
|
|
Primary Sponsor
|
| Name |
D Y Patil University School of Dentistry |
| Address |
D. Y. Patil University School of Dentistry department of pediatric and preventive dentistry Basement room no 1,Nerul,
Navi Mumbai 400704. |
| Type of Sponsor |
Private medical college |
|
|
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 Rutuja Lakhotiya |
Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7,
Nerul, Navi Mumbai 400706
Mumbai (Suburban)
MAHARASHTRA |
08329844287
rutujalakhotiya14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICAL BOARD DY PATIL UNIVERSITY SCHOOL OF DENTISTRY NAVI MUMBA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal healthy children without any systemic and medical conditions |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group II- Binaural beats with tell- show –do method |
Group II- oral prophylaxis and sealants procedure with Binaural beats with tell- show –do method using Boat wireless Headphones entire procedure should be completed within 30 min |
| Comparator Agent |
Group III- Western classical music playing with tell- show –do method |
Group III- oral prophylaxis and sealants procedure with Western classical music playing with tell- show –do method using Boat Wireless headphones entire procedure should be completed within 30 min |
| Intervention |
Group IV- tell show-do-method only ( no music) |
Group IV- oral prophylaxis and sealants procedure with tell show-do-method only ( no music) entire procedure should be completed within 30 min |
| Comparator Agent |
Group I– Hamsadwani Raga with tell show-do-method |
Group I– oral prophylaxis and sealants procedure with Hamsadwani Raga playing in background with tell show-do-method using Boat wireless headphone entire procedure should be completed within 30 min |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with first dental visit and without previous experience of any dental treatment and with parental consent.
2. Tooth indicated for oral prophylaxis and sealants among the children between 5- 10 years of age.
|
|
| ExclusionCriteria |
| Details |
1. Teeth indicated for any other dental treatment
2. Children with previous dental experience.
3. .Children with any systemic
disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Music has a significant impact on the mind and body, offering several health benefits such as reducing anxiety and increasing calmness. Hindustani classical music is composed of various ragas, each with its own characteristic effect on mood. For example, Raga Hamsadwani is known to induce calmness and reduce anxiety.Children visiting the dentist often feel anxious, which can be an obstacle to providing quality dental care. Raga therapy can help reduce anxiety in children during routine dental treatments, making the experience more comfortable for them.
|
At Baseline, after 5min music in waiting area , during procedure after procdure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Raga therapy can help reduce anxiety in children during routine dental treatments, making the experience more comfortable for them |
At Baseline, after 5 min music in waiting area , during procedure after procedure |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
16/05/2026 |
| 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 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 - NO
|
|
Brief Summary
|
| Music has a significant impact on the mind and body, offering several health benefits such as reducing anxiety and increasing calmness. Hindustani classical music is composed of various ragas, each with its own characteristic effect on mood. For example, Raga Hamsadwani is known to induce calmness and reduce anxiety. Children visiting the dentist often feel anxious, which can be an obstacle to providing quality dental care. Raga therapy can help reduce anxiety in children during routine dental treatments, making the experience more comfortable for them. | |