| CTRI Number |
CTRI/2025/08/092402 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Behavior Techniques to Reduce Dental Anxiety in Children During Dental Treatment |
|
Scientific Title of Study
|
Comparative evaluation of the effectiveness of Tell-Show-Ask-Show-Do technique vs Tell-Show- Do Technique in the Management of Dental anxiety in Pediatric dental Patients -A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 07072501-01-15-07-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monisha Baskaran |
| Designation |
Undergraduate |
| Affiliation |
Tagore dental college and hospital |
| Address |
Tagore dental college and hospital
Department of pediatric and preventive dentistry
Rathinamangalam melakottaiyur post chennai 600127
Chennai TAMIL NADU 600127 India |
| Phone |
9791140129 |
| Fax |
|
| Email |
monishabaskaran01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vijayakumar M |
| Designation |
Reader department of pediatric and preventive dentistry |
| Affiliation |
Tagore dental college and hospital |
| Address |
Tagore dental college and hospital
Department of pediatric and preventive dentistry
Rathinamangalam melakottaiyur post chennai 600127
Chennai TAMIL NADU 600127 India |
| Phone |
9884411172 |
| Fax |
|
| Email |
drvijaypedo6@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vijayakumar M |
| Designation |
Reader department of pediatric and preventive dentistry |
| Affiliation |
Tagore dental college and hospital |
| Address |
Tagore dental college and hospital
Department of pediatric and preventive dentistry
Rathinamangalam melakottaiyur post chennai 600127
Chennai TAMIL NADU 600127 India |
| Phone |
9884411172 |
| Fax |
|
| Email |
drvijaypedo6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tagore dental college and hospital
Department of pediatric and preventive dentistry
Rathinamangalam melakottaiyur post chennai 600127 Tamil Nadu India
|
|
|
Primary Sponsor
|
| Name |
Monisha Baskaran |
| Address |
Tagore dental college and hospital
Department of pediatric and preventive dentistry
Rathinamangalam melakottaiyur post chennai 600127
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR VIJAYAKUMAR M |
TAGORE DENTAL COLLEGE AND HOSPITAL
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
RATHINAMANGALAM MELAKOTTAIYUR POST CHENNAI 600127 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Monisha Baskaran |
Tagore dental college and hospital |
Tagore dental college and hospital
Department of pediatric and preventive dentistry
Rathinamangalam melakottaiyur post chennai 600127
Chennai TAMIL NADU |
9791140129
monishabaskaran01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Tagore dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ORAL CAVITY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tell-Show- Do Technique |
The Tell-Show-Do (TSD) technique, introduced by Addelston in 1959, is a conventional
behaviour management method. It emphasizes ensuring children are well-informed and
verbally guided through procedures (Tell), followed by demonstration through visual, tactile,
and auditory means in a non-threatening way (Show), and finally, performing the procedure
without deviating from the explanation (Do).It is a single session administered prior to treatment lasting for 15-20 minutes |
| Intervention |
Tell-Show-Ask-Show-Do technique |
The Tell-Show-Ask-Show-Do technique includes a verbal explanation of the procedures
using simple, non-threatening language to help children understand the process (Tell). The
dentist demonstrates the procedures on a dental model to familiarize children with the
procedures (Show), followed by asking to reproduce or repeat the explanation provided by the
dentist (Ask). This engages the child, assesses their understanding, encourages participation,
and reinforces learning by making them to perform the procedure on the dental model (Show).
This will improve the cognitive and neuro motor skill development which is associated with
the dental procedure. This improves the child’s behavioural response to treatment. Finally, the
procedure is carried out by the dentist without deviating from the what been explained (Do).It is a single session administered prior to treatment lasting for 15-20 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of 6 - 10 years of age.
2. Children without any past dental experience.
3. Healthy children who are free of systemic disease.
4. Children are willing to participate in the study.
5. Children who have positive or negative behavior based on Frankl behavior rating scale.
6. Children requiring class 1 restorative procedures |
|
| ExclusionCriteria |
| Details |
1. Children presenting with any of the systemic or mental disorders.
2. Children or parents who refused to participate in the study.
3. Children were definitely positive or definitely negative based on Frankl behavior rating
scale.
4. Children requiring invasive procedures such as local anesthesia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Physiological Response-Changes in heart rate will be recorded using a heart rate monitor
2.Subjective Anxiety Level-Changes in the RMS-PS scale. |
1.Heart rate recorded baseline, intra operative and immediately post treatment
2.RMS PS SCALE assessed baseline and immediately post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Behavior & cooperation |
Baseline, intra operative & immediately post operative |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/09/2025 |
| Date of Study Completion (India) |
27/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Dental anxiety and fear are the most common challenges faced by dentists in paediatric patients during dental procedures. These are major obstacles that interfere with providing effective dental care to children. Dental anxiety can influence a child’s behaviour. Behaviour management plays a vital role in providing an effective and efficient dental care and to instil a positive dental attitude to the child. The Tell-Show-Do (TSD) technique is a conventional behaviour management method. It emphasizes ensuring children are well-informed and verbally guided through procedures (Tell), followed by demonstration through visual, tactile, and auditory means in a non-threatening way (Show), and finally, performing the procedure without deviating from the explanation (Do). Tell-Show-Ask-Show-Do (TSASD) technique it is new form of behaviour shaping that actively involves the child in the learning process under the concept of learning by doing. The Tell-Show-Ask-Show-Do technique includes a verbal explanation of the procedures using simple, non-threatening language to help children understand the process (Tell). The dentist demonstrates the procedures on a dental model to familiarize children with the procedures (Show), followed by asking to reproduce or repeat the explanation provided by the dentist (Ask). This engages the child, assesses their understanding, encourages participation, and reinforces learning by making them to perform the procedure on the dental model (Show). This will improve the cognitive and neuro motor skill development which is associated with the dental procedure. This improves the child’s behavioural response to treatment. Finally, the procedure is carried out by the dentist without deviating from the what been explained (Do). Therefore, this study aims to assess the effectiveness of the tell-show-ask-show-do technique compared to the tell-show-do technique in managing dental anxiety in pediatric dental patients. OUTCOME MEASURES: Physiological Response: Changes in heart rate will be recorded before, during, and after the dental procedure using a heart rate monitor Subjective Anxiety Level: Changes in the RMS-PS scale (pre- and post-treatment). |