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: 10347192
• 负责人: Sharon Andrea Cermak
• 金额: $ 34.62万
• 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/10347192
• 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 of activation protein; 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; Randomized Clinical Trials; 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; anxious; arm; autistic children; base; effectiveness trial; ethnic diversity; experience; health related quality of life; improved; innovation; intervention cost; intervention effect; novel; oral care; primary outcome; procedure cost; recruit; response; satisfaction; scientific organization; secondary analysis; secondary outcome; sensory stimulus; social observations; sound; 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.

项目摘要/摘要 牙齿恐惧和动画（DFA）角色多达42％的小儿人群，并预测负面 牙科诊所的行为，不规则的任命出勤，全身麻醉的需求和口腔差 健康。感官过度反应性（SOR）发生在多达33％的小儿种群中，可能是 DFA的贡献者，也可能独立于DFA。在牙科诊所，患有SOR的儿童可能 表现出对灯，声音，触摸和其他感觉刺激的行为过度反应，导致破坏性 类似于与DFA相关的行为。该项目将测试感官适应的牙齿环境 （Sade），一种新颖的干预措施，可提供舒缓的视觉，听觉和触觉输入，以减少儿童 牙科治疗期间的焦虑或恐惧。在我们以前由NIDCR资助的R34研究中，Sade降低了生理 患有自闭症和通常患有儿童的孩子的焦虑和行为困扰。因为萨德 利用感觉修改作为其关键的活动成分，它可以完成 - 可以与 - 可以结合使用 - 减轻焦虑的策略，例如建模，基于社会观察和模仿的策略。 研究参与者将是312名6-12岁的种族多样化的儿童，DFA和156 没有。使用随机平衡研究设计，每个孩子将接受两种牙齿清洁4-6 在四个条件中的两个情况下，几个月：与基于视频的建模（sade-vbm）结合使用SADE，SADE 单独（SADE），基于视频的建模（VBM）和常规的牙科环境（RDE）。 由于我们的萨德干预和程序的可接受性和可行性已在我们 试点工作，在我们的UG3计划阶段，我们将仅评估拟议研究的三个新要素 - VBM视频的内容和交付，使用加权毯子以及在新环境中招募技术。 在UH3阶段，具体的目的是进行一项随机临床试验：测试sade-vbm， Sade，vbm和RDE对牙齿期间身体动画和行为困扰的相对影响 清洁以及次要结果（AIM 1）；评估身体焦虑是否介导每个 干预措施对行为困扰的影响，以及DFA和SOR中度干预对生理的影响 动画和行为困扰（目标2）；并进行探索性分析以检查DFA和SOR的独特 以及互动贡献对临界生理动画和行为困扰的整体水平 干预的成本影响以及其他方法论问题，例如治疗测序效应（AIM 3）。 该项目很重要，因为它是感官适应干预措施的第一个全尺度RCT来修改 通常开发儿童的牙科环境。研究目的的完成将使您能够完善 基于Sade的方法，提供了一种简单，廉价且高度可扩展的治疗模型 后来在一项多站点有效性试验中进行测试。长期项目成果将具有巨大的利益潜力 在美国，无数的儿童表现出牙科诊所的破坏性焦虑反应。