| CTRI Number |
CTRI/2025/03/081715 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of Anxiety levels by Tell-Show-Do, Preferred music and Folk songs as a behavior Management methods in children aged 6-12 years |
|
Scientific Title of Study
|
Evaluation of Anxiety levels using Tell-Show-Do, Music of Choice and Folk Music Songs as Audio Distraction Behaviour Guidance Techniques in Children aged 6-12years undergoing Dental Treatment: A Randomized Clinical 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 |
Dr Shweta Kajjari |
| Designation |
Reader |
| Affiliation |
KLE V. K. Institute of Dental Sciences, KLE Academy of Higher Education And Research |
| Address |
Room no 6, Department of Pediatric and Preventive Dentistry, KLE V.K. Institute of Dental Sciences, KLE Academy of Higher Education and Research, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09964525733 |
| Fax |
|
| Email |
drshwetakajjari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivayogi M Hugar |
| Designation |
Professor |
| Affiliation |
KLE V. K. Institute of Dental Sciences, KLE Academy of Higher Education And Research |
| Address |
Professor ,Department of Pediatric And Preventive Dentistry, KLE V. K. Institute of Dental Sciences, KLE Academy of Higher Education And Research, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9986436448 |
| Fax |
|
| Email |
dr.hugarsm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Kajjari |
| Designation |
Reader |
| Affiliation |
KLE V.K. Institute of Dental Sciences, KLE Academy of Higher Education and Research |
| Address |
Room no 6, Department of Pediatric and Preventive Dentistry, KLE V.K. Institute of Dental Sciences, KLE Academy of Higher Education and Research, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09964525733 |
| Fax |
|
| Email |
drshwetakajjari@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KAHERS KLE Institute of Dental Sciences |
| Address |
Department of Pediatric And Preventive Dentistry, KLE Academy of Higher Education And Research, KLE V. K. Institute of Dental Sciences,Belagavi ntistry, |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shweta Kajjari |
KLE V.K.Institute of Dental Sciences |
Department of Pediatric and Preventive Dentistry, Room no 6,First floor
Belgaum
KARNATAKA |
9964525733
drshwetakajjari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Dental Caries |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music Distraction |
Two types of music distractions are used: Folk music and Music of Choice |
| Comparator Agent |
Tell-Show-Do |
Behavior will guided by conventional Tell-Show-Do method |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children between the age group of 6-12 years
Children reporting for dental treatment for first time.
Children requiring Scaling/Restoration/Fluoride application without local anaesthesia
Children requiring Restorations of deep carious lesions/Pulp therapy/ Extractions under local anaesthesia
|
|
| ExclusionCriteria |
| Details |
Children with special health care needs
Children showing Frankl Behavior rating 1 (i.e. Definitely negative)
Children with Auditory impairment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety in children undergoing dental treatment |
Before and after dental treatment at first and second visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frankle Behaviour Rating Scales |
Before & after dental treatment at first & Second visit |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
15/03/2025 |
| 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="1"
Months="3"
Days="3" |
|
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
|
Music
therapy as a audio-distraction technique is a behavior guidance method. Suitable
music has been shown to influence human brain waves, leading to deep relaxation
and alleviating pain and anxiety. The present study protocol is designed in
concordance with a novel behavior management technique ‘music distraction’ or
‘audio distraction’. ‘Audio distraction’ is the non-aversive technique in which
the patient hears to music throughout a stressful dental treatment procedure. The musical melodies system of India is deeply rooted in
folk songs which influences the folk music through the ages by one generation
to another .There are number of folk songs available
but no scientific literature on folk songs which reduces the anxiety in
children undergoing dental treatment. Aim of the study is to evaluate and compare the anxiety levels using
Tell-Show-Do, Music of Choice and Folk Music songs as Audio Distraction Behavior
Guidance Techniques in Children aged 6-12years undergoing Dental Treatment. CLINICAL SIGNIFICANCE: Audio
distraction used in the study will be non-aversive behavior guidance
technique to manage a child appropriately in dental clinic. Music
distraction will be an effective means of stress reduction in anxious
pediatric dental patients undergoing dental treatment. Folk music songs and music of choice will be an alternative music distraction techniques as a emerging
trend.
EXPECTED OUTCOME: The audio
distraction behavior guidance(non-pharmacological) technique using folk music
songs could be used successfully to
alleviate anxiety in children undergoing dental treatment
|