| CTRI Number |
CTRI/2024/02/062989 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| 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 on Anxiety in patients in need of teeth removal |
|
Scientific Title of Study
|
Effect of Virtual Reality Distraction on Anxiety Levels in Patients Undergoing Exodontia -A randomized controlled 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 |
Dr B krishnan |
| Designation |
Proffessor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Dentistry
, 1st Floor Screening
OPD ,Pondicherry
Pondicherry
PONDICHERRY
Department of Dentistry
1st Floor Screening
OPD ,Pondicherry
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09488540931 |
| Fax |
|
| Email |
Krishident@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Litti Maria k |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Thadaparambath
Nellicode post
Kozhikode
Kozhikode
KERALA
673016
India |
| Phone |
9495363604 |
| Fax |
|
| Email |
Littimaria2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Litti Maria k |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Thadaparambath
Nellicode post
Kozhikode
KERALA
673016
India |
| Phone |
9495363604 |
| Fax |
|
| Email |
Littimaria2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research |
| self budget |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Jipmer Campus
Danwantiri Nagar
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 litti maria k |
JIPMER |
Department of Dentistry
, 1st Floor Screening
OPD ,Pondicherry
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
9495363604
littimaria2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients requiring exodontia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
patients with virtual reality distractor |
| Comparator Agent |
Group B |
individuals without virtual reality distractor |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
healthy individuals |
|
| ExclusionCriteria |
| Details |
patients history of claustrophobia |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of anxiety levels with virtual reality distraction |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction with virtual reality distraction |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
28/02/2024 |
| 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)
|
Open to Recruitment |
| 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
|
The study is about to assess anxiety in patients undergoing exodontia with virtual reality distraction and estimated sample size is 90 in which both group A and Group B will be given and each group,group A is intervention group and group B is control group. |