| CTRI Number |
CTRI/2024/06/068296 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate and compare three behaviour modification techniques for children of 4-9years of age for dental treatments that requires local anesthesia application |
|
Scientific Title of Study
|
Comparative evaluation of the effectiveness of three different
non-pharmacological behaviour guidance techniques during dental procedures
requiring local anaesthesia in 4–9-year-old children : 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 |
Maneesha Babu |
| Designation |
Principal Investigator |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry
C block Ground floor
All India Institute of Medical Sciences
Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
08129528557 |
| Fax |
|
| Email |
drmaneesha242@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Virat Galhotra |
| Designation |
Head of the Department |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of dentistry,C-block,Ground floor, AIIMS Raipur. Chhattisgarh
Raipur CHHATTISGARH 492099 India |
| Phone |
9216274600 |
| Fax |
|
| Email |
drviratgalhotra@aiimsraipur.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Virat Galhotra |
| Designation |
Head of the Department |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry,C-Block,Ground floor, AIIMS Raipur. Chhattisgarh
Raipur CHHATTISGARH 492099 India |
| Phone |
9216274600 |
| Fax |
|
| Email |
drviratgalhotra@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Tatibandh , Raipur, Chhattisgarh , India
pincode 492099 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical SciencesRaipur |
| Address |
All India Institute of Medical Sciences, G E Road, Tatibandh Raipur Chhattisgarh India
pincode 492099 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Maneesha Babu |
All India Institute of Medical Sciences,Raipur |
Department of Dentistry,C-Block,Ground floor, Gate no 4, AIIMS RAIPUR, G E Road,Tatibandh
492099 Raipur CHHATTISGARH |
8129528557
drmaneesha242@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparison of Non-pharmacological behaviour management techniques |
The behaviour management techniques namely Tell-show-do, Tell-show-play-doh with teach back and filmed modelling will be applied on children before the dental treatment and compared based on reduction in anxiety and improvement in co-operativeness that will be assessed using changes in heart rate sp02 and scales such as facial image scale and frankels behaviour rating scale.
duration of intervention : 18months |
| Comparator Agent |
comparison of Non-pharmacological behaviour management techniques |
the techniques tell show do, tell play doh with teach back and filmed modelling will be compared with each other |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children between age group of 4 to 9 years
Children with Frankl’s behavior rating score of 2 or 3
Children coming for first dental visit / 6 months elapsed between current and previous dental visit.
Children with a treatment need that requires the administration of local anesthesia
Children whose parent/legal guardian give consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Children with Frankl’s behavior rating score of 1 or 4
Children below 4 years of age and above 9 years of age
Children with systemic,neurological,coagulopathy, psychiatric or behavioral conditions, which precludes the ability to display suitable behavior
Children coming for treatment modalities not requiring local anesthesia.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in anxiety accessed using change in heart rate and sp02 |
baseline-pretreatment
during treatment
post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in cooperativess of child assessed using frankels behaviour rating scale |
baseline-pretreatment
during treatment
post treatment |
|
|
Target Sample Size
|
Total Sample Size="126" Sample Size from India="126"
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)
|
17/06/2024 |
| 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="1" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmaneesha242@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 04-01-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The phenomena of dental fear and anxiety in children is a pervasive and often underestimated issue that has significant implications for both the oral health of young individuals and their overall well-being. Children may experience various levels of apprehension due to dental treatment, which may be mild and temporary, or severe and protracted, and may develop even before the scheduled visit. The amount of information that is perceived by a child depends on the cognitive development of the child. The "Tell-Show-Do (TSD)" communication model, is regarded as the foundation of behavior control strategies. Its goal is to reduce the child’s fear by acquainting them with the dental environment. A modified version of this technique is tell-show-play doh, which makes use of the principle of learning by doing. Learning through observation is known as modeling, and it can occur when children mimic a model’s actions in a similar circumstance. Modelling can be live modelling or filmed modelling. Research has shown that modeling can help children learn better coping mechanisms for stressful medical situations and can be a therapeutic tool for managing anxiety. Teach back is a verbal communication strategy, is an efficient way to reinforce or provide health education to both adults and children. Combining Tell-Show-Play-Doh and teach back techniques is expected to provide the child a clear understanding of what he/she is going to be experience, and can help prepare the child for the treatment by alleviating the associated anxiety. JUSTIFICATION OF THE STUDY Only limited studies are available comparing Tell-show-Play-Doh and Filmed modelling. Also, no such studies have been done combining teach back technique with Tell-Show-Play-Doh. Moreover, most of the studies have been done during preventive treatment procedure. Hence this study will be undertaken during procedures which require local anesthesia administration, for assessment of the reduction in anxiety and improvement in cooperativeness of behavior after applying the behavior modification technique |