Efficacy of Virtual Reality in Reducing Injection Pain and Anxiety During Local Anesthesia in Children
Condition: Injection Pain; Local Anesthesia
Study type: Interventional

Summary: 
      The aim of this study is to determine the efficacy of a 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 8-12 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 VR is allocated to either first or 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 or CS+VR.
    

Detailed description: 
      Achieving local anesthesia in children is one of the critical aspects of pain management.

      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.

      The aim of this study is to determine the efficacy of 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 Noon VR, FXGear, compatible with a mobile phone.

      The clinical trial is a randomized split-mouth assignment. Included patients are healthy
      positive children 8-12 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 as
      the virtual reality distraction is allocated to either first or 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 - traditional infiltration or virtual reality device-assisted injection.
    

Intervention name(s): Local anesthesia with conventional syringe; Local anesthesia with conventional syringe + VR device
Intervention type(s): Procedure; Device
Intervention description(s): 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.
Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL; Virtual reality device (Noon VR, Gear FX) is placed on the face of the patient, playing a video of soothing and peaceful natural landscapes.
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.
Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Intervention Model: Split-mouth assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual reality; pain control; pediatric dental patients; pediatric pain management; local anesthesia children