| CTRI Number |
CTRI/2024/02/062788 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to observe effect of virtual reality device on anxiety during dental treatment, involving use of local anaesthesia in children |
|
Scientific Title of Study
|
Effect of distraction using virtual reality on anxiety in children during administration of local anaesthesia: A clinical study. |
| 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 Farkhaunda ilyas |
| Designation |
Student |
| Affiliation |
THE OXFORD DENTAL COLLEGE BANGALORE INDIA |
| Address |
Department of Pediatric and Preventive Dentistry
The Oxford Dental College,
Hongasandra, Bommannahalli
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
06005085167 |
| Fax |
|
| Email |
farkhandailyas96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudhan. K.S |
| Designation |
Reader |
| Affiliation |
THE OXFORD DENTAL COLLEGE BANGALORE INDIA |
| Address |
Department of Pediatric and Preventive Dentistry
The Oxford Dental College,
Hongasandra, Bommannahalli,
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
09886035137 |
| Fax |
|
| Email |
sudhannks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Farkhaunda ilyas |
| Designation |
Student |
| Affiliation |
THE OXFORD DENTAL COLLEGE BANGALORE INDIA |
| Address |
Department of Pediatric and Preventive Dentistry
The Oxford Dental College,
Hongasandra, Bommanahalli,
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
06005085167 |
| Fax |
|
| Email |
farkhandailyas96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry,
The Oxford Dental College,
Hongasandra, Bommannahalli,
Bangalore, Karnataka, 560068 |
|
|
Primary Sponsor
|
| Name |
Dr Farkhaunda Ilyas |
| Address |
C-601 PHASE 2 UBER VARDANT DODDAKANNALI SARJAPURA ROAD BANGALORE |
| 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 Farkhaunda Ilyas |
The Oxford Dental College |
Department of Pediatric and Preventive Dentistry,
Hongasandra,
Bommannahalli,
Bangalore
Bangalore
KARNATAKA |
06005085167
farkhandailyas96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Committee, Oxford Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
volunteers who require dental procedures under local anasthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Virtual Reality device used |
Total duration: 20 minutes |
| Intervention |
PICO 4 VR , used in dental procedures under local anaesthesia |
PICO 4 VR (A8110) from Pico Interactive, Europe, S.L & Exertis (UK Ltd) is an all-in-one virtual reality headset that offers a 105° ultra-wide field of view, a 90Hz Flash-LCD display, and a sub-millimetre tracking system.
Total duration per intervention: 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy and cooperative 5 to 12 year old children who had no prior dental treatment experience.
2. Treatment requiring bilateral administration of local anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Children allergic to local anaesthesia.
2. Children with special health care needs.
3. Children requiring emergency dental treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determined from:
1 Pulse Oximeter readings
2 Childrens Emotional Manifestation Scale Readings
3 Venhams Picture Test results
4 Facial Image Scale results
5 Faces Version of Modified Child Dental Anxiety Scale |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Determined from:
1 Pulse Oximeter readings
2 Childrens Emotional Manifestation Scale Readings
3 Venhams Picture Test results
4 Facial Image Scale results
5 Faces Version of Modified Child Dental Anxiety Scale |
1 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A Clinical study which includes total of 60 children of aged 5 to 12 year old will be included in the study based on the (MCDAS(f)).2 They will be divided in two study groups (group I and group II) based on split-mouth design and assigned to the left or right quadrant. In group I (VR group), administration of local anaesthesia will be done with wearing VR headset and in group II (control group), administration of local anaesthesia will be done without wearing VR headset. Each patient will receive VR headset during invasive dental procedure and receive no VR during the second comparable procedure on a different day. Before the administration of local anaesthesia, the child will be assessed for his/her physiological parameters using pulse oximeter at three time points: (1) once the subject is on dental chair as a baseline; (2) during local anaesthesia administration with VR and without VR; (3) after the completion of the procedure. During the dental procedure anxiety will be assessed by using Children’s Emotional Manifestation Scale (CEMS)1 and Venham Picture Test (VPT).2 After the completion of dental procedure, a questionnaire will be given to the subject, and the results will be compared to evaluate the impact of VR on dental anxiety during local anaesthesia administration. |