A Virtual Dental Office Experience for Children With Autism Spectrum Disorder - A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Dental visit "completeness"
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of virtual reality (360° video) compared to a social story for reducing pre-visit dental anxiety for children with autism spectrum disorder (ASD) improve the dental visit experience for children, their families, and clinicians. The secondary objective is to perform a cost comparison analysis of the 360° video product as compared to a social story for Holland Bloorview's dental clinic.
详细描述
Participation in this research study will include daily at-home use of either the 360° video (experimental condition) or social story (control condition) for seven days prior to participant's first visit to the dental clinic, as well as parent, child, and dental clinician questionnaires. Both pre-visit experiences will be delivered remotely, in-home, and through the use of a study-provided tablet. Participants will be asked to access the pre-visit experience exclusively through use of the study-provided tablet, and to document daily use of the tablet experience on a Daily Journal log provided to families with the tablet. Tablets will have the assigned pre-visit experience pre-loaded (360° video or social story) and will be locked with a passcode, to ensure that participants do not engage with the tablet or pre-visit experience prior to 7-days before their dental visit. Tablets and pre-visit questionnaires will be mailed out to families two weeks prior to their onsite dental appointment. One week plus one business day prior to their initial dental visit at Holland Bloorview, families will be contacted by telephone to provide them with the tablet passcode so participants can access their assigned pre-visit experience (360° video or social story) and to remind them of the study protocol. Parents can be provided with a copy of the instructions by email as well if participants prefer, however, tablet passcodes will only be provided over the telephone.
Randomization This will be a single-blinded study, whereby participants will know which experimental group participants have been allocated to, but the dental clinician will not. Research study staff will also be aware of participant allocation.
Experimental Condition (360° Video) The 360° video has been developed by Shaftesbury Films in consultation with Holland Bloorview dental, research study staff, and family advisors. The 360° video is from the point of view of a seated dental client and the participant will be able to explore the scene around them (navigating through the tablet's touch screen). The simulation will include scenes/features that may be anxiety-provoking for some participants. These will include loud noises commonly encountered in the dentist's office (e.g. tooth brushing, dental drills), as well as social stimuli (e.g. the dental clinician), and new environments (e.g., the dental visit room). The investigators will ensure that participants understand that they can stop at any time (e.g., if participants are feeling anxious or overwhelmed), and the investigators will ask parents to explore the 360° video with their child.
Control Condition (Social Story) The control condition is a social story, which is treatment as usual for preparing clients for their initial visit at Holland Bloorview's dental clinic. As for the experimental condition, the control condition will be delivered through the study tablet. The investigators will ask parents to read it to their child once a day for the week leading up to their appointment. If the child is reading on their own, the investigators will request that parents be in the room with participants. The social story takes approximately five minutes to read.
PRE-DENTAL VISIT
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
- Single (Care Provider)
入排标准
- 年龄范围
- 4 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A community diagnosis of ASD
- •Aged 4-12
- •First time client of Holland Bloorview dental (has not previously received dental services at Holland Bloorview dental)
- •Dental appointment at least 3 weeks away from time of initial contact
- •Parent-predicted difficulty for child to sit through entire dental appointment
排除标准
- •Parent predicts no difficulty for child to sitting through entire dental appointment
研究组 & 干预措施
Experimental Condition (360° Video)
The 360° video (experimental) group will be mailed a study tablet with the 360° video prior to the dental visit.
干预措施: Experimental Condition (360° Video) (Device)
Control Condition (Social Story)
The treatment-as-usual (control) group will be mailed a study tablet with a social story prior to the dental visit.
干预措施: Control Condition (Social Story) (Device)
结局指标
主要结局
Dental visit "completeness"
时间窗: During the dental appointment
The investigators will compare the difference in the number of children who complete each stage of the appointment between the two intervention groups using the clinician-rated, post-visit questionnaire. This questionnaire assesses a five-step checklist of visit completeness (1 = Waiting room, 2 = Sitting in dental chair, 3 = Teeth counting, 4 = Teeth cleaning, and 5 = Fluoride painting).
次要结局
- Pre-visit anxiety(Immediately preceding dental appointment)
研究者
Azadeh Kushki
Senior Scientist
Holland Bloorview Kids Rehabilitation Hospital
