| CTRI Number |
CTRI/2024/01/061878 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Tell Show Do Vs Ask Tell Ask to reduce dental fear and anxiety: A clinical trial |
|
Scientific Title of Study
|
Evaluation of the effectiveness of Ask-Tell-Ask and Tell-Show-Do in the management of dental fear and anxiety: A randomized control 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 |
Niharika Reddy |
| Designation |
Post graduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive dentistry, Division 7,Room no: 7, Narayana Dental College and Hospital, Chinthareddypalem , Nellore, Andhrapradesh.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
09398463787 |
| Fax |
|
| Email |
niharikaelicherla13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K.V.SAIKIRAN |
| Designation |
Assistant professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive dentistry, Division 7 Room no: 7, Narayana Dental College and Hospital, Chinthareddypalem , Nellore, Andhrapradesh.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8125774535 |
| Fax |
|
| Email |
saikiran4u2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sivakumar Nuvvula |
| Designation |
Professor and Head of the department |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive Dentistry, Division 7, Room no: 7, Narayana Dental College and Hospital, Chinthareddypalem , Nellore, Andhrapradesh.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441624429 |
| Fax |
|
| Email |
dentist4kids@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Niharika |
| Address |
Chintareddypalem, Narayana Dental College and Hospital |
| 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 |
| Niharika |
Narayana Dental College and Hospital |
Department of Paediatric and Preventive dentistry, Division 7, Room no:7.
Nellore
ANDHRA PRADESH |
9398463787
niharikaelicherla13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC, NDCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ask Tell Ask group |
The child was inquired to share his/ her emotions and fears regarding the dental procedure. To make children feel at ease with the dentist and the dental setting, they were free to express themselves without feeling compelled or afraid. After being addressed, the child was queried again about his views towards the treatment, and the procedure was explained using euphemisms appropriate to his cognitive level. |
| Comparator Agent |
Tell Show Do group |
The child received verbal explanations of the treatment procedure and an explanation of precisely what would be done. Following this, the child received demonstrations of the visual, auditory, and tactile aspects of the procedure, meaning that the child was demonstrated with all the equipment and materials needed for the treatment, informed about the noise produced by the airotor, and shown how the suction, three-way syringe, and airotor work. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Children without any dental antiquity
2. Children in the age range of 7-11 years.
3. Children who exhibited positive (+) or negative (-) grounded on Wright’s modification of the Frankl behaviour rating scale [13].
4. Children who agreed to take part in the study
5. Obtained informed written consent from their parents
|
|
| ExclusionCriteria |
| Details |
1. Children presenting with any of the systemic or mental disorders.
2. Children who illustrated positive (++) or negative (- -) based on Wright’s modification of the Frankl behaviour rating scale [13].
3. Children unable to cope up with the treatment procedures.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Reduction of dental fear and anxiety |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
31/01/2024 |
| 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="2"
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
|
Background: The objective of behaviour guidance is to establish effective communication that aligns with the child’s requirements in order to manage their disruptive behavior. Objective: The objective of this study was to evalute the effectiveness of the tell show do and ask tell ask techniques in managing anxiety among children during their initial dentist appointment. Methods: The study comprised fifty children (28 boy child and 22 girl child) between the ages of 7 to 11 years, in their first dental visit without any prior experience. The children were randomly categorized into two groups: Group 1: Tell Show Do; Group 2: Ask-Tell-Ask. Later, all the children underwent non-invasive treatment procedures like restorations, sealants, and oral prophylaxis. Further, behaviour management techniques were employed based on the allocated group. Finally, anxiety levels for all the children were assessed using the RMS pictorial scale and a heart rate at three different intervals (before, during, and after). The obtained data were entered in Microsoft Excel, and statistical analysis was executed by employing the SPSS software.
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