Sensory Adapted Dental Environments to Enhance Oral Care for Children with and without Dental Fear and Anxiety
Sensory Adapted Dental Environments to Enhance Oral Care for Children with and without Dental Fear and Anxiety
批准号:
10599839
负责人:
Leah I. Stein Duker
金额:
$31.74万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-04-01 至 2024-03-31
关键词:
AnxietyAppointmentAuditoryBehaviorBehavioralCaringChildChild BehaviorChild CareChildhoodClinicClinical TrialsComplementConsumer SatisfactionDentalDental AnxietyDental CareDental ClinicsDentistsDistressElementsEnvironmentExhibitsFluoridesFrightFundingGalvanic Skin ResponseGeneral AnesthesiaGoalsInterventionLos AngelesMediatingMediatorMethodologyModelingModificationNational Institute of Dental and Craniofacial ResearchNoiseOralOral ExaminationOral cavityOral healthOutcomePainParticipantPediatric HospitalsPhasePhysiologicalPilot ProjectsPopulationProceduresProphylactic treatmentProtocols documentationQuality of CareRandomizedReactionResearchResearch DesignRisk FactorsRoleRoot Canal TherapySedation procedureSensoryServicesSiteSmell PerceptionTactileTaste PerceptionTechniquesTestingTouch sensationTreatment EfficacyU-Series Cooperative AgreementsVisualWell in selfWorkacceptability and feasibilityagedanxiety reductionanxiousarmautistic childreneffectiveness trialethnic diversityexperiencehealth related quality of lifeimprovedinnovationintervention costintervention effectnoveloral careprimary outcomeprocedure costrandomized, clinical trialsrecruitresponsesatisfactionsecondary analysissecondary outcomesensory stimulussocial observationssoundtrial planningvideo delivery
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英文摘要
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.
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