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

Official title

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)

Overview

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.

Detailed 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

Interventions

• Behavioral Lavender essential oil in the inhaler
  The children will be asked to inhale the aroma (Lavender) from the inhalers for 2 minutes before local anesthetic agent injection to reduce pain and anxiety.
• Behavioral Bitter Orange essential oil in the inhaler
  The children will be asked to inhale the aroma ( bitter Orange) from the inhalers for 2 minutes before local anesthetic agent injection to reduce pain and anxiety.
• Behavioral Epmty inhaler (Placebo)
  The children will be asked to inhale from an empty inhaler for 2 minutes before local anesthetic agent injection.

Primary outcome measures

• Anxiety level (objective) [Time frame: baseline (5 minutes before session), during injection (real time), and immediately post injection (within 5 minutes)]

Secondary outcome measures (2)

• anxiety level (objective) [Time frame: immediately before the injection (baseline), immediately after the injection (post injection)]
• pain assessment [Time frame: during the injection]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Supportive care

Study locations

Egypt · 1 center

• October University for Modern Science and Art — Giza

Identifiers

NCT: NCT07367594 · Menna MSA University

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗