Effectiveness of Mobile Applications During the Administration of Local Anesthesia in Pediatric Dentistry

Study Overview
=================
Brief Summary
-----------------
To evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing dental pain and anxiety levels in pediatric patients.

Detailed Description
-----------------
a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: mobile application (little lovely dentist) control group: Tell-Show-Do technique. in children aged 4-6 years who need local anesthesia for dental treatment during their first dental visit. For both groups: Taking personal data, medical and dental history. Diagnosis and determination of the required treatment. Measuring preoperative anxiety using a pulse oximeter. Evaluate preoperative anxiety using RMS-pectorial scale. Using the behavior guidance technique: Intervention group: Allow the child to play the module simulating the required procedure. Control group: tell-show-do technique is used to explain the procedure to the child 6) Administration of local anesthesia with the observation of intraoperative signs of pain or anxiety. 7) Measuring postoperative anxiety using the pulse oximeter. 8) Evaluate postoperative anxiety using RMS-pectorial scale. 9) Evaluate postoperative pain using the visual analog scale. 10) Asking the child and the parent about satisfaction. 11) Evaluation of child behavior during the second dental visit using Venham's behavior rating scale and Frankl behavior rating scale. outcome: ry: Pre and postoperative anxiety using Pulse oximeter and RMS-pectorial scale. ry: Postoperative pain using Visual analog scale, Intraoperative assessment of pain and anxiety by Observing the child, Child satisfaction by asking the child, Parent satisfaction by asking the parent, Completion of treatment and Attitude during the second dental visit using -Venham's behavior rating scale-Frankl behavior rating scale. the study will be held in 2 visits.

Official Title
-----------------
Mobile App (Little Lovely Dentist) Versus Tell-Show-Do Technique in Reduction of Anxiety and Pain During Administration of Local Anaesthesia in Children (A Randomized Clinical Trial)

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: mobile application (little lovely dentist).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 4-6 years. Children without any systemic or mental disorders. Children without any prior experience with the dental environment or treatment procedures (first dental visit). Children whose behavior could be rated as positive or negative based on the Frankl behavior rating scale. Exclusion Criteria: Children seeking dental treatment that does not necessitate local anesthesia. Children suffering from any systemic or mental disorders. Children who are not willing to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel-group and allocation ratio (1:1) Intervention: mobile application (little lovely dentist). Control: Tell-Show-Do technique.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mobile application (little lovely dentist).<br>intervention mobile application simulating the dental procedure that will be done to the child | Behavioral: mobile application (little lovely dentist).<br>* mobile application<br>|
| No Intervention: Tell-Show-Do technique.<br>control behavior technique where ''tell'' is to tell the child about the procedure in non-threatening words, ''show'' is to demonstrate the procedure to the child, and ''do'' is the execution of the procedure | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety | Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM) | before administration of local anesthesia during the first dental visit | 
| postoperative anxiety | postoperative anxiety will be measured immediately after administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM) | immediately after administration of local anesthesia during the first dental visit | 
| Preoperative anxiety score | will be assessed by RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety | before administration of local anesthesia during the first dental visit | 
| post-operative anxiety score | will be assessed by RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) immediately after administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety | immediately after administration of local anesthesia during the first dental visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain will be measured immediately after administration of local anesthesia by the visual analog scale in a numerical unit 0-10 where 0 denotes no pain and 10 denotes the worst pain | immediately after administration of local anesthesia during the first dental visit | 
| Attitude during the second dental visit using frankle behavior rating scale | evaluation of child behavior during the second visit using frankle behavior rating scale in a numerical unit rating 1-4 where, Definitely Negative: Refusal of treatment, crying forcefully, fearful, or any other overt evidence of extreme negativism. Negative: Reluctant to accept treatment, uncooperative, some evidence of negative attitude but not pronounced withdrawn. Positive: Acceptance of treatment; at times curious, willing to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively Definitely positive: Good rapport with the dentist, interested in dental procedures, and laughing and enjoying the situation. | during administration of local anasthesia during the second dental visit (after 1 week) | 
| Attitude during the second dental visit using Venham's behavior rating scale | evaluation of child behavior during the second visit using Venham's behavior rating scale in a numerical unit using score 0-3 where, 0- Total cooperation, best working conditions, no crying, or physical protest. Mild, soft verbal protest or quiet crying as a signal of discomfort, but doesn't obstruct progress. Appropriate behavior for the procedure. Protest more prominent. Both crying and hand signals. May move head around making it hard to perform the treatment. Protest more distracting and troublesome. However, the child still complies with the request to cooperate. Protest presents a real problem to the dentist. Complies with demands reluctantly, requiring more effort by dentist + Body movement. | during administration of local anasthesia during the second dental visit (after 1 week) |