Effects of The Virtual Reality "Dream" Game on Anxiety During Dental Procedures in Children (VR-TOOTH): A Pilot Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- The patient recruitment rates and of completion rate of planned procedures
研究概览
简要总结
Introduction. Dental fear and anxiety (DFA) is a condition that affects approximately a quarter of children and adolescents. Lack of patient cooperation due to DFA can create an environment of stress, often obligating dentists to end appointments prematurely. Virtual reality use could improve DFA in children with special health care needs (SHCN) undergoing dental procedures.
Aim. Assess the feasibility and acceptability of VR immersion as a tool to reduce dental fear and anxiety in pediatric special needs patients undergoing dental procedures and gain insight on parents and healthcare providers perspectives on the use of VR during dental appointments.
Methods. This pilot randomized controlled trial study will follow a parallel design including two groups: A control group (clinic's standard care) and an experimental group (virtual reality). Twenty participants will be randomized to either group. Recruitment will be carried out at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary-quaternary care center that mostly serves pediatric patients with SHCN. The experimental group will receive the VR video game Dream designed specifically for this study. It aims at reducing anxiety in children aged 6 to 17 years old by mean of immersive distraction. The VR headset offers children with the ability of viewing the game they are playing in real time while simultaneously obstructing the partial view they would normally have of the procedure. The primary outcome will be assessment of dental fear and anxiety in children using both observation-based proxy assessment with the Venham Anxiety and Behavior Rating Scale (VABRS) and a physiological biomarker such as the level of salivary alpha-amylase. Sociodemographic characteristics, measures of level of satisfaction of parents and healthcare professionals, occurrence of side effects and any deviation from normal procedure length will also be collected. Analysis will be carried out using statistical analysis software SAS (version 9.4; Cary, NC, USA). Descriptive statistics will be conducted for demographic and clinical variables and will be used to present parents and healthcare professionals' satisfaction levels, and also procedural time.
Discussion. The investigators believe that the results of this pilot study will provide a better understanding of the feasibility and effect of VR on DFA in children with SHCN.
详细描述
Background
Dental fear and anxiety (DFA) is a condition that affects approximately 13.3% to 29.3% of children and adolescents, and is a significant cause of patients avoiding dental care. In children, DFA is also associated with a lower oral-health-related quality of life. Although the etiology of DFA is multifactorial, often stemming from both exogenous and endogenous sources, a previous traumatic dental experience is the most predictive factor for DFA. The majority of DFA experienced by adults stems from poor dental experiences as children. These findings highlight the importance of keeping each dental experience a positive one for pediatric patients. Short term distress during appointments that is not managed properly can accumulate into poor dental experiences, and in turn, reinforcing DFA into adulthood. Long term effects of these poor dental experiences as children can lead patients to avoid seeking proper dental care in the future.
Dental patients with special health care needs (SHCN) are defined as patients requiring additional time and special consideration when receiving treatment due to medical, physical, cognitive or developmental conditions. The population includes children with behaviour (e.g. autism spectrum, anxiety, ADHD), congenital (e.g. trisomy 21, congenital heart disease), developmental (e.g. cerebral palsy), systemic (e.g. childhood cancer, sickle cell disease), or cognitive disorders (eg. intellectual disability). Children with SHCN face more barriers to dental care than the overall population. Barriers include external factors (transportation, cost, inadequate dental facilities) and internal factors (fear and poor tolerance). Many children with SHCN are cared for by dentists in the community, or more often times, in hospital dental clinic settings. They likewise experience more anxiety than those without a disability, which can result in more difficult dental visits. The importance in providing well-rounded care and making each dental visit a positive one for pediatric patients with SHCN is crucial in promoting a good oral health routine, as well as improving their oral health into adulthood.
Understanding and assessing DFA in children is important for delivering successful dental care with high satisfaction in this age group. Among the vast assessment method options available today, self-report assessment, parental proxy assessment, observation-based assessment and physiological assessment are the four major types for children with SHCN. Further, salivary alpha-amylase, an enzyme correlated to both adrenaline and noradrenaline, has also been used as a marker for autonomic nervous system activity and stress.
Factors in the dental setting that trigger DFA include the loud sounds of dental instruments, presence of strangers examining the oral cavity, and the fear of pain. Of these, the anticipation and use of local anesthetic injections are by far the main triggers. Although necessary to provide adequate pain control during certain treatments, local anesthetic injections are uncomfortable. For children, the initial injection combined with the feeling of numbness during the procedure is especially distressing. Pharmacological agents, combined with light to moderate sedation, or general anesthesia can also be considered for non-cooperative patients, but they are often time consuming and at a higher cost as well as generating health risks. Audiovisual distractions such as tablets/TV screens have been used as distraction techniques during dental procedures with overall positive results. However, there is a lack of interactivity of these techniques, and as a result, are not enough to distract children from the stressful procedure. Further, lack of patient cooperation due to DFA often requires dentists treating pediatric populations to end appointments prematurely, and sometimes without completion of the planned procedure. Treating an anxious and fearful patient can also create an environment of stress for the clinician and associated dental team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6 to 17 years
- •Received the dentist's recommendation to participate
- •Required to undergo any dental procedure
- •Accompanied by a parent or a legal guardian who can understand, read, and write in either French or English.
排除标准
- •Suffer from epilepsy or any other conditions preventing them from using virtual reality (VR).
结局指标
主要结局
The patient recruitment rates and of completion rate of planned procedures
时间窗: Patient requirement rates and completion rate of planned procedures will be reported throughout study completion (approx 1 year)
The feasibility and acceptability of VR distraction for children with special needs requiring dental procedures will be assessed by recording patient recruitment rates and of completion rate of planned procedures.
Healthcare professional's satisfaction
时间窗: Satisfaction questionnaire is reported by healthcare professional immediately following completion of the dental procedure
Healthcare professional's satisfaction on the intervention and side effects will be assessed using the Visual Analog Scale, (VAS; ranked from 0-10, where 0 is very dissatisfied and 10 in very satisfied) used to answer the 7-item tailored questionnaire.
Anxiety
时间窗: Anxiety scale score is recorded by the operator at the following timepoints: Before the dental procedure to establish baseline; immediately after of completion of dental intervention appointment
Mean difference in dental fear and anxiety score as measured by proxy using the Venham Anxiety and Behavioral Rating Scale
Change in Salivary Alpha-Amylase Concentrations before and after dental procedure
时间窗: Salivary amylase swab will be performed at the following timepoints: Baseline pre-dental procedure; immediately after completion of dental intervention appointment
Mean difference in salivary alpha-amylase concentration results.
Parent's or legal guardian's satisfaction
时间窗: Satisfaction questionnaire is reported by parents immediately following completion of the dental procedure
Parent's or legal guardian's satisfaction on the intervention and side effects will be assessed using the Visual analog Scale, (0-10, where 0 is very dissatisfied and 10 in very satisfied) and following the recommended question by Pediatric Initiatives on Methods, Measurement and Pain Assessment in Clinical Trials (PedIMMPACT): "Considering anxiety relief, side effects and emotional recovery, how satisfied were you with the intervention used to manage dental fear and anxiety experienced by your child?"
次要结局
- Number of rescheduled of procedures(Any need to reschedule procedures immediately after completion of dental intervention appointment)
- Occurrence of side effects(Any occurence in side effects will be recorded at the following timepoints: baseline pre- dental intervention , during the dental intervention, and immediately after completion of dental intervention appointment)
- Length of procedure(The length of the procedure will be noted immediately after completion of the dental intervention appointment)
研究者
Sylvie Le May
Principal Investigator
St. Justine's Hospital
