The Impact of Dental Anxiety Coping Module on Children With Dental Anxiety: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) score
研究概览
简要总结
The aim of this study is to evaluate the impact of the Dental Anxiety Coping Module (DACM) in children with dental anxiety. The main questions to answer are:
- Will the Dental Anxiety Coping Module has any effect on dental anxiety in primary school children based on MY-ACDAS and HRV-Biofeedback?
- Is there any difference in dental anxiety between control and intervention group on baseline and post-test measured with MY-ACDAS?
- Is there any difference in dental anxiety between control and intervention group on baseline, during and post-test measured with and HRV-Biofeedback?
详细描述
Dental Anxiety Coping Module (DACM) is a combination of Dental Tour and Expressive Art Therapy. Participants will be randomised into 2 groups, Control group and Intervention group (with DACM). Control group will have dental procedure without any intervention. While the Intervention group will start with dental tour where they will be shown around the dental clinic followed by Expressive Art Therapy where they will have collage and finger painting done. After DACM, participants will continue with the same dental procedure as the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Malaysian child, age 7 to 11 years old that understand basic Malay and English language.
- •Children that fulfil both MY-ACDAS score 26 and above and HRV-Biofeedback of very low coherence score (incoherence).
- •Children with American Society of Anaesthesiologists (ASA) I and ASA II classification.
排除标准
- •Children requiring emergency treatment such as pain, facial cellulitis, and trauma cases.
- •Child with learning disabilities, hearing, or visual impairment, developmental or intellectual disability and cognitive impairment.
- •Parents/guardians who refuse to allow their child to participate in this trial.
研究组 & 干预措施
Control group
Baseline MY-ACDAS and HRV-Biofeedback assessment followed with dental procedures (dental charting and oral prophylaxis). HRV-Biofeedback will be recorded during dental procedures. Once completed, post dental procedures assessment of MY-ACDAS and HRV-Biofeedback will be recorded.
Intervention group
Baseline MY-ACDAS and HRV-Biofeedback assessment followed Dental Anxiety Coping Module. The participants will continue with dental procedures (dental charting and oral prophylaxis). HRV-Biofeedback will be recorded during dental procedures. Once completed, post dental procedures assessment of MY-ACDAS and HRV-Biofeedback will be recorded.
干预措施: Dental Anxiety Coping Module (Behavioral)
结局指标
主要结局
Changes in Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) score
时间窗: Before intervention and dental procedure and immediately afterwards on the same day
Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) range value from 13-39, a child is considered anxious if his/her overall score is equal or more than 26. Hence participant that score 26 and above considered having dental anxiety and will be included in the study
次要结局
- Changes in HRV-Biofeedback coherence(Before intervention and dental procedure, during dental procedure and immediately afterwards on the same day)