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
|
|
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
|
|
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 | |