| CTRI Number |
CTRI/2026/01/101851 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Intervention of Audio aid and braille oral hygiene instructions in reducing dental anxiety among visually impaired children. |
|
Scientific Title of Study
|
Audio-Tactile Assistance in Reducing Dental Anxiety among Visually Impaired 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 |
Dr Sahana S |
| Designation |
Post graduate |
| Affiliation |
AME S dental college and hospital, bijangera, raichur, karnataka |
| Address |
Department of pedodontics and preventive dentistry, AME S dental college and hospital, bijangera, raichur, karnataka
Raichur
KARNATAKA
584103
India |
| Phone |
9663902139 |
| Fax |
|
| Email |
sahanasridhar14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Havale |
| Designation |
Professor and Head of department |
| Affiliation |
AME S dental college and hospital, bijangera, raichur, karnataka |
| Address |
Department of pedodontics and preventive dentistry, AMES Dental college and Hospital, Bijangera, Raichur, Karnataka
Raichur
KARNATAKA
584103
India |
| Phone |
944840730 |
| Fax |
|
| Email |
raghavendrahavale@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DRSHRUTHA S P |
| Designation |
PROFESSOR |
| Affiliation |
AME S Dental college and hospital, bijangera, raichur, karnataka |
| Address |
Department of pedodontics and preventive dentistry, AME S dental college and hospital, Bijangera, Raichur, Karnataka
Raichur
KARNATAKA
584103
India |
| Phone |
09483329406 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMES Dental college and hospital bijingera road, Raichur Karnataka 584103 |
|
|
Primary Sponsor
|
| Name |
Dr Sahana S |
| Address |
AME S Dental college and hospital, bijangera, Raichur-584103, Karnataka,India. |
| 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 Sahana S |
AME S dental college and hospital, bijangera, raichur, karnataka |
Department of pedodontics and preventive dentistry, AME S dental college and hospital, bijangera, raichur, karnataka
Raichur
KARNATAKA |
09663902139
sahanasridhar14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of AME s Dental college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z40-Z53||Encounters for other specific health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oral hygiene instructions using White noise along with Audio Aid |
Visually impaired children were provided oral hygiene instructions using White noise along with Audio Aid for 5 mins |
| Comparator Agent |
Regional BRAILLE ORAL HYGIENE INSTRUCTIONS |
Visually impaired children were provided with oral hygiene instructions in regional Braille Script for 5 mins
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Visually impaired children of 7 to 12 years with ability to read in Braille,Need of oral prophylaxis with subgingival calculus,Children anxious to dental treatment
|
|
| ExclusionCriteria |
| Details |
Cognitive impairments & communication affecting comprehension,Severe anxiety or mental health disorders unrelated to needle anxiety,Significant medical conditions posing risks to safe participation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the impact of White noise along with Audio-aid in reducing dental anxiety in Visually Impaired Children.
|
5 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of Audio-Tactile-Braille oral hygiene educational method in Visually Impaired Children |
5 mins |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 2/ Phase 3 |
|
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="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 evaluated the effectiveness of audio-based and Braille-based oral hygiene education in reducing dental anxiety among visually impaired children aged 7–12 years. Anxiety was assessed using the Modified Dental Anxiety Scale and pulse rate measurements. Children who received white noise along with audio-aided oral hygiene instructions showed a significantly greater reduction in anxiety compared to those who received regional braille-based oral hygiene instructions. The study concludes that white noise along with audio aided oral hygiene instructions are more effective than regional braille scripts-based oral hygiene instructions in reducing intraoperative dental anxiety in visually impaired children. |