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CTRI Number  CTRI/2022/12/048384 [Registered on: 22/12/2022] Trial Registered Prospectively
Last Modified On: 21/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Story telling and tell play do in reducing dental anxiety 
Scientific Title of Study   Impact of story telling in reducing dental anxiety among 4-8 year old children – A randomized clinical trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kakollu Harsha Veena 
Designation  Post graduate 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Dental division, Room number 7, Narayana Dental College and Hospital, Chinthareddypalem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  8185069336  
Fax    
Email  harshaveena13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SVSG NIRMALA  
Designation  PROFESSOR 
Affiliation  Narayana Dental College and Hospital 
Address  Narayana Dental College and Hospital, Chinthareddypalem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  9440206976  
Fax    
Email  nimskrishna2007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kakollu Harsha Veena 
Designation  Post graduate 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Dental division, Room number 7, Narayana Dental College and Hospital, Chinthareddypalem, Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  8185069336  
Fax    
Email  harshaveena13@gmail.com  
 
Source of Monetary or Material Support  
Narayana Dental College and Hospital 
 
Primary Sponsor  
Name  Kakollu Harsha Veena 
Address  Narayana Dental College and Hospital, Chinthareddypalem, Nellore 
Type of Sponsor  Other [self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kakollu Harsha Veena  Narayana Dental College and Hospital  Room number-7, Department of Paediatric and Preventive Dentistry, Narayana Dental College and Hospital, Nellore
Nellore
ANDHRA PRADESH 
8185069336

harshaveena13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, NDCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Story telling procedure  Story telling helps children what they can expect to see, hear, and do at the dental clinic. Also imparts knowledge which is an important factor that will make the children less anxious, increases children’s confidence, cooperation and familiarity on the treatment, thus decreasing stress and fear of dental visits. so intervention is given for 10 minutes. 
Comparator Agent  Tell play do technique  Tell-Show-Do technique was modified into tell play do, using the concept of learning by doing, in reducing childrens fear and anxiety towards dental treatment and promoting adaptive behavior. so this tell play do technique is used for 10 minutes. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Children aged between 4 -8 years.
2.Children without any past dental experience.
3.Children who will be scored 2 and 3 under Frankl behavior rating.
4.Children requiring preventive resin restorations/pit and fissure sealants/composites.
 
 
ExclusionCriteria 
Details  1.If operator uses any other behavior modification techniques.
2.Children or their parents who are unwilling to participate in the study.
3.Children with any systemic disorders or special health care needs.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of dental anxiety using physiological measure (pulse rate)  Before the intervention (baseline), after the intervention, immediately after the dental procedure on the same day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of dental anxiety using subjective measure (RMS-PS)  Before the intervention (baseline), after the intervention, immediately after the dental procedure on the same day 
 
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)   30/12/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction: 

Child dental anxiety has been a matter of concern for many years. A pediatric dentist’s role in guiding a child with dental anxiety to cooperativeness is two-fold: primarily, treating the child’s chief complaint and secondarily, to instill a positive attitude with effective management of fear and anxiety.

Every pediatric dentist has variety of techniques in managing patient such as tell-show-do, relaxation, distraction, systemic desensitization, modelling. Additionally, a number of communication-aided approaches, like applied behavioural analyses, visual pedagogies, pictorial or iconic images and audio-visual aids, have been proposed to aid behavioural changes among people.

Story telling helps children what they can expect to see, hear, and do at the dental clinic. It can also lead to establishing a sense of bond, trust and comfort, between story teller and audience. It is an important method of conveying what the dentists want to tell the children in ways they can understand. Also imparting knowledge is an important factor that will make the children less anxious, increases children’s confidence, cooperation and familiarity on the treatment, thus decreasing stress and fear of dental visits, and maintains their psychological health.

The Tell-Show-Do technique is based on the principles of learning theory. Playing with a dental imitation toy and using euphemisms instead of demonstrating on a model or observing one, provides a better explanatory concept of the dental procedure. Thus Tell-Show-Do technique was modified into the tell play do, using the concept of learning by doing, in reducing children’s fear and anxiety towards dental treatment and promoting adaptive behavior.

Aim: 

To evaluate the impact of story telling in reducing dental anxiety among 4-8 year old children.

Objectives:

1.     1) To evaluate anxiety levels in story telling and tell play do groups before and after intervention and immediately after the dental procedure using physiological (pulse rate) and subjective measures (RMS-PS).

2.      2)To compare anxiety levels in story telling and tell play do groups before and after intervention and immediately after the dental procedure using physiological (pulse rate) and subjective measures (RMS-PS).

       Methodology: 

This study will be carried out in a sample of 30 children attending the Department of Pediatric and Preventive Dentistry, Narayana Dental College and Hospital, Nellore. Healthy children between the age group of 4-8 years and meeting the inclusion criteria will be divided into two groups (15 in each) by simple random sampling. Group 1: Story telling and Group 2: Tell play do. In both the groups, physiological measures (pulse rate) by pulse-oximeter and subjective measures by RMS pictorial scale will be recorded prior to the intervention. Child will be asked to select the image from RMS pictorial scale that he/she could closely associate with that moment. Following which the child will receive the particular intervention i.e., Story telling/Tell play do. After the intervention, the physiological measures (pulse rate) by pulse-oximeter and subjective measures by RMS pictorial scale will be recorded. This will be followed with the needed treatment to the child i.e., preventive resin restorations/pit and fissure sealants/composites. Both Physiological as well as subjective measures will be noted again immediately after the completion of the treatment.

       

 
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