Pain & Anxiety Reduction Using a Vibrating Eye Massage Device With

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05592587
Study type	Interventional
Source	Damascus University
Contact
Status	Completed
Phase	N/A
Start date	June 15, 2022
Completion date	January 25, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms