The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Children's pain perception during dental treatment
研究概览
简要总结
The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.
This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 6 and 12 years and their accompanying parent/legal-guardian.
- •Children scheduled for one of the following procedures: restorative treatments (amalgam, composite or stainless-steel crowns), pulp therapy and extractions
- •Children that can understand and speak French or English.
排除标准
- •Children diagnosed with a cognitive, auditory, or cognitive impairment preventing them from interacting with the VR game.
- •Children diagnosed with epilepsy or any other condition preventing them from playing the VR game.
- •Children requiring urgent dental care
- •Children requiring dental treatment with conscious sedation (i.e. nitrous oxide inhalation and/or oral sedation with benzodiazepines)
结局指标
主要结局
Children's pain perception during dental treatment
时间窗: Baseline
Children's perception of pain during dental treatment will be assessed by the Wong- Baker FACES scale. The 'Face, Legs, Activity, Cry, Consolability' (FLACC), a common behavioral pain external observation scale, will also be used. Higher the score more discomfort and pain experienced by the patient.
Children's fear during dental treatment
时间窗: Baseline
The Child Fear Scale will be used to assess the anxiety felt by the participants during dental treatment
次要结局
- Oral health care provider's acceptability of virtual reality during dental care(Baseline)
- Children's acceptability of virtual reality intervention during dental care(Baseline)
研究者
Beatriz Ferraz dos Santos
Pediatric dentist; research director
McGill University Health Centre/Research Institute of the McGill University Health Centre