Assessing the Efficacy of Lemongrass and Lavender Aromatherapy in Reducing Dental Anxiety and Pain Associated With Local Anesthetic Injections in Pediatric Dental Patients

NCT07113080 | Recruiting Phase 4 DMC

• 1 other identifier: PED-24-13M
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether aromatherapy using lemongrass or lavender essential oils can reduce dental anxiety and pain perception in children aged 7-11 years undergoing local anesthetic administration in a pediatric dental setting. The main questions it aims to answer are: Does lemongrass or lavender aromatherapy reduce anxiety levels, as measured by salivary cortisol, in children receiving local anesthesia? Does aromatherapy influence pain perception and physiological stress (heart rate) during the procedure? Researchers will compare a lavender aromatherapy group, a lemongrass aromatherapy group, and a control group without aromatherapy to see if the essential oils have a calming effect that reduces anxiety and pain compared to no intervention. Participants will: Inhale either lavender, lemongrass, or no essential oil (control) for two minutes via nebulizer. Undergo local anesthesia administration for a dental procedure. Provide unstimulated and stimulated saliva samples before and after the procedure for cortisol analysis. Report their pain level using the Wong-Baker Faces Pain Rating Scale. Have their heart rate measured before and after the procedure using a finger-type pulse oximeter.

Conditions

Dental Fear and Anxiety

Keywords

aromatherapy; cortisol; dental anxiety

Outcome Measures

Primary Outcomes (1)

• anxiety level

  anxiety will be measured by measuring salivary cortisol levels after taking saliva samples

  salivary cortisol will be assessed by taking saliva samples at baseline, and within 30 minutes of the procedure

Secondary Outcomes (2)

• pain perception

  immediately after local anesthetic administration

• physiological changes(heart rate)

  as baseline and 1 minute after local anesthetic administration

Study Arms (3)

lavender aromatherapy

ACTIVE COMPARATOR

participants in this arm will receive lavender aromatherapy before local anesthesia administration

Drug: lavender essential oil inhaled using face mask

lemongrass aromatherapy

ACTIVE COMPARATOR

participants in this arm will receive lemongrass aromatherapy before the local anesthesia administration

Drug: lemongrass essential oil inhaled using face mask

control

NO INTERVENTION

participants in this arm will not receive any aromatherapy before the local anesthesia administration

Interventions

lavender essential oil inhaled using face mask DRUG

participants will inhale lavender essential oil via nebulizer before local anesthesia administration

lavender aromatherapy

lemongrass essential oil inhaled using face mask DRUG

participants will inhale lemongrass essential oil via nebulizer before the local anesthesia administration

lemongrass aromatherapy

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children aged 7-11 years
• medically free
• children category 3 or 4 according to Frankle behavior rating scale
• patients who approve of signing informed consent and give child assent
• children with at least one vital primary molar with deep carious lesion

You may not qualify if:

• children with a previous dental visit
• children suffering from any upper or lower respiratory tract problems
• children with any history of allergy children who currently use any medications

Sponsors & Collaborators

• Hiba Ahmed Eltayeb: lead

Study Sites (1)

pediatric dentistry and dental public health department, faculty of dentistry, Ain shams university, Cairo, egypt

Cairo, Cairo Governorate, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ola Mohamed Abd El-geleel Associate Professor

  Faculty of Dentistry, Ain Shams University.

  STUDY DIRECTOR

• Basma Gamal Awad Lecturer

  Faculty of Dentistry, Ain Shams University.

  STUDY DIRECTOR

Central Study Contacts

hiba AE suliman, master degree candidate

CONTACT

1119078420; hibaeltayeb@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: master degree candidate

Model Details: participants will be randomly assigned into lavender, lemongrass or the control group in which they will be receiving lavender aromatherapy, lemongrass aromatherapy or no intervention respectively

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: August 8, 2025
• Study Start: February 21, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)