| CTRI Number |
CTRI/2026/01/100820 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Virtual Reality device to Reduce Pain, Anxiety, and Distress in Patients Undergoing Root Canal Treatment |
|
Scientific Title of Study
|
Clinical evaluation of Virtual Reality Device as an Audio-Visual Distraction method in pain and anxiety reduction and overall distress management in patients undergoing root canal treatment: an in vivo 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 Umair Hussain Khan |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Conservative Dentistry and Endodontics, Himachal dental college and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital, Sundernagar, Mandi
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9419202303 |
| Fax |
|
| Email |
drumairhussainkhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munish Goel |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Conservative Dentistry and Endodontics, Himachal dental college and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital, Sundernagar, Mandi
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9816034034 |
| Fax |
|
| Email |
goelmuni2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Munish Goel |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Conservative Dentistry and Endodontics, Himachal dental college and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital, Sundernagar, Mandi
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9816034034 |
| Fax |
|
| Email |
goelmuni2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital, Sundarnagar, Mandi, Himachal Pradesh, 175019 |
|
|
Primary Sponsor
|
| Name |
Dr Umair Hussain khan |
| Address |
Department of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital, Sundarnagar, Mandi, Himachal Pradesh, 175019 |
| 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 Umair Hussain Khan |
Himachal Dental College and Hospital |
Department of Conservative Dentistry and Endodontics Himachal Dental College and Hospital Sundernagar
Mandi
HIMACHAL PRADESH |
9419202303
drumairhussainkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE HIMACHAL DENTAL COLLEGE SUNDERNAGAR |
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 |
control group (no intervention) |
The patients will undergo treatment without any intervention or device during root canal treatment. |
| Intervention |
Virtual reality |
The patients in the intervention group will be exposed to virtual reality through the use of head mounted immersive type of display device powered by a smartphone during the root canal treatment.The intervention will be administered for the duration of the dental procedure, up to a maximum of one hour, or until completion of treatment, whichever occurs earlier. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients in age category of 15-50 years.
Patients undergoing non surgical endodontic therapy.
Patients who had anxiety during dental treatment according to the Dental Anxiety Scale-Revised (DAS-R) and had anxiety levels above 9. |
|
| ExclusionCriteria |
| Details |
Patients with a history of psychological problems (based on the medical records).
History of claustrophobia.
History of epilepsy.
Intellectual disabilities.
Dental abscess and fistula. |
|
|
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 |
| To study the effect of Virtual Reality Device on Pain reduction,anxiety reduction and overall distress management of patients undergoing routine non surgical endodontic treatment. |
outcomes will be assessed at baseline, during the procedure, and immediately after treatment completion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dental anxiety scale revised |
At Baseline: Prior to initiation of the endodontic procedure |
| blood pressure, pulse rate & oxygen saturation |
At Baseline: Prior to initiation of the endodontic procedure
During treatment: While the procedure is ongoing
Post-treatment: Immediately after completion of the endodontic procedure |
| visual analog scale |
at baseline (before the start of treatment) & immediately after completion of the endodontic procedure. |
| hamilton Anxiety rating scale |
at baseline (before the start of treatment) & immediately after completion of the endodontic procedure. |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
15/01/2026 |
| 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="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Pain and anxiety remain significant challenges in dental practice, often leading patients to delay or avoid treatment despite advances in dental technology. Pain perception has a strong psychological component and requires conscious attention, making distraction-based interventions effective in reducing pain and associated distress. Virtual reality (VR) is an advanced, nonpharmacological distraction technique that creates immersive, multisensory virtual environments, diverting patient attention away from painful stimuli. Dental anxiety is among the most commonly reported fears and contributes to increased patient discomfort as well as practitioner stress. Evidence suggests that VR-based interventions enhance pain tolerance by engaging active cognitive processing and limiting the brain’s capacity to perceive pain and reduce anxiety. This study evaluates the effectiveness of Virtual Reality Device as an Audio -Visual Distraction Method in pain and anxiety reduction and overall distress management in patients undergoing root canal treatment. |