| CTRI Number |
CTRI/2024/04/065499 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison between Virtual Reality, Audio Analgesia and Aroma Therapy in Anxiety Reduction Among 5-12 years Old Children |
|
Scientific Title of Study
|
Comparative Evaluation of Virtual Reality, Audio Analgesia and Aroma Therapy in Anxiety Reduction of 5-12 Years Patient: 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 |
Dr Shambhavi Kumari |
| Designation |
2nd year M.D.S. Student |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Maharishi Markandeshwar College of Dental Sciences and Research
Maharishi Markandeshwar Deemed to be University Ambala HARYANA
Ambala
HARYANA
133207
India |
| Phone |
7718057350 |
| Fax |
|
| Email |
shambhavi.100495@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Jain |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Maharishi Markandeshwar College of Dental Sciences and Research
Maharishi Markandeshwar Deemed to be University Ambala HARYANA
Ambala
HARYANA
133207
India |
| Phone |
9882600156 |
| Fax |
|
| Email |
mansijainsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shambhavi Kumari |
| Designation |
M.D.S. Student |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Maharishi Markandeshwar College of Dental Sciences and Research
Maharishi Markandeshwar Deemed to be University Ambala HARYANA
Ambala
HARYANA
133207
India |
| Phone |
7718057350 |
| Fax |
|
| Email |
shambhavi.100495@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar (Deemed to be University) Colllege of Dental Sciences and Research, Mullana,Ambala |
|
|
Primary Sponsor
|
| Name |
Dr Shambhavi Kumari |
| Address |
Maharishi Markandeshwar College of Dental Sciences and Research
Maharishi Markandeshwar Deemed to be University |
| 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 Shambhavi Kumari |
Maharishi Markandeshwar College of Dental Sciences and Research Mullana Ambala |
MMCDSR, Department of Pediatric and Preventive Dentistry Mulana Ambala Haryana
Ambala
HARYANA |
7718057350
shambhavi.100495@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee M.M. Institute of Medical Sciences and Research Mullana Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tell Show Do combined with Virtual Reality |
Child will be explained about the dental procedure and then Virtual Reality through a complete head gear consisting of virtual reality viewing box attached with headset playing cartoons for children will be showed. The device will be used throughout the dental procedure. |
| Intervention |
Tell Show Do |
Patient will be explained about the instrument that will be used for the dental treatment. |
| Intervention |
Tell Show Do combined with Aroma Therapy |
Child will be explained about the dental procedure and a scent of lavender will be diffused into the dental environment and complete dental procedure will take place in the scent. |
| Intervention |
Tell Show Do combined with Audio Analgesia |
The child will be explained about the dental procedure and a Noise cancelling headphones playing childs favorite music will be given. This will be used on the patient throughout the dental procedure. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children visiting the department to undergo routine dental treatments
Patient with no previous dental experience
Children with Frankl behavior rating 2 and 3 |
|
| ExclusionCriteria |
| Details |
Children suffering from common cold
Children suffering from any kind of respiratory allergy
Children with phobia of confined space |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Virtual reality or Audio analgesia or Aroma therapy along with Tell Show Do will be more effective in reducing dental anxiety and will help to improve the behavior of children towards the dental treatment than Tell Show Do alone |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be no difference in the effectiveness of Virtual reality or Audio analgesia or Aroma therapy & Tell Show Do in reducing dental anxiety & improving behavior of children towards dental treatment. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 |
|
Date of First Enrollment (India)
|
20/04/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
The present study will be conducted on 52 children in the out-patient department of Pediatric and Preventive dentistry (MMDU). The child between 5-12 years will be selected according to the inclusion and exclusion criteria and will be randomly divided into four groups with the help of custom-made colored board, single color indicating a group |