| 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
|
|
|
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
|
|
|
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. |