| CTRI Number |
CTRI/2025/10/095894 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study comparing the use of binaural beats (relaxing sound therapy) and audiovisual tools, with or without immersive projection (virtual reality), to see how well they reduce anxiety in children during dental treatments |
|
Scientific Title of Study
|
Impact of binaural audiovisual aid with and without immersive projection on behaviour assessment in children undergoing dental treatment - A Randomized Crossover 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 |
Nilesh V Rathi |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Dr D Y Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune
Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9960100010 |
| Fax |
|
| Email |
nilesh.rathi@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Raksha A Shetty |
| Designation |
Post - graduate |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Dr D Y Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune
Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8422009503 |
| Fax |
|
| Email |
shettyrakshaa07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raksha A Shetty |
| Designation |
Post - graduate |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Dr D Y Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune
Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8422009503 |
| Fax |
|
| Email |
shettyrakshaa07@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Raksha A Shetty |
| Address |
Dr. D. Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Raksha A Shetty |
Dr. D. Y. Patil Dental college and Hospital |
Department of Pediatric and Preventive Dentistry
Dr D Y Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA |
8422009503
shettyrakshaa07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub committee Dr. D. Y. Patil Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Audiovisual aid with binaural beats with immersive projection |
Children in this group were provided the same choice of animated videos with integrated binaural beats. However, instead of conventional delivery, the audiovisual stimulus was presented through an immersive projection system combined with noise cancellation headphones. This immersive setup was designed to maximize sensory engagement by creating a more enveloping visual field and isolating external operatory sounds. As in the control group, the audiovisual stimulus was presented for 10 minutes prior to the dental procedure and continued during administration of local anesthesia and extraction
|
| Comparator Agent |
Audiovisual aid with binaural beats without immersive projection
|
Children in this group were given the option to select an animated cartoon video of their choice from a pre-curated library. The chosen video was combined with binaural beats at a carrier frequency of 432 Hz with a 6 Hz interaural difference (theta brainwave range), delivered through noise cancellation headphones by Sony. Each participant was exposed to the audiovisual stimulus for 10 minutes as preconditioning prior to the dental procedure. The distraction continued seamlessly throughout the administration of local anesthesia and the subsequent extraction procedure.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children requiring dental restoration.
Moderate to high levels of baseline dental anxiety, as determined by the Modified Child Dental Anxiety Scale (MCDAS).
Ability to understand and comply with study procedures.
|
|
| ExclusionCriteria |
| Details |
Hearing impairments.
Neurological or psychological disorders.
Use of anxiety-reducing medication within 24 hours prior to the procedure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study was the reduction in dental anxiety levels during treatment, assessed both physiologically and behaviorally. |
baseline
immediate post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome was the level of cooperation during dental procedures, inferred from FLACC FIS scores |
baseline
post intervention |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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)
|
Open to Recruitment |
| 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 randomized controlled crossover trial aims to evaluate the impact of a binaural audiovisual aid with and without immersive projection on reducing dental anxiety in children undergoing dental treatment. Children often experience high levels of fear and anxiety in dental settings, which can interfere with treatment compliance and overall experience. Audiovisual distraction techniques, especially when combined with binaural sound and immersive projection, may provide a more engaging and effective method to alleviate anxiety compared to conventional methods. The study will randomly allocate participants into intervention and control groups to assess differences in dental anxiety levels during treatment. The findings are expected to inform safer, child-friendly approaches for anxiety management in pediatric dentistry. |