The Efficacy of Chamomile Gummies on Dental Anxiety in Children A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Assessment of anxiety
研究概览
简要总结
The aim of this study is to evaluate the effect of oral chamomile on reducing dental anxiety in children. Anxiety assessments will be done by recording the pulse rate and blood pressure and by using modified child dental anxiety scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients exhibiting Frankl's behavior rating grade III or IV.
- •Children requiring invasive dental treatment in their primary teeth
排除标准
- •Patients with severe dental symptoms (e.g. spontaneous pain, pain not relieved by analgesics).
- •History of allergy to local anesthesia
- •Children who currently use any medication
研究组 & 干预措施
intervention group
Participants in the intervention group will receive one chamomile gummy to chew approximately 30 minutes prior to their dental appointment. The gummy used in this study was Zarbee's Gentle Bedtime Gummies for Kids (Zarbee's Inc., USA).
干预措施: chamomile gummy (Drug)
The control group
The control group will receive a multivitamin gummy, as a placebo, administered at the same time point (30 minutes prior to the appointment)
干预措施: a multivitamin gummy (Dietary Supplement)
结局指标
主要结局
Assessment of anxiety
时间窗: 1st measurement before gummy chewing and swallowing 2nd measurement 30 mins after gummy swallowing 3rd measurement after local anesthesia injection 4th measurement after completion of dental work one dental visit
Anxiety assessments will be done using: 3) Modified Child Dental Anxiety Scale:
次要结局
未报告次要终点