Virtual Reality Distraction and Dental Anxiety Among Anxious Pediatric Patients
Condition: Children's Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Objective: This study evaluated the effect of Virtual Reality Distraction (VRD) on dental
      anxiety among anxious children undergoing prophylactic dental treatment by utilizing both
      subjective (Venham Anxiety and Behavioral Rating Scale (VABRS)) and objective (heart rate
      (HR) and salivary cortisol level (SCL)) measures. Method and Materials: This randomized
      controlled study included 36 6- to 14-year-old healthy and anxious children who needed
      prophylactic dental treatment and who had a history of previous dental treatment. The
      eligible children's anxiety level was evaluated using a modified version of Abeer Dental
      Anxiety Scale-Arabic version (M-ACDAS) and those who scored at least 14 or more out of 21
      were included. Participants were randomly distributed to either the VRD or control group. In
      the VRD group, participants wore the VRD device during prophylactic dental treatment. In the
      control group, subjects received their treatment while watching a video cartoon on a regular
      screen. The participants were videotaped during the treatment and their HR was recorded at
      four time points. Also, a sample from each participant's saliva was collected twice, at the
      baseline and after the procedure.
    

Detailed description: 
      The aim of this study was to evaluate the effect of virtual reality distraction among 6- to
      14-year-old anxious children undergoing prophylactic dental treatment by utilizing both
      subjective (Venham Anxiety and Behavioral Rating Scale (VABRS)) and objective (heart rate and
      salivary cortisol level) measures.

      This two-arms parallel randomized controlled study was conducted at the Department of
      Pediatric Dentistry at King Abdulaziz University Dental Hospital (KAUDH) between January and
      May 2022, after obtaining the ethical approval from the Research Ethics Committee of the
      Faculty of Dentistry (341-11-21) at King Abdulaziz University. The study is reported
      according to the protocol established by the Consolidated Standards of Reporting Trials
      (CONSORT) statement (18).

      The inclusion criteria were 6- to 14-year-old, healthy children with a history of previous
      dental treatment. The included subjects also had to have high dental anxiety (high score on a
      modified version of Abeer Children Dental Anxiety Scale (M-ACDAS)) . Children with visual or
      auditory deficits, a history of epilepsy, and/or anxiety disorder, and non-Arabic speaking
      children were excluded.

      Records of pediatric patients on the dental treatment waiting list were reviewed and
      potentially eligible children were contacted via the phone. The aim of the study was
      introduced to the parents/guardians, and upon agreement to participate, an appointment was
      scheduled.

      Abeer Children Dental Anxiety Scale (ACDAS), a cognitive dental anxiety scale, is the first
      Arabic validated cognitive dental anxiety scale developed to measure anxiety in children and
      adolescents. It consists of 19 self-reported questions arranged in a logical order to assess
      dental anxiety in children (19). In this study, the ACDAS was modified (M-ACDAS), and only
      seven of the 19 self-reported questions were included to avoid a lengthy questionnaire with
      the children (Figure 1). Each question can be scored 1, 2, or 3 by choosing between three
      faces with different expressions. The first face is a smily face and reflects the feeling of
      being relaxed, happy, and not scared, while the second face represents a neutral feeling; and
      the third face is a sad face and represents anxious and scared feeling. The children were
      asked to circle the face that best represented his/her response to the question. Therefore,
      the total values ranged from 7 to 21. The M-ACDAS was used at the beginning of the scheduled
      appointment in the waiting area to assess the pre-treatment anxiety level of the potentially
      eligible children. Those who scored 14 (66.7% of the maximum score) or more were considered
      anxious and were included in the study. Those who scored less than 14 in the M-ACDAS were
      excluded from the study.

      An Arabic consent form was obtained from the parents/guardians, and a verbal assent was
      obtained from the child before participation. The participants' age, gender, the timing, type
      of treatment provided, and behavior during their most recent dental visit were also recorded.

      A stratified block randomization process was used to randomize the 36 participants into
      either a VRD or a control group. The participants were stratified by gender and then a block
      size of six was used in each stratum. The sequence of assignments in each block was generated
      using a random number generator. To ensure allocation concealment, the allocation assignment
      and sequence were kept with a dental assistant not involved in the study. In the VRD group,
      participants wore a VRD device and watched a previously selected favorite cartoon during the
      prophylactic dental treatment. The device was introduced to the participants using the
      Tell-Show-Do technique at the beginning of the appointment. In the control group,
      participants received their treatment while watching a previously selected favorite cartoon
      on a regular screen. For both groups, only speakers with no headphones were used.

      The subjects underwent a dental prophylactic treatment performed by a single trained dental
      intern using a low-speed handpiece and a rubber cup with prophy paste. The dental treatment
      was conducted in the same order, the upper right, upper left, lower left, and lower right
      quadrants with all the participants. The participants were allowed to choose the prophy paste
      flavor (Bubble Gum, Cherry Tart, Concord grape, Mint Parfait, Raspberry Jam, and Valencia
      Orange). During the treatment, the HR was recorded using a pulse oximeter (TECNO-GAS pulse
      oximeter VITAL TEST) at four-time points: (1) in the waiting area as a baseline; (2) in the
      dental chair before starting the procedure and after the VRD device or the regular screen
      were turned on; (3) during prophylactic dental treatment (after prophy of the two quadrants
      in the upper arch was completed); (4) after the procedure was completed and before taking off
      the VRD device in the VRD group or turning off the regular screen in the control group.

      During the treatment, participants were videotaped using a high-resolution camera. Later, two
      trained and calibrated evaluators assessed the participant's anxiety using the VABRS
      independently. The scale consists of five defined behavioral categories ranging from zero to
      five. A higher score indicates a greater level of anxiety (20).

      Two saliva samples were collected from each participant: (1) as a baseline in the waiting
      area; (2) after the dental procedure was completed. Approximately two mL of saliva was
      collected using Salivettes®, and the samples were stored at -20oC until evaluation. To
      minimize the effects of the diurnal cortisol cycle, all study procedures and saliva sample
      collection were performed between 10:00 am and 2:00 pm. The cortisol levels were measured
      using the Cortisol Saliva Enzyme-Linked Immunosorbent Assay (ELISA) Assay Kit (ab 154996-
      cortisol ELISA kit, Abcam, UK) following the manufacturer's instructions.

      Sample size and statistical analysis A sample size of 18 in each group will have 80% power to
      detect a difference in means of -1.5 assuming that the common standard deviation is 1.5 with
      a 5% two-sided significance level. The Statistical Package for Social Science software for
      Windows was used for the statistical analysis (SPSS, Chicago, IL, USA). The participants'
      baseline characteristics were compared using the Mann-Whitney U test, chi-square test, or
      Fisher exact test. The Mann-Whitney U test was used to compare the three outcomes of the
      research (HR, SCL, and VABRS) between the VRD and control groups. The significance threshold
      was set at 0.05.
    

Intervention name(s): Virtual Reality Distraction during dental treatment of children.; Control: watching cartoon on screen as distraction during dental treatment of children.
Intervention type(s): Device; Other
Intervention description(s): One of the behavior management techniques used with children in dental clinics to allow for delivering quality dental treatment is the use of Virtual Reality distraction (VRD). Virtual reality distraction immerses the patient in an environment generated by a computer and works by simulating as many senses as possible: vision, hearing, and touch. In dentistry, VRD has exhibited great results in reducing anxiety and fear among children and adolescents compared to those who received no intervention or more conventional BMTs. VRD may allow the dentist to provide more efficient dental treatments, ranging from simple anesthesia to more advanced forms of dental treatment; The American Academy of Pediatric Dentistry (AAPD) recommends a series of non-pharmacological behavior management techniques for managing children during dental care including distraction. Distraction is defined by AAPD as "the technique of diverting the patient's attention from what may be perceived as an unpleasant procedure". It is widely used as it provides an effective and relaxing experience during treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dental anxiety; heart rate; salivary cortisol; virtual reality