FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082171 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of effectiveness of distraction techniques on dental anxiety among children with hearing and speech disability 
Scientific Title of Study   Evaluation of effectiveness of distraction techniques on dental anxiety among children with hearing and speech disability: A comparative 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 Rasika Gogawale  
Designation  Post Graduate 
Affiliation  Bharati vidyapeeth dental college and hospital 
Address  Bharati Vidyapeeth (Deemed to be University), Dental College And Hospital, Sangli-Miraj Road, Wanlesswadi, Sangli
Avnish apartment wanlesswadi sangli 416416
Sangli
MAHARASHTRA
416414
India 
Phone  8975968564  
Fax    
Email  rasikagogawale20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujatha P 
Designation  Associate Professor 
Affiliation  Bharati vidyapeeth dental college and hospital 
Address  Bharati Vidyapeeth (Deemed to be University), Dental College And Hospital, Sangli-Miraj Road, Wanlesswadi, Sangli

Sangli
MAHARASHTRA
416414
India 
Phone  7259215556  
Fax    
Email  drsuji912@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rasika Gogawale  
Designation  Post Graduate 
Affiliation  Bharati vidyapeeth dental college and hospital 
Address  Bharati Vidyapeeth (Deemed to be University), Dental College And Hospital, Sangli-Miraj Road, Wanlesswadi, Sangli
avnish apartment wanlesswadi sangli 416416
Sangli
MAHARASHTRA
416414
India 
Phone  8975968564  
Fax    
Email  rasikagogawale20@gmail.com  
 
Source of Monetary or Material Support  
Bharati vidyapeeth dental college and hospital,India, Maharashtra,Sangli -416416 
 
Primary Sponsor  
Name  Dr Rasika Gogawale 
Address  Bharati Vidyapeeth (Deemed to be University), Dental College And Hospital, Sangli-Miraj Road, Wanlesswadi, Sangli 
Type of Sponsor  Other [other] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rasika Gogawale  Bharati Vidyapeeth dental college and hospital  Department Of Pediatric And Preventive Dentistry Division- 3rd year roll no -1
Sangli
MAHARASHTRA 
8975968564

rasikagogawale20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee ,Bharati vidyapeeth deemed university medical college and hospital sangli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hearing and speech disabled 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children with speech and hearing impairment.
Children requiring oral prophylaxis.
Children from 6-12 years of age. 
 
ExclusionCriteria 
Details  Children whose parents denied their participation.
Children having history of other systemic diseases.
Children with definetly negative behaviour according to Frankl’s behavior rating scale. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
reduction in anxiety levels  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in pulse rate  3 months 
 
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   N/A 
Date of First Enrollment (India)   24/03/2025 
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="0"
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  

Fear and anxiety are the primary emotions in children, which need consideration during the dental management of children, especially children with special health care needs.

Dental anxiety and the fear of pain associated with dental visit remain widespread among children.

 

Children with special health care needs are at a higher risk of poor oral health due to their inability to communicate and/or inadequate oral health education.(1) Therefore, dental treatment portrays a potential threat to the child which can induce stress, fear, and anxiety. (2)

To assist in the management of a child with anxiety, several research  have shown that distraction techniques such as television watching, use of virtual reality and audio-visual  eyeglasses, may effectively help to distract the child’s attention from anxiety-provoking stimuli, leading to a relaxing experience for the child.(3)

Various techniques have been used in literature for the assessment of dental anxiety and distraction techniques but scanty literature is available, in anxiety management of children with hearing and speech disabilities.

Fidget spinners and kaleidoscope  with the help of mirrors and reflected lights displays a variety of ever-changing shapes and colour schemes are said to reduce stress and help children focus on daily tasks.(4)

Hence, the study attempts to evaluate the effect by these two distraction techniques on dental anxiety among the children with hearing and speech disability.

 

 

  1. PURPOSE OF THE STUDY: 

·       Children with special health care needs are more prone to dental anxiety and therefore, exhibit poor oral health.

·       Dental treatment portrays a threat to the child which can induce anxiety.

·       When they, report routine management protocol will not be suitable because of various barriers.

·       However, scanty literature is available, in terms of anxiety management in children with hearing and speech disabilities.

To evaluate and compare the anxiety levels of children with hearing and speech disability undergoing dental treatment using PJSPictorial Scale and physiologic parameter such as pulse rate at two intervals that is before and after treatment 
Close