跳至主要内容
临床试验/NCT06182462
NCT06182462招募中不适用

The Effects of A Virtual Reality Game on Anxiety During Dental Procedures in Children (VR-TOOTH): A Randomized, Controlled Trial Protocol

St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
88
试验地点
2
主要终点
Anxiety

研究概览

简要总结

The aim of this randomized clinical trial is to verify the efficacy of VR immersion over a muted cartoon on a wall-mounted TV to decrease dental fear and anxiety of children undergoing dental procedures. The study also aims to gain insight on the satisfaction of parents and healthcare providers on the use of VR during dental appointments.

Main research question: Does VR immersion compare to a cartoon on a wall-mounted TV is more efficacious to decrease dental fear and anxiety of children requiring dental procedures?

Participants will be playing through a VR immersive game wearing a eye-tracking VR headset that requires no movement of the head to play, facilitating the dental procedure.

The investigators will take measures of the stress levels of participants and their parents using a validated stress scale and also by taking salivary samples to verify the levels of a stress biomarker (alpha-amylase).

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, 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. Short term distress during appointments that is not managed properly can accumulate into poor dental experiences, and in turn, reinforcing DFA into adulthood.

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 or multiple reports of visits.

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 of measures for children with SHCN. Further, salivary alpha-amylase, an enzyme correlated to both adrenaline and noradrenaline, has also been used as a biomarker 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

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,
  • Paralysis or paresis of the hand
  • Has any diagnosed eye disease/problem,
  • Any other conditions preventing them from using virtual reality (VR) (e.g., epidermolysis bullosa).

结局指标

主要结局

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 the completion of dental intervention appointment

To evaluate and observe preliminary effects of VR distraction, we will be using the Venham Anxiety and Behavioural Scale (VABRS). It is an observation-based assessment by proxy for dental fear and anxiety and are among the most frequent behavior scoring models for DFA. It is composed of two scales used to assess the anxiety and uncooperative behavior of children in the dental setting. Both scales consist of a 6-point scale, with 6 defined behavioral levels that range from 0 to 5. The highest score defines the highest anxiety level or lack of cooperation.

次要结局

  • Salivary alpha-amylase(Salivary Alpha-Amylase will be measured immediately before and 10-minutes after the procedure)
  • Length of procedure in minutes(Reported immediately after the procedure.)
  • Healthcare professional's satisfaction(Satisfaction questionnaire is reported by healthcare professional immediately following completion of the dental procedure)
  • Heart rate in beats per minute(Heart rate will be measured immediately before the procedure and for the entire duration of the procedure (Approximately 30-60 minutes))
  • Oxygen saturation(Oxygen saturation will be measured immediately before the procedure and for the entire duration of the prodedure (Approximately 30-60 minutes))
  • Parent's or legal guardian satisfaction(Satisfaction questionnaire is reported by parents immediately following completion of the dental procedure)
  • Occurrence of side effects(Any side effects will be noted along with the time at which they occurred during the procedure.)
  • Intervention completion(Intervention completion will also be documented by the research assistant at the end of the dental procedure.)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Le May

Principal Investigator

St. Justine's Hospital

研究点 (2)

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