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

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)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07367594
Enrollment
26
Registered
2026-01-26
Start date
2026-02-01
Completion date
2026-04-01
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety, Local Anesthesia

Keywords

aromatherapy, local anesthesia injection, lavender essential oil, bitter orange essential oil, dental anxiety

Brief summary

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

BEHAVIORALLavender 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.

BEHAVIORALBitter 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.

BEHAVIORALEpmty inhaler (Placebo)

The children will be asked to inhale from an empty inhaler for 2 minutes before local anesthetic agent injection.

Sponsors

October University for Modern Sciences and Arts
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

statistician will be masked

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Anxiety level (objective)baseline (5 minutes before session), during injection (real time), and immediately post injection (within 5 minutes)tool: pulse oximeter unit: beats per minute

Secondary

MeasureTime frameDescription
anxiety level (objective)immediately before the injection (baseline), immediately after the injection (post injection)tool: digital blood pressure monitor, unit: systolic/diastolic mmhg
pain assessmentduring the injectionassessment of pain by FLACC (face-leg-activity-cry-consolability) scale score (0-2) (0 is the best outcome) (2 is the worst)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026