Effects of Clown therapy in children with Down Syndrome: A Randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduction in dental anxiety assessed using objective assessment of anxiety(pulse rate)
研究概览
简要总结
Aim: The aim of the study is to assess the effects of presence of a medical clown on the dental anxiety of children with Down’s Syndrome during dental treatment.
Methodology: Children fulfilling the inclusion criteria will be randomly allocated to one of the two groups and prior to the start of the study, a written consent will be obtained from the parents or guardians after explaining them about the study procedure. For both the groups pulse rate will be recorded at baseline, during treatment, after treatment. Use of Venham’s anxiety scale by a separate operator before and after treatment will be recorded. Group A (control group) treatment will be delivered without the presence of a medical clown. Group B (intervention group) treatment will be delivered with the presence of a medical clown; with frequent interaction of the child with the medical clown during the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of age 5 to 12 years diagnosed with Down Syndrome requiring oral prophylaxis, fluoride varnish application and minor restorations, parents/guardians willing to give consent for the study.
排除标准
- •History of seizures, convulsion disorders, vertigo, visual or hearing impairments.
- •Severe or profound intellectual disability Pain or swelling in the oral cavity Patients requiring emergency treatment.
结局指标
主要结局
reduction in dental anxiety assessed using objective assessment of anxiety(pulse rate)
时间窗: during treatment and post treatment
次要结局
- subjective assessment of dental anxiety(pre and post treatment)
研究者
Dr Sonal Mali
D.Y. Patil University School of Dentistry