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

NCT05592587 | Completed

• 1 other identifier: UDDS-Pedo-04-2022
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavior, Child; Dental Anxiety; Anesthesia, Local

Keywords

Eye massage device; Vibratory stimulation; Nature sounds; Distraction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

• 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

Study Arms (3)

Distraction using eye massage device producing both vibrations and nature sounds.

EXPERIMENTAL

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.

Distraction using eye massage device producing vibratory stimulations only.

EXPERIMENTAL

Behavioral: Evaluation of the effectiveness of eye massage device producing vibratory stimulations 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.

OTHER

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.

Interventions

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

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

Distraction using eye massage device producing both vibrations and nature sounds.

Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve. BEHAVIORAL

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

Distraction using eye massage device producing vibratory stimulations only.

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. BEHAVIORAL

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

Using basic behavior guidance techniques and without using any type of distraction aids.

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• previous dental experience
• systematic or mental disorders.
• definitely negative or negative ratings of Frankel scale
• Any contraindication for regional anesthesia

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (5)

• Crego A, Carrillo-Diaz M, Armfield JM, Romero M. Dental fear and expected effectiveness of destructive coping as predictors of children's uncooperative intentions in dental settings. Int J Paediatr Dent. 2015 May;25(3):191-8. doi: 10.1111/ipd.12126. Epub 2014 Jul 22.

  PMID: 25047094 BACKGROUND

• Attar RH, Baghdadi ZD. Comparative efficacy of active and passive distraction during restorative treatment in children using an iPad versus audiovisual eyeglasses: a randomised controlled trial. Eur Arch Paediatr Dent. 2015 Feb;16(1):1-8. doi: 10.1007/s40368-014-0136-x. Epub 2014 Nov 22.

  PMID: 25416522 BACKGROUND

• Buxton RT, Pearson AL, Allou C, Fristrup K, Wittemyer G. A synthesis of health benefits of natural sounds and their distribution in national parks. Proc Natl Acad Sci U S A. 2021 Apr 6;118(14):e2013097118. doi: 10.1073/pnas.2013097118.

  PMID: 33753555 BACKGROUND

• Canbulat N, Ayhan F, Inal S. Effectiveness of external cold and vibration for procedural pain relief during peripheral intravenous cannulation in pediatric patients. Pain Manag Nurs. 2015 Feb;16(1):33-9. doi: 10.1016/j.pmn.2014.03.003. Epub 2014 Jun 7.

  PMID: 24912740 BACKGROUND

• Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.

  PMID: 26156269 BACKGROUND

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Dajma Abed, DDs

  Damascus University

  PRINCIPAL INVESTIGATOR

• Nada G Bshara, Phd

  Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: October 24, 2022
• Study Start: June 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: January 25, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)