| CTRI Number |
CTRI/2026/01/102217 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of simulated breathing musical soft toy in reducing dental anxiety during restorative procedures in 4-8-year-old children |
|
Scientific Title of Study
|
Effectiveness of simulated breathing musical soft toy in alleviating dental anxiety during restorative procedures in 4-8-year old children: a randomized clinical 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 |
Department of Pediatric and Preventive Dentistry. 301, 3rd floor.
Ranjeet Deshmukh Dental College and Research Center
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9284512730 |
| Fax |
|
| Email |
mohinipawshekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Purva Chaudhari |
| Designation |
Reader |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Center |
| Address |
Department of Pediatric and Preventive Dentistry. 301, 3rd floor.
Ranjeet Deshmukh Dental College and Research Center
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8600604334 |
| Fax |
|
| Email |
PurvaChowdhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Purva Chaudhari |
| Designation |
Reader |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Center |
| Address |
Ranjeet Deshmukh Dental College and Research Center
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8600604334 |
| 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, 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 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: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group
|
Children in the control group will receive conventional behavior management during restorative dental procedures. Standard non-pharmacological behavior guidance approaches, such as tell-show-do and verbal reassurance, will be used as part of standard pediatric dental practice. No additional distractions or anxiety-reducing aids will be included during the treatment. |
| Intervention |
Simulated breathing musical soft toy group |
A simulated breathing musical soft toy is an innovative approach. It combines a variety of sensory inputs, including tactile comfort from its silky fur and slow breathing motions, auditory relaxation from continuous peaceful music, and visual engagement from its brightly illuminated tummy. The device functions for 15 minutes.
Additionally, gentle tactile interaction may activate neuroendocrine mechanisms that promote oxytocin release, contributing to reduced stress and improved emotional comfort |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
The study includes healthy children aged 4–8 years who had no prior dental experience, presented with ICDAS scores of 1, 2, or 3, and exhibited Frankl’s behavior rating of 2 and 3.
|
|
| ExclusionCriteria |
| Details |
1. Children with known anxiety disorders
2. Medically compromised
3. 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 the effectiveness of a simulated breathing musical soft toy in reducing anxiety during dental restorative procedures in children aged 4–8 years.
|
2nd visit
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the acceptance of a simulated-breathing musical soft toy in children aged 4 to 8 years. |
2nd visit after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
26/02/2026 |
| 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="3"
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 clinical trial is aimed at assessing the efficacy of a simulated breathing musical soft toy in reducing dental anxiety in children aged 4 to 8 years during restorative dental procedures. Participants will be randomly assigned to either an intervention group, in which the child uses a simulated-breathing musical soft toy during treatment, and a control group, in which the child receives only standard behavior management. Dental anxiety will be measured with validated behavioral measures and physiological markers such as heart rate. The study aims to examine if this convenient, non-pharmacological distraction strategy will increase cooperation and reduce anxiety in dental patients. |