| CTRI Number |
CTRI/2025/07/091692 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Virtual Reality distraction among Teenagers in reducing Pain and Anxiety During Dental Injections |
|
Scientific Title of Study
|
Virtual Reality distraction on dental pain and anxiety during local anaesthesia administration among teenagers: 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 |
Sri Sai Srinivas Patta |
| Designation |
MDS |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, ANdhraPradesh, 531162
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9490106987 |
| Fax |
|
| Email |
ssssonu1011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Vamsi Krishna Reddy |
| Designation |
Professor and Head of Department |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, ANdhraPradesh, 531162
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9908200033 |
| Fax |
|
| Email |
principal.anids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L Vamsi Krishna Reddy |
| Designation |
Professor and Head of Department |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, ANdhraPradesh, 531162
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9908200033 |
| Fax |
|
| Email |
principal.anids@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute of Dental Sciences, sanghivalasa, bheemunipatnam, Visakhapatnam, 531162 |
|
|
Primary Sponsor
|
| Name |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, AndhraPradesh |
| 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 |
| Sri Sai Srinivas Patta |
Anil Neerukonda Institute of Dental Sciences |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, ANdhraPradesh, 531162
Visakhapatnam
ANDHRA PRADESH |
9490106987
ssssonu1011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee- ANIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional local anesthesia delivery method |
local anesthesia administration using a single used disposable syringe(24 gauge needle) |
| Intervention |
Virtual Reality distraction device |
VR goggles (Meta quest 2) connected to internet and the chosen video was played. The sounds of the videos were played on the speakers of the headset |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
with dental pain as chief complaint |
|
| ExclusionCriteria |
| Details |
individuals with underlying systemic diseases
individuals who do not give informed consent
individuals whose parents do not give informed consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate
|
before and after administration of Local anesthesia
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Rating Scale |
after the administration of local anesthesia |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/09/2025 |
| 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="0"
Months="2"
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 - NO
|
|
Brief Summary
|
Background: Various distraction methods have been employed in dentistry with excellent effectiveness when administering local anaesthesia. Virtual reality is a technology which can be implemented in distraction of patients from dental pain and anxiety. Objective: To assess the effectiveness of virtual reality distraction on dental pain and anxiety during local anaesthesia procedure among teenagers. Methods: Individuals aged 12-19years who attended the dentist for the first time and need a treatment procedure involving local anaesthesia injection will be randomly distributed to test group(n=25) and control group(n=25). A virtual reality device will be administered to test group participants to watch a video while the local anaesthesia will be administered. Participants in the control group will be administered local anaesthesia conventionally. A pulse oximeter will be used to record heart rates at three different times during the procedure in order to measure dental anxiety levels in both the groups. A self-administered questionnaire will also be used to assess anxiety levels of study participants. Numeric rating scale will be used to assess anxiety. |