Pain and Anxiety Reduction Using a Vibrating Eye Massage Device With Relaxing Nature Sounds
Condition: Behavior, Child; Dental Anxiety; Anesthesia, Local
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): 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.; Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve.; 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.
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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; 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eye massage device; Vibratory stimulation; Nature sounds; Distraction