| CTRI Number |
CTRI/2024/01/061464 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of effectiveness of virtual reality and clown dentist as anxiety management tools among 3-13-year old children for dental procedures-A randomised control trial |
|
Scientific Title of Study
|
Comparison of effectiveness of virtual reality and clown dentist as anxiety management tools among 3-13-year old children for dental procedures. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sfurty Prakash |
| Designation |
MDS resident |
| Affiliation |
Pt. B.D. Sharma university of dental sciences and research |
| Address |
Room no.-6, Department of Pedodontics,
Sudha Rustagi dental college, Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9717906088 |
| Fax |
|
| Email |
fundamentallyfunny@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Sheoran |
| Designation |
Professor |
| Affiliation |
Pt. B.D. Sharma university of dental sciences and research |
| Address |
Room no.-6, Department of Pedodontics,
Sudha Rustagi dental college, Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9717906088 |
| Fax |
|
| Email |
sheoran.neha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sfurty Prakash |
| Designation |
MDS resident |
| Affiliation |
Pt. B. D. Sharma university dental sciences and research |
| Address |
Room no.-6, Department of Pedodontics,
Sudha Rustagi dental college, Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9717906088 |
| Fax |
|
| Email |
fundamentallyfunny@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sudha Rustagi College of Dental Sciences and Research, Faridabad ,Haryana-121002 |
|
|
Primary Sponsor
|
| Name |
Sfurty Prakash |
| Address |
Room no-6, Department of pediatric and preventive dentistry, Sudha Rustagi college of Dental Sciences and Research, Faridabad, Haryana-121002 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sfurty Prakash |
Room no-6, Department of Pediatric and Preventive Dentistry, Sudha Rustagi College of dental sciences and research, Faridabad, Haryana-121002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sfurty Prakash |
Sudha Rustagi College of Dental Sciences and Research |
Room no.-6, Department of Pediatric and preventive dentistry, Sudha Rustagi college of dental sciences and research, Faridabad
Faridabad
HARYANA |
9717906088
fundamentallyfunny@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRCDSR INSTITUTIONAL ETHICAL COMMITTEE |
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 |
| Intervention |
Clown Dentist |
Dental anxiety is best combated with the use of distraction aids, which in this case happens to be Clown Dentist,which makes the treatment experience pleasant for the child.The recordings will be taken before the procedure and after the procedure. In the case of intervention after introduction of the anxiety management tool during the dental treatment. |
| Comparator Agent |
None |
To compare the effectiveness of distraction aids (Visual Reality Device and Clown Dentist).One group was not given any intervention and thus was used as control.The recordings will be taken before the procedure and after the procedure |
| Intervention |
Visual Reality Device |
Dental anxiety is best combated with the use of distraction aids, which in this case happens to be Visual Reality Device ,which makes the treatment experience pleasant.The recordings will be taken before the procedure and after the procedure. In the case of intervention after introduction of the anxiety management tool during the dental treatment. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Children with the chronological age of 3-13-year-old.
2. Children for whom parent consent was given
|
|
| ExclusionCriteria |
| Details |
1. Any chronic illness, severe malnutrition, endocrinal problems, physical and mental defects, those with apparent obesity induced or associated syndrome.
2. Children for whom parental consent was not given. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the effectiveness of clown dentist as an anxiety management tool for dental procedures in children between age group 3-13 years.
2. To study the effectiveness of virtual reality as an anxiety management tool for dental procedures in children between age group 3-13 years.
3. To evaluate and compare the pre and post - hemodynamic changes using a pulse oximeter for measuring anxiety.
4. To compare between VR and clown dentist as anxiety management tools for dental procedures in children.
5. To compare the level of acceptance between VR and clown dentist among parents.
|
At the visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the level of acceptance between VR & clown dentist among parents. |
At a consecutive dental appointment. |
|
|
Target Sample Size
|
Total Sample Size="159"
Sample Size from India="159"
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 1 |
|
Date of First Enrollment (India)
|
30/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/01/2024 |
| 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 Applicable |
| 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
|
From the dawn of emergence of Pediatric Dentistry as a branch of Dentistry, a common problem which is encountered from newcomers to stalwarts alike is ‘Management of Dental Fear, Anxiety and Phobia’.This leads to circumvention of dental treatment. The estimated prevalence of dental anxiety among 5 to 10 year old children in the Indian population is 6.3%.So to combat this,various techniques dealing with the behavioral, cognitive, emotional and physiological elements of fear and anxiety have been developed.Distraction techniques attract a patient’s attention away from the noxious stimuli helping to reduce anxiety and may be active or passive. Studies suggest that distraction is a low-cost strategy that may have a positive impact on fear and anxiety. THE AIM OF THIS TRAIL IS TO ASSESS THE EFFECTIVENESS & COMPARISON OF VIRTUAL REALITY AND CLOWN DENTIST AS ANXIETY MANAGEMENT TOOL IN CHILDREN FOR DENTAL PROCEDURES. Pediatric dentistry which along with treating the patient also focuses on ‘instilling a positive attitude’,as childhood experiences largely contribute in the shaping of an individual. |