| CTRI Number |
CTRI/2024/04/065443 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Use of Hindustani classical music and Tell Show Do technique in reducing anxiety in children undergoing dental treatment |
|
Scientific Title of Study
|
EVALUATION OF EFFECTIVENESS OF HINDUSTANI CLASSICAL MUSIC AND TELL SHOW DO TECHNIQUE ON THE ANXIETY OF CHILDREN RECEIVING ORAL HEALTH CARE:A SINGLE BLINDED STUDY |
| 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. Niraj S. Gokhale |
| Designation |
Part time PhD Scholar |
| Affiliation |
KAHERS KLE VK INSTITUTE OF DENTAL SCIENCES |
| Address |
KAHERS KLE VK INSTITUTE OF DENTAL SCIENCES
Department of Pediatric and Preventive Dentistry, KLE VK Institute Of Dental Sciences, Nehru Nagar, Belagavi
KARNATAKA
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9535551937 |
| Fax |
|
| Email |
neerajpedo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shivayogi M. Hugar |
| Designation |
Professor and Head |
| Affiliation |
KAHERS KLE VK INSTITUTE OF DENTAL SCIENCES |
| Address |
KAHERS KLE VK INSTITUTE OF DENTAL SCIENCES
Department of Pediatric and Preventive Dentistry, KLE VK Institute Of Dental Sciences, Nehru Nagar, Belagavi
KARNATAKA
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9986436448 |
| Fax |
|
| Email |
dr.hugarsm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Niraj S. Gokhale |
| Designation |
Part time PhD Scholar |
| Affiliation |
KAHERS KLE VK INSTITUTE OF DENTAL SCIENCES |
| Address |
KAHERS KLE VK INSTITUTE OF DENTAL SCIENCES
Department of Pediatric and Preventive Dentistry, KLE VK Institute Of Dental Sciences, Nehru Nagar, Belagavi
KARNATAKA
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9535551937 |
| Fax |
|
| Email |
neerajpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material Support
Clarification(s) with Reply
KAHERS KLE VK Institute Of Dental Sciences Department of Pediatric and Preventive Dentistry Nehru Nagar Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Niraj Gokhale |
| Address |
Department of Pediatric and Preventive Dentistry KLE VK Institute Of Dental Sciences, Nehru Nagar, Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
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 Niraj S Gokhale |
KAHERS KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi |
Department of Pediatric and Preventive Dentistry Room number 6
Belagavi
Belgaum
KARNATAKA |
9535551937
neerajpedo@kledental-bgm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Audio distraction using raga Bhimpalas |
Audio distraction is one of the methods in behaviour guidance. Here we proppose to use raga Bhimpalas for the distraction during the course of dental treatment for treatments not requiring Local anesthesia and ones requiring Local anesthesia. Raga Bhimpalas will be made to listen to during the course of dental treatment twice for a duration of 45 minutes once during treatment not requiring anesthesia and once during treatment requiring local anesthesia. |
| Intervention |
Audio distraction using raga Todi |
Audio distraction is one of the methods in behaviour guidance. Here we proppose to use raga Todi for the distraction during the course of dental treatment for treatments not requiring Local anesthesia and ones requiring Local anesthesia. Raga Todi will be made to listen to during the course of dental treatment twice for a duration of 45 minutes once during treatment not requiring anesthesia and once during treatment requiring local anesthesia. |
| Comparator Agent |
Tell Show Do Technique |
Tell Show Do Technique of behaviour management is considered to be gold standard in behaviour management strategy. Technique will be applied during the course of dental treatment for treatments not requiring Local anesthesia and ones requiring Local anesthesia. Tell show do technique will be adinisterd during the course of dental treatment twice ie once duringg the treatments not requiring Local anesthesia and once for treatment requiring Local anesthesia |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children between the age group of 4-12 years.
Children reporting for dental treatment for first time.
Children requiring both non invasive (scaling and restorations) and invasive treatments (pulp therapy and extraction) |
|
| ExclusionCriteria |
| Details |
Patients with painful dental experience in past
Patients with special health care needs
Children with hearing defects
Patients who do not want to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulse Rate |
Before and at the end of the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Self administered anxiety using Venhams picture scale & Operator Assessed behaviour by Frankls behaviour rating scale |
Before & After the completion of the treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| Date of Study Completion (India) |
27/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Music has shown to be a non pharmacological adjuvant to reduce stress and anxiety Indian classical music in particular has shown promising results in reducing the anxiety and stress during various procedures. There are a number of ragas which exist, but on literature search it was seen that Raga Todi which is played in the morning time and Raga Bhimpalas played in the afternoon are particularly helpful in reducing anxiety. Hence these two ragas are selected for the study |