FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/02/040233 [Registered on: 11/02/2022] Trial Registered Prospectively
Last Modified On: 19/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON AND EVALUATION OF ANXIETY LEVELS IN CHILDREN UNDER GOING FILLING USING NO MUSIC, NURSERY RHYMES AND MUSIC OF CHOICE IN CHILDREN BETWEEN 4-12 YEARS OF AGE 
Scientific Title of Study   “COMPARATIVE EVALUATION OF ANXIETY LEVELS IN CHILDREN UNDER GOING RESTORATIVE PROCEDURE USING,NO MUSIC, NURSERY RHYMES AND MUSIC OF CHOICE AS A BEHAVIOUR MANAGEMENT TECHNIQUE IN CHILDREN BETWEEN 4-12 YEARS- AN IN VIVO STUDY.” 
Trial Acronym  CANMN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna S Kadam 
Designation  POST GRADUATE STUDENT 
Affiliation  KAHERs KLE VK INSTITUTE OF DENTAL SCIENCES 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY KAHERs KLE VK INSTITUTE OF DENTAL SCIENCES, NEHRU NAGAR

Belgaum
KARNATAKA
590010
India 
Phone  09604201393  
Fax    
Email  kadamkrishnasp1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Niraj Gokhale 
Designation  Reader 
Affiliation  KAHERs KLE VK INSTITUTE OF DENTAL SCIENCES 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY KAHERs KLE VK INSTITUTE OF DENTAL SCIENCES, NEHRU NAGAR

Belgaum
KARNATAKA
590010
India 
Phone  9535551937  
Fax    
Email  neerajpedo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Krishna S Kadam 
Designation  POST GRADUATE STUDENT 
Affiliation  KAHERs KLE VK INSTITUTE OF DENTAL SCIENCES 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY KAHERs KLE VK INSTITUTE OF DENTAL SCIENCES, NEHRU NAGAR

Belgaum
KARNATAKA
590010
India 
Phone  09604201393  
Fax    
Email  kadamkrishnasp1996@gmail.com  
 
Source of Monetary or Material Support  
KLE VK Institute of Dental Sciences, Belagavi 
 
Primary Sponsor  
Name  Department of Pediatric and Preventive Dentistry 
Address  Department of Pediatric and Preventive Dentistry, KLE VK Institute of Dental sciences, Belagavi 
Type of Sponsor  Research institution and hospital 
 
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 
Krishna Kadam  KLE VK INSTITUTE OF DENTAL SCIENCES  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY ROOM NO 6
Belgaum
KARNATAKA 
09604201393

kadamkrishnasp1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH AND ETHICS COMMITTEE KLE VK INSTITUTE OF DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Music of Choice  Restorative procedure will be carried while the patient is hearing to music of choice for about 40 minutes. Anxiety levels will be assessed At the begining of the treatment and at end of the treatment using Venham’s picture test, pulse rate using pulse oximeter. 
Comparator Agent  No music Group  Restorative procedure will be carried while the patient is not hearing to music. Anxiety levels will be assessed At the begining of the treatment and at end of the treatment using Venham’s picture test, pulse rate using pulse oximeter. 
Intervention  Nursery rhymes  Restorative procedure will be carried while the patient is hearing to nursery rhymes for about 40 minutes. Anxiety levels will be assessed At the begining of the treatment and at end of the treatment using Venham’s picture test, pulse rate using pulse oximeter 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children of age group 4-12 years.
Patients visiting dental clinic for the first time.
teeth having caries involving enamel and dentin.
Children who did not underwent dental procedures, impressions, endodontics and surgery.
 
 
ExclusionCriteria 
Details  Patients below 4 years and above 12 years of age.
Primary molars grossly decayed having spontaneous pain, swelling, abscess, fistula.
Children with special health care needs.
Patients visiting the dental clinic for second time.
Patients/ parents unwilling to participate in the study
 
 
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 Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in anxiety  At baseline and At end of treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Pulse rate  At baseline and At end of treatment  
 
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)   25/02/2022 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A child’s first dental visit is pivotal for reduction of dental anxiety and for success of treatment in future. If this is not managed, it might possibly continue in their adolescence1. Fear and stress are the main factors that cause anxiety in children when they undergo dental treatment. Numerous factors are responsible for these situations, such as dental instruments and equipment and negative experiences of family members from dental treatment. The child’s hesitancy or uncooperative behavior may curb the effective delivery of dental care that may compromise the quality of treatment provided.2

 

The role of pediatric dentist in managing an anxious child is not only to control the ailment with which the child reports but also to teach the child appropriate means to manage dental fear. One such non-aversive modality to manage a child appropriately in dental clinic is distraction. The disruptive behavior of few pediatric dental patients’ can be controlled by diverting their attention and engaging them in alternative activities like watching TV, playing video games, or listening to audio taped music. Thus, it enhances child’s effective coping skills for acceptance of dental treatment.3

 

Music reduces anxiety through its effect on the autonomic nervous responses which regulates bodily functions such as the heart rate, digestion, respiratory rate and pupillary response. Secondly, the anxiolytic effect of music is achieved through its suppressive action on the sympathetic nervous system, leading to lowered adrenergic activity and fall in neuromuscular arousal.4

 

Moreover, to avoid the side effects of the various drugs, patients opt for conservative approaches like music therapy which is an effective, non�’invasive and cost�’effective intervention, which decreases anxiety and therefore optimizes the outcome of a medical intervention. The assessment of anxiety will be done using Venham’s picture test, pulse rate will be measured using pulse oximeter during first dental visit.5

 

During the literature search we found that no such studies have been conducted where comparison of anxiety levels has been done using nursery rhymes and music of choice of the children vising dental clinic.  In this research, we will be aiming to study the role of music therapy on reducing dental anxiety in patients undergoing restorations, so that various pharmacological methods for reducing anxiety can be avoided.6

 
Close