Behaviour management of children with high dental fear.

Not yet recruiting

• Conditions: Dental caries on pit and fissure surface,

• Registration Number: CTRI/2023/04/051874
• Lead Sponsor: Sneha Madhu Nair

Brief Summary

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|***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.***

 Â·         **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.

 Â·         ***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.

 Â·         **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)

 Â·         **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.

 

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|**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*

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|**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 crossâ€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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-06
• Study Start: 2023-04-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dr. D. Y. Patil Dental College and Hospital, Pimpri Pune; 🇮🇳 Pune, MAHARASHTRA, India

Dr. D. Y. Patil Dental College and Hospital, Pimpri Pune

🇮🇳Pune, MAHARASHTRA, India

Aditi Mathur

Principal investigator

8376055529

aditi.mathur@dpu.edu.in