| CTRI Number |
CTRI/2026/01/101967 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reducing Dental Anxiety in Hearing-Impaired Children Using Four Distraction Techniques |
|
Scientific Title of Study
|
Effectiveness of Four Different Distraction Techniques in Management of Anxiety during Preventive Dental Treatment in Hearing Impaired Pediatric Dental Patients of age 4 -14 years of age - A Randomized Clinical Study |
| 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 Anshula K Deshpande |
| Designation |
Professor |
| Affiliation |
K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University |
| Address |
Room number 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Vadodara, Gujarat 391760
India
Vadodara
GUJARAT
390019
India |
| Phone |
07600916400 |
| Fax |
|
| Email |
dranshula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshula K Deshpande |
| Designation |
Professor |
| Affiliation |
K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University |
| Address |
Room number 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Vadodara, Gujarat 391760
India
Vadodara
GUJARAT
390019
India |
| Phone |
07600916400 |
| Fax |
|
| Email |
dranshula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshula K Deshpande |
| Designation |
Professor |
| Affiliation |
K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University |
| Address |
Room number 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Vadodara, Gujarat 391760
India
Vadodara
GUJARAT
390019
India |
| Phone |
07600916400 |
| Fax |
|
| Email |
dranshula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Pediatric Dentistry, K M Shah Dental College and Hospital, Sumandeep vidyapeeth deemed to be university, Piparia, waghodia road, vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Anshula Deshpande |
| Address |
Room number 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Vadodara, Gujarat 391760
India
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sumandeep vidyapeeth |
Sumandeep Vidyapeeth An Institution Deemed to be University At & Po. Piparia, Ta. Waghodia, Dist. Vadodara - 391760, Gujarat, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anshula Deshpande |
Akshar Hearing Impaired School |
Akshar Hearing Impaired School, Sherki Sindhrot , Vadodara
Vadodara
GUJARAT |
07600916400
dranshula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Akshar Trust |
Not Applicable |
| SVIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H749||Unspecified disorder of middle earand mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fidget spinner (Distractor) |
Children will actively participate in fidget spinner play throughout the procedure when topical fluoride application will be done. |
| Intervention |
Picture Exchange Cards (aromatic paper) |
Children will be given cards explaining the procedure of treatment and simultaneously treatment will be done. PEC will be carried out throughout the procedure when topical fluoride application will be done. |
| Intervention |
teddy bear (off mode) |
Children will actively participate Sensory-based distraction methods, which engages enhanced senses like touch, sight, and will keep teddy bear (off mode) on chest throughout the procedure when topical fluoride application will be done. |
| Intervention |
teddy bear (on mode) |
Children will actively participate Sensory-based distraction methods, which engages enhanced senses like touch, sight, and will keep teddy bear (on mode) on chest throughout the procedure when topical fluoride application will be done. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with high caries risk
2. Children with defs, deft, DMFT and DMFS score 3 or more
3. Children who will be willing to participate in the study
4. No previous dental experience and who were aware of their surroundings
5. Children with partial or complete hearing loss
6. Children with cochlear or hearing devices will be included in study.
7. Children whose parents will give informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Children allergic to fluoride agents used in the trial.
2. Children mentally challenged or disabled, and children with any type of dentofacial abnormality or syndrome were excluded from the study.
3. Children allergic to soft toys will be excluded to study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Result of present study will provide dental professionals, the better evidence for the choice of distraction in special children. The result and interpretation could be a valuable addition to the already available distraction technique |
baseline, 30 minutes, 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| acceptance of fluoride gel |
baseline, 30 minutes, 1 hour |
|
|
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)
|
05/02/2026 |
| 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) |
Open to Recruitment |
|
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 study aims to evaluate and compare the effectiveness of four different distraction techniques in managing dental anxiety among hearing-impaired pediatric patients aged 4–14 years undergoing preventive dental treatment. Sixty eligible children will be randomly allocated into four groups: breathing-stimulated teddy bear (on mode), breathing-stimulated teddy bear (off mode), fidget spinner, and Picture Exchange Communication System (PECS). All participants will receive routine behavior guidance and topical fluoride application. Anxiety levels will be assessed using physiological parameters (pulse rate and oxygen saturation) and a psychological parameter (Venham’s Picture Scale) recorded before and after the procedure. The study seeks to identify a safe, non-pharmacological, and effective distraction technique to improve cooperation and reduce anxiety in hearing-impaired children during dental care. |