| 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
|
|
|
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
|
|
|
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.
- 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 |