A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia.
Condition: Anxiety; Pain
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study is to determine the efficacy of sweet in compare to virtual reality
      (VR) device in reducing injection pain and anxiety associated with local anesthesia in
      pediatric dental patients.

      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: 
      Achieving local anesthesia in children is one of the critical aspects of pain management and
      they effect the quality of treatment as well as behavior of child.

      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.
    

Intervention name(s): Lidocaine Hydrochloride; Virtual reality device (Harga Miniso Vr Glass 3d terbaru); Xylitol
Intervention type(s): Drug; Device; Dietary Supplement
Intervention description(s): 1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle; 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; 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 name(s): lignocaine; VR; Xylitol candy
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Intervention Model: Split-mouth assignment
Masking: Single (Participant)
Primary purpose: Treatment