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CTRI Number  CTRI/2025/08/093208 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Effect of Virtual Reality and Brainwave Music on Reducing Dental Anxiety in Children Aged 7 to 12 Years During Simple Dental Treatment 
Scientific Title of Study   Comparative Evaluation of Virtual Cognitive Distraction and Brainwave Entrainment in Reducing Dental Anxiety in Children Aged 7–12 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  DrAsifa Gazali 
Designation  POST GRADUATE  
Affiliation  Maratha Mandal N G H Institute of Dental Sciences , Belagavi  
Address  room no.7 , dept of pediatric and preventive dentistry , Maratha mandal N G H Institute of dental sciences
room no.7 , dept of pediatric and preventive dentistry , Maratha mandal N G H Institute of dental sciences
Belgaum
KARNATAKA
590010
India 
Phone  8618366991  
Fax    
Email  asifagazali15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Ramya Pai 
Designation  Reader 
Affiliation  Maratha Mandal N G H Institute of Dental Sciences , Belagavi  
Address  room no.7 , dept of pediatric and preventive dentistry , Maratha mandal N G H Institute of dental sciences
room no.7 , dept of pediatric and preventive dentistry , Maratha mandal N G H Institute of dental sciences

KARNATAKA
590010
India 
Phone  9481266096  
Fax    
Email  ramyapai87@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrAsifa Gazali 
Designation  POST GRADUATE  
Affiliation  Maratha Mandal N G H Institute of Dental Sciences , Belagavi  
Address  room no.7 , dept of pediatric and preventive dentistry , Maratha mandal N G H Institute of dental sciences
room no.7 , dept of pediatric and preventive dentistry , Maratha mandal N G H Institute of dental sciences
Belgaum
KARNATAKA
590010
India 
Phone  8618366991  
Fax    
Email  asifagazali15@gmail.com  
 
Source of Monetary or Material Support  
Maratha Mandal N G H Institute of Dental sciences , Belagum-590010 
 
Primary Sponsor  
Name  DrAsifa Gazali 
Address  room no.7 , dept of pediatric and preventive dentistry , Maratha mandal N G H Institute of dental sciences  
Type of Sponsor  Other [Individual] 
 
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 
DrAsifa Gazali  Maratha Mandal N G H Institute of Dental Sciences ,Belagavi   room no.7 , dept of pediatric and preventive dentistry , Maratha mandal N G H Institute of dental sciences
Belgaum
KARNATAKA 		 08618366991

asifagazali15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maratha mandal N G H Institute of dental sciences Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Brainwave Entrainment  Children will listen to binaural beats in the alpha/theta frequency range (4–8 Hz) via noise-cancelling headphones, along with synchronized relaxing visual content. The session will begin 2 minutes before the procedure and continue throughout (~15–20 minutes). 
Intervention  Virtual Cognitive Distraction  Children will use an interactive, age-appropriate virtual distraction application (Roogies app) displayed on a mobile device with headphones to reduce external noise. The session will begin 2 minutes before the minimal invasive dental procedure and continue throughout (~15–20 minutes). 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Healthy children aged between 7–12 years
Cooperative behavior (Frankl rating scale 3 or 4)
No history of traumatic dental experiences
Child who is visiting the dental clinic for the first time
 
 
ExclusionCriteria 
Details  Children with neurological, psychological, or developmental disorders
Children with visual or auditory impairments
Children under medication that may affect mood, behavior, or
anxiety levels.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean change in Facial Image Scale (FIS) score from baseline (pre-procedure, immediately before local anesthesia) to during local anesthesia administration (at the time of injection), comparing Group A (Virtual Cognitive Distraction), Group B (Brainwave Entrainment) and Group C (Standard behaviour management).  at baseline single visit  
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in pulse rate (beats per minute) from baseline (pre-procedure) to during the procedure, measured using a pulse oximeter.
Mean change in systolic & diastolic blood pressure (mm Hg) from baseline to during the procedure, measured using an automated BP monitor appropriate for children. 		 at baseline single visit 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   31/08/2025 
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="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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ruby74574@gmail.com].

  6. For how long will this data be available start date provided 25-08-2025 and end date provided 09-04-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Dental anxiety in children is a common barrier to providing optimal dental care, often resulting in behavioural management challenges and incomplete treatment. Non- pharmacological distraction techniques have been shown to reduce anxiety by diverting the child’s attention from the dental procedure. Among these, Virtual cognitive Distraction using immersive virtual reality ( VR) environments and brainwave entrainment using binural beats are emerging approaches that offer engaging and non-invasive alternatives to conventional methods. This RCT aims to compare the effectiveness of Virtual Cognitive Distraction and Brainwave Entrainment in reducing anxiety among children aged 7-12 years undergoing minimal invasive dental procedures. Fifty-six healthy children meeting the inclusion criteria will be randomly allocated into two groups - group-1 Virtual cognitive distraction and group-2 Brainwave entrainment via headphones. 
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