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.

项目概要/摘要 高达 42% 的儿科人群有牙科恐惧和焦虑 (DFA) 的特征，并预测负面影响 牙科诊所的行为、不规律的预约出勤、需要全身麻醉以及口腔不良 高达 33% 的儿科人群可能会出现感觉过度反应 (SOR)。 导致 DFA 的因素，也可能独立于 DFA 发生 在牙科诊所，患有 SOR 的儿童可能会出现这种情况。 行为表现出对光、声音、触摸和其他感官刺激的过度反应，导致破坏性的 与 DFA 相关的行为类似 该项目将测试感官适应牙科环境。 （SADE），一种新颖的干预措施，提供舒缓的视觉、听觉和触觉输入，以减少儿童的 在我们之前 NIDCR 资助的 R34 研究中，SADE 降低了牙科治疗期间的焦虑或恐惧。 自闭症儿童和正常发育儿童的焦虑和行为困扰都是因为 SADE。 利用感官修饰作为其关键活性成分，它补充 - 并可以与 - 减少焦虑的策略，例如建模，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 岁的不同种族儿童，其中 156 名拥有 DFA，156 名拥有 DFA 的儿童 使用随机平衡研究设计，每个孩子将接受两次牙齿清洁 4-6。 在四种情况中的两种情况下相隔数月：SADE 与基于视频的建模 (SADE-VBM) 结合使用、SADE 单独的（SADE）、单独基于视频的建模（VBM）和常规牙科环境（RDE）。 由于 SADE 干预和程序的可接受性和可行性已在我们的 在试点工作中，在 UG3 规划阶段，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、加权毯子的使用以及新环境中的招募技术。 在UH3阶段，具体目标是进行随机临床试验：测试SADE-VBM， SADE、VBM 和 RDE 对牙科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结果 干预对行为困扰的影响，以及 DFA 和 SOR 是否适度干预对生理的影响 焦虑和行为困扰（目标 2）；并进行探索性分析以检验 DFA 和 SOR 的独特性 以及对临床生理焦虑​​和行为困扰总体水平的交互贡献， 干预的成本影响以及其他方法问题，例如治疗顺序效应（目标 3）。 该项目意义重大，因为它是第一个针对感官适应干预的全面随机对照试验，旨在改变 完成研究目标将有助于改善正常发育儿童的牙科环境。 基于 SADE 的方法提供简单、廉价且高度可扩展的治疗模型，我们将 稍后在多地点有效性试验中进行的测试将具有巨大的受益潜力。 在美国，无数儿童在牙科诊所表现出破坏性焦虑反应。