The Effectiveness of Audiovisual Distraction Behavior Guidance Technique in Children With Dental Anxiety
Condition: Dental Anxiety; Dental Pain and Sensation Disorder
MeSH terms: Sensation Disorders; Anxiety Disorders
Study type: Interventional

Summary: 
      This randomized, two-armed, placebo-controlled, cross-over, controlled trial aimed to
      evaluate the effect of virtual reality exposure therapy (VRET) on dental anxiety, pain, and
      behaviour among children undergoing dental treatment under local anaesthesia. The null
      hypotheses were as follows: VRET has no effect on reducing dental anxiety and dental pain
      scores of participants; and there is no difference between subjective and objective measure
      scores of dental anxiety and pain when VRET and attention palcebo-controlled (APC) groups are
      used to reduce anxiety in children undergoing dental treatment with local anaesthesia.
    

Detailed description: 
      This randomized, two-armed, placebo-controlled, cross-over, controlled trial adhered to the
      principles of the Declaration of Helsinki, good clinical practice guidelines, and applicable
      regulatory requirements. Ethics approval was obtained from the Health Ethics Committee of
      Sivas Cumhuriyet University (Sivas, Turkey; ID: 2018-02/08). All parents or guardians of
      children were educated about the study before enrollment and provided informed written
      consent to participate. The trial adhered to the Consolidated Standards of Reporting Trials
      (CONSORT) guidelines.

      The parameters used to calculate the sample size included a 95% confidence interval (CI), 80%
      statistical power, and a standard deviation of 1.90; accordingly, at least 64 subjects were
      required. This number was adjusted to 76 subjects to compensate for a projected loss of
      approximately 20% during follow-up. Thus, 76 healthy subjects between 7 and 11 years of age
      were included in the study. Participants who fulfilled the following criteria were included:
      systemically and mentally healthy; required restorative treatment for first mandibular
      permanent molar tooth with dentin caries in each mandibular quadrant with a bilateral
      inferior alveolar nerve block; absence of co-operative disability; and Frankl Scale score 2
      or 3 during first dental examination. Patients with systemic or mental illnesses, reduced
      audiovisual capabilities, acute dental pain or trauma, those with previous painful or
      negative dental experience, and those who were extremely uncooperative were excluded.

      The present randomized, two-armed, within-subject, cross-over, controlled trial included
      patients who applied to Department of Pediatric Dentistry, Cumhuriyet University, for routine
      dental treatment.The study comprised three visits: V0, baseline dental examination and
      inclusion; V1, first restorative treatment session; and V2, second restorative treatment
      session for symmetrical teeth. The initial oral and radiographic examination and Frankl
      Behaviour Scale scoring of all patients were performed by one experienced and pre-calibrated
      researcher. A dental assistant not participating in the study used a random-order generator
      (http://www.random.org) to randomize patients to the experimental group according to block
      randomization.

      Eligible participants were treated in two different appointments: protective glasses only,
      without distraction (APC); or with the treatment condition (VRET). All procedures were
      performed by a single experienced and calibrated paediatric dentist (BB).

      Participants were randomly assigned by a computer algorithm to receive VR with the first or
      second sequential dental treatment session and with protective glasses for the other
      treatment session. The investigators were blinded to treatment sequence until before the
      first dental treatment was to begin. Before VRET, the VR headset was shown to the patients,
      who were permitted to handle it. This enabled the patient to recognize the device and be
      familiar with it before treatment. Before starting treatment, the VR headset was placed on
      each patient's head, and the patient was asked whether the device caused pain or discomfort,
      and the patient's consent was confirmed. In the APC group, each patient was informed about
      the dental procedure and was provided with protective glasses. All patients were told that
      they were wearing these glasses to ensure a pain- and stress-free treatment, and that the
      dentist would devote additional attention to the treatment. This aimed to provide the patient
      with feeling like being in an experimental session. The reason for choosing an APC group with
      the routine protective glasses without distraction was to mitigate possible Hawthorne
      effects.

      Regardless of experimental group, in the first treatment session, the mandibular first
      permanent molar tooth of each patient was restored with composite filling under local
      anaesthesia, while the opposite symmetrical tooth was treated in the second session. The
      duration of treatment in each session was noted and defined as the time from the subject sat
      on the chair to occlusal adjustment of restoration. First, the teeth were cleaned using
      fluoride-free prophylactic paste. The preparation was limited to removal of the caries,
      followed by rounding of the inner line and point angles. Cavity preparation was performed
      using an 80 µm grit diamond bur and completed using a 25 µm grit diamond bur (Intensiv,
      Viganello-Lugano, Switzerland). Isolation and contamination were controlled with suction and
      cotton rollers. In cases for which this was not sufficient, a rubber dam was used. Metal
      matrix bands and wooden wedges were also used where necessary.

      Statistical analyses were performed using SPSS version 22.0 (IBM Corporation, Armonk, NY,
      USA). Descriptive analysis was used to summarize demographic characteristics and responses of
      the participants on each scale. The chi-squared test was used to compare age and sex
      differences at baseline. Repeated measures ANOVA was performed to analyse changes according
      treatment group, dental visit sequence and time point of treatment procedure. Differences
      with p < 0.05 were considered to be statistically significant.
    

Intervention name(s): Virtual Reality Device; Protective glasses
Intervention type(s): Device; Device
Intervention description(s): The Virtual Reality system (PlayStation 4 VR, Sony Inc.) is a simple and easy to use distraction device. The system consists of a screen mounted on a binocular headset connected to a console or personal computer. The head-mounted display provides a high-resolution visual display and unmutes the sound from the headphones using a soundproof mechanism that provides clear sound.; Each patient was informed about the dental procedure and was provided with protective glasses. All patients were told that they were wearing these glasses to ensure a pain- and stress-free treatment, and that the dentist would devote additional attention to the treatment.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, two-armed, within-subject, cross-over, controlled
Masking: None (Open Label)
Primary purpose: Treatment