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CTRI Number  CTRI/2025/04/085842 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 26/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A comparison between the effects of gentle tapping on the temples and relaxing music played in temple bone for reducing anxiety during IANB block administration. 
Scientific Title of Study   Evaluation of Temporal Tapping and Temporal Binaural Beats Music Therapy in reduction of dental anxiety during local anesthesia administration in pediatric dentistry A Comparative Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mrunmayi D Patil 
Designation  Post Graduate Student 
Affiliation  Bharati Vidhyapeeth Dental College and Hospital 
Address  Bharati Vidhyapeeth Dental College and Hospital Department of Pediatric and Preventive Dentistry Division 2 Room no 106, Sangli- Miraj road Wanlesswadi. Sangli

Sangli
MAHARASHTRA
416416
India 
Phone  7987915770  
Fax    
Email  patilmrunmayee@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujatha P 
Designation  Associate Professor 
Affiliation  Bharati Vidhyapeeth Dental College and Hospital 
Address  Bharati Vidhyapeeth Dental College and Hospital Department of Pediatric and Preventive Dentistry Room No 106, Sangli- Miraj road Wanlesswadi. Sangli

Sangli
MAHARASHTRA
416416
India 
Phone  7259215556  
Fax    
Email  drsuji912@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mrunmayi D Patil 
Designation  Post Graduate Student 
Affiliation  Bharati Vidhyapeeth Dental College and Hospital 
Address  Bharati Vidhyapeeth Dental College and Hospital Department of Pediatric and Preventive Dentistry Room No 106 Division 2, Sangli- Miraj road Wanlesswadi. Sangli

Sangli
MAHARASHTRA
416416
India 
Phone  7987915770  
Fax    
Email  patilmrunmayee@yahoo.com  
 
Source of Monetary or Material Support  
Bharati Vidhyapeeth Dental College and Hospital Sangli Miraj Road Wanlesswadi Sangli Maharashtra 416416 
 
Primary Sponsor  
Name  Dr Mrunmayi D Patil 
Address  Bharati Vidhyapeeth Dental College and Hospital Sangli Miraj Road Wanlesswadi, Sangli Maharashtra Pin Code 416416 
Type of Sponsor  Private 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 Mrunmayi D Patil  Bharati Vidhyapeeth Dental College and Hospital  Department of Pediatric and Preventive Dentistry Division- 2nd year roll no- 03
Sangli
MAHARASHTRA 
7987915770

patilmrunmayee@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee BVDU Medical College and Hospital Sangli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  8-12 years Healthy Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients portraying negative behaviour when assessed by Frankl’s behaviour rating scale.
Patients undergoing pulpectomy, pulpotomy, or extraction of mandibular deciduous teeth and required administration of Inferior Alveolar Nerve Block (IANB).
 
 
ExclusionCriteria 
Details  Children who’s parents denied their participation.
Patients with hearing defects, systemic conditions or any special health care needs.
Patients with previous history of dental treatment.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Anxiety reduction during local anesthesia administration  Over the course of 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Pulse rate Reduction  3 months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   08/05/2025 
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="3"
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  
Dental anxiety in children often leads to avoiding dental visits, and pediatric dentists manage it using various techniques by assessing and addressing anxiety.
Earplug and Temporal Tap Technique (E-TTT) is a noninvasive method that combines acupressure and Cognitive Behavioral Therapy (CBT) to reduce anxiety by stimulating acupressure points linked to the trigeminal nerve. 
Music therapy, particularly binaural beats, helps regulate emotions and physiological responses, alleviating anxiety, with bone conduction devices being safer than earphones for prolonged use.
Limited research exists on the effectiveness of E-TTT and binaural beats in pediatric dental patients, driving this study to compare the two approaches.
PURPOSE OF THE STUDY: 
Although various studies have been conducted on behavior management in pediatric patients, there is a scarcity of research on the use of temporal tapping and temporal binaural beats music therapy in pediatric dental patients.
Secondly, use of earphones for binaural beats music is a limitation for its use, hence the device which will be used in the study works on bone conduction technology for music transmission.
Consequently, this study seeks to evaluate the effectiveness of these therapies in alleviating dental anxiety in children. 

To evaluate the effectiveness of no distraction, temporal tapping with earplugs and temporal binaural beats music therapy in reduction of dental anxiety for children during the administration of local anesthesia.

 
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