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CTRI Number  CTRI/2023/04/051874 [Registered on: 21/04/2023] Trial Registered Prospectively
Last Modified On: 02/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Behaviour management of children with high dental fear. 
Scientific Title of Study   EVALUATION AND COMPARISON OF THE EFFECTIVENESS OF TELL SHOW DO, TELL SHOW PLAY DO AND SMART PHONE GAME APP IN BEHAVIOUR MANAGEMENT OF 4–7-YEAR-OLD CHILDREN WITH HIGH DENTAL FEAR AND ANXIETY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha Madhu Nair 
Designation  Post Graduate Student 
Affiliation  Dr. D. Y Patil Dental College and Hospital, Pimpri Pune 
Address  Department of Pediatric and preventive dentistry, Dr. D. Y. Patil Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune – 411018

Pune
MAHARASHTRA
411018
India 
Phone  8390749779  
Fax    
Email  snehanair7997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Aditi Mathur 
Designation  Professor 
Affiliation  Dr. D. Y. Patil Dental College & Hospital Pimpri Pune 
Address  Department of Pediatric and preventive dentistry, Dr. D. Y. Patil Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune – 411018

Pune
MAHARASHTRA
411018
India 
Phone  8376055529  
Fax    
Email  aditi.mathur@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Aditi Mathur 
Designation  Professor 
Affiliation  Dr. D. Y. Patil Dental College & Hospital Pimpri Pune 
Address  Department of Pediatric and preventive dentistry, Dr. D. Y. Patil Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune – 411018

Pune
MAHARASHTRA
411018
India 
Phone  8376055529  
Fax    
Email  aditi.mathur@dpu.edu.in  
 
Source of Monetary or Material Support  
Department of Pediatric and preventive dentistry, Dr. D. Y. Patil Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune – 411018 
 
Primary Sponsor  
Name  Sneha Madhu Nair 
Address  Flat number 1, Guru Kripa Park Kamgarnagar, Opposite Mahindra Composites, Pimpri Pune 411018. 
Type of Sponsor  Research institution and hospital 
 
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 
Aditi Mathur  Dr. D. Y. Patil Dental College and Hospital, Pimpri Pune  Department number 8, second floor, Department of Pediatric and preventive dentistry
Pune
MAHARASHTRA 
8376055529

aditi.mathur@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. D. Y. Patil Dental College and Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  To evaluate and compare the effectiveness of Tell Show Do, Tell Show Play Do and Smart phone game app for managing 4–7-year-old children with high dental fear and anxiety.  1. To evaluate the effectiveness of Tell-Show-Do technique in managing 4–7-year-old children with high dental fear and anxiety. 2. To evaluate the effectiveness of Tell-Show-Play-do technique in managing 4–7-year-old children with high dental fear and anxiety. 3. To evaluate the effectiveness of Smartphone dental game app technique in managing 4–7-year-old children with high dental fear and anxiety.  
Comparator Agent  To evaluate and compare the effectiveness of Tell Show Do, Tell Show Play Do and Smart phone game app for managing 4–7-year-old children with high dental fear and anxiety.  To compare the effectiveness of Tell-show-do technique with Tell-show-play-do Technique and smartphone dental game app in managing 4–7-year-old children with high dental fear and anxiety. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details 
1.Children aged 4-7 years reporting to Department of Pediatric and preventive dentistry.
2.Children with no previous history of dental treatment.
3.Children requiring Class I restoration (ICDAS Code 2 and Code 3) in any of the maxillary and mandibular molars.
4.Children whose parents agree to participate in the study.
 
 
ExclusionCriteria 
Details  1.Children who report with pain.
2.Children with underlying medical conditions.
3.Children not accompanied by their parents for the visit.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effectiveness of Tell Show Do, Tell Show Play Do and Smart phone game app for managing 4–7-year-old children with high dental fear and anxiety.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   21/04/2023 
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
Modification(s)  
none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aditi.mathur@dpu.edu.in].

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 01-06-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - data will be shared after the completion of trial
Brief Summary  

7.1 Need for the study

 

Dental fear and anxiety are one of the major concerns which leads to avoidance in seeking dental care by children and their parents resulting in neglect of oral health, delayed visits, poor oral hygiene and symptom driven treatments. 1 Child’s fearful and uncooperative behaviour may also compromise the quality of dental treatment rendered by impeding the effective and efficient delivery of dental care. Dental fear has a direct relationship with decayed teeth and was shown to be a significant determinant of clinical consequences of untreated dental caries. 2 Therefore, the success of pediatic dental practice not only depends upon the dentist technical skills but also on successful management of pediatric patients.

 

 The American Academy of Pediatric Dentistry has recommended that more focus should be given on the non-pharmacological behaviour interventions in future studies.3 The Tell-show-do method is one of the most commonly used non-pharmacological behaviour modification techniques. However, for children in pre-operational stage of cognitive development, explaining and observing may not always be sufficient as children in this stage have difficulty in understanding dentist’s frame of reference. Utilizing the idea of learning by doing concept Tell-show-do technique was further modified to tell-play-do.4 In this, children will be asked to play with dental pretend set toys and explained about it which includes various instruments to familiarise the children with the treatments.

 

Recently, there have been studies undertaken to evaluate the usage of smartphone dental game apps in reducing dental fear and anxiety among children. These smartphone game apps give an overview to the child about the nature of their treatment will be. The children are virtually made dentists and they perform dental procedures that includes oral prophylaxis, filling, and extractions.4 The use of videogame as a behaviour management tool is based on the principles of cognitive-behavioural therapy and neurofeedback mechanism for children with anxiety disorders.5 Since this generation alpha is exposed to the digital environment at an early stage and technology is a part of their everyday lives, the use of technically driven smart phone dental game apps may prove to be an effective tool in behaviour management.

 

However, very few studies have been conducted to evaluate the effectiveness of the tell show play do and smart phone dental game apps as a behaviour management technique in children having high dental fear and anxiety. Hence, this study will be undertaken with an aim to evaluate and compare the effectiveness of three different behavioural modification techniques:  Tell Show Do, Tell Show Play Do, and the use of smartphone dental game app in the management of 4–7-year-old children having high dental fear and anxiety.

 

 

 

 

 

 

 

 

 

 

 

7.2 Review of Literature:

 

1.      Aruna Vishwakarma et al. (2017) in conducted a randomized clinical trial to evaluate effectiveness of two customized tell-play-do technique with live modeling for behavior management of children. Ninety-eight Children in the age group of 5-7 years were enrolled in the study randomly allocated into two groups and underwent oral prophylaxis in first visit and rotary restorative treatment on second visit. Heart rate, Facial Image Scale (FIS), and Venham-6-point index were used before intervention, after intervention and during dental procedure. They concluded that, Tell Play Do is effective in reducing children’s fear and anxiety about dental treatment and enjoyed playing with customized dental object. 3

 

2.      Vidyavati Patil et al (2017) conducted a pilot study and evaluated the effectiveness of dental apps in management of child’s anxiety and behaviour. Sixty children aged 8-12 years, were made to use the mobile app My Little Dentist on smartphones. Their anxiety levels were noted before and after playing the game using face imaging scale. Parents were questioned on child’s anxiety levels using Corah’s Dental anxiety scale. They concluded that the mobile app was found to be very useful to reduce the fear and anxiety of pediatric patients. 6

 

3.      Sreeraksha Radhakrishna et al. (2019) conducted a comparative study on the techniques of Tell-show-play-do, a smartphone dentist app and a conventional tell-show-do method in the behavior modification of anxious children. Children in the age group of 4-8 years with Frank’s behaviour rating score of 2 or 3 requiring Class I and Class II restorations were divided into three groups. The sample size was 60 children divided with 20 children in each group. Pulse rate, Facial Image Scale (FIS), Frankl’s behaviour rating scale, and FLACC (Face, Leg, Activity, Cry, Consolability) behaviour scales were used. They concluded that, the Tell-Show-Play-Do and smartphone techniques were effective tools to reduce dental anxiety in children. 7

 

4.      Sainath Reddy Elichera et al (2019) conducted a randomized control trial which measured the effectiveness of a mobile app Little lovely dentist compared to Tell-show-do technique in managing anxious children during their first dental visit. Fifty children aged from 7 to 11 years were randomly allocated into either dental app or tell show do group. The pre and post-operative anxiety were assessed using heart rate measurement and RMS pictorial scale. The children underwent oral prophylaxis treatment. They concluded that using a smartphone application such as little lovely dentist can alleviate anxiety and engage children in dental treatment during their first visit. 8

 

5.      Hiraabbasi et al (2021) evaluated the efficacy of little lovely dentist, dental song, and tell-show-do techniques in alleviating dental anxiety in pediatric patients. One hundred sixty patients aged 6 to 11 years, divided in 4 groups,40 children each with group 1: Little lovely dentist mobile app group 2: YouTube dental video songs group 3: tell show do and group 4: control. Dental prophylaxis treatment was provided to all patients. Anxiety levels were assessed by measuring heart rate with pulse oximeter, distress levels with facial image scale. Post-operative anxiety was assessed using same methods after application of techniques. They concluded that Smartphone application Little lovely dentist and dental songs can alleviate dental anxiety experienced by pediatric patients. The tell show do technique did not prove to be beneficial in reduction of the anxiety levels. 9

 

           

7.3  Aim and Objectives of the study

Aim of the study:

To evaluate and compare the effectiveness of Tell Show Do, Tell Show Play Do and Smart phone game app for managing 4–7-year-old children with high dental fear and anxiety.

Objectives:

1. To evaluate the effectiveness of Tell-Show-Do technique in managing 4–7-year-old children with high dental fear and anxiety.

2. To evaluate the effectiveness of Tell-Show-Play-do technique in managing 4–7-year-old children with high dental fear and anxiety.

3. To evaluate the effectiveness of Smartphone dental game app technique in managing 4–7-year-old children with high dental fear and anxiety.

4. To compare the effectiveness of Tell-show-do technique with Tell-show-play-do Technique and smartphone dental game app in managing 4–7-year-old children with high dental fear and anxiety.

Materials and Methods

8.1 Source of data.

 

·         Type of study: Comparative Study - Randomised control trial                         

·         In-vivo/in-vitro/survey:  In-vivo Study

·         Source from where the cases, patients, subjects or study material will be selected:  Department of Pediatric and preventive dentistry, Dr. D. Y Patil Dental college and hospital Pimpri, Pune.

·         Name and place where the study will be conducted: Department of Pediatric and preventive dentistry, Dr. D. Y Patil Dental college and hospital Pimpri, Pune.

 

 

 

 

 

 

 

 

 

 

8.2 Method of data collection

·         Sampling technique used: Convenient Sampling

                                            

·         Sample Size: Total- 60

Groups - 3

Subgroup – Group 1: Tell-Show-Do Technique (n=20)

                   Group 2: Tell-Play-Do Technique (n=20)

                   Group 3: Smartphone Dental Game App (n=20)

 

Sample Formula:  n = N*X / (X + N – 1),

                               where,

                               X = Zα/22 Â­*p*(1-p) / MOE2

 

·         Inclusion criteria

 

1.      Children aged 4-7 years reporting to Department of Pediatric and preventive dentistry.

2.      Children with no previous history of dental treatment.

3.      Children requiring Class I restoration (ICDAS Code 2 and Code 3) in any of the maxillary and mandibular molars.

4.      Children whose parents agree to participate in the study.                 

 

·         Exclusion criteria

 

1. Children who report with pain.

2. Children with underlying medical conditions.

3.Children not accompanied by their parents for the visit.

·         Written informed consent:  Written informed consent stating the purpose of study, procedure in brief and confidentiality will be taken.

 

·         Materials/Instruments/armamentarium to be used in the study:

·         Dentist Pretend play set

·         “Baby Shark – Dentist Game” Smartphone dental game app

·         Armamentarium:  

·         Diagnostic instruments: mouth-mirror, explorer, tweezer, probe.

·         Mouth-mask, head cap, gloves.

·         Pulse oximeter

·         Airotor

·         GIC spatula and mixing pad.

·         GIC

·         Scales used: Children’s Fear Survey Schedule Scale (CFSS-DS)

                                 Modified Child Dental Anxiety Scale – faces (MCDAS-f)

 

·         Procedure:

 

Step 1: Children who fulfilled the inclusion and exclusion criteria will be included in the study after taking written informed consent from the parents.

Step 2: CFSS-DS Questionnaire will be administered to parents to determine dental fear and anxiety among their children.

Step 3: Children with high anxiety score of more than 38 in the CFSS-DS scale 10 will be further included in the study.

Step 4: Block Randomization and allocation of the children into three groups will be done.

Step 5: On first appointment complete dental checkup along with detailed medical history and radiographs if required, will be taken and children will be appointed for second visit.

Step 6: Children will be appointed for GIC restorative procedure. (Class I restorations with ICDAS Code 2 or Code 3.)

Step 7: On the second visit prior to the start of the behaviour modification intervention pre-operative anxiety of the child will be assessed using the MCDAS-f scale and by measuring heart rate and Spo2 levels using Pulse oximeter by the second examiner.

Step 8: The children will be introduced to the behaviour modification techniques according to their allocated groups. (Examiner 1)

Step 9: GIC restorative treatment will be performed and pulse oximeter reading of heart rate and Spo2 will be taken during the procedure. (Examiner 1)

All the examination and restorative procedure will be done by a single operator.

Step 10: Post-operative children’s anxiety levels will be evaluated again. MCDAS-f scale will be administered to the children again post procedure. (Examiner 2)

Step 11: Data will be tabulated and analysed.

 

8.3    Duration of study: 6 months

8.4 Method of Data Analysis: Paired t test (pre and post behaviour management technique)
                                                Anova with Post hoc test (for comparison between the groups)

8.5 Does the study require any investigation or intervention to be made on patients, any human or animals?  Yes

List of References

(1)  Jason M, Stewart J, Armfield, Spencer J. The vicious cycle of dental fear: Exploring the interplay between oral health, service utilization and dental fear. BMC Oral Health 2007, 7:1.

(2) Murthy A. K., Pramila M, Ranganath S. Prevalence of clinical consequences of untreated dental caries and its relation to dental fear among 12–15-year-old schoolchildren in Bangalore city, India. European Academy of Paediatric Dentistry 2014;15 (1): 45–49.

(3) Vishwakarma AP, Bondarde PA, Patil SB, Dodamani AS, Vishwakarma PY, Mujawar SA. Effectiveness of two different behavioral modification techniques among 5-7-year-old children: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2017;35(2):143-149.

(4) Baakdah R.A, Turkistani J.M, Al-Qarni, A.M. Pediatric dental treatments with pharmacological and non-pharmacological interventions: a cross‐sectional study. BMC Oral Health 2021; 21(1):186.

(5) Wijnhoven L A, Creemers D H, Engels R C, Granic I. The effect of the videogame mindlight on anxiety symptoms in children with an autism spectrum disorder. BMC Psychiatry 2015; 15:138.

(6) Patil VH, Vaid K, Gokhale NS, Shah P, Mundada M, Hugar SM. Evaluation of effectiveness of dental apps in management of child behaviour: A pilot study. Int J Pedod Rehabil 2017; 2(1):14-18.

(7) Radhakrishna S, Srinivasan I, Setty JV, D R MK, Melwani A, Hegde KM. Comparison of three behavior modification techniques for management of anxious children aged 4-8 years. J Dent Anesth Pain Med. 2019;19(1):29-36.

(8) Elicherla SR, Bandi S, Nuvvula S, Challa RS, Saikiran KV, Priyanka VJ. Comparative evaluation of the effectiveness of a mobile app (Little Lovely Dentist) and the tell-show-do technique in the management of dental anxiety and fear: a randomized controlled trial. J Dent Anesth Pain Med. 2019;19(6):369-378.

(9) Abbasi H, Muhammad S, Jouhar R, Lal A, Ahmed N, Muhammad AA, Mohammad KA. The Efficacy of Little Lovely Dentist, Dental Song, and Tell-Show-Do Techniques in Alleviating Dental Anxiety in Paediatric Patients: A Clinical Trial, BioMed Research International. 2021.


    (10) Beena JP. Dental subscale of children’s fear survey schedule and dental caries prevalence. Eur J Dent 2013; 7(2):181-185.


 
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