Comparative Evaluation of the Effect of Lavender Versus Bitter Orange Essential Oils Aromatherapy on Decreasing Dental Anxiety and Pain of Children During Administration of Local Anesthetic: (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Anxiety level (objective)
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate and compare the effectiveness of lavender essential oil and bitter orange essential oil aromatherapy in reducing dental anxiety and pain in children during the administration of local anesthesia. Children aged 6-12 years undergoing dental procedures requiring local anesthetic infiltration will be randomly assigned to lavender aromatherapy, bitter orange aromatherapy, or placebo (empty inhaler). Dental anxiety will be assessed using pulse rate and blood pressure measurements, while pain will be evaluated using the FLACC behavioral pain scale. The findings are expected to provide evidence on the role of aromatherapy as a non-pharmacological, safe, and cost-effective behavior guidance method in pediatric dentistry.
详细描述
Dental anxiety is a significant challenge in pediatric dentistry and is especially pronounced during invasive procedures such as the administration of local anesthetics. High levels of anxiety can amplify pain perception, reduce cooperation, and negatively affect the child's overall dental experience. Although pharmacological approaches such as sedation are available, they may cause undesirable side effects and are not always suitable for children. Consequently, there is increasing interest in safe, non-pharmacological alternatives such as aromatherapy, which utilizes essential plant oils to reduce anxiety and improve patient comfort.
Lavender and bitter orange essential oils have demonstrated anxiolytic and calming effects in several clinical studies, with evidence suggesting reductions in physiological stress markers such as pulse rate, blood pressure, and cortisol levels. Aromatherapy via inhalation is non-invasive, inexpensive, and well-tolerated by children. However, despite promising findings, limited research has explored and compared the clinical efficacy of different essential oils specifically in pediatric dental settings during local anesthetic injections.
This randomized controlled trial will be conducted at the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Children aged 6-12 years requiring local anesthetic infiltration will be randomly assigned to one of three groups: lavender inhalation, bitter orange inhalation, or placebo (empty inhaler). Participants will inhale the assigned aroma for 2 minutes prior to the injection. Dental anxiety will be measured using pulse oximetry and blood pressure recordings before and after the procedure, while pain will be evaluated using the FLACC scale during the injection.
The results of this study are expected to provide evidence regarding the relative effectiveness of lavender and bitter orange aromatherapy in decreasing dental anxiety and pain during anesthetic administration. The findings may support the integration of aromatherapy as a complementary, child-friendly behavior guidance technique in pediatric dental practice, promoting safer and more holistic anxiety-reduction strategies for young patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
statistician will be masked
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with the age range of 6-12 years
- •Any dental procedure that requires injection of local anesthesia.
- •Cooperative patients.(according to Frankl's classification class 1 and 2)
- •Parents or guardians willing to participate in the study.
- •Healthy child
排除标准
- •Children with complicated systemic disease.
- •Uncooperative patients. .(according to Frankl's classification class 3 and 4)
- •Children with severe cognitive impairment or developmental disorders
- •Children with respiratory tract infections.
- •Children experiencing dental pain such as (acute pain or hyperemia).
研究组 & 干预措施
Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo
In the first visit: Children will receive lavender essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
In the second visit: Children will receive bitter orange essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
in the third visit: Children will receive an empty inhaler 2 minutes before the administration of a local anesthetic agent.
干预措施: Lavender essential oil in the inhaler (Behavioral)
Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo
In the first visit: Children will receive lavender essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
In the second visit: Children will receive bitter orange essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
in the third visit: Children will receive an empty inhaler 2 minutes before the administration of a local anesthetic agent.
干预措施: Bitter Orange essential oil in the inhaler (Behavioral)
Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo
In the first visit: Children will receive lavender essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
In the second visit: Children will receive bitter orange essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
in the third visit: Children will receive an empty inhaler 2 minutes before the administration of a local anesthetic agent.
干预措施: Epmty inhaler (Placebo) (Behavioral)
Arm B: Bitter Orange essential oil then Lavender essential oil then Placebo
In the first visit: Children will receive bitter orange essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
In the second visit: Children will receive lavender essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
in the third visit: Children will receive an empty inhaler 2 minutes before the administration of a local anesthetic agent.
干预措施: Lavender essential oil in the inhaler (Behavioral)
Arm B: Bitter Orange essential oil then Lavender essential oil then Placebo
In the first visit: Children will receive bitter orange essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
In the second visit: Children will receive lavender essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
in the third visit: Children will receive an empty inhaler 2 minutes before the administration of a local anesthetic agent.
干预措施: Bitter Orange essential oil in the inhaler (Behavioral)
Arm B: Bitter Orange essential oil then Lavender essential oil then Placebo
In the first visit: Children will receive bitter orange essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
In the second visit: Children will receive lavender essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
in the third visit: Children will receive an empty inhaler 2 minutes before the administration of a local anesthetic agent.
干预措施: Epmty inhaler (Placebo) (Behavioral)
Arm C: Placebo then Lavender essential oil then Bitter Orange essential oil
In the first visit: Children will receive an empty inhaler 2 minutes before the administration of a local anesthetic agent.
In the second visit: Children will receive lavender essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
In the third visit: Children will receive bitter orange essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
干预措施: Lavender essential oil in the inhaler (Behavioral)
Arm C: Placebo then Lavender essential oil then Bitter Orange essential oil
In the first visit: Children will receive an empty inhaler 2 minutes before the administration of a local anesthetic agent.
In the second visit: Children will receive lavender essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
In the third visit: Children will receive bitter orange essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
干预措施: Bitter Orange essential oil in the inhaler (Behavioral)
Arm C: Placebo then Lavender essential oil then Bitter Orange essential oil
In the first visit: Children will receive an empty inhaler 2 minutes before the administration of a local anesthetic agent.
In the second visit: Children will receive lavender essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
In the third visit: Children will receive bitter orange essential oil in the inhaler 2 minutes before the administration of a local anesthetic agent.
干预措施: Epmty inhaler (Placebo) (Behavioral)
结局指标
主要结局
Anxiety level (objective)
时间窗: baseline (5 minutes before session), during injection (real time), and immediately post injection (within 5 minutes)
tool: pulse oximeter unit: beats per minute
次要结局
- anxiety level (objective)(immediately before the injection (baseline), immediately after the injection (post injection))
- pain assessment(during the injection)
研究者
Mennatallah Khaled
general practitioner
October University for Modern Sciences and Arts