| CTRI Number |
CTRI/2024/09/074206 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between Reframing and Tell-Show-Do techniques for managing child behaviour for dental treatment |
|
Scientific Title of Study
|
Comparative evaluation of Reframing and Tell-Show-Do behaviour guidance technique in the management of dental anxiety among children aged 6 to 12 years undergoing dental treatment without and with administration of local anesthesia: A single blind randomized clinical 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 Vidyavathi H Patil |
| Designation |
Ph.D research Scholar |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Dept. of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campu, Nehru nagar, Belagavi. Nehru nagar Belgaum KARNATAKA 590010 India |
| Phone |
09611835828 |
| Fax |
|
| Email |
nisarga_vhp@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivayogi M Hugar |
| Designation |
Professor |
| Affiliation |
KAHERSs KLE VK Institute of Dental Sciences |
| Address |
Dept. of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campu, Nehru nagar, Belagavi.
Belgaum KARNATAKA 590010 India |
| Phone |
9986436448 |
| Fax |
|
| Email |
drhugarsm@kledental-bgm.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Vidyavathi H Patil |
| Designation |
Ph.D research Scholar |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Dept. of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campu, Nehru nagar, Belagavi. JNMC Campus
Nehru nagar Belgaum KARNATAKA 590010 India |
| Phone |
09611835828 |
| Fax |
|
| Email |
nisarga_vhp@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KAHERs KL VK Institute of Dental Sciences, JNMC Campus, Nehru nagar, Belagavi-590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Vidyavathi H Patil |
| Address |
Dept. of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campu, Nehru nagar, Belagavi. |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 VidyavathI H Patil |
KAHERs KLE VK Institute of Dental Sciences |
Room No. 6,
Department of Pediatric and Preventive Dentistry,
KAHERs KLE VK Institute of Dental Sciences,
JNMC Campus
Nehru nagar Belagavi -590010 Belgaum KARNATAKA |
9611835828
nisarga_vhp@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE KLE VKIDS |
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 |
Reframing |
Reframing technique (six steps of reframing to bring change from first order to second order by content reframing) will be used as behaviour guidance technique; that is, Identify the behavior to be changed, Establish communication to know the behavior, Separate the behavior with positive intension, Access a creative part, and generate new behaviors to accomplish the positive function, Willing to take responsibility and Ecological check.The required dental treatment will then be provided for children undergoing dental treatment without and with local anesthesia |
| Comparator Agent |
Tell Show Do |
A brief, age-appropriate description of the care to be completed will be explained to the child followed by Demonstration of the care to be completed/ equipment to be used and lastly Carrying out the care required with minimal delay for children undergoing dental treatment without and with local anesthesia |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children reporting for dental treatment for the first time.
Children between the age group of 6-12 years.
Children requiring dental procedures without and with administration of local anesthesia.
|
|
| ExclusionCriteria |
| Details |
• Patients with past dental experience.
Patients with special health care needs.
Patients who were definitely negative as per Frankel behaviour rating scale .
Patients who were not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in anxiety level |
At the beginning and end of the treatment procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| Date of Study Completion (India) |
24/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
|
Dental anxiety is defined as a nonspecific feeling of apprehension,
worry, uneasiness or dread, the source of which may be vague or unknown. It accounts to 5 to 33 percent worldwide among children. It is
the primary emotions seen in a child while entering the dental operatory. Hence it is a matter of concern both to parents and dentist as and is
challenging for effective treatment since it can potentially thwart child
from seeking dental care. Stimuli such as strange environment,
sound, sight and sensation of airotor, bright light seen in dental operatory
can easily arose dental anxiety. To render high quality and successful
treatment cooperation of the child plays an important role. Hence it is
important to mold the child’s attitude towards pediatric dentistry and dental
outcomes.
Various behavior guidance techniques are available both
pharmacological and non-pharmacological to reduce anxiety in a child.
However, many parents prefer non-pharmacological techniques as they regard
aversive and pharmacological techniques objectionable for the behavior
guidance of children in dental office. The non-pharmacological
behavior guidance techniques are the corner stone of successes in pediatric
dentistry as they help in coping skills, assist to develop appropriate
behaviour, alleviates fear and anxiety there by building trust with the
dentist and dental team.
Tell-Show-Do (TSD) is the linchpin in behavior guidance and education
for children which involves a brief, age-appropriate description of the care
to be completed (Tell), demonstration of the care to be completed or
equipment to be used (Show) and carrying out the care required with minimal
delay (Do). The orderly rational way of thinking as in TSD may
lead to differing of what is expected from child where in the solution of
telling may become a problem. However, the dentist can create a
different reality by changing the frame of the content, which in turn changes
the behavior and response of a person. This can be done through
reframing. Reframing is defined as
taking a situation outside the frame that up to that moment contained the
individual in different conditions and visualize (reframe) it in a way
acceptable to the person involved and with this reframing both the original
threat and threatened solution can be safely abandoned. Also many
fields have used reframing, like therapy, education, marketing and sales. In
medical literature reframing is commonly used both by the caregiver as well
as by the patient for coping with stressful situations. The literature search
revealed that there are no randomised clinical trials done with this
reframing technique in pediatric dentistry. Hence this study is aimed at
evaluating Reframing and Tell-Show-Do technique in the management of anxiety
among children undergoing dental treatment without and with administration of
local anesthesia.
|
|