Effect of a Candy Flavoring Before Local Anesthesia on Anxiety and Pain Perception in Children

Study Overview
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Brief Summary
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This is a randomized clinical trial that aims to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group. We expect that using the flavor before injecting local anesthesia will distract the child and reduce pain and anxiety.

Detailed Description
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Background: Distraction techniques can be very useful in managing children on the dental chair and to guide their attention away from a painful stimulus. No studies so far have used a sugar-free solution as a distraction method. Aim: To test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group, using a split-mouth randomized study design. Methods: A total of 200 children aged 4-10 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally will be included in this study. The children will be randomly allocated into two groups, group 1 will receive the first injection after applying a flavor, and group 2 will receive the first injection after applying sterile water. The children will receive the first injection on the right or left side and switch sides on the next visit. The observed pain perception will be assessed using the SEM scale. Wong-Baker Faces pain rating scale will be used to assess the pain reported by the child. Pulse rate, BMI, and sweet taste preference will also be recorded by an independent observer to ensure blinding. Expected results: Using a sugar-free candy flavor before injecting local anesthesia will distract the child and reduce pain and anxiety accompanying local anesthesia.

Official Title
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The Effect of Using a Sugar-free Candy Flavoring Before Local Anesthesia Injection on Anxiety and Pain Perception in Children: a Split-mouth Randomized Clinical Trial

Conditions
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Local Anesthesia

Intervention / Treatment
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* Procedure: Local Anesthesia 1
* Procedure: Local Anesthesia 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy (ASA Grade 1 status) children First dental experience for the child including local anesthesia. Children with caries lesions that require restorative treatment. Children who require the same treatment on upper primary first or second molars bilaterally. Exclusion Criteria: Children with poor behavior (unable to cooperate for dental treatment). Previous unpleasant dental experience (dental phobia). History of abscess, redness, fistula in the injection site (need for extraction). Presence of a systemic disease, mental, cognitive and intellectual disabilities.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>Will initially receive the infiltration injection after applying a candy flavor first, followed by sterile water in the next visit | Procedure: Local Anesthesia 1<br>* Local anesthesia injection after applying a candy flavor<br>Procedure: Local Anesthesia 2<br>* Local anesthesia injection after applying sterile water<br>|
| Active Comparator: Control group<br>Will initially receive the infiltration injection after applying sterile water first, followed by candy flavor in the next visit | Procedure: Local Anesthesia 1<br>* Local anesthesia injection after applying a candy flavor<br>Procedure: Local Anesthesia 2<br>* Local anesthesia injection after applying sterile water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Reported pain by the child will be assessed using the Wong-Baker Faces Pain Rating Scale, Scores range from 0-10, higher scores mean more pain | During injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety will be assessed through pulse rate measurements recorded before, during and the injection using a fingertip pulse oximeter. | Before and during injection |