Pain and Anxiety Reduction Using a Vibrating Eye Massage Device With Relaxing Nature Sounds
NCT ID: NCT05592587
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2022-06-15
2023-01-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Distraction using eye massage device producing both vibrations and nature sounds.
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.
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 vibratory stimulations only.
Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve.
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.
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.
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
Interventions
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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.
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
Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve.
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
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.
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
Eligibility Criteria
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Inclusion Criteria
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
2. systematic or mental disorders.
3. definitely negative or negative ratings of Frankel scale
4. Any contraindication for regional anesthesia
8 Years
10 Years
ALL
Yes
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Dajma Abed, DDs
Role: PRINCIPAL_INVESTIGATOR
Damascus University
Nada G Bshara, Phd
Role: STUDY_DIRECTOR
Damascus University
Locations
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Damascus University
Damascus, , Syria
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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UDDS-Pedo-04-2022
Identifier Type: -
Identifier Source: org_study_id
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