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临床试验/NCT01784276
NCT01784276已完成不适用

A PILOT AND FEASIBILITY STUDY OF ELECTRONIC SCREEN MEDIA TO REDUCE DENTAL FEAR AMONG CHILDREN WITH AUTISM SPECTRUM DISORDER

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Anxiety

研究概览

简要总结

Specific Aims Our study objective is to investigate if video peer modeling before the visit, plus immersive virtual reality during a preventive dental visit, reduces dental fear and uncooperative behaviors among children with ASD.

SPECIFIC AIM: To pilot and test the feasibility and effectiveness of video peer modeling and immersive virtual reality in reducing dental fear among children with autism undergoing preventive dental visits.

Methods: The investigators will enroll eighty (80) subjects aged 7-17 years with a known diagnosis of autism, who had a history of dental fear, per parental report.

Study hypotheses:

The primary hypotheses of interest are:

(i) The mean change in the Venham Anxiety Score (VAS) over the 4 month period in children with ASD who receive the video intervention (Group B) is different from the mean change in the VAS over the 4-month period in children with ASD in the control group.

(ii) The mean change in the VAS over the 4-month period in children with ASD who receive the immersive VR intervention (Group C) is different from the mean change in the VAS over the 4-month period in children with ASD in the control group.

(iii) The mean change in the VAS over the 4-month period in children with ASD who receive the video intervention plus the immersive VR intervention (Group D) is different from the mean change in the VAS over the 4-month period in children with ASD in the control group.

The secondary hypothesis is:

(i) The mean change in the Venham Behavior Score over the 4-month period in children with ASD in Group D is different from the mean change in the Venham Behavior Score over the 4-month period in children with ASD in Group B or C.

详细描述

Dental care is a significant unmet health care need for children with Autism Spectrum Disorders (ASD). Many children with ASD do not receive dental care because of fear associated with dental procedures; oftentimes they require general anesthesia for regular dental procedures, placing them at risk of associated complications. Many children with ASD have a strong preference for visual stimuli, particularly electronic screen media; this affinity has been utilized in their educational instruction.

Objective: To determine if an innovative strategy using two types of electronic screen media was feasible and beneficial in reducing fear and uncooperative behaviors in children with ASD undergoing dental visits.

Study procedures

For this randomized control study, we will randomize participants into one of 4 groups: a) control group (Group A); b) video peer modeling only group (Group B); c) immersive VR only group (Group C) and d) video peer modeling plus immersive VR group (Group D). All enrolled children will have a pre-visit in the dental clinic, where they will receive usual care and baseline values of all parameters will be obtained. Medical records of all study children will be flagged so that they are identified upon arrival by the RA. In the exam room, the dental assistant will measure their pulse rate using a pulse oximeter. The dentist and RA will complete the Venham Anxiety and Behavioral Scale during the dental procedure for all study children. All study subjects will be scheduled to return for a follow up preventive dental visit in 4-6 months, which is the usual practice at CHB, depending on the child's oral health status. Children assigned to intervention Groups B and D will be mailed a copy of a DVD of the pre-recorded peer modeled visit 4 weeks before the scheduled return for the preventive dental visit. The parents will be asked to review the video with their child to orient them to all stages of the dental visit. In addition, children assigned to Group C and D will be given a virtual reality headset to watch movies or images during the dental visit. Children assigned to Group A (control group) will receive neither the DVD nor VR headset during the visit. We will repeat all measurements during the return visit for all study children.

Participant randomization: Once we identify the entire sample of eligible subjects, we will generate a list of subjects that have enrolled for the study. With the assistance of the statistician, we will do a random allocation of each subject to Group A, B, C or D.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • subjects aged 7-17 years with a known diagnosis of autism, who had a history of dental fear, per parental report.

排除标准

  • children with motor handicaps (e.g. cerebral palsy), and sensory, vision and hearing impairments (as these would have limited their ability to utilize intervention materials);
  • children with parents who did not speak English or Spanish; and
  • children who presented to clinic without their legal guardian.

结局指标

主要结局

Anxiety

时间窗: 6 month

Primary outcome: Anxiety: To assess the subject's level of anxiety, we will use the Venham Anxiety Rating Scale which assigns numerical values to the child's observable behaviors. It consists of 5 behaviorally defined categories that range from 0-5, and higher scores indicate greater levels of anxiety.(ref) The treating dentist and RA will use the Venham Scale to indicate their perception of level of anxiety experienced by the participant during the dental procedure.

次要结局

  • Uncooperative behavior(6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Inyang Isong

MD

Boston Children's Hospital

研究点 (2)

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