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

Not Applicable

Completed

• Conditions: Dental Anxiety; Anesthesia, Local; Behavior, Child
• Interventions: 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 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 basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve.

• Registration Number: NCT05592587
• Lead Sponsor: Damascus University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-09-17
• Primary Completion: 2022-10-15
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-24
• Study Completion: 2023-01-25
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. age between 7 and 9 years.
2. no previous dental experience.
3. definitely positive or positive ratings of Frank scale.
4. Need of IAN block for any dental treatment.

Exclusion Criteria

1. previous dental experience
2. systematic or mental disorders.
3. definitely negative or negative ratings of Frankel scale
4. Any contraindication for regional anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distraction using eye massage device producing vibratory stimulations only.	Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve.	-
Distraction using eye massage device producing both vibrations and nature sounds.	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.	-
Using basic behavior guidance techniques and without using any type of distraction aids.	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.	-

Primary Outcome Measures

Name	Time	Method
Pain levels	5 minutes following the inferior alveolar nerve block injection.	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
Anxiety levels	five minutes following the inferior alveolar nerve block injection	This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety').

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic