Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:25 AM
Study NCT ID:
NCT07367594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-28
First Post:
2026-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lavender vs Bitter Orange Aromatherapy to Reduce Anxiety and Pain in Pediatric Local Anesthesia
Sponsor:
October University for Modern Sciences and Arts
Organization:
Study Overview
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)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: