Anesthesia, Local Clinical Trial
Official title:
Evaluating Acceptance and Efficacy of an Eye Massage Device in Reducing Pain and Anxiety During Dental Anesthesia in Children.
Verified date | February 2023 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 105 |
Est. completion date | January 25, 2023 |
Est. primary completion date | October 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Damascus University | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Pulse rate | Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter. | (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug | |
Secondary | Blood pressure | Blood pressure (millimeters of mercury mmHg) will be evaluated using a Wrist Digital Blood Pressure Monitor. | (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug |
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