| CTRI Number |
CTRI/2026/03/106316 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
"Reduction of anxiety in children in a 3D environment and Relaxing Sound Therapy during Dental Procedures.” |
|
Scientific Title of Study
|
Augmenting virtual reality with binaural beats in reducing dental anxiety in children - 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 |
K Swapna Sundari |
| Designation |
Post graduate student |
| Affiliation |
GITAM dental college and hospital |
| Address |
Room number -3
Department of Pedodontics and Preventive Dentistry
GITAM Dental college and Hospital
Visakhapatnam
Room number -3
Department of Pedodontics and Preventive Dentistry
GITAM Dental college and Hospital
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
09618422549 |
| Fax |
|
| Email |
k.swapnasundari19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Swapna Sundari |
| Designation |
Post graduate student |
| Affiliation |
GITAM dental college and hospital |
| Address |
Room number -3
Department of Pedodontics and Preventive Dentistry
GITAM Dental college and Hospital
Visakhapatnam
Room number -3
Department of Pedodontics and Preventive Dentistry
GITAM Dental college and Hospital
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
09618422549 |
| Fax |
|
| Email |
k.swapnasundari19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Swapna Sundari |
| Designation |
Post graduate student |
| Affiliation |
GITAM dental college and hospital |
| Address |
Room number -3
Department of Pedodontics and Preventive Dentistry
GITAM Dental college and Hospital
Visakhapatnam
Room number -3
Department of Pedodontics and Preventive Dentistry
GITAM Dental college and Hospital
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
09618422549 |
| Fax |
|
| Email |
k.swapnasundari19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KSwapna Sundari |
| Address |
Room number -3
Department of Pedodontics and Preventive Dentistry
GITAM Dental college and Hospital
Visakhapatnam |
| Type of Sponsor |
Private medical college |
|
|
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 |
| K Swapna Sundari |
GITAM DENTAL COLLEGE AND HOSPITAL |
Room number -3
Department of Pedodontics and Preventive Dentistry
GITAM Dental college and Hospital
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH |
09618422549
k.swapnasundari19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients who have fear and anxiety requiring dental restoration procedure |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional virtual reality
|
A conventional virtual reality headset, which plays regular videos, is presented to the children undergoing restorative dental treatment
|
| Intervention |
Sensory adapted dental environment
|
Sensory adapted dental environment is where
GLOW STICKERS-visual adaptation
AROMA DIFFUSER-olfactory adaptation
BINAURAL BEATS-auditory adaptation
these sensory stimuli are presented to children while undergoing the restorative dental procedure
|
| Intervention |
Sensory adapted dental environment with binaural beats
|
Sensory-adapted dental environment, including the visual, olfactory, and auditory stimuli, with binaural beats playing through a headset, is presented to the children while undergoing a restorative dental procedure |
| Intervention |
Virtual reality augmented with binaural beats
|
virtual reality headset playing childrens favourite cartoons augmented with binaural beats are played during the restorative dental procedure |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between the age group of 6-12 years requiring Class I restorative procedures.
2. Children who fall under categories II and III on Frankl’s behaviour rating scale
|
|
| ExclusionCriteria |
| Details |
1. Children with systemic and intellectual disorders
2. Children who are claustrophobic
3. Children who require pharmacological behaviour management
|
|
|
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 |
| Reduction in dental anxiety score measured using RMS-PS scale before and after the restorative dental procedure. |
Measured before the procedure and immediately after completion of the restorative procedure (same visit). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
physiological measure
heart rate
oxygen saturation |
Recorded baseline (before intervention),and after treatment. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
13/04/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Dental anxiety is a common problem among children and often interferes with the successful delivery of dental treatment. Various non-pharmacological behaviour management techniques have been introduced to reduce anxiety and improve cooperation. Virtual Reality (VR) is an emerging distraction technique that immerses children in an engaging virtual environment, thereby diverting their attention from the dental procedure. Binaural beats are a form of auditory stimulation believed to promote relaxation and reduce stress.
This randomized controlled trial aims to evaluate the effectiveness of combining binaural beats with Virtual Reality and Sensory Adapted Dental Environment (SADE) in reducing dental anxiety among children aged 6–12 years undergoing restorative dental treatment. A total of 60 children will be randomly allocated into four groups: conventional VR, VR with binaural beats, SADE alone, and SADE with binaural beats. Anxiety levels will be assessed using self-reported scales and physiological parameters such as heart rate and oxygen saturation.
The study aims to identify an effective non-pharmacological strategy for reducing dental anxiety and improving cooperation in pediatric dental patients. |