CTRI/2026/02/103692 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On:
11/02/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Behavioral
Study Design
Randomized, Crossover Trial
Public Title of Study
Comparision Of Indian Raga based Audio and Audio visual aids on Dental Anxiety of children with Autism Spectrum Disorder
Scientific Title of Study
Comparative Evaluation of Indian raga based procedural instructions in rhyming verse form and audio-visual aids on dental anxiety in children with autism spectrum disorder during administration of local anaesthesia: A randomized crossover 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
Hitarth Vaishnav
Designation
Post Graduate Student
Affiliation
Dr. D.Y. Patil Dental College and Hospital Pune
Address
Dept no 8, Second Floor, Department of Pediatric and Preventive Dentistry, Dr. D.Y. Dental College and Hospital, Sant Tukaram Nagar, Pimpri Dept no 8, Second Floor, Department of Pediatric and Preventive Dentistry, Dr. D.Y. Dental College and Hospital, Sant Tukaram Nagar, Pimpri Pune MAHARASHTRA 411013 India
Phone
8237848419
Fax
Email
hitarthv26@gmail.com
Details of Contact Person Scientific Query
Name
Dr Madhura Pawar
Designation
Professor
Affiliation
Dr. D.Y. Patil Dental College and Hospital Pune
Address
Dept no 8, Second Floor, Department of Pediatric and Preventive Dentistry, Dr. D.Y. Dental College and Hospital, Sant Tukaram Nagar, Pimpri Dept no 8, Second Floor, Department of Pediatric and Preventive Dentistry, Dr. D.Y. Dental College and Hospital, Sant Tukaram Nagar, Pimpri Pune MAHARASHTRA 411018 India
Phone
9860079769
Fax
Email
drmadhura4@gmail.com
Details of Contact Person Public Query
Name
Dr Madhura Pawar
Designation
Professor
Affiliation
Dr. D.Y. Patil Dental College and Hospital Pune
Address
Dept no 8, Second Floor, Department of Pediatric and Preventive Dentistry, Dr. D.Y. Dental College and Hospital, Sant Tukaram Nagar, Pimpri Dept no 8, Second Floor, Department of Pediatric and Preventive Dentistry, Dr. D.Y. Dental College and Hospital, Sant Tukaram Nagar, Pimpri Pune MAHARASHTRA 411018 India
Phone
9860079769
Fax
Email
drmadhura4@gmail.com
Source of Monetary or Material Support
Nil
Primary Sponsor
Name
Dr Hitarth Vaishnav
Address
Dr DY Patil Dental College & Hospital Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Type of Sponsor
Other [self]
Details of Secondary Sponsor
Name
Address
Dr Madhura Pawar
Dr DY Patil Dental College & Hospital Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Hitarth Vaishnav
Dr DY Patil Dental College and Hospital
Department no 8, Second Floor, Department of Pediatric and Preventive Dentistry, Dr. D.Y. Dental College and Hospital, Sant Tukaram Nagar, Pimpri Pune MAHARASHTRA
08237848419
hitarthv26@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Dr DY Patil Vidyapeeth Pune
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Audio Visual Aid
audio visual aid like cartoons of the liking of the patient or any other media in the AV form as per the choice of the patient
Intervention
Rhyming procedural instructions based on indian raga
Procedural instructions in rhyming verse form composed in the indian raga based tune for autistic children undergoing administration of local anesthesia for dental procedure
Inclusion Criteria
Age From
6.00 Year(s)
Age To
12.00 Year(s)
Gender
Both
Details
Children aged 6–12 years with a confirmed diagnosis of ASD requiring dental treatment under local anesthesia. Informed consent from parent or local guardian
ExclusionCriteria
Details
patients with Profound hearing impairment or uncorrected auditory deficits, use of sedatives or anxiolytic medications. Patients with diagnosis of Intellectual Disability or Down’s Syndrome or showing Severe uncooperative behavior unsuitable for non-pharmacological interventions
Method of Generating Random Sequence
Random Number Table
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The customized raga-based audio intervention with rhythmic and rhyming procedural instructions results in a greater reduction in dental anxiety and improves behavioral cooperation among autistic children
Baseline and 1 month
Secondary Outcome
Outcome
TimePoints
The customized raga based audio intervention with rhythmic & rhyming procedural instructions reduces electrodermal activity, heart rate, pulse rate & improves oxygen saturation
baseline
comparator
1 week of washout period
baseline
intervention
Target Sample Size
Total Sample Size="40" Sample Size from India="40" 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)
23/02/2026
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="8" Days="0"
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
Children with Autism Spectrum Disorder (ASD) often experience heightened dental anxiety, particularly during invasive procedures such as administration of local anaesthesia, due to sensory sensitivities and communication difficulties. Conventional audiovisual distraction techniques may not always be effective or well tolerated in this population. Music therapy, especially structured Indian raga-based music, has shown potential in modulating emotional and physiological responses and may serve as a sensory-adaptive, non-pharmacological intervention.
This randomized crossover clinical trial aims to compare the effectiveness of customized Indian raga-based audio incorporating rhythmic and rhyming procedural instructions with audio-visual distraction aids in reducing dental anxiety in children aged 6–12 years with ASD during administration of local anaesthesia. Each participant will undergo two intervention visits—one with audiovisual distraction and one with the raga-based audio intervention—separated by a washout period of at least one week.
Dental anxiety will be assessed using physiological parameters including electrodermal activity, heart rate, pulse rate, and oxygen saturation, along with behavioural assessment tools such as Venham’s Picture Test and Venham’s Clinical Anxiety Rating Scale. The study seeks to determine whether the raga-based auditory intervention provides superior anxiety reduction and improved cooperation compared to standard audiovisual distraction during dental procedures in children with ASD.