| CTRI Number |
CTRI/2026/03/106375 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing different types of sound therapy to reduce anxiety and pain during dental injections in children aged 5–8 years. |
|
Scientific Title of Study
|
Comparing effectiveness of multilayered binaural beats, binaural beats and music in reducing dental anxiety and pain during maxillary buccal infiltration injection in children aged 5-8 years– a randomized controlled study. |
| 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 Prajakta Zende |
| Designation |
Postgraduate Resident |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440016
India |
| Phone |
09403241988 |
| Fax |
|
| Email |
zendeprajakta2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Nagpal |
| Designation |
Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9764271839 |
| Fax |
|
| Email |
drdevendra19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devendra Nagpal |
| Designation |
Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9764271839 |
| Fax |
|
| Email |
drdevendra19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre,Nagpur, Maharashtra, India 440016 |
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur, Maharashtra, India 440016 |
| 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 Prajakta Zende |
Department of Pediatric and Preventive Dentistry |
301, Department of Pediatric and Preventive Dentistry
Nagpur
MAHARASHTRA |
09403241988
zendeprajakta2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RDDCRCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anxiety and Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Binaural beats |
Binaural beat is a third “beat” frequency (commonly alpha or theta range ) introduced by two slightly different frequencies delivered separately to each ear. These are known to reduce anxiety and pain by influencing brainwave activity. |
| Intervention |
Multilayered binaural beats |
Multilayered Binaural Beats are combination of multiple frequency ranges (commonly alpha: 8–12 Hz and theta: 4–8 Hz). Layered sound design with background soothing tones or ambient music designed to enhance brainwave entrainment more effectively than single-frequency binaural beats. Thus potentially reducing both dental anxiety and pain more effectively. |
| Comparator Agent |
Music |
Music acts as a distraction technique and may reduce anxiety and perceived pain through emotional soothing and attention diversion. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children of 5-8 years age.
Children indicated for dental procedure requiring maxillary buccal infiltration injection.
Children whose parents/caretakers have given consent of participation.
|
|
| ExclusionCriteria |
| Details |
Uncooperative children
Child with hearing disability, neurobehavioral disorders, chronic illness, history of previous surgery/ hospitalization and any other disorder.
Patient having acute pain on the day of procedure.
Children with known history to allergy to any topical or local anesthetic agent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of multilayered binaural beats, binaural beats and music in reducing dental
anxiety and pain during maxillary buccal infiltration injection in children aged 5-8 years |
Baseline, during procedure, after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the acceptance of multilayered binaural beats, binaural beats & music using 5 point structured questionnaire in children aged 5-8 years. |
After procedure |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="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 - NO
|
|
Brief Summary
|
The purpose of the present study is to compare the effectiveness of
multilayered binaural beats, binaural beats and music in reducing dental anxiety and pain using Venham’s picture test (VPT), Venham’s Clinical
Anxiety Scale (VCA), Physiological parameters (HR & SpO2) and Wong baker FACES pain scale, Sound eye motor scale (SEM) respectively during
maxillary buccal infiltration injection in children aged 5-8 years |