Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Physiologic arousal states
研究概览
简要总结
The objective of the present study is to determine the effect of sensory adapted dental environment (SADE) in healthy children during a routine dental restorative treatment. The hypothesis is that the SADE would have a favorable effect in calming the subjects during dental treatment.
the study is a random cross-over design. The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive regular dental environment (RDE) on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).
详细描述
- Dental treatment- will include restorations, crowns, pulp treatment, with local anesthesia. The use of oral/inhaled sedation will be decided according to the patient's behavior and cooperation assessment.
- Dental settings- The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers. The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.
- Instruments- 1) the children will be observed during the treatments. The observer will code all behaviors according to the Houpt Scale used for rating patient behavior during treatment. In addition, the examiner will count the number and duration (in minutes) of the anxious behavior (crying and movements). Because of the nature of the study (one environment with sensory adaptation and the other without), the observer cannot be blind to the treatment environment. 2) Physiologic arousal states, evaluated by the assessment of EDA (Mindlife Co, Jerusalem, Israel). Changes in the electrical conductance of the skin are a sensitive way of monitoring autonomic responses to external stimuli.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Needs at least 2 similar dental treatment appointments
排除标准
- •Needs only one dental treatment
结局指标
主要结局
Physiologic arousal states
时间窗: Data will be reported through study completion, an average of 2 years
Evaluated by palmar electrodermal activity (EDA) during dental treatment
次要结局
- Anxious behavior-duration(Data will be reported through study completion, an average of 2 years)
- Houpt Scale(Data will be reported through study completion, an average of 2 years)
- Anxious behavior-number(Data will be reported through study completion, an average of 2 years)
研究者
Avia Fux
pediatric dentist
Hadassah Medical Organization