| CTRI Number |
CTRI/2025/07/091113 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of virtual reality screened in a child’s mother tongue to reduce pain and anxiety during dental treatment in children |
|
Scientific Title of Study
|
Effect of mother tongue based immersive virtual reality distraction on anxiety and pain in pediatric dental patients during pulpectomy: A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupama R |
| Designation |
Post Graduate Student |
| Affiliation |
Kannur Dental College |
| Address |
Department of Pediatric and Preventive Dentistry
Room Number 2
Ground Floor
Anjarakandy
Kannur
KERALA
670612
India |
| Phone |
8157012903 |
| Fax |
|
| Email |
dranupamar342@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faizal CP |
| Designation |
Professor and HOD |
| Affiliation |
Kannur Dental College |
| Address |
Department of Pediatric and Preventive Dentistry
Room Number 2
Ground Floor
Anjarakandy
Kannur
KERALA
670612
India |
| Phone |
9746975730 |
| Fax |
|
| Email |
drfaizalcp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupama R |
| Designation |
Post Graduate Student |
| Affiliation |
Kannur Dental College |
| Address |
Department of Pediatric and Preventive Dentistry
Room Number 2
Ground Floor
Anjarakandy
Kannur
KERALA
670612
India |
| Phone |
8157012903 |
| Fax |
|
| Email |
dranupamar342@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Pediatric and Preventive Dentistry |
| Address |
Room Number2
Ground Floor
Kannur Dental College
Anjarakandy
670611
|
| 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 |
| Anupama R |
Kannur Dental College |
Department of Pediatric and Preventive Dentistry
Room Number 2
Ground Floor
Anjarakandy
670612
Kannur
KERALA |
8157012903
dranupamar342@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kannur Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
English-language immersive virtual reality distraction |
Pediatric patients in this group will be exposed to immersive virtual reality (VR) content in the English language during the pulpectomy procedure. The VR content will be identical in visual experience to the intervention group but delivered in English. The headset will be worn during the entire treatment. Pain and anxiety levels will be recorded using the same scales and physiological parameters for comparison |
| Intervention |
Mother tongue-based immersive virtual reality distraction
|
Pediatric patients in this group will be exposed to an immersive virtual reality experience in their native or mother tongue language during the pulpectomy procedure. The VR content will be age-appropriate, non-threatening, and culturally relevant. The headset will be worn throughout the procedure, and anxiety and pain levels will be assessed at multiple intervals using the Facial Anxiety Scale (FAS), Modified Behavioral Pain Scale (MBPS), and physiological parameters (heart rate, respiratory rate, SpO2) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
6 to 8 year old children with irreversible pulpitis indicated for Pulpectomy in primary lower molars.
Frankles behavioral rating scale 3 and 4.
|
|
| ExclusionCriteria |
| Details |
Hearing and visual impairment.
History of epileptic seizure.
Children consuming anxiolytics.
Claustrophobic Children.
Motion sickness.
Mentally challenged.
Patient who requires any emergency dental treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in anxiety and pain levels in pediatric dental patients undergoing pulpectomy using mother tongue-based immersive virtual reality distraction |
Before the procedure,
During administration of LA,
At the start of procedure,
10 minutes after start of procedure,
After the procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dranupamar342@gmail.com].
- For how long will this data be available start date provided 26-08-2026 and end date provided 26-08-2027?
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 aims to evaluate the effectiveness of mother tongue-based immersive virtual reality (VR) distraction in reducing anxiety and pain in pediatric dental patients undergoing pulpectomy. The study compares two groups: one receiving VR content in their native language (mother tongue) and the other receiving the same content in English. Anxiety and pain levels will be assessed using behavioral scales (Facial Anxiety Scale, Modified Behavioral Pain Scale) and physiological parameters (heart rate, respiratory rate, and oxygen saturation). Primary Purpose:
To Assess the effectiveness of using immersive virtual reality in the child’s mother tongue to reduce anxiety and pain Study Hypothesis:
The mother tongue-based immersive virtual reality has an effect in reducing anxiety and pain levels, in pediatric dental patients during pulpectomy |