Assessing the Efficacy of Lemongrass and Lavender Aromatherapy in Reducing Dental Anxiety and Pain Associated With Local Anesthetic Injections in Pediatric Dental Patients
NCT ID: NCT07113080
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
48 participants
INTERVENTIONAL
2025-02-21
2025-11-30
Brief Summary
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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.
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Detailed Description
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Aromatherapy, a non-pharmacological method utilizing essential oils from plants, has shown potential in reducing anxiety and promoting relaxation. Lavender essential oil (Lavandula angustifolia) has been extensively studied for its calming and anxiolytic properties in children and adults. Lemongrass (Cymbopogon citratus) also contains bioactive compounds believed to have similar relaxing effects, though its use in pediatric dental settings has not been adequately evaluated.
This randomized clinical trial aims to investigate the effects of lavender and lemongrass aromatherapy on anxiety levels and pain perception in children aged 7-11 years undergoing local anesthetic administration at the pediatric dentistry department, Faculty of Dentistry, Ain Shams University.
Forty-eight medically free children, with no prior dental visits and who fall within Frankl behavioral rating scale levels 3 or 4, will be randomly assigned to one of three groups:
Lavender aromatherapy group
Lemongrass aromatherapy group
Control group (no aromatherapy)
Children in the intervention groups will inhale either lavender or lemongrass essential oil via a nebulizer for 2 minutes prior to receiving local anesthesia. The control group will receive standard care with no aromatherapy. All local anesthetic injections will be performed using 4% articaine with 1:100,000 epinephrine after applying topical anesthesia to dry mucosa.
To objectively assess anxiety levels, salivary cortisol will be collected before and after the procedure using an unstimulated/stimulated saliva method. Cortisol concentrations will be analyzed using a commercial ELISA kit. Pain perception will be evaluated immediately after the procedure using the Wong-Baker Faces Pain Rating Scale - a validated self-reported tool for children. Heart rate will also be recorded before and after treatment using a finger-type pulse oximeter as a physiological stress marker.
The primary objective is to determine whether either essential oil significantly reduces anxiety levels, as evidenced by changes in salivary cortisol. Secondary outcomes include differences in reported pain and heart rate between groups. The study uses simple randomization with opaque envelope allocation concealment and blinding of outcome assessors (statistician and lab technician). Due to the nature of the intervention, operator and participant blinding is not possible.
This study may offer a practical, non-invasive adjunctive method to manage dental anxiety and pain in children, improving patient cooperation and long-term dental health outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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lavender aromatherapy
participants in this arm will receive lavender aromatherapy before local anesthesia administration
lavender essential oil inhaled using face mask
participants will inhale lavender essential oil via nebulizer before local anesthesia administration
lemongrass aromatherapy
participants in this arm will receive lemongrass aromatherapy before the local anesthesia administration
lemongrass essential oil inhaled using face mask
participants will inhale lemongrass essential oil via nebulizer before the local anesthesia administration
control
participants in this arm will not receive any aromatherapy before the local anesthesia administration
No interventions assigned to this group
Interventions
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lavender essential oil inhaled using face mask
participants will inhale lavender essential oil via nebulizer before local anesthesia administration
lemongrass essential oil inhaled using face mask
participants will inhale lemongrass essential oil via nebulizer before the local anesthesia administration
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* children suffering from any upper or lower respiratory tract problems
* children with any history of allergy children who currently use any medications
7 Years
11 Years
ALL
Yes
Sponsors
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Hiba Ahmed Eltayeb
OTHER
Responsible Party
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Hiba Ahmed Eltayeb
master degree candidate
Principal Investigators
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Ola Mohamed Abd El-geleel Associate Professor
Role: STUDY_DIRECTOR
Faculty of Dentistry, Ain Shams University.
Basma Gamal Awad Lecturer
Role: STUDY_DIRECTOR
Faculty of Dentistry, Ain Shams University.
Locations
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pediatric dentistry and dental public health department, faculty of dentistry, Ain shams university, Cairo, egypt
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Other Identifiers
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PED-24-13M
Identifier Type: -
Identifier Source: org_study_id
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