Lavender vs Bitter Orange Aromatherapy to Reduce Anxiety and Pain in Pediatric Local Anesthesia

October University for Modern Sciences and Arts

Status: Not yet enrolling

Conditions: Dental Anxiety; Local Anesthesia

Treatments: Behavioral: Bitter Orange essential oil in the inhaler; Behavioral: Lavender essential oil in the inhaler; Behavioral: Epmty inhaler (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT07367594

Menna MSA University

Details and patient eligibility

About

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.

Full description

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

Enrollment: 26 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 3 patient groups

Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo

Experimental group

Description:

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.

Treatment:

Behavioral: Epmty inhaler (Placebo)

Behavioral: Lavender essential oil in the inhaler

Behavioral: Bitter Orange essential oil in the inhaler

Arm B: Bitter Orange essential oil then Lavender essential oil then Placebo

Experimental group

Description:

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.

Treatment:

Behavioral: Epmty inhaler (Placebo)

Behavioral: Lavender essential oil in the inhaler

Behavioral: Bitter Orange essential oil in the inhaler

Arm C: Placebo then Lavender essential oil then Bitter Orange essential oil

Active Comparator group

Description:

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.

Treatment:

Behavioral: Epmty inhaler (Placebo)

Behavioral: Lavender essential oil in the inhaler

Behavioral: Bitter Orange essential oil in the inhaler