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CTRI Number  CTRI/2025/08/092802 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 09/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Reducing pain and anxiety in children during dental injections using visual and sound distraction 
Scientific Title of Study   Comparative evaluation of the effectiveness of optical illusion, binaural beats and combination of both on pain perception and anxiety levels in children aged 8-10 years during local anesthesia administration: A randomized control 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  Kunal Audichya 
Designation  Post graduate student 
Affiliation  Pacific dental college and hospital 
Address  Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur

Udaipur
RAJASTHAN
313024
India 
Phone  7597172819  
Fax    
Email  kunalaudichya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dinesh Rao 
Designation  Head of Department PG Guide 
Affiliation  Pacific dental college and hospital 
Address  Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur

Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Kunal Audichya 
Designation  Post graduate student 
Affiliation  Pacific dental college and hospital 
Address  Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur

Udaipur
RAJASTHAN
313024
India 
Phone  7597172819  
Fax    
Email  kunalaudichya@gmail.com  
 
Source of Monetary or Material Support  
Pacific dental college and hospital, Debari, Udaipur (Rajasthan) 313024 
 
Primary Sponsor  
Name  Kunal Audichya 
Address  Pacific dental college and hospital, Debari, Udaipur (Rajasthan) 313024 
Type of Sponsor  Other [[Self]] 
 
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 Kunal Audichya  Pediatric and preventive dentistry  Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur
Udaipur
RAJASTHAN 
7597172819

kunalaudichya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee Sai Tirupati Univercity Udaipur Rajasthan India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individual 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Binaural Beats  Children will listen to binaural beats via stereo earphone played from a mobile phone using brain wave application 
Intervention  Combination of optical illusion and binaural beats  Children will simultaneously use a virtual reality headset showing optical illusion videos and listen to binaural beats via earphone during inferior alveolar nerve block procedure 
Intervention  Optical illusion   Children will wear a Virtual reality headset displaying optical illusion videos during inferior nerve block administration 
Comparator Agent  Standard procedure  No audiovisual distraction used Children receive standard local anesthesia IANB without and behavioral distraction 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Healthy cooperative children aged 8–10 years
Moderate dental anxiety Corah scale
Requiring inferior alveolar nerve block
Capable of communication and understanding 
 
ExclusionCriteria 
Details  Children with systemic illness
Mental or physical impairment
Visual or auditory impairment
Prior painful dental experience
Requiring emergency treatment 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain perception and Anxiety levels  pain perception will be assessed at the time of injecting local anesthesia and anxiety level will be assessed before during and after injecting local anesthesia  
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/08/2025 
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)  Open to Recruitment 
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 trial is designed to evaluate and compare the effectiveness of three non-pharmacological distraction techniques—optical illusion using virtual reality, binaural beats, and a combination of both—on reducing pain perception and anxiety levels in children aged eight to ten years undergoing inferior alveolar nerve block during dental procedures. Effective pain and anxiety management is essential in pediatric dentistry to ensure cooperation and long-term positive dental behavior. Local anesthesia is often associated with discomfort and fear, making it necessary to explore child-friendly alternatives.

The study will follow a parallel-arm randomized design with one hundred and twenty participants equally divided into four groups. Group A will receive distraction through virtual reality headsets displaying optical illusions. Group B will listen to binaural beats through earphones. Group C will experience both interventions simultaneously, while Group D will serve as the control group without any distraction. Each intervention will be applied during the administration of local anesthesia, with binaural beats also played for ten minutes beforehand in the relevant groups.

Participants will be selected based on inclusion criteria such as age between eight and ten years, medically fit status, moderate dental anxiety levels, and need for inferior alveolar nerve block. Exclusion criteria include children requiring emergency treatment, those with systemic illness, previous painful dental experiences, or sensory impairments.

Pain perception will be assessed using the Wong Baker Faces Pain Rating Scale. Anxiety levels will be measured both objectively by monitoring heart rate before, during, and after anesthesia, and subjectively using the FLACC scale and the Modified Venham scale. The same clinician will perform all procedures in a controlled setting to minimize variability. Randomization will be done using color-coded ball selection. While blinding is not feasible for the operator and participants, both the outcome assessor and data analyst will be blinded to group allocations.

Statistical analysis will be conducted using SPSS software. One-way ANOVA will be used to compare differences between groups, and Tukey’s post hoc test will be applied for multiple comparisons. Ethical approval has been obtained from the Institutional Ethics Committee. Written informed consent will be taken from parents or guardians, and verbal assent will be obtained from the participating children.

The expected outcome of this study is to provide evidence for safe, cost-effective, and easily implementable distraction methods that can significantly improve the dental experience for children. If proven effective, these techniques could reduce the need for sedation or physical restraint, promote cooperative behavior, and be integrated into routine pediatric dental practice. The results may also inspire further research into sensory-based behavior management in pediatric healthcare.

 
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