A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia.
NCT ID: NCT04585061
Last Updated: 2021-11-11
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
31 participants
INTERVENTIONAL
2020-11-01
2021-02-18
Brief Summary
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The clinical trial is a randomized split-mouth assignment. Included patients are 5 - 12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally.
Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas sweet is allocated to first local anesthesia procedure and VR is allocated to second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS+sweet or CS+VR.
Detailed Description
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A contemporary engaging form of distraction is represented by virtual reality devices. Virtual reality (VR) devices create a virtual environment of view and sound that allow patients to be immersed in an interactive, simulated world to distract them from pain. The VR devices have a wide viewing field and three-dimensional displays that project the images right in front of the user. They not only show potentially attractive audio-visual stimuli, but also exclude all other visual environmental stimuli that may affect the patient.
While sweet-tasting reduce signs of pain during painful procedures. This effect is considered to be mediated both by the release of endorphins and by a pre absorptive mechanism related to the sweet taste.
The aim of this study is to determine the efficacy of sweet-testing compare to a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.
The device used in this study is Harga Miniso Vr Glass 3d terbaru, compatible with a mobile phone.
The sweet used is xylitol tablet The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 5-12 years old requiring local anesthetic infiltration for conservative treatment of two primary maxillary molars bilaterally.
Eligible patients undergo two single-visit treatments after measurement of dental fear prior to each according to the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS). Local anesthetic is delivered through buccal infiltration with conventional syringe, where is the sweet-test applied with first local anesthesia procedure and the virtual reality distraction is allocated to second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to Faces, Legs, Activity, Cry, Consolability (FLACC) scale; heart-rate dynamics; patient preference to local anesthesia method - sweet test infiltration or virtual reality device-assisted injection.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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sweet test group
Local anesthesia with conventional syringe Procedure: Local anesthesia with conventional syringe + xylitol sublingual tablet Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
Lidocaine Hydrochloride
1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle
Xylitol
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized while xylitol tablet putted under tongue
Virtual reality group
Local anesthesia with conventional syringe + VR device Device: Local anesthesia with conventional syringe + VR device Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon.
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
Lidocaine Hydrochloride
1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle
Virtual reality device (Harga Miniso Vr Glass 3d terbaru)
Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon.
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized
Interventions
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Lidocaine Hydrochloride
1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle
Virtual reality device (Harga Miniso Vr Glass 3d terbaru)
Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon.
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized
Xylitol
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized while xylitol tablet putted under tongue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally.
* Children without previous experience with local anesthesia for dental treatment.
* Obtained informed consent from parents or gave-givers to participate in the study.
Exclusion Criteria
* Vision requiring correction with eyeglasses.
* Recent injury to the eyes or face that prevents comfortable use of VR hardware or software.
* Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
* Patients with allergy to local anesthetics, xylitol.
* Children, who are first time ever dental patients.
5 Years
12 Years
ALL
Yes
Sponsors
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Riyadh Elm University
OTHER
Responsible Party
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Abdulrahman Alasmari
Principal Investigator
Principal Investigators
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AbdulRahman Alasmari, Resident
Role: PRINCIPAL_INVESTIGATOR
Riyadh Elm University
Locations
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AbdulRahman Alasmari
Riyadh, , Saudi Arabia
Countries
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References
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Bikmoradi A, Khaleghverdi M, Seddighi I, Moradkhani S, Soltanian A, Cheraghi F. Effect of inhalation aromatherapy with lavender essence on pain associated with intravenous catheter insertion in preschool children: A quasi-experimental study. Complement Ther Clin Pract. 2017 Aug;28:85-91. doi: 10.1016/j.ctcp.2017.05.008. Epub 2017 May 24.
Zhang C, Qin D, Shen L, Ji P, Wang J. Does audiovisual distraction reduce dental anxiety in children under local anesthesia? A systematic review and meta-analysis. Oral Dis. 2019 Mar;25(2):416-424. doi: 10.1111/odi.12849. Epub 2018 Sep 21.
Messieha Z. Risks of general anesthesia for the special needs dental patient. Spec Care Dentist. 2009 Jan-Feb;29(1):21-5; quiz 67-8. doi: 10.1111/j.1754-4505.2008.00058.x.
Buchanan H, Niven N. Validation of a Facial Image Scale to assess child dental anxiety. Int J Paediatr Dent. 2002 Jan;12(1):47-52.
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007 Jan;127(1-2):140-50. doi: 10.1016/j.pain.2006.08.014. Epub 2006 Sep 25.
Malviya S, Voepel-Lewis T, Burke C, Merkel S, Tait AR. The revised FLACC observational pain tool: improved reliability and validity for pain assessment in children with cognitive impairment. Paediatr Anaesth. 2006 Mar;16(3):258-65. doi: 10.1111/j.1460-9592.2005.01773.x.
ten Berge M, Veerkamp JS, Hoogstraten J, Prins PJ. Childhood dental fear in the Netherlands: prevalence and normative data. Community Dent Oral Epidemiol. 2002 Apr;30(2):101-7. doi: 10.1034/j.1600-0528.2002.300203.x.
Keefe FJ, Rumble ME, Scipio CD, Giordano LA, Perri LM. Psychological aspects of persistent pain: current state of the science. J Pain. 2004 May;5(4):195-211. doi: 10.1016/j.jpain.2004.02.576.
Locker D, Thomson WM, Poulton R. Psychological disorder, conditioning experiences, and the onset of dental anxiety in early adulthood. J Dent Res. 2001 Jun;80(6):1588-92. doi: 10.1177/00220345010800062201.
Thomson WM, Locker D, Poulton R. Incidence of dental anxiety in young adults in relation to dental treatment experience. Community Dent Oral Epidemiol. 2000 Aug;28(4):289-94. doi: 10.1034/j.1600-0528.2000.280407.x.
Other Identifiers
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FPGRP/2020/489/269
Identifier Type: -
Identifier Source: org_study_id