| CTRI Number |
CTRI/2025/12/099407 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of distraction cards in reducing anxiety and pain in children during restorative treatment |
|
Scientific Title of Study
|
Effectiveness of distraction cards in reducing anxiety and pain perception during restorative treatment in 6-8-year-old children—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 |
Mohini Anil Pawshekar |
| Designation |
Post graduate student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Center |
| Address |
Ranjeet Deshmukh Dental College and Research Center
NAGPUR
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9284512730 |
| Fax |
|
| Email |
mohinipawshekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Purva Chaudhari |
| Designation |
Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Center |
| Address |
Ranjeet Deshmukh Dental College and Research Center, Digdoh hills
NAGPUR
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8600604340 |
| Fax |
|
| Email |
PurvaChowdhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Purva Chaudhari |
| Designation |
Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Center |
| Address |
Ranjeet Deshmukh Dental College and Research Center, Digdoh hills
NAGPUR
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8600604340 |
| Fax |
|
| Email |
PurvaChowdhari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Center Hingna road, Digdoh hills,Police nagar, Nagpur, Maharashtra, India Pin code: 440019 |
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College and Research Center |
| Address |
Ranjeet Deshmukh Dental College and Research Center Hingna road, Digdoh hills,Police nagar, Nagpur, Maharashtra, India Pin code: 440019 |
| 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 Mohini Anil Pawshekar |
Ranjeet Deshmukh Dental College and Research Centre |
Department of Pediatric
and Preventive
Dentistry
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9284512730
mohinipawshekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RDDCRCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DISTRACTION CARDS |
Children in the intervention group will be given both traditional behavior management strategies and distraction cards. Investigator 1 will give the child with four sets of distraction cards before the procedure, each featuring a new cartoon character and story-based artwork with questions printed on the other side. During the restorative procedure, investigator 2 will ask the child questions about the visuals on the cards. |
| Comparator Agent |
TRADITIONAL BEHAVIOUR MANAGEMENT TECHNIQUES |
Children in the comparator group will receive traditional behavior management strategies commonly employed during pediatric dental procedures. These include Tell-Show-Do (TSD), positive reinforcement, voice control, and distraction through verbal engagement or audiovisual aids. These techniques aim to establish rapport, reduce anticipatory anxiety, and promote cooperative behavior without the use of specialized distraction tools like cards. No pharmacological or advanced psychological interventions will be used in this group.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children with ICDAS scores of 3 to 5 who exhibited Frankel’s behavior ratings of 3 or 4 during dental procedures were included |
|
| ExclusionCriteria |
| Details |
Children with severe caries potentially involving the pulp, who are medically compromised and have a relevant past dental history.
|
|
|
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 |
To evaluate change in anxiety and pain perception while using distraction cards as
compared to traditional behavior management techniques for 6-8-year-old children during their restorative treatment. |
Baseline (pre-intervention): Day 0, before procedure
Immediate post-intervention: Day 0, within 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/12/2025 |
| 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="1"
Months="6"
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
|
This randomized controlled trial will determine whether distraction cards will reduce anxiety and pain perception in 6- to 8-year-old children during restorative dental treatment. Children will be randomly randomized to either distraction cards (presented before and during the procedure) or usual care, and investigators will measure their behavioral and self-reported responses during treatment. It is expected that the distraction-card group will have lower anxiety and discomfort levels than the controls. The study anticipate that distraction cards are a simple, low-cost, and effective behavioral tool for lowering distress during pediatric restorative procedures. |