Sensory Adapted Dental Environments to Enhance Oral Care for Children (SADE-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR)
研究概览
简要总结
The goal of this project is to examine the efficacy of a sensory adapted dental environment (SADE) for children who have difficulty tolerating oral care in the dental clinic. The investigators hypothesize that adapting the sensory environment in the dental office by modifying the sounds, sights,and tactile experiences will result in decreased anxiety, increased cooperation, and fewer behavior problems for children with Autism Spectrum Disorders (ASD). This has the potential to contribute to increased child comfort as well as safer, more efficient, and less costly treatment for a large population, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.
详细描述
This project, which builds upon the investigator's previous R34 National Institute of Dental and Craniofacial Research (NIDCR) Planning and Feasibility study, is designed to examine the efficacy of a sensory adapted dental environment (SADE) to enhance oral care for children with autism spectrum disorders (ASD). Children with ASD often exhibit sensory over-responsivity when confronted with experiential aspects of dental visits such as exposure to bright fluorescent lighting, touch in or around the mouth, or the texture and smell of various oral care products. This often results in increased anxiety and negative behavioral responses which hinder the dentist's ability to perform treatment. In the proposed project, the investigators test a SADE intervention designed to reduce children's anxiety and negative responses during oral care.
The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
The specific aims are to conduct a randomized clinical trial in order to:
- Determine if SADE, relative to a regular dental environment (RDE), reduces physiological anxiety and negative responses (behavioral distress, perception of pain, sensory discomfort) during dental cleaning for children with ASD.
- Identify whether physiological anxiety mediates the beneficial effects of the intervention and whether severity of ASD and communication ability, or dental anxiety, sensory over-responsivity, and age act as moderating variables.
- Assess the quality of care and cost effectiveness/savings of the dental cleaning associated with SADE.
Research participants will be 220 ethnically diverse children aged 6-12 years. Using a randomized counterbalanced study design, each child will undergo two dental cleanings four months apart: one dental cleaning in RDE and one dental cleaning in SADE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of autism using ADOS;
- •Parents speak English or Spanish;
- •Have experienced at least one prior dental cleaning;
- •In need of an oral cleaning (no previous cleaning within past four months).
排除标准
- •Cleft palate or other oral condition which makes dental care more difficult than usual practice;
- •Prescription of anti-cholinergic drugs (which may alter EDA);
- •Presence of orthodontia (braces);
- •Significant motor impairment, such as cerebral palsy;
- •Any known genetic, endocrine, or metabolic dysfunctions;
- •Participation in the R34 SADE pilot study;
- •Any medical condition such as significant cardiac problems that would place the individual at increased risk in the study.
结局指标
主要结局
Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR)
时间窗: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.
Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress. Each unique increase \>0.05uS in the EDA waveform is counted as an NS-SCR, indicating a increase in sympathetic nervous system activation; NS-SCRs are measured as a frequency per minute (calculated as the number of NS-SCRs/time).
Electrodermal Activity (EDA) - Skin Conductance Level (SCL)
时间窗: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.
Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress.
Electrodermal Activity (EDA) - Skin Conductance Level (SCL)
时间窗: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.
Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress.
Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR)
时间窗: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.
Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress. Each unique increase \>0.05uS in the EDA waveform is counted as an NS-SCR, indicating a increase in sympathetic nervous system activation; NS-SCRs are measured as a frequency per minute (calculated as the number of NS-SCRs/time).
次要结局
- Children's Dental Behavior Rating Scale (CDBRS)(Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.)
- Faces Pain Scale - Revised(Completed at the end of each dental cleaning (approximately 1-2 minutes))
- Dental Sensory Sensitivity Scale(Completed at the end of each dental cleaning (approximately 3 minutes))
- Anxiety and Cooperation Scale(Completed at the end of each dental cleaning (approximately 1 minute))
- Frankl Scale(Completed at the end of each dental cleaning (approximately 1 minute))
- Duration(Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit)
- Number of Hands Used to Restrain Child(Recorded throughout the dental cleaning (approximately 10-45 minutes))
- Children's Dental Behavior Rating Scale (CDBRS)(Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.)
- Whimper, Cry, Scream Duration(Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.)
- Faces Pain Scale - Revised(Completed at the end of each dental cleaning (approximately 1-2 minutes))
- Whimper, Cry, Scream Frequency(Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.)
- Mouth Movement Frequency(Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.)
- Head Movement Frequency(Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.)
- Dental Sensory Sensitivity Scale(Completed at the end of each dental cleaning (approximately 3 minutes))
- Frankl Scale(Completed at the end of each dental cleaning (approximately 1 minute))
- Anxiety and Cooperation Scale(Completed at the end of each dental cleaning (approximately 1 minute))
- Duration(Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit)
- Number of Hands Used to Restrain Child(Recorded throughout the dental cleaning (approximately 10-45 minutes))
研究者
Sharon Cermak
Professor
University of Southern California