The Effect of Lemongrass and Lavender Aromatherapy on Dental Anxiety and Pain Perception in Children Undergoing Local Anesthetic Administration: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- anxiety level
研究概览
简要总结
The goal of this clinical trial is to evaluate whether aromatherapy using lemongrass or lavender essential oils can reduce dental anxiety and pain perception in children aged 7-11 years undergoing local anesthetic administration in a pediatric dental setting.
The main questions it aims to answer are:
Does lemongrass or lavender aromatherapy reduce anxiety levels, as measured by salivary cortisol, in children receiving local anesthesia?
Does aromatherapy influence pain perception and physiological stress (heart rate) during the procedure?
Researchers will compare a lavender aromatherapy group, a lemongrass aromatherapy group, and a control group without aromatherapy to see if the essential oils have a calming effect that reduces anxiety and pain compared to no intervention.
Participants will:
Inhale either lavender, lemongrass, or no essential oil (control) for two minutes via nebulizer.
Undergo local anesthesia administration for a dental procedure.
Provide unstimulated and stimulated saliva samples before and after the procedure for cortisol analysis.
Report their pain level using the Wong-Baker Faces Pain Rating Scale.
Have their heart rate measured before and after the procedure using a finger-type pulse oximeter.
详细描述
Dental anxiety is a common behavioral challenge in pediatric dentistry and can significantly influence the quality of dental care, potentially leading to avoidance of necessary treatments. One of the most anxiety-inducing procedures is the administration of local anesthesia. Excessive fear and pain perception can negatively impact the child's dental experience and long-term oral health behavior.
Aromatherapy, a non-pharmacological method utilizing essential oils from plants, has shown potential in reducing anxiety and promoting relaxation. Lavender essential oil (Lavandula angustifolia) has been extensively studied for its calming and anxiolytic properties in children and adults. Lemongrass (Cymbopogon citratus) also contains bioactive compounds believed to have similar relaxing effects, though its use in pediatric dental settings has not been adequately evaluated.
This randomized clinical trial aims to investigate the effects of lavender and lemongrass aromatherapy on anxiety levels and pain perception in children aged 7-11 years undergoing local anesthetic administration at the pediatric dentistry department, Faculty of Dentistry, Ain Shams University.
Forty-eight medically free children, with no prior dental visits and who fall within Frankl behavioral rating scale levels 3 or 4, will be randomly assigned to one of three groups:
Lavender aromatherapy group
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
- Single (Outcomes Assessor)
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
- •children aged 7-11 years
- •medically free
- •children category 3 or 4 according to Frankle behavior rating scale
- •patients who approve of signing informed consent and give child assent
- •children with at least one vital primary molar with deep carious lesion
排除标准
- •children with a previous dental visit
- •children suffering from any upper or lower respiratory tract problems
- •children with any history of allergy children who currently use any medications
研究组 & 干预措施
lavender aromatherapy
participants in this arm will receive lavender aromatherapy before local anesthesia administration
干预措施: lavender essential oil inhaled using face mask (Drug)
lemongrass aromatherapy
participants in this arm will receive lemongrass aromatherapy before the local anesthesia administration
干预措施: lemongrass essential oil inhaled using face mask (Drug)
结局指标
主要结局
anxiety level
时间窗: salivary cortisol will be assessed by taking saliva samples at baseline, and within 30 minutes of the procedure
anxiety will be measured by measuring salivary cortisol levels after taking saliva samples
次要结局
- pain perception(immediately after local anesthetic administration)
- physiological changes(heart rate)(as baseline and 1 minute after local anesthetic administration)
研究者
Hiba Ahmed Eltayeb
master degree candidate
Ain Shams University