Evaluation of Sensory Adapted Dental Environment in Reducing Dental Anxiety in Children with Intellectual Disability - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dental anxiety will be measured through physiologic parameters like pulse rate, blood pressure and temperature and scales like Venhams anxiety and cooperation scale and negative dental behavior checklist.
研究概览
简要总结
This study is a randomized, single blind, cluster trial evaluating the effectiveness of Sensory Adapted Dental Environment (SADE) in reducing the negative behaviour and physiological responses of dental anxiety in children and adolescents with mild intellectual disabilities (ID). Children with mild ID will be treated in SADE and regular dental environment (RDE). Dental treatment of typically developing (TD) children will also be done in SADE and RDE. Comparison will be done with TD children. Primary outcomes that will be assessed are physiologic response (pulse rate, blood pressure, temperature), Venham’s anxiety and cooperation scale, negative dental behavior checklist. Secondary outcomes included Frankl behavior rating scale, time taken for dental treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children or adolescents from 3 to 14 years of age.
- •Children or adolescents with confirmed diagnosis of mild intellectual disability (ID), reporting for their first time in need of dental treatment.
- •Typically developing children or adolescents reporting for their first time in need of dental treatment.
- •Children or adolescents who have an accompanying parent/guardian who are able to read or understand the questionnaire in English or Tamil.
- •Children or adolescents having at least one carious lesion either in the primary or permanent molar.
排除标准
- •Children or adolescents having disability such as cleft lip, significant motor impairments (cerebral palsy), or any known genetic, endocrine or metabolic dysfunction that would interfere with the physiological readings being taken.
- •Children or adolescents taking anticholinergic medication.
- •Typically developing (TD) children and adolescents with sibling diagnosed with ID.
结局指标
主要结局
Dental anxiety will be measured through physiologic parameters like pulse rate, blood pressure and temperature and scales like Venhams anxiety and cooperation scale and negative dental behavior checklist.
时间窗: Physiologic parameters and Venhams anxiety and cooperation scale will be measured at 2 points during the first visit at baseline and after completion of the dental treatment which may last upto 60 minutes based on the cooperation of the child. Negative dental behavior checklist will be measured at the first dental visit and will be assessed from the start of the treatment at baseline till the end of the treatment which may last upto 60 minutes based on the cooperation of the child.
次要结局
- Dental behavior using Frankl behavior rating scale.(Frankl behavior rating scale will be assessed in the first visit at baseline & after completion of the dental treatment which may last upto approximately 60 minutes depending upon the cooperation of the child.)
- Time taken for dental treatment(Time taken for dental treatment will be assessed at first visit from the start of the dental treatment till the completion of the dental treatment which may last upto 60 minutes depending upon the cooperation of the child.)