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

Primary Purpose

Behavior, Child, Dental Anxiety, Anesthesia, Local

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
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.
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior, Child focused on measuring Eye massage device, Vibratory stimulation, Nature sounds, Distraction

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

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

Distraction using eye massage device producing vibratory stimulations only.

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

Arm Description

Outcomes

Primary Outcome Measures

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
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).
Anxiety levels
This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety').

Secondary Outcome Measures

Pulse rate
Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter.
Blood pressure
Blood pressure (millimeters of mercury mmHg) will be evaluated using a Wrist Digital Blood Pressure Monitor.

Full Information

First Posted
September 17, 2022
Last Updated
February 7, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05592587
Brief Title
Pain and Anxiety Reduction Using a Vibrating Eye Massage Device With Relaxing Nature Sounds
Official Title
Evaluating Acceptance and Efficacy of an Eye Massage Device in Reducing Pain and Anxiety During Dental Anesthesia in Children.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior, Child, Dental Anxiety, Anesthesia, Local
Keywords
Eye massage device, Vibratory stimulation, Nature sounds, Distraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distraction using eye massage device producing both vibrations and nature sounds.
Arm Type
Experimental
Arm Title
Distraction using eye massage device producing vibratory stimulations only.
Arm Type
Experimental
Arm Title
Using basic behavior guidance techniques and without using any type of distraction aids.
Arm Type
Other
Intervention Type
Behavioral
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.
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve.
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
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 Description
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
Primary Outcome Measure Information:
Title
Pain levels
Description
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
Time Frame
5 minutes following the inferior alveolar nerve block injection.
Title
Anxiety levels
Description
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).
Time Frame
1 minute during inferior alveolar nerve block administration.
Title
Anxiety levels
Description
This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety').
Time Frame
five minutes following the inferior alveolar nerve block injection
Secondary Outcome Measure Information:
Title
Pulse rate
Description
Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter.
Time Frame
(1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
Title
Blood pressure
Description
Blood pressure (millimeters of mercury mmHg) will be evaluated using a Wrist Digital Blood Pressure Monitor.
Time Frame
(1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: previous dental experience systematic or mental disorders. definitely negative or negative ratings of Frankel scale Any contraindication for regional anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dajma Abed, DDs
Organizational Affiliation
Damascus University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nada G Bshara, Phd
Organizational Affiliation
Damascus University
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25047094
Citation
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.
Results Reference
background
PubMed Identifier
25416522
Citation
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.
Results Reference
background
PubMed Identifier
33753555
Citation
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.
Results Reference
background
PubMed Identifier
24912740
Citation
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.
Results Reference
background
PubMed Identifier
26156269
Citation
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.
Results Reference
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Pain and Anxiety Reduction Using a Vibrating Eye Massage Device With Relaxing Nature Sounds

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