Sensory Adapted Dental Environments to Enhance Oral Care for Children with and without Dental Fear and Anxiety

感官适应的牙科环境可增强有或没有牙科恐惧和焦虑的儿童的口腔护理

• 批准号: 10599839
• 负责人: Leah I. Stein Duker
• 金额: $ 31.74万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10599839
• 关键词: Anxiety; Appointment; Auditory; Behavior; Behavioral; Caring; Child; Child Behavior; Child Care; Childhood; Clinic; Clinical Trials; Complement; Consumer Satisfaction; Dental; Dental Anxiety; Dental Care; Dental Clinics; Dentists; Distress; Elements; Environment; Exhibits; Fluorides; Fright; Funding; Galvanic Skin Response; General Anesthesia; Goals; Intervention; Los Angeles; Mediating; Mediator; Methodology; Modeling; Modification; National Institute of Dental and Craniofacial Research; Noise; Oral; Oral Examination; Oral cavity; Oral health; Outcome; Pain; Participant; Pediatric Hospitals; Phase; Physiological; Pilot Projects; Population; Procedures; Prophylactic treatment; Protocols documentation; Quality of Care; Randomized; Reaction; Research; Research Design; Risk Factors; Role; Root Canal Therapy; Sedation procedure; Sensory; Services; Site; Smell Perception; Tactile; Taste Perception; Techniques; Testing; Touch sensation; Treatment Efficacy; U-Series Cooperative Agreements; Visual; Well in self; Work; acceptability and feasibility; aged; anxiety reduction; anxious; arm; autistic children; effectiveness trial; ethnic diversity; experience; health related quality of life; improved; innovation; intervention cost; intervention effect; novel; oral care; primary outcome; procedure cost; randomized, clinical trials; recruit; response; satisfaction; secondary analysis; secondary outcome; sensory stimulus; social observations; sound; trial planning; video delivery

PROJECT SUMMARY/ABSTRACT Dental fear and anxiety (DFA) characterizes up to 42% of the pediatric population and predicts negative behaviors in the dental clinic, irregular appointment attendance, need for general anesthesia, and poor oral health. Sensory over-responsivity (SOR), which occurs in up to 33% of the pediatric population, is a likely contributor to DFA and may also occur independently from DFA. In the dental clinic, children with SOR may exhibit behavioral overreactions to lights, sounds, touch, and other sensory stimuli, leading to disruptive behaviors akin to those associated with DFA. This project will test the Sensory Adapted Dental Environment (SADE), a novel intervention which provides soothing visual, auditory, and tactile input to reduce children’s anxiety or fear during dental treatment. In our previous NIDCR-funded R34 study, SADE reduced physiological anxiety and behavioral distress in both children with autism and typically developing children. Because SADE utilizes sensory modifications as its key active ingredient, it complements – and could be combined with – anxiety-reducing strategies such as modeling, a strategy based on social observation and imitation. Research participants will be 312 ethnically diverse children aged 6-12 years, 156 with DFA and 156 without. Using a randomized counterbalanced study design, each child will undergo two dental cleanings 4-6 months apart in two of four conditions: SADE in conjunction with video-based modeling (SADE-VBM), SADE alone (SADE), video-based modeling alone (VBM), and a regular dental environment (RDE). As acceptability and feasibility of the SADE intervention and procedures have been established in our pilot work, in our UG3 planning phase we will assess only the three new elements of the proposed study – content and delivery of VBM videos, use of a weighted blanket, and recruitment techniques in new settings. In the UH3 phase, the specific aims are to conduct a randomized clinical trial to: test SADE-VBM, SADE, VBM, and RDE’s relative effects on physiological anxiety and behavioral distress during dental cleaning, as well as on secondary outcomes (Aim 1); assess whether physiological anxiety mediates each interventions’ effect on behavioral distress, and if DFA and SOR moderate intervention effects on physiological anxiety and behavioral distress (Aim 2); and conduct exploratory analyses to examine DFA and SOR’s unique and interactive contributions to overall levels of in-clinic physiological anxiety and behavioral distress, the intervention’s cost implications, and other methodological issues such as treatment sequencing effects (Aim 3). This project is significant because it is the first full-scale RCT of a sensory adapted intervention to modify the dental environment for typically developing children. Completion of the study aims will enable refinement of the SADE-based approach to provide a simple, inexpensive, and highly scalable treatment model that we will later test in a multi-site effectiveness trial. Long-term project outcomes will have excellent potential to benefit countless children in the US who manifest disruptive anxiety reactions in the dental clinic.

项目总结/摘要 牙科恐惧和焦虑（DFA）的特点高达42%的儿童人口和预测消极的 在牙科诊所的行为，不规则的预约出席，需要全身麻醉，和口腔不良 健康感觉过度反应（SOR），发生在高达33%的儿科人群，是一个可能的 也可以独立于DFA发生。在牙科诊所，患有SOR的儿童可能 对光线、声音、触觉和其他感官刺激表现出行为过度反应，导致破坏性 与DFA相关的行为类似。本项目将测试感官适应牙科环境 （SADE），一种新的干预措施，提供舒缓的视觉，听觉和触觉输入，以减少儿童的 牙科治疗期间的焦虑或恐惧。在我们之前的NIDCR资助的R34研究中，SADE降低了生理性 自闭症儿童和正常发育儿童的焦虑和行为困扰。因为SADE 利用感官修饰作为其关键活性成分，它补充-并可与- 减少焦虑的策略，如模仿，一种基于社会观察和模仿的策略。 研究参与者将是312名6-12岁的不同种族的儿童，156名患有DFA，156名 没有.使用随机平衡研究设计，每个儿童将接受两次牙齿清洁4-6 在四种情况中的两种情况下间隔两个月：SADE与基于视频的建模（SADE-VBM），SADE 单独（SADE）、单独基于视频的建模（VBM）和常规牙科环境（RDE）。 由于我们的SADE干预措施和程序的可接受性和可行性已经确立， 在第三次政府研究报告的策划阶段，我们只会评估建议研究的三项新内容： VBM视频的内容和交付，加权毯子的使用，以及新环境中的招聘技术。 在UH 3阶段，具体目标是进行一项随机临床试验，以：检测SADE-VBM， SADE、VBM和RDE对牙科治疗期间生理焦虑和行为困扰的相对影响 清洁，以及次要结果（目标1）;评估生理焦虑是否介导每个 干预对行为困扰的影响，以及DFA和SOR是否适度干预对生理困扰的影响。 焦虑和行为困扰（目标2）;并进行探索性分析，以检查DFA和SOR的独特 和互动的贡献，整体水平的临床生理焦虑和行为困扰， 干预的成本影响，以及其他方法学问题，如治疗顺序效应（目标3）。 该项目意义重大，因为它是第一个全面的感觉适应性干预RCT， 发育中的儿童的牙齿环境。研究目标的完成将使 基于SADE的方法提供了一个简单、廉价和高度可扩展的治疗模型，我们将 随后在多中心有效性试验中进行测试。长期项目成果将具有良好的受益潜力 美国有无数儿童在牙科诊所表现出破坏性的焦虑反应。