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CTRI Number  CTRI/2025/07/091840 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   What Works Better—Cartoons or Binaural Beats for Easing Dental Anxiety in Young Children 
Scientific Title of Study   Comparative Evaluation Of The Effectiveness Of Binaural Beats With Cartoons In Alleviating Anxiety In 4 To 8 Year- Old Paediatric Dental Patients: 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 Gopal Babu 
Designation  Junior Resident 
Affiliation  King Georges Medical University, Lucknow 
Address  4th floor, New Dental Building, King Georges Medical University, Lucknow.

Lucknow
UTTAR PRADESH
226013
India 
Phone  9412893168  
Fax    
Email  drgopal96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Afroz Alam Ansari 
Designation  Professor 
Affiliation  King Georges Medical University, Lucknow 
Address  New dental building, 4th floor Dept of pediatric and preventive dentistry, KGMU

Lucknow
UTTAR PRADESH
226003
India 
Phone  9335166662  
Fax    
Email  afrozalamansari@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Rajeev Kumar Singh 
Designation  Professor & Head of the Department 
Affiliation  King Georges Medical University, Lucknow 
Address  New dental building, 4th floor Dept of pediatric and preventive dentistry, KGMU

Lucknow
UTTAR PRADESH
226003
India 
Phone  9450849528  
Fax    
Email  rajkids2000@yahoo.co.in  
 
Source of Monetary or Material Support  
King Georges Medical University, Lucknow, 226003 ,uttar Pradesh, india  
 
Primary Sponsor  
Name  King Georges Medical University Lucknow 
Address  Shahmina road, Chowk, Lucknow. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Afroz Alam Ansari  King Georges Medical University, Lucknow  New dental building, 4th floor Dept of pediatric and preventive dentistry, KGMU 4th floor Dept of pediatric and preventive dentistry, KGMU
Lucknow
UTTAR PRADESH 		 09335166662

afrozalamansari@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F430||Acute stress reaction, (2) ICD-10 Condition: F409||Phobic anxiety disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Binaural Beats with cartoons  10 Minutes in total 
Comparator Agent  Cartoons Video  Pediatric dental patients will be presented with only Cartoons in the form of videos. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Children who require an extraction.
2.Children with Frankel rating scale 2 and 3
3.Children who have the cognitive ability to understand and engage with the intervention.
4.Children who are willing to wear headphones to listen to the binaural beats.
• Children who are willing to watch cartoons on a screen
• Children without significant medical problems that could affect anxiety levels.
 
 
ExclusionCriteria 
Details  1. Any medical condition such as epilepsy, psychiatric illness or hearing impairment.
2. Children with a Frankel rating scale of 1 and 4
3. Patients who find sounds unpleasant.
4. Children with cognitive impairments that could affect their ability to follow instructions.
• Children who have already been exposed to binaural beats.
• Patients who are not willing to wear headphones or watch cartoons.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in anxiety and pulse rate will be observed   Baseline, 5 minutes after starting the procedure and after completion of the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   25/08/2025 
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="1"
Months="0"
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 randomized controlled clinical study aims to evaluate and compare the effectiveness of two non-pharmacological behavioral interventions—(i) binaural beats combined with cartoons and (ii) only cartoons—in alleviating dental anxiety among pediatric patients aged 4 to 8 years undergoing tooth extraction.

Background & Rationale:
Dental anxiety is a prevalent behavioral barrier in pediatric dentistry, affecting treatment compliance and quality of care. Distraction methods like cartoons (visual) and audio inputs are well-recognized techniques for anxiety reduction. Binaural beats, based on brainwave entrainment using auditory stimuli, represent a novel yet evidence-based method to reduce stress and anxiety. Combining both modalities offers a potentially synergistic effect, which has not been adequately explored in the target ...

Objectives:
- Primary Objective:
  To evaluate the effect of binaural beats in reducing dental anxiety in pediatric patients.
- Secondary Objectives:
  - To assess changes in physiological indicators (pulse rate) during the intervention.
  - To compare the effectiveness of binaural beats with cartoons versus only cartoons.

Study Design:
Open-label, randomized controlled study with two arms:
- Group A (Control): Only visual distraction (cartoons).
- Group B (Intervention): Combined auditory (binaural beats) and visual distraction (cartoons).

Sample Size:
A total of 48 participants (24 per group) calculated using standard formulas to detect a clinically significant difference in anxiety scores with 90 percent power and 5 percent significance.

Study Duration:
18 months (October 2024 to April 2026)
Each subject’s participation will last approximately 12 months.

Inclusion Criteria:
- Children aged 4 to 8 years requiring tooth extraction.
- Frankel Behavior Rating Scale score of 2 or 3.
- Willingness to participate and use headphones/watch cartoons.

Exclusion Criteria:
- Severe behavioral issues (Frankel 1 or 4).
- Epilepsy, hearing impairments, psychiatric illness.
- Prior exposure to binaural beats.

Outcome Measures:
- Venham Picture Test (VPT): A validated pictorial tool for measuring pediatric anxiety.
- Pulse Oximeter Readings: Pulse rate as an objective physiological marker of anxiety.

Statistical Analysis:
Data will be analyzed using SPSS. Paired and unpaired t-tests will be used for intra- and inter-group comparisons. A p-value less than 0.05 will be considered statistically significant.

Ethical Considerations:
- Approved by Institutional Ethics Committee of KGMU, Lucknow.
- Written informed consent from parents and assent from children will be obtained.
- Minimal risk study with no invasive procedures or pharmacological agents.
- Confidentiality and voluntary participation assured.

Funding Source:
Self-funded.

Expected Benefit:
Establishing a safe, non-invasive, and cost-effective behavioral management technique for reducing anxiety in pediatric dental patients, thereby improving cooperation and clinical outcomes.


 
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