Pain and Anxiety Control During Traditional Mandibular Anesthesia in Children Using Distracting Tools
NCT ID: NCT03428282
Last Updated: 2018-07-30
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
102 participants
INTERVENTIONAL
2017-05-15
2018-07-15
Brief Summary
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Group A (Control group): IAN will be administrated with basic behavior guidance techniques and without using any type of distraction aids.
Group B: IAN will be administrated with using AV eyeglasses "VR BOX" and wireless headphone.
Group C: IAN will be administrated with using tablet device and wireless headphone
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 (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator
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Detailed Description
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The first measure of heart pulse rate will be recorded directly when the patient seated comfortably on the dental chair, after anesthesia, the second heart pulse rate will be taken and the child patients will ask to choose a face that describe their status from one of the Wong Baker faces scale.
For each child patient, all of the body responses will be recorded during the whole procedure and then will be evaluated by an external assessor to determine the children behavioral score according to FLACC scale.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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VR Box
Inferior alveolar nerve block will be performed with the aid of VR box as a means of distracting patients' attention.
VR Box
Distraction will be made during the injection of the drug using this method.
Tablet device
Inferior alveolar nerve block will be performed with the aid of a tablet device as a means of distracting patients' attention.
Tablet Device
Distraction will be made during the injection of the drug using this method
Anesthesia
Inferior alveolar nerve block will be performed in the normal manner without any specific intervention to distract patients' attention. Classic anesthesia will be applied.
Anesthesia
Anesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment.
Interventions
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VR Box
Distraction will be made during the injection of the drug using this method.
Tablet Device
Distraction will be made during the injection of the drug using this method
Anesthesia
Anesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment.
Other Intervention Names
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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
6 Years
10 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Mohammed Nour Al-Halabi, DDS
Role: PRINCIPAL_INVESTIGATOR
MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria
Zuhair AlNerabieah, DDS
Role: PRINCIPAL_INVESTIGATOR
MSc student in Pedodontics, University of Damascus Dental School, Syria
Nada Bshara, MD MSc Phd
Role: STUDY_DIRECTOR
Associate Professor of Pedodontics, University of Damascus Dental School, Syria
Locations
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Department of Peadodontics, University of Damascus Dental School
Damascus, , Syria
Countries
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References
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Madhok M, Teele M. Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics. 2006 Sep;118(3):1321; author reply 1321-2. doi: 10.1542/peds.2006-1351. No abstract available.
Wang ZX, Sun LH, Chen AP. The efficacy of non-pharmacological methods of pain management in school-age children receiving venepuncture in a paediatric department: a randomized controlled trial of audiovisual distraction and routine psychological intervention. Swiss Med Wkly. 2008 Oct 4;138(39-40):579-84. doi: 10.4414/smw.2008.12224.
Al-Namankany A, Petrie A, Ashley P. Video modelling and reducing anxiety related to dental injections - a randomised clinical trial. Br Dent J. 2014 Jun;216(12):675-9. doi: 10.1038/sj.bdj.2014.497.
El-Sharkawi HF, El-Housseiny AA, Aly AM. Effectiveness of new distraction technique on pain associated with injection of local anesthesia for children. Pediatr Dent. 2012 Mar-Apr;34(2):e35-8.
Hoge MA, Howard MR, Wallace DP, Allen KD. Use of video eyewear to manage distress in children during restorative dental treatment. Pediatr Dent. 2012 Sep-Oct;34(5):378-82.
Fakhruddin KS, Hisham EB, Gorduysus MO. Effectiveness of audiovisual distraction eyewear and computerized delivery of anesthesia during pulp therapy of primary molars in phobic child patients. Eur J Dent. 2015 Oct-Dec;9(4):470-475. doi: 10.4103/1305-7456.172637.
Other Identifiers
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UDDS-Pedo-03-2017
Identifier Type: -
Identifier Source: org_study_id
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