| CTRI Number |
CTRI/2023/07/054626 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
29/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study to evaluate effect of Virtual Reality glasses during Dental extractions to reduce anxiety |
|
Scientific Title of Study
|
Effect of Virtual Reality in Reducing Anxiety during Dental extractions- A Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIWANGI JAISWAL |
| Designation |
POST GRADUATE |
| Affiliation |
KAHERS KLE V.K. INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTE OF DENTAL SCIENCES, BELGAUM
JNMC CAMPUS,
NEHRU NAGAR
Belgaum
KARNATAKA
590010
India |
| Phone |
7353312960 |
| Fax |
|
| Email |
jaiswalshiwangi14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARATI NEELI |
| Designation |
READER |
| Affiliation |
KAHERS KLE V.K. INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTE OF DENTAL SCIENCES, BELGAUM
JNMC CAMPUS,
NEHRU NAGAR
Belgaum
KARNATAKA
590010
India |
| Phone |
9342988955 |
| Fax |
|
| Email |
aratiaqua@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SHIWANGI JAISWAL |
| Designation |
POST GRADUATE |
| Affiliation |
KAHERS KLE V.K. INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTE OF DENTAL SCIENCES, BELGAUM
JNMC CAMPUS,
NEHRU NAGAR
Belgaum
KARNATAKA
590010
India |
| Phone |
7353312960 |
| Fax |
|
| Email |
jaiswalshiwangi14@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTTE OF DENTAL SCIENCES, BELGAUM, KARNATAKA |
|
|
Primary Sponsor
|
| Name |
SHIWANGI JAISWAL |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, KLE VK INSTITUTE OF DENTAL SCIENCES |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 |
| SHIWANGI JAISWAL |
KLE VK INSTITUTE OF DENTAL SCIENCES |
ROOM NO 5 , DEPT OF ORAL AND MAXILLOFACIAL SURGERY
Belgaum
KARNATAKA |
7353312960
jaiswalshiwangi14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee , KAHER , BELGAUM, KARNATAKA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group (no agent) |
no device to be used during procedure |
| Intervention |
PROCUS ONE virtual reaity headset gear 40 mm lenses |
VR set to be worn during the entire procedure till completion with a display of images of underwater visuals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to the age category of 18-65 years.
Patient’s requiring non surgical or surgical extractions .
Patients who are willing to give informed consent.
Patients with ASA status I and having normal bleeding & clotting times.
|
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the study.
Patients who are mentally challenged or with any learning disabilities.
Patients who are on anti-anxiety or anti-depressants.
Patients with presence of any systemic disorders.
Patients with smoking habit.
Pregnant or lactating female subjects.
Patients who suffered from motion sickness or claustrophobia
Patients with a history of cybersickness or vertigo were excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of anxiety level using modified anxiety scale |
AT BASELINE(PREOPERATIVE)
AT POD 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AVAERAGE HEART RATE VALUE |
AT BASELINE
AT POD 0 (DURING PROCEDURE) |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/07/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized control clinical trial where we are assessing the anxiety score of a patient when he is subjected to virtual reality headset gear, along with assessment of heart rate and patients perception . |