| CTRI Number |
CTRI/2025/09/095102 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative evaluation of use of different music such as solfeggio music and binaural beats as interventions for reducing child dental anxiety in children aged 4-10 years |
|
Scientific Title of Study
|
A comparative evaluation of neuro-acoustic music interventions for alleviating pediatric dental anxiety in children aged 4-10 years: 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 ADHITHI PRAKASH |
| Designation |
SENIOR LECTURER |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE(MRIIRS), FARIDABAD |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SCHOOL OF DENTAL SCIENCES, MANAV RACHNA DENTAL COLLEGE, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SCHOOL OF DENTAL SCIENCES, MANAV RACHNA DENTAL COLLEGE, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD
Faridabad
HARYANA
121010
India |
| Phone |
7022803380 |
| Fax |
|
| Email |
dradhithiprakash1811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ADHITHI PRAKASH |
| Designation |
SENIOR LECTURER |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE(MRIIRS), FARIDABAD |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SCHOOL OF DENTAL SCIENCES, MANAV RACHNA DENTAL COLLEGE, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SCHOOL OF DENTAL SCIENCES, MANAV RACHNA DENTAL COLLEGE, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD
Faridabad
HARYANA
121010
India |
| Phone |
7022803380 |
| Fax |
|
| Email |
dradhithiprakash1811@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ADHITHI PRAKASH |
| Designation |
SENIOR LECTURER |
| Affiliation |
MANAV RACHNA DENTAL COLLEGE(MRIIRS), FARIDABAD |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SCHOOL OF DENTAL SCIENCES, MANAV RACHNA DENTAL COLLEGE, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SCHOOL OF DENTAL SCIENCES, MANAV RACHNA DENTAL COLLEGE, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD
Faridabad
HARYANA
121010
India |
| Phone |
7022803380 |
| Fax |
|
| Email |
dradhithiprakash1811@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR ADHITHI PRAKASH |
| Address |
SCHOOL OF DENTAL SCIENCES, MANAV RACHNA DENTAL COLLEGE, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD |
| Type of Sponsor |
Other [self funded] |
|
|
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 ADHITHI PRAKASH |
MANAV RACHNA DENTAL COLLEGE |
DEPARTMENT OF PEDODONTICS, Q BLOCK, DEPARTMENT 9.
Faridabad
HARYANA |
7022803380
dradhithiprakash1811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PEDIATRIC DENTAL ANXIETY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BINAURAL BEATS |
MUSIC PLAYED AT DIFFERENT FREQUENCIES IN RIGHT AND LEFT EAR SIMULTANEOUSLY |
| Intervention |
GAMMA WAVES |
MUSIC PLAYED AT 40 HZ |
| Intervention |
ISOCHRONIC TONES |
PULSATING FREQUENCY MUSIC |
| Comparator Agent |
NO MUSIC |
NO MUSIC PLAYED |
| Intervention |
SOLFEGGIO FREQUENCY |
MUSIC PLAYED AT FREQUENCY OF 528 HZ |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
a) Children requiring inferior alveolar nerve block for therapy of mandibular posterior teeth
b) Children from 4-10 years of age
c) Children with negative behavior according to Frankl’s behavior rating scale
|
|
| ExclusionCriteria |
| Details |
a) Presence of systemic disease
b) Hearing disabilities
c) Children with special healthcare needs
d) Patients who primarily require treatment in maxillary arch
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IS MUSICAL INTERVENTION EFFECTIVE FOR ALLEVIATION OF ANXIETY AFTER ADMINISTRATION OF LOCAL ANESTHETIC AGENT DURING DENTAL TREATMENT? |
ANXIETY LEVELS AT ARRIVAL(BASELINE), ANXIETY AFTER MUSIC FOR 10 MINUTES AND ANXIETY AFTER LOCAL ANESTHETIC AGENT ADMINISTRATION AFTER 15 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IS THERE ALTERATIONS IN PULSE RATE AFTER MUSICAL INTERVENTION FOR ADMINISTRATION OF LOCAL ANESTHETIC AGENT RESULTING IN IMPROVED BEHAVIOR |
PULSE RATE AT ARRIVAL(BASELINE), PULSE RATE AFTER MUSICAL INTERVENTION(10 MINUTES) AND AFTER LOCAL ANESTHETIC (AT 15 MINUTES) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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 - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - DATA WILL BE AVAILABLE ON REQUEST TO AUTHORS BY MAIL ONLY-dradhithiprakash1811@gmail.com
- For how long will this data be available start date provided 02-01-2026 and end date provided 02-01-2120?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This
study design outlines a clinical trial evaluating the impact of neuroacoustic
music interventions on pediatric dental anxiety during inferior alveolar nerve
block (IANB) administration. The process begins with baseline data collection,
which includes assessing the child’s behavior and anxiety levels using the
Facial Behavior Rating Scale (FBRS), the RMS Pictorial Scale (RMS-PS), and
recording their pulse rate. Participants are then randomly allocated into one
of five groups through the use of sealed envelopes to ensure unbiased group
assignment. Following group allocation, a neuroacoustic intervention is
performed in the experimental groups by playing specific sound frequencies—such
as Solfeggio tones, binaural beats, or isochronic tones—through headphones for
a duration of 10 minutes. After the audio intervention, the dental procedure
involving the administration of the inferior alveolar nerve block is carried
out. Post-procedure, the children’s anxiety and behavior are re-evaluated using
the same FBRS and RMS-PS tools to determine any changes in response to the
intervention. Finally, all data is tabulated and subjected to statistical
analysis to assess the efficacy of the neuroacoustic approach in reducing
anxiety and improving patient behavior during local anesthesia. |