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
|
|
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
|
|
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.
|