Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety

Обзор

This study is a randomized clinical trial investigating the effectiveness of a Sensory Adapted Dental Environment (SADE) alone and together with a video-based modeling (VBM) component (VBM-SADE), compared to a regular dental environment (RDE) and/or VBM alone, to reduce anxiety, distress behavior, pain, and sensory discomfort during a dental cleaning in children with and without dental fear and anxiety.

Вмешательства

• Другое Sensory Adapted Dental Environment
  The SADE condition consists of physical adaptations (visual, auditory, tactile modifications) to the dental environment meant to create a less anxiety-provoking sensory experience. Direct overhead fluorescent lighting and the regular dental overhead lamp will be turned off and darkening curtains will cover the windows. Adapted lighting will include slow moving visual color effects (Snoezelen) shining on the ceiling in the child's visual field. The dentist will wear a surgical dental headlamp dir
• Другое Video-based Modeling
  Participants will watch an approximately 5-minute video depicting a dental cleaning being performed on a sex and age-matched cooperative child, designed to expose the participant to the activities of the dental cleaning and thereby create a less anxiety-provoking dental experience.

Первичные конечные точки

• Electrodermal Activity (EDA; Skin Conductance Level [SCL]) [Срок оценки: Periprocedural]
• Electrodermal Activity (EDA; Non-specific Skin Conductance Responses [NS-SCR]) [Срок оценки: Periprocedural]
• Frequency of Distress Behaviors [Срок оценки: Periprocedural]
• Duration of Distress Behaviors [Срок оценки: Periprocedural]

Вторичные конечные точки (12)

• Frankl Scale [Срок оценки: Collected immediately after each dental cleaning]
• Anxiety and Cooperation Scale [Срок оценки: Collected immediately after each dental cleaning]
• Wong Baker Faces Pain Scale [Срок оценки: Collected immediately after each dental cleaning]
• Dental Sensory Sensitivity Scale [Срок оценки: Collected immediately after each dental cleaning]
• Subjective Thoroughness of Cleaning Scale [Срок оценки: Collected immediately after each dental cleaning]
• Client Satisfaction Questionnaire [Срок оценки: Collected immediately after each dental cleaning]
• Child Intervention Experience Form [Срок оценки: Collected immediately after each dental cleaning]
• Caregiver Intervention Experience Form [Срок оценки: Collected immediately after each dental cleaning]
• Dentist Intervention Experience Form [Срок оценки: Collected immediately after each dental cleaning]
• State-Trait Anxiety Inventory - Short Form [Срок оценки: Collected immediately after each dental cleaning]
• Stress Appraisal Measure [Срок оценки: Collected immediately after each dental cleaning]
• Semi-Structured Interview of Dentists [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Male or female, aged 6 through 12 years, of any race/ethnicity;
• English- or Spanish-speaking child and parent;
• Have experienced at least one prior dental cleaning;
• If recruited from the emergency department, Emergency Severity Index (ESI) must be level V or IV (to ensure that greater severity PED patients not be recruited).

Критерии исключения

• Dental cleaning within the previous 4 months (i.e., not in need of cleaning);
• Plan to move out of the area within 6 months;
• Intellectual or developmental disability (e.g. autism; highly co-morbid with sensory processing difficulties);
• Disability that would interfere with oral care (e.g. cleft lip/palate, cerebral palsy, genetic/endocrine/metabolic dysfunction) or medical condition that would place the child at increased risk during the study (e.g., uncontrollable seizures);
• Daily use of anti-cholinergic drugs (i.e., interferes with EDA recordings);
• Presence of orthodontia (braces) or with a plan to get braces in the upcoming 6 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT06912854 · CHLA-24-00096 · UH3DE031222

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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