| CTRI Number |
CTRI/2024/10/075674 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study to evaluate the effective of kaleidoscope and fidget spinner as distractions while performing non invasive dental treatments |
|
Scientific Title of Study
|
Comparative evaluation of Effectiveness of Kaleidoscope and Fidget Spinner as Distraction Techniques to Reduce Anxiety While Performing Non-Invasive Dental Procedures in Children. |
| 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 Sai Vaishnavi Alahari |
| Designation |
pedodontic post graduate student |
| Affiliation |
Sri Sai College of Dental Surgery |
| Address |
Department of Pedodontics and Preventive Dentistry
Sri Sai College of Dental Surgery
1-2-64 kotherepally
oppo shivsagar lake
vikarabad 501102
TELANGANA
Hyderabad
TELANGANA
501102
India |
| Phone |
8008733770 |
| Fax |
|
| Email |
saivaishnavialahari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CH Sampath Reddy |
| Designation |
Head Of The Department |
| Affiliation |
Sri Sai College of Dental Surgery |
| Address |
Department of Pedodontics and Preventive Dentistry
Sri Sai College of Dental Surgery
1-2-64 kotherepally
oppo shivsagar lake
vikarabad 501102
TELANGANA
Hyderabad
TELANGANA
501102
India |
| Phone |
9246371730 |
| Fax |
|
| Email |
sampathcheruku@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CH Sampath Reddy |
| Designation |
Head Of The Department |
| Affiliation |
Sri Sai College of Dental Surgery |
| Address |
Department of Pedodontics and Preventive Dentistry
Sri Sai College of Dental Surgery
1-2-64 kotherepally
oppo shivsagar lake
vikarabad 501102
TELANGANA
Hyderabad
TELANGANA
501102
India |
| Phone |
9246371730 |
| Fax |
|
| Email |
sampathcheruku@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
Sri Sai college of Dental Surgey, opp.shiv sagar lake, kothrepally,Vikarabad, Telangana 501102. |
|
|
Primary Sponsor
|
| Name |
Dr Sai Vaishnavi Alahari |
| Address |
Sri Sai College Of
Dental Surgery, 1-2-64/1, Kotherepally,opp.shiv sagar lake,vikarabd,Telangana 501102. |
| 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 Sai Vaishnavi Alahari |
Sri sai college of dental surgery |
Room No 9,Department of pedodontics and preventive Dentistry,Sri sai college of dental surgery, opp shiv sagar lake, kothrepally, vikarabad,501102.
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
8008733770
saivaishnavialahari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional rewiew committee on Ethical issues of Sri Sai College of Dental Surgery,Vikarabad. |
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 |
Fidget Spinner |
Distraction with Fidget spinner during non invasive dental procedures for the entire length of treatment procedure(15-30 min) |
| Intervention |
Kaleidoscope |
Distraction with Kaleidoscope during non-invasive dental procedures for the entire length of treatment procedure (15-30 min) |
| Comparator Agent |
no distraction |
no distraction during non invasive dental procedure for the entire length of treatment procedure(15-30 min) |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 7-13 years requiring non-invasive dental procedures with informed consent.
Children with no systemic illnesses or known anxiety disorders.
|
|
| ExclusionCriteria |
| Details |
Children with cognitive or behavioral impairments.
Children undergoing invasive procedures or with acute dental pain
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of a kaleidoscope and a fidget spinner in reducing anxiety during non-invasive dental procedures |
Anxiety levels will be recorded using Venham’s picture test and pulserate, at baseline and at the end of treatment procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine if one distraction technique is superior to other in managing dental anxiety among children aged 7-13 years. |
Anxiety levels will be recorded using Venham’s picture test & pulserate, at baseline & at the end of treatment procedure |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| Date of Study Completion (India) |
09/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/12/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Distraction techniques are a key part of behavior management in pediatric dentistry, and introducing new methods like fidget spinners and kaleidoscopes could improve dental care delivery. Understanding which method is more effective will help pediatric dentists employ better anxiety management strategies and reduce the need for sedation or pharmacological interventions. Moreover, both methods are inexpensive and easy to implement, making them highly practical in clinical settings |