To Compare And Evaluate The Effectiveness Of Three Different Distraction Methods In Combating Children Dental Anxiety And Fear By Assessing Psychological And Physiological Parameters: A Randomized Clinical 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
- Expected outcome in general, is to help combat dental anxiety and fear among children, so that they grow into adults who arent fearful of getting any dental treatment done on themselves in the future upon requirement
研究概览
简要总结
This study is basically being performed to compare the effectiveness of using three different behaviour modification techniques, to reduce dental anxiety and fear in children who are visiting a dental clinic for the first time.
The three non-pharmacological methods of behaviour management being employed are:
Visual-distraction,
Thaumaturgic-distraction and
Audio-distraction
Anxiety levels in children will be assessed at baseline, before and after treatment, by the use of the Chotta Bheem Chutki Scale,Dental fear will be assessed at baseline, before and after treatment by the use of Traffic Light Color Codes and measurement of hemodynamic parameters ( oxygen saturation rate, heart rate, breathing rate and sweating), and biochemical analysis of salivary biomarkers (viz.- alpha amylase) from collected samples of unstimulated saliva.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children within age group of 6-10 years, having their first dental visit.
- •Children who fall under the American Society of Anaesthesiology (ASA) category I (defined as normal healthy patient).
- •Guardians and Children who are willing to participate in the study.
- •Children without any systemic and mental disorders.
- •Children who require oral prophylaxis treatment.
排除标准
- •Children with special healthcare needs.
- •Guardians or children who refused to participate in the study.
- •A child having carious or cavity lesion, in any of the teeth requiring restoration or any treatment other than oral prophylaxis.
- •Emergency needs such as a drainage of abscess or extraction.
- •Children with a previous history of painful invasive dental procedures.
- •Children who did not have parental consent.
结局指标
主要结局
Expected outcome in general, is to help combat dental anxiety and fear among children, so that they grow into adults who arent fearful of getting any dental treatment done on themselves in the future upon requirement
时间窗: Baseline
次要结局
- Expectation is to develop a society of individuals who donot fear and become anxious in the dental environment so as to have lower prevelance of dental problems in the future(10 weeks)
研究者
Dr Manash Pratim Baruah
Sardar Patel Post Graduate Institute of Dental and Medical Sciences