| CTRI Number |
CTRI/2025/08/092802 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Reducing pain and anxiety in children during dental injections using visual and sound distraction |
|
Scientific Title of Study
|
Comparative evaluation of the effectiveness of optical illusion, binaural beats and combination of both on pain perception and anxiety levels in children aged 8-10 years during local anesthesia administration: A randomized control 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 |
Kunal Audichya |
| Designation |
Post graduate student |
| Affiliation |
Pacific dental college and hospital |
| Address |
Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur
Udaipur RAJASTHAN 313024 India |
| Phone |
7597172819 |
| Fax |
|
| Email |
kunalaudichya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Head of Department PG Guide |
| Affiliation |
Pacific dental college and hospital |
| Address |
Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur
Udaipur RAJASTHAN 313024 India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Kunal Audichya |
| Designation |
Post graduate student |
| Affiliation |
Pacific dental college and hospital |
| Address |
Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur
Udaipur RAJASTHAN 313024 India |
| Phone |
7597172819 |
| Fax |
|
| Email |
kunalaudichya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific dental college and hospital, Debari, Udaipur (Rajasthan) 313024 |
|
|
Primary Sponsor
|
| Name |
Kunal Audichya |
| Address |
Pacific dental college and hospital, Debari, Udaipur (Rajasthan) 313024 |
| Type of Sponsor |
Other [[Self]] |
|
|
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 Kunal Audichya |
Pediatric and preventive dentistry |
Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur Udaipur RAJASTHAN |
7597172819
kunalaudichya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee Sai Tirupati Univercity Udaipur Rajasthan India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Binaural Beats |
Children will listen to binaural beats via stereo earphone played from a mobile phone using brain wave application |
| Intervention |
Combination of optical illusion and binaural beats |
Children will simultaneously use a virtual reality headset showing optical illusion videos and listen to binaural beats via earphone during inferior alveolar nerve block procedure |
| Intervention |
Optical illusion |
Children will wear a Virtual reality headset displaying optical illusion videos during inferior nerve block administration |
| Comparator Agent |
Standard procedure |
No audiovisual distraction used Children receive standard local anesthesia IANB without and behavioral distraction |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Healthy cooperative children aged 8–10 years
Moderate dental anxiety Corah scale
Requiring inferior alveolar nerve block
Capable of communication and understanding |
|
| ExclusionCriteria |
| Details |
Children with systemic illness
Mental or physical impairment
Visual or auditory impairment
Prior painful dental experience
Requiring emergency treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain perception and Anxiety levels |
pain perception will be assessed at the time of injecting local anesthesia and anxiety level will be assessed before during and after injecting local anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This randomized controlled trial is designed to evaluate and compare the effectiveness of three non-pharmacological distraction techniques—optical illusion using virtual reality, binaural beats, and a combination of both—on reducing pain perception and anxiety levels in children aged eight to ten years undergoing inferior alveolar nerve block during dental procedures. Effective pain and anxiety management is essential in pediatric dentistry to ensure cooperation and long-term positive dental behavior. Local anesthesia is often associated with discomfort and fear, making it necessary to explore child-friendly alternatives.
The study will follow a parallel-arm randomized design with one hundred and twenty participants equally divided into four groups. Group A will receive distraction through virtual reality headsets displaying optical illusions. Group B will listen to binaural beats through earphones. Group C will experience both interventions simultaneously, while Group D will serve as the control group without any distraction. Each intervention will be applied during the administration of local anesthesia, with binaural beats also played for ten minutes beforehand in the relevant groups.
Participants will be selected based on inclusion criteria such as age between eight and ten years, medically fit status, moderate dental anxiety levels, and need for inferior alveolar nerve block. Exclusion criteria include children requiring emergency treatment, those with systemic illness, previous painful dental experiences, or sensory impairments.
Pain perception will be assessed using the Wong Baker Faces Pain Rating Scale. Anxiety levels will be measured both objectively by monitoring heart rate before, during, and after anesthesia, and subjectively using the FLACC scale and the Modified Venham scale. The same clinician will perform all procedures in a controlled setting to minimize variability. Randomization will be done using color-coded ball selection. While blinding is not feasible for the operator and participants, both the outcome assessor and data analyst will be blinded to group allocations.
Statistical analysis will be conducted using SPSS software. One-way ANOVA will be used to compare differences between groups, and Tukey’s post hoc test will be applied for multiple comparisons. Ethical approval has been obtained from the Institutional Ethics Committee. Written informed consent will be taken from parents or guardians, and verbal assent will be obtained from the participating children.
The expected outcome of this study is to provide evidence for safe, cost-effective, and easily implementable distraction methods that can significantly improve the dental experience for children. If proven effective, these techniques could reduce the need for sedation or physical restraint, promote cooperative behavior, and be integrated into routine pediatric dental practice. The results may also inspire further research into sensory-based behavior management in pediatric healthcare. |