| CTRI Number |
CTRI/2026/02/102674 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of audio distraction techniques to reduce dental anxiety in children undergoing dental treatment |
|
Scientific Title of Study
|
A Comparative Evaluation of Low-Frequency Weighted Noise, High-Frequency Weighted Noise, and Animated Audio Stimuli on Dental Anxiety in Pediatric Patients Aged 5–7 Years: A Randomized Controlled 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 Saumya Parashar |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Q block, Manav Rachna Dental College, Sector 43, Delhi-Surajkund Badhkal Road, Faridabad, Haryana
4033 B block, Sector 43, Delhi-Surajkund Badhkal Road, Faridabad, Haryana
Faridabad
HARYANA
121010
India |
| Phone |
8826686890 |
| Fax |
|
| Email |
saumyap185@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gauri Kalra |
| Designation |
Proffessor |
| Affiliation |
Manav Rachna Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Q block, Manav Rachna Dental College, Sector 43, Delhi-Surajkund Badhkal Road, Faridabad, Haryana
4033, b block, sec 43, greenfields, faridabad, haryana
Faridabad
HARYANA
121010
India |
| Phone |
8826686890 |
| Fax |
|
| Email |
drgauri_dentist@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saumya Parashar |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Q block, Manav Rachna Dental College, Sector 43, Delhi-Surajkund Badhkal Road, Faridabad, Haryana
4033, b block, Greenfield colony, Sector 43, Delhi-Surajkund Badhkal Road, Faridabad, Haryana
Faridabad
HARYANA
121010
India |
| Phone |
8826686890 |
| Fax |
|
| Email |
saumyap185@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manav Rachna Dental College |
| Address |
department of pediatric and preventive dentistry, Dept No. 9, Q block, Manav Rachna Dental college, Delhi-Surajkund road, sector 43, faridabad, haryana |
| Type of Sponsor |
Other [not applicable] |
|
|
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 Saumya Parashar |
Manav Rachna Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, Q block, Manav Rachna Dental College, Sector 43, Delhi-Surajkund Badhkal Road, Faridabad, Haryana
Faridabad
HARYANA |
8826686890
saumyap185@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental anxiety in pediatric patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Animated Audio Stimuli |
Animated Audio Stimuli delivered through noise-cancelling headphones during restorative dental treatment at mid operative stage and post operative stage |
| Intervention |
High-Frequency Weighted Noise |
High-Frequency Weighted Noise delivered through noise-cancelling headphones during restorative dental treatment at mid operative stage and post op stage |
| Comparator Agent |
Low-Frequency Weighted Noise |
Low-Frequency Weighted Noise delivered through noise-cancelling headphones during restorative dental treatment at mid operative stage and post operative stage |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 5–7 years, Frankl Behavior Rating Scale 3 (Positive) and 4 (Definitely Positive),Children requiring restorative dental treatment.Written informed consent obtained from parent/guardian |
|
| ExclusionCriteria |
| Details |
Children with systemic diseases, Children with special health care needs, Children whose parents/guardians do not provide consent |
|
|
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 |
| Dental anxiety assessed using the FLACC Scale during the dental procedure |
intraoperative at baseline day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Behavioral response assessed using Frankl Behavior Rating Scale |
Baseline, mid procedure, & post-procedure on the same day of intervention |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/02/2026 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [saumyap185@gmail.com].
- For how long will this data be available start date provided 07-02-2026 and end date provided 07-08-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled trial evaluates the effect of low frequency weighted noise high frequency weighted noise and animated audio stimuli on dental anxiety in children aged five to seven years undergoing restorative dental treatment. Pediatric dental anxiety often results in poor cooperation and difficulty in completing treatment. Audio distraction is a simple non pharmacological method used to reduce anxiety in children. Forty five children will be randomly allocated into three groups of fifteen each. Group A will receive low frequency weighted noise Group B will receive high frequency weighted noise and Group C will receive animated audio stimuli through noise cancelling headphones during the dental procedure. Dental anxiety will be assessed using the FLACC scale and behavior will be evaluated using the Frankl behavior rating scale. The study aims to identify an effective audio distraction method for behavior management in pediatric dentistry. |