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

Last updated: February 7, 2023
Sponsor: Damascus University
Overall Status: Completed

Phase

N/A

Condition

Mood Disorders

Panic Disorders

Anxiety Disorders

Treatment

N/A

Clinical Study ID

NCT05592587
UDDS-Pedo-04-2022
  • Ages 8-10
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 105
Study Start date:
June 15, 2022
Estimated Completion Date:
January 25, 2023

Study 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.

Connect with a study center

  • Damascus University

    Damascus,
    Syrian Arab Republic

    Site Not Available

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