| CTRI Number |
CTRI/2026/02/103273 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Comparative Study of Distraction Techniques to Reduce Pain and Anxiety in Children During Dental Treatment |
|
Scientific Title of Study
|
Comparative Evaluation of Effect of Distraction Techniques using Virtual Reality, Binaural Beats and Cartoon Assisted Visual/Audio Analgesia Methods on Pain Perception and Anxiety Levels in 6 –10-year-old Children |
| 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 Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD of Department of Pediatric and Preventive Dentistry |
| Affiliation |
SMBT Dental College and Hospital, Sangamner |
| Address |
102, Department of Pediatric & Preventive Dentistry, SMBT Dental College and Hospital, Amrutnagar, Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD, Department of Pediatric and Preventive Dentistry |
| Affiliation |
SMBT Dental College and Hospital, Sangamner |
| Address |
102, Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Amrutnagar, Ghulewadi, Sangamner
102, Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Amrutnagar, Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD of Department of Pediatric and Preventive Dentistry |
| Affiliation |
SMBT Dental College and Hospital, Sangamner |
| Address |
102, Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Amrutnagar, Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital, Amrutnagar, Ghulewadi, Sangamner, Ahmednagar, Maharashtra, India. Pincode-422608 |
|
|
Primary Sponsor
|
| Name |
SMBT Dental college and Hospital |
| Address |
Amrutnagar, Ghulewadi, Sangamner, Maharashtra, India. Pincode-422608 |
| Type of Sponsor |
Other [Private dental college and hospital] |
|
|
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 Vinaya Kumar Kulkarni |
SMBT Dental College and Hospital |
Division/Room No. 102, Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Amrutnagar, Ghulewadi, Sangamner, Maharashtra, India. Pincode-422608
Ahmadnagar
MAHARASHTRA |
8830483436
vinayakumar53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics, SMBT Dental College and Hospital, Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Binaural Beats distraction technique |
Group B (Binaural Beats): Children wear headphones playing binaural beats with visual recording on a phone. |
| Intervention |
Cartoon Audio-Visual distraction technique |
Group C (Cartoon Audio-Visual): Children watch their favourite cartoons on a
tablet with audio via headsets. |
| Comparator Agent |
Negative control without any distraction |
Group D (Control): Children in this group received standard care without any distraction. |
| Intervention |
Virtual reality distraction technique |
Group A (VR): Children use a virtual reality headset with immersive video and audio during administration of the inferior alveolar nerve block. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6–10 years, healthy, positive Frankl rating
Undergoing routine dental procedures with consent or assent will be included
Patient undergoing first dental visit
|
|
| ExclusionCriteria |
| Details |
Medical or developmental conditions which prevent behavior guidance
Sensory impairments
Prior use of distraction methods
Medication affecting anxiety/behavior
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison Among Techniques:
VR may show the greatest reduction in both pain and anxiety due to its immersive nature. Binaural beats may help with anxiety reduction more than pain. Cartoon-assisted methods may be moderately effective in both dimensions.
Improved Child Cooperation:
Children exposed to these distraction techniques may demonstrate better behavioral compliance during dental treatment. |
Objective for assessment of anxiety will be evaluated by pulse oximeter at T0 before treatment, T1 during treatment, and T2 after treatment.
Subjective assessment of anxiety will be evaluated by using Modified Yale Anxiety Scale at T0 before treatment and T1 during treatment.
Subjective assessment of pain will be evaluated by an observer during the procedure by FLACC Scale and after the procedure by the participants using Wong-Baker FACES scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/02/2026 |
| 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="6"
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
|
Title:
Comparative Evaluation of the Effect of Distraction Techniques Using Virtual Reality, Binaural Beats, and Cartoon-Assisted Visual/Audio Analgesia on Pain Perception and Anxiety Levels in 6–10-Year-Old Children Objective:
To evaluate and compare the effectiveness of Virtual Reality (VR), Binaural Beats, and Cartoon-Assisted Visual/Audio Analgesia in reducing pain perception and anxiety during administration of local anesthesia in children aged 6–10 years. Study Design:
Randomized Clinical Trial Setting:
Postgraduate Clinical Section, Department of Paediatric and Preventive Dentistry Participants:
80 children (aged 6–10 years), undergoing their first dental visit, with positive Frankl behavior rating. Sampling Technique:
Stratified random sampling with lottery method for group allocation. Intervention Groups: -
Group A (VR): Immersive VR video/audio during procedure -
Group B (Binaural Beats): Headphones with binaural beats and visual display -
Group C (Cartoon): Favorite cartoon on tablet with headphones -
Group D (Control): Standard care without distraction Outcomes Measured: -
Pain Perception: Wong-Baker FACES Scale (child) and FLACC Scale (observer) -
Anxiety Levels: Modified Yale Preoperative Anxiety Scale (m-YPAS) -
Biological Indicator: Pulse rate using pulse oximeter Inclusion Criteria:
Healthy, cooperative children aged 6–10 years undergoing routine dental procedures for the first time. Exclusion Criteria:
Children with developmental/sensory impairments, previous distraction use, or medications affecting behavior. Data Analysis: -
Shapiro-Wilk test for normality -
One-Way ANOVA with Post Hoc Bonferroni for group comparisons -
Significance level: p < 0.05; Power: 80%; CI: 95% |