| CTRI Number |
CTRI/2025/06/088565 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bright Lights and Talking Toys: Easing Anxiety and Pain for Preschoolers during dental procedures
|
|
Scientific Title of Study
|
EVALUATION OF PATIENT ACCEPTANCE, REDUCTION IN ANXIETY, AND PAIN PERCEPTION BY ACTIVE DISTRACTION TECHNIQUE USING THUMB LIGHT AND TALKING BACK TOY IN 3-5 YEAR-OLD CHILDREN
|
| Trial Acronym |
Randomized clinical trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
annie elizabeth abraham |
| Designation |
postgraduate student |
| Affiliation |
Kvg dental college and hospital |
| Address |
KVG Dental College and Hospital, Sullia, department of pediatric and preventive dentistry
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
08156989662 |
| Fax |
|
| Email |
anniesafe29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
krishnamoorthy S H |
| Designation |
professor |
| Affiliation |
Kvg dental college and hospital |
| Address |
KVG Dental College and Hospital, Sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9964428004 |
| Fax |
|
| Email |
kmoorthysh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
annie elizabeth abraham |
| Designation |
postgraduate student |
| Affiliation |
Kvg dental college and hospital |
| Address |
kvg dental college and hospital, sullia D K
department of pediatric and preventive dentistry
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
08156989662 |
| Fax |
|
| Email |
anniesafe29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
annie elizabeth abraham |
| Address |
kvg dental colleeg and hospital |
| Type of Sponsor |
Research institution |
|
|
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 |
| annie elizabeth abraham |
kvg dental hospital |
room no. 10, department of pediatric and preventive dentistry, 3rd floor
Dakshina Kannada
KARNATAKA |
08156989662
anniesafe29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics commitee kvg dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
moderately to highly anxious children |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
active distraction using talking back cactus and thumb light |
active distraction using talking back cactus and thumb light to reduce childs dental fear and anxiety during the dental procedure |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 3 to 5 years.
2. Children who must undergo dental procedures where the child is administered local anesthesia for the first time.
3. Children with facial anxiety scale score between moderately anxious to highly anxious.
4.Consent from the parent or guardian.
|
|
| ExclusionCriteria |
| Details |
• Children with special health care needs.
• Children with physical and mental disability
• Children who require emergency treatment
• Children who are allergic to local anesthesia.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to reduce anxiety and fear |
baseline and during intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction of abnormal pulse rate |
baseline ad during intervention |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
19/06/2025 |
| 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="2"
Months="0"
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
|
active distraction using talking back cactus and thumb light technique is used to reduce anxiety and fear in children in the age group of 3-5years which is based on jean piagets theory of cognitive devolopment |