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)
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2026
CompletedFirst Posted
Study publicly available on registry
January 26, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedJanuary 28, 2026
November 1, 2025
Same day
January 17, 2026
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety level (objective)
tool: pulse oximeter unit: beats per minute
baseline (5 minutes before session), during injection (real time), and immediately post injection (within 5 minutes)
Secondary Outcomes (2)
anxiety level (objective)
immediately before the injection (baseline), immediately after the injection (post injection)
pain assessment
during the injection
Study Arms (3)
Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo
EXPERIMENTALIn 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.
Arm B: Bitter Orange essential oil then Lavender essential oil then Placebo
EXPERIMENTALIn 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.
Arm C: Placebo then Lavender essential oil then Bitter Orange essential oil
ACTIVE COMPARATORIn 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.
Interventions
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.
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.
The children will be asked to inhale from an empty inhaler for 2 minutes before local anesthetic agent injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
October University for Modern Science and Art
Giza, Giza Governorate, 12611, Egypt
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- statistician will be masked
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- general practitioner
Study Record Dates
First Submitted
January 17, 2026
First Posted
January 26, 2026
Study Start
February 1, 2026
Primary Completion
February 1, 2026
Study Completion
April 1, 2026
Last Updated
January 28, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share