The Efficacy of Melatonin Patches on Dental Anxiety in Children A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Modified Child Dental Anxiety Scale
研究概览
简要总结
Statement of Problem:
Dental anxiety significantly impacts dental treatment outcomes, particularly in pediatric patients. Given the side effects associated with current oral anxiolytic medications, there is a need to clinically evaluate safe and natural alternatives, such as melatonin patches, to validate their efficacy.
Aim of Study:
The aim of this study is to evaluate the effect of melatonin patches on reducing dental anxiety in children. Anxiety assessments will be done by recording the pulse rate, blood pressure, and by utilization of the modified child dental anxiety scale in pediatric dental patients.
Materials and Methods:
Fifty two children will be divided into two groups. One group (n=26) will be given two melatonin patches per patient and the other group (n=26) will receive two placebo stickers 30 minutes before dental treatment. Pulse rate, blood pressure and modified child dental anxiety scale will be recorded before and after dental treatment completion as well as after the intervention for both groups.
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, Investigator)
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 5-7 years old.
- •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 melatonin
- •Children who currently use any medication
- •Orphans and special health care needs patient.
研究组 & 干预措施
Group1: Melatonin Patch
Group 1 (n=26): Participants in the intervention group will receive two melatonin patches (each containing 1mg of melatonin, AVEELA, USA) attached to the skin of their forearm 30 minutes prior to their dental appointment according to the manufacturer's instructions. Pulse rate, blood pressure, and modified child dental anxiety scale will be measured prior to patch placement, 30minutes after their placement, after local anesthesia injection, and after completion of invasive dental treatment.
干预措施: Melatonin Patches (Drug)
Group 2: Placebo Group
Group 2 (n=26): The control group will receive two placebo stickers attached to the skin of their forearm at the same time point (30 minutes prior to the appointment). Pulse rate, blood pressure, and modified child dental anxiety scale will be measured prior to patch placement, 30minutes after their placement, after local anesthesia injection, and after completion of invasive dental treatment.
干预措施: Placebo Group (Other)
结局指标
主要结局
Modified Child Dental Anxiety Scale
时间窗: 1 day: from recruitment to end of treatment 1 day.
The child's anxiety will be measured using the five faces version of the modified child dental anxiety scale (MCDAS). It contains five-point Likert scale each corresponding to a smiley face that describe one of the feelings ranging from "relaxed/not worried" (1) to "very worried" (5). This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Blood Pressure
时间窗: 1 day: from recruitment to end of treatment 1 day.
Measuring patients' systolic and diastolic blood pressure using a digital blood pressure scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Pulse rate
时间窗: 1 day: from recruitment to end of treatment 1 day.
Measuring patients' pulse rate using digital pulse oximeter scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
Oxygen Saturation
时间窗: 1 day: from recruitment to end of treatment 1 day.
Measuring patients' oxygen saturation using digital pulse oximeter scale. This will be recorded at baseline (pre-intervention), 30 minutes after melatonin patch placement (peri-operatively phase I), then immediately after local anesthesia injection (peri-operatively phase II), and immediately post-operatively.
次要结局
未报告次要终点
研究者
Nour Wahba
Lecturer of Pediatric Dentistry
Ain Shams University