Pain and Anxiety Reduction Using a Vibrating Eye Massage Device With Relaxing Nature Sounds

Study Overview
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Brief Summary
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This study aims to evaluate the effectiveness and acceptance of an eye massage device that produces nature sounds and vibratory stimulations in the management of anxious pediatric patients during inferior alveolar nerve block Group A (Control group): inferior alveolar nerve block will be administrated with basic behavior guidance techniques and without distraction aids. Group B: inferior alveolar nerve block will be administrated with the usage of the eye massage device producing both vibrations and nature sounds Group C: inferior alveolar nerve block will be administrated with the eye massage device producing vibratory stimulations only. All of the children who experienced an inferior alveolar block with/without distraction will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability FLACC scale external evaluator) Acceptance will be measured using a two-point Likert scale.

Detailed Description
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This study will evaluate the effectiveness and acceptance of a distraction aid that produces both vibratory and natural sound stimulations. pain and anxiety will be assessed during inferior alveolar nerve block using four behavioral scales, Wong-Baker pain scale and Children's Fear Scale (self-report), pulse rate and blood pressure (physiological), and behavior (using FLACC behavior rating scale external evaluator. Heart pulse rate measurement will be recorded firstly when the patient is seated comfortably on the dental chair, during anesthesia, and finally, after the procedure is done and the child patients will be asked to choose a face that describes their status from one of both Wong Baker faces scale and Children's Fear Scale. Blood pressure will be recorded before, during, and after anesthesia. Body responses of all child patients will be recorded during the whole procedure and then will be evaluated by an external evaluator to determine the children's behavioral score according to the FLACC scale.

Official Title
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Evaluating Acceptance and Efficacy of an Eye Massage Device in Reducing Pain and Anxiety During Dental Anesthesia in Children.

Conditions
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Behavior, Child, Dental Anxiety, Anesthesia, Local

Intervention / Treatment
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* Behavioral: Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve.
* Behavioral: Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve.
* Behavioral: Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 7 and 9 years. no previous dental experience. definitely positive or positive ratings of Frank scale. Need of IAN block for any dental treatment. Exclusion Criteria: previous dental experience systematic or mental disorders. definitely negative or negative ratings of Frankel scale Any contraindication for regional anesthesia

Ages Eligible for Study
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Minimum Age: 8 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distraction using eye massage device producing both vibrations and nature sounds.<br> | Behavioral: Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve.<br>* The child will be provided inferior alveolar nerve during eye massage device producing both vibrations and nature sounds. Children will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability FLACC scale external evaluator). Acceptance will be measured using a two-point Likert scale<br>|
| Experimental: Distraction using eye massage device producing vibratory stimulations only.<br> | Behavioral: Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve.<br>* The child will be provided inferior alveolar nerve during eye massage device producing vibratory stimulations. Children will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability FLACC scale external evaluator). Acceptance will be measured using a two-point Likert scale<br>|
| Other: Using basic behavior guidance techniques and without using any type of distraction aids.<br> | Behavioral: Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve.<br>* The child will be provided inferior alveolar nerve during eye massage device producing vibratory stimulations. Children will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability FLACC scale external evaluator). Acceptance will be measured using a two-point Likert scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain levels | Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale: 0 no Hurt - 1 Hurts little Bit - 2 Hurts little More - 3 Hurts Even More - 4 Hurts Whole Lot - 5 Hurts Worst | 5 minutes following the inferior alveolar nerve block injection. | 
| Anxiety levels | This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale (0 low anxiety and pain level - 10 high anxiety and pain level). | 1 minute during inferior alveolar nerve block administration. | 
| Anxiety levels | This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety'). | five minutes following the inferior alveolar nerve block injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse rate | Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter. | (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug | 
| Blood pressure | Blood pressure (millimeters of mercury mmHg) will be evaluated using a Wrist Digital Blood Pressure Monitor. | (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye massage device, Vibratory stimulation, Nature sounds, Distraction