| CTRI Number |
CTRI/2025/03/082634 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of medical clown on down syndrome during dental procedures |
|
Scientific Title of Study
|
Effects of Clown therapy in children with Down Syndrome: 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 Sonal Mali |
| Designation |
Post graduate student |
| Affiliation |
D.Y. Patil University School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Basement, D.Y.Patil University School of Dentistry, sector 7, Nerul Navimumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
09969950552 |
| Fax |
|
| Email |
dr.sonalmali97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa S Naik |
| Designation |
Head of Department of Pediatric and Preventive Dentistry |
| Affiliation |
D.Y. Patil University School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Basement, D.Y.Patil University School of Dentistry, sector 7, Nerul Navimumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
09769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa S Naik |
| Designation |
Head of Department of Pediatric and Preventive Dentistry |
| Affiliation |
D.Y. Patil University School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Basement, D.Y.Patil University School of Dentistry, sector 7, Nerul Navimumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
09769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D Y Patil University school of dentistry, Nerul, Navimumbai - 400706, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
D Y Patil University school of dentistry Navimumbai |
| Address |
sector 7, nerul, Navimumbai, 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 Shilpa S Naik |
D.Y. Patil University School of Dentistry |
Postgraduate clinic, Department of Pediatric and preventive Dentistry, Basement, D.Y.Patil university school of dentistry, Sector 7, Nerul, Navimumbai-400706
Thane
MAHARASHTRA |
09769600440
shilpa.naik@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethical Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K036||Deposits [accretions] on teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control |
absence of a medical clown during treatment on dental anxiety of pediatric dental patients with Down Syndrome |
| Intervention |
medical clown |
presence of a medical clown during treatment on dental anxiety of pediatric dental patients with Down Syndrome. clown therapy was carried out throughout treatment of 20 minutes, as and when child wanted to interact with the medical clown during treatment |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of age 5 to 12 years diagnosed with Down Syndrome requiring oral prophylaxis, fluoride varnish application and minor restorations, parents/guardians willing to give consent for the study. |
|
| ExclusionCriteria |
| Details |
History of seizures, convulsion disorders, vertigo, visual or hearing impairments.
Severe or profound intellectual disability
Pain or swelling in the oral cavity
Patients requiring emergency treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in dental anxiety assessed using objective assessment of anxiety(pulse rate) |
during treatment and post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| subjective assessment of dental anxiety |
pre and post treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/03/2025 |
| 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="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
|
Aim: The aim of the study is to assess the effects of presence of a medical clown on the dental anxiety of children with Down’s Syndrome during dental treatment. Methodology: Children fulfilling the inclusion criteria will be randomly allocated to one of the two groups and prior to the start of the study, a written consent will be obtained from the parents or guardians after explaining them about the study procedure. For both the groups pulse rate will be recorded at baseline, during treatment, after treatment. Use of Venham’s anxiety scale by a separate operator before and after treatment will be recorded. Group A (control group) treatment will be delivered without the presence of a medical clown. Group B (intervention group) treatment will be delivered with the presence of a medical clown; with frequent interaction of the child with the medical clown during the treatment. |