| CTRI Number |
CTRI/2025/03/083558 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Indian flute Music and Sitar Music on relieving dental anxiety among Dental patients. |
|
Scientific Title of Study
|
Effect of Indian Music using two different instruments on relieving dental anxiety among patients aged 18 years and above in Mangaluru- A Prospective 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 Pravina P Gaonkar |
| Designation |
Post Graduate student |
| Affiliation |
Yenepoya Dental college |
| Address |
Room No 03 Department of public Health Dentistry Yenepoya Dental College Yenepoya University University Road Deralakatte Mangaluru Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8550974174 |
| Fax |
|
| Email |
Pravinagaonkar8550@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha P Shenoy |
| Designation |
Head of Department and Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Room No 03 Department of public Health Dentistry Yenepoya Dental College Yenepoya University University Road Deralakatte Mangaluru Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845132999 |
| Fax |
|
| Email |
rekhashenoy@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha P Shenoy |
| Designation |
Head of Department and Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Room No 03 Department of public Health Dentistry Yenepoya Dental College Yenepoya University University Road Deralakatte Mangaluru Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845132999 |
| Fax |
|
| Email |
rekhashenoy@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Dental College and hospital. |
|
|
Primary Sponsor
|
| Name |
Yenepoya Dental College |
| Address |
room no 03 Department of public health Dentistry Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018 |
| Type of Sponsor |
Other [Deemed University] |
|
|
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 Pravina P Gaonkar |
Yenepoya Dental College |
room no 3 Department of Public Health Dentistry Yenepoya University University Road Deralakatte Mangaluru Karnataka 575018
Dakshina Kannada
KARNATAKA |
8550974174
Pravinagaonkar8550@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music |
A total of 87 participants will be selected based on inclusion and exclusion criteria.
Group A: participants will be asked to listen to the flute music by means of bluetooth speakers as an intervention before and during the dental treatment.
Group B: participants will asked to listen to the sitar music by means of bluetooth speakers as an intervention before and during the dental treatment.
Group C: participants who will be the Control group with no music intervention. Regular treatment will be continued for the control group without any musical intervention.
Intervention arm will comprise of group A and Group B including 29 and 29 Participants respectively in each group.
Group C will be control arm comprising of 29 participants.
The participant will then be seated on the dental chair. Group A and Group B, participants will be asked to listen to the music played, which will be a recording of Indian flute Music, which will be played for 10 min before starting the dental treatment through bluetooth speakers for Group A and will be continued till the end of the treatment and sitar music for 10 min before starting the dental treatment through bluetooth speakers in Group B which will be continued till the end of the dental treatment. This recording of Indian instrumental music played for both the groups will be played at a moderate volume under which corresponds to 75dB.19 The intervention group will be exposed to slow rhythm and free of words music before the treatment, that produces physical and emotional relaxation and the music will be continued till the end of the dental treatment.• Group A : The Group A participant will be seated on the dental chair. Group A participants will be asked to listen to the music played, which will be a recording of Indian flute Music, which will be played for 10 min before starting the dental procedure through bluetooth speakers and which will be continued till the end of the dental treatment. The participant will be permitted to withdraw from the study if he/she is not comfortable with the music being played. However, dental treatment will be continued following the standard of care.
• Group B: The Group B participant will be seated on the dental chair. Group B participants will be asked to listen to the music played, which will be a recording of Indian Sitar Music, which will be played for 10 min before starting the dental procedure through bluetooth speakers and which will be continued till the end of the dental treatment. The participant will be permitted to withdraw from the study if he/she is not comfortable with the music being played. However, dental treatment will be continued following the standard of care.
Frequency of intervention: Once
Duration of Intervention: 30 Min. for the intervention group |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a. Participant aged 18 years and above.
b. Participant who will be undergoing dental treatment for the first time.
|
|
| ExclusionCriteria |
| Details |
Participants with sensory processing disorders, musculoskeletal disorders and recent ear surgery.
Participants under permanent drug treatments such as antihistamines, antidepressants and anticholinergics.
Participants whose initial anxiety scores are very high will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dental anxiety scores |
AT baseline and immediately on the same day just after the completion of dental treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
10/04/2025 |
| 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="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
From the recent past, scientific and neuro-scientific studies have found out and documented various influences of music on human body and mind. This potential of music later led to its scientific application in the form of music therapy particularly in psychological or mental health related problems. Music distraction is considered to be an efficient relaxation practice. It is considered safe and inexpensive, which can help during short and painful dental procedures. There are many studies conducted to see the effect of music on anxiety this could be the first study wherein we will be comparing the effects of two different Indian instrumental music on relieving preoperative dental anxiety.
Study titled ‘Effect of Indian Music using two different instruments on relieving dental anxiety among patients aged 18 years and above in Mangaluru- A Prospective Study.’ will be conducted in Department of Public health dentistry, Yenepoya Dental College, from October 2024 to December 2024. Participants included in the study will be patients visiting Yenepoya dental college for dental treatment (who will be equally divided into Flute music group and Sitar music and third group will be the control). Indian instrumental music (Flute music ,Sitar music) will be used as an intervention in the first two groups. Prior to the experiment, participants of all three groups will be asked to fill Modified Corah’s Dental Anxiety Scale (MDAS), to assess the dental anxiety. The post operative questionnaire will be administered to the participants at the end of the treatment
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