Dental fear and anxiety (DFA) is defined as a patient’s psychological state of worry, anxiety, or even dread that is specific to a dental procedure [1]. Although different, dental fear and dental anxiety, which respectively represent an emotional response and a heightened state of apprehension to potential distress from dental treatment, are challenging to distinguish in clinical practice [2,3]. Consequently, the term “dental fear and anxiety” is frequently used to describe these intense negative emotional states associated with dental procedures. Children’s DFA disorder refers to the clinical manifestations of dental phobia or anxiety in children, including reduced cooperation, lessened compliance, and even resistance to treatment [4,5]. DFA are conditions that affect approximately 13.3% to 29.3% of children and adolescents and are a significant reason why patients avoid dental care [3,6]. In children, DFA is also associated with lower oral health-related quality of life [7]. Although the etiology of DFA is multifactorial, often stemming from both exogenous and endogenous sources, a past traumatic dental experience is the most predictive factor for DFA [8,9]. A study by Ten Berge et al [10] states that the majority of DFAs experienced by adults originates from poor dental experiences during childhood. These findings highlight the importance of making each dental visit a positive experience for pediatric patients. Short-term distress during appointments, if not managed appropriately, can accumulate into poor dental experiences and consequently, reinforce DFA into adulthood [11]. The long-term effects of these negative childhood dental experiences can lead patients to avoid seeking proper dental care in the future [12].

Pediatric dental patients with special health care needs (SHCN), such as patients with cancer, neurodivergent patients, or those with chronic conditions, including cardiovascular or pulmonary conditions or neurological afflictions, require extra time and special considerations during treatment due to medical, physical, cognitive, or developmental conditions [13]. This population includes children with behavior disorders (eg, autism spectrum, anxiety, and attention-deficit/hyperactivity disorder), congenital conditions (eg, trisomy 21 or congenital heart disease), developmental disorders (eg, cerebral palsy), systemic illnesses (eg, childhood cancer or sickle cell disease), or cognitive disabilities (eg, intellectual disability) [13]. Children with SHCN face more barriers to dental care than the overall population [13], including external factors like transportation, cost, inadequate dental facilities, as well as internal factors such as fear and poor tolerance [13,14]. Many children with SHCN are cared for by dentists in community settings or, more often, in hospital dental clinics [13]. They tend to experience a higher level of DFA, which can make dental visits more challenging [13]. Providing comprehensive care and ensuring each dental visit is positive for pediatric patients with SHCN is crucial in promoting good oral health habits and improving their oral health as they transition into adulthood [13]. Understanding and assessing DFA in children is key to delivering successful dental care with high satisfaction in this age group. Among the vast array of assessment methods available, self-report, parental proxy, observation-based, and physiological assessments are the four major types used to evaluate DFA in children [15]. Recently, salivary alpha-amylase, an enzyme linked to both adrenaline and noradrenaline, has also been used as a marker for autonomic nervous system activity and stress [16].

Factors in the dental setting that trigger DFA include loud dental instrument sounds, the presence of unfamiliar people examining the oral cavity, and fear of pain [17]. Of these, the biggest trigger of DFA is the anticipation and use of local anesthesia injections [9,17]. Although necessary for effective pain control during certain procedures, local anesthesia injections are understandably uncomfortable [9]. For children, the initial injection combined with the feeling of numbness during the procedure can be especially distressing [9]. Pharmacological agents, combined with light to moderate sedation or general anesthesia, can also be considered for noncooperative patients, who are often time-consuming and more costly and carry higher health risks [3]. In current research, audiovisual distractions such as tablets and TV screens have been used as additional distraction techniques beyond traditional tell-show-do methods, yielding overall positive results [18]. However, these techniques lack interactivity, resulting in less immersive distraction environments for children [19]. The lack of cooperation due to DFA often forces dentists treating pediatric patients to end appointments prematurely, sometimes without completing the planned procedures. Treating anxious and fearful patients can create a stressful environment for the clinician and the dental team [3]. Particularly when treating children with SHCN, extra time and tools are needed to ensure comfortable dental care. Depending on the child’s diagnosis, some may experience hypersensitivity to external stimuli such as loud noises, aversion to specific tastes, or difficulty straying from usual daily routines [20]. Furthermore, Pagano et al [20] showed that augmented reality was well suited for patients with autism spectrum disorder as preparation for their dental visits.

Additionally, a systematic review by Cunningham et al [21] concluded that virtual reality (VR) is a promising tool in dentistry, especially for children with autism spectrum disorder or other special health care needs. VR is defined as an artificial environment experienced through sensory stimuli [22]. It is a modern tool that immerses patients in a “game” or “virtual world.” Commonly used in medicine to distract patients during unpleasant procedures such as vaccination, cast removal, and short bedside interventions, VR has been proven effective at decreasing procedural anxiety and creating a more positive patient experience [23]. Limited existing research on VR in dentistry shows positive results for anxiety management during dental procedures. A recent clinical trial by Alshatrat et al [19] found that VR was effective in reducing anxiety in young children during dental procedures.

Additionally, a previous study by Ram et al [24] reported high satisfaction among both parents and clinicians using audiovisual glasses to guide children during dental treatments. However, research on clinical VR applications in pediatric dentistry remains limited, especially within populations with SHCN. VR offers potential as an additional nonpharmacologic tool for pediatric dentists. A clinical study assessing VR’s effectiveness during dental appointments in pediatric patients with SHCN could lead to better control of DFA and possibly facilitate easier procedures.

This randomized controlled trial (RCT) will follow a parallel design with two groups: a control group (watching cartoons on a muted wall-mounted TV or a tablet) and an experimental group (VR intervention during the dental procedure).

In mid-2023, we conducted a pilot study to evaluate feasibility and identify recruitment challenges before moving forward with the full RCT [27]. Between June 6, 2023, and July 20, 2023, 25 patients were recruited over 44 days at a single research site. Among these 25 patients, the mean VARS and Venham Behavioral Rating Scale scores before the procedure were 0.08 (SD = 0.28) for both scales, and during the procedure, the mean scores were 0.625 (SD = 1.35) and 0.667 (SD = 1.37), respectively. The variability in scores was higher at the time point with the higher average scores; therefore, we assumed a test with unequal variances. For the SAA outcome, data from a separate RCT conducted by our group were used [28]. This study measured changes in SAA before and during magnetic resonance imaging in children assigned to either a VR or a control condition. In that RCT, the mean difference in log-transformed SAA was 0.171 (SD = 1.05) in the control group and −0.096 (SD = 0.495) in the VR group. Because the expected difference in log SAA was smaller, this outcome guided our sample size calculations.

Therefore, to achieve 80% power to detect a mean difference of −0.096 (SD = 0.495) in log SAA using a 2-sided, 2-sample t test with unequal variances and a type-I error (α) of .05, a sample size of 364 participants (n=182 per group) was needed. Given the two primary outcomes, a Bonferroni correction was applied, reducing the α to .025. Based on an estimated 10% attrition rate from our pilot study, the final sample size was increased to 400 participants. Patients are currently being recruited for this study.

Recruitment is taking place at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a pediatric hospital in Montréal, Canada. This clinic mainly serves patients with SHCN, such as craniofacial abnormalities, autism spectrum disorder, or children battling cancer. Pediatric patients with SHCN make up about 80% of the clinic’s total clientele, while the remaining patients are otherwise healthy with dental trauma or other emergencies. The clinic sees roughly 5000 visits annually, including around 4000 patients with SHCN. Typically, about 600 (15%) of these patients have a severe diagnosis and are known to be completely uncooperative. Therefore, we estimate that approximately 3400 patients would be eligible for recruitment. Based on our pilot recruitment rate, we anticipate recruiting roughly 3 participants per week during September through April and 9 participants per week during May through August. Date collection is currently ongoing, and we expect to reach our target enrollment of 400 patients by the end of December 2025.

Participants will be identified by the clinic’s resident dentist using the scheduling system for upcoming appointments involving specific painful dental procedures, such as examinations, prophylaxis, extractions, and restorations. The research assistants will then contact the parents or legal guardians to provide information about the study and obtain their approval in advance. An independent individual, separate from the clinical dental team, will review the consent with both participants and parents. The information and consent form will be signed by a parent or legal guardian on the day of the visit. Whenever possible, patient assent will be sought.

Children participating in this study must meet the following criteria: (1) be aged 6 to 17 years; (2) have received the dentist’s recommendation to participate; (3) need to undergo any dental procedure; and (4) be accompanied by a parent or legal guardian who can read, write, and understand either French or English.

Participants will be excluded from this study if they (1) are diagnosed with epilepsy; (2) have paralysis or paresis of the hand; (3) have any diagnosed eye disease or problem; or (4) have any other conditions preventing them from using VR (eg, epidermolysis bullosa). Patients with a strong history of motion sickness will not be excluded from this study, but this information will be documented, and additional monitoring will be provided. The use of medication (opioid and nonopioid analgesics, antiemetics, anxiolytics, or any other drugs) prior to the procedure within the last 4 hours will not exclude participants from this study, but this information will be collected before the procedure and included as part of the sociodemographic and clinical information form. Patients who have received previous dental procedures at the recruiting setting will not be excluded.

Randomization will be performed using the electronic REDCap (Research Electronic Data Capture; Vanderbilt University) system. Allocation to either intervention will be randomized by an independent biostatistician from the Unité de recherche clinique appliquée (Applied Clinical Research Unit). To equalize participants across both arms, permuted block randomization with randomly selected block sizes design will be used to randomize participants to their intervention [29]. Access to the randomization list will be granted only to the biostatistician, and allocation will be concealed in REDCap to reduce selection bias.

Participants will be screened by a resident dentist or a research assistant via the appointment scheduling system for any dental procedure. Since DFA can arise from multiple procedures, such as simple cleaning to teeth extraction. A research assistant will review consent with participants and parents. Written consent by the parents or legal guardian—including the child’s assent (if possible)—will be obtained on arrival at the clinic, the day of the procedure, while completing the preprocedural questionnaire. After verifying that the participant meets all inclusion and exclusion criteria, the research assistant will log into REDCap only 10 minutes before the start of the intervention to minimize the risk of bias toward the intervention, obtain the group allocation, and then announce it to the participant. Because of the nature of VR, no blinding will be possible to staff, participants, parents, or legal guardians. Baseline data collection prior to the dental procedure, including a sociodemographic questionnaire, recording of physiological parameters, and SAA sampling, will take approximately 15 minutes to complete. The VR headset will be adjusted to the child’s size, and approximately 5 minutes will be allotted for the child to familiarize themselves with the room, equipment, and the game (VR or cartoon on TV or tablet) before the start of the procedure. The intervention will last the entire dental procedure, and its duration will be documented for each patient. DFA assessment by proxy using the VARS will be performed on site by the research assistant present. As per the clinic’s protocol, if a child becomes restless and uncooperative, they will be held by parents for the remainder of the procedure if it cannot be safely stopped at this time or if the procedure is considered an emergency. If the procedure can be safely stopped, rescheduling will be discussed with the parents, including the possible need for sedation. The involvement of parents will be recorded, as will any other distractions used during treatment, such as stickers, teddy bears, music, and others. The occurence of side effects and medications used will be recorded. The former will be transmitted to the ethics committee if they are serious or life-threatening. As VR has the potential to cause nausea, dizziness, and motion sickness, if participants experience any of these, they will be managed in accordance with the clinic’s protocols.

If participants experience severe side effects, the treatment will be safely discontinued. All instruments in the mouth will be removed. The VR device will be removed from the participant. The dental chair will be adjusted to a comfortable position, and the patient will rest until they feel comfortable and recovered. The option to continue the treatment (without the VR headset) or to postpone it to another day will be discussed. Postprocedure SAA sampling and completion of questionnaires on parents’ and health care professionals’ satisfaction levels will take approximately 10 minutes. Equipment used by children will be disinfected and reset before the next participant.

The primary analyses for this study will follow an intent-to-treat approach, using randomization status as the independent variable, and the mean difference in anxiety (using the anxiety subscale of the Venham) during the dental procedure (T1) and the SAA mean difference between T0 and T2 as the primary outcomes. As there are two primary outcomes (anxiety subscale and SAA), a Bonferroni correction will be applied, and a significance level of P=.025 will be used to determine statistical significance of primary outcomes. An ANCOVA, adjusting for unequal variances and adjusted for the time of the procedure, age, and baseline (T0) anxiety or behavioral score, will be used to assess the mean difference in Venham anxiety score during the dental procedure (T1) between the experimental and the control groups. An ANCOVA, adjusted for time of procedure, neurodevelopmental diagnosis, age, and baseline SAA level (T0), will be used to assess the mean difference in SAA level between groups 10 minutes after the procedure (T2).

For the secondary outcomes analyses, parametric tests adjusted for procedural type, age, sex, and parental presence will be used. Comparisons of dichotomous variables, including the necessity of procedural retakes, the use of other nonpharmacological interventions, and the occurrence of side effects, will be assessed using the Cochran-Mantel-Haenszel test. We will also perform subgroup analyses by age group (6‐12 y vs 13‐17 y) and sex and gender (boys, girls, or other) using ANCOVA. Any side effects will be reported using the Medical Dictionary for Regulatory Activities terminology [42], and their proportions will be compared between groups.

A research assistant will review consent with participants and parents. The information and consent form will be signed by one of the parents on the day of the visit. At enrollment, children are assigned a code used on all data collection forms to protect their confidentiality. Patient identifying information is kept separate from the case reports and is linked to study enrollment by a study ID number. The consent form also identifies all the information that may be collected during this study. All data collected on paper from the day of the intervention will subsequently be transferred into REDCap. No recording of the child’s screen will be collected, nor will their game inputs. As per usual, all information, including links between patient identifiers and study ID, and paper copies of forms and questionnaires, will be stored and double-locked in a cabinet for 7 years (starting from the end of the trial) at the principal investigator’s office at the research center. This trial was approved by the research and ethics board of the Centre Hospitalier Universitaire Sainte-Justine (#2024‐5983). The participants received no compensation.

The literature reports that some VR games can induce cybersickness, such as nausea or dizziness associated with computer games, especially in younger individuals with motion sickness susceptibility, or in those who have experienced recent headaches [43]. However, the game used in this study was specifically designed for pediatric patients with reduced speed and eye tracking to minimize these side effects. If the participant feels any symptoms, the game will be stopped and the HMD will be removed. Should the participant experience an injury of any kind following the administration of the study intervention or following any other procedure related to this research, they will receive the appropriate care and services required by their condition.

The results of the study could be used to better understand how VR distraction reduces dental anxiety and pain in children with SHCN, as well as the satisfaction of parents, patients, and health care professionals with its use during dental procedures. This study may also lead to more comfortable and less traumatic dental care for pediatric patients. In turn, VR can be a valuable tool for managing anxiety in children, which can be a disturbing and anxiety-inducing experience for both parents and health care professionals during dental procedures.