Dental Fear and AnxietyPhase 4NCT07113080
Assessing the Efficacy of Lemongrass and Lavender Aromatherapy in Reducing Dental Anxiety and Pain Associated With Local Anesthetic Injections in Pediatric Dental Patients
A Phase 4 study testing lavender essential oil inhaled using face mask and lemongrass essential oil inhaled using face mask in people with Dental Fear and Anxiety, run by Hiba Ahmed Eltayeb at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Fear and Anxiety
- What is being tested?
- lavender essential oil inhaled using face mask and lemongrass essential oil inhaled using face mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Feb 2025to Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
pediatric dentistry and dental public health department, faculty of dentistry, Ain shams university, Cairo, egypt
Cairo, Cairo Governorate, 11566
About this study
Official title: The Effect of Lemongrass and Lavender Aromatherapy on Dental Anxiety and Pain Perception in Children Undergoing Local Anesthetic Administration: A Randomized Clinical Trial
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:
Read more
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.
Read the detailed description
Dental anxiety is a common behavioral challenge in pediatric dentistry and can significantly influence the quality of dental care, potentially leading to avoidance of necessary treatments. One of the most anxiety-inducing procedures is the administration of local anesthesia. Excessive fear and pain perception can negatively impact the child's dental experience and long-term oral health behavior.
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
- Dental Fear and Anxiety
- Being tested
- lavender essential oil inhaled using face mask, lemongrass essential oil inhaled using face mask
- Keywords
- aromatherapy, cortisol, dental anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lavender essential oil inhaled using face maskDrug
participants will inhale lavender essential oil via nebulizer before local anesthesia administration
lemongrass essential oil inhaled using face maskDrug
participants will inhale lemongrass essential oil via nebulizer before the local anesthesia administration
| Study group | Role | What they receive |
|---|---|---|
| lavender aromatherapy | Active comparator | participants in this arm will receive lavender aromatherapy before local anesthesia administration Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety level
anxiety will be measured by measuring salivary cortisol levels after taking saliva samples
Measured: salivary cortisol will be assessed by taking saliva samples at baseline, and within 30 minutes of the procedure
Secondary outcomes (2)
pain perception
using Wong-Baker faces pain rating scale Arabic version, the scale has six faces from a happy face for no pain to a crying face for extreme pain, scoring from 0 to 10. Children will be asked to choose the face that expresses their perceived pain intensity
Measured: immediately after local anesthetic administration
physiological changes(heart rate)
using a finger-type pulse oximeter
Measured: as baseline and 1 minute after local anesthetic administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start21 Feb 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Fear and AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiba Ahmed Eltayeb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hiba Ahmed Eltayeb, Ain Shams University
- Investigators
- Ola Mohamed Abd El-geleel Associate Professor, Study director, Faculty of Dentistry, Ain Shams University.Basma Gamal Awad Lecturer, Study director, Faculty of Dentistry, Ain Shams University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113080
- Sponsor's protocol ID
- PED-24-13M
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Faculty of dentistry Ain Shams University research ethics committee, state that data will not be shared to preserve the confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lemongrass and Lavender Aromatherapy on Dental Anxiety and Pain Perception in Children Undergoing Local Anesthetic Administration: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07113080
- Acronym / sponsor ID
- PED-24-13M
- Conditions
- Dental Fear and Anxiety
- Keywords
- aromatherapy, cortisol, dental anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hiba Ahmed EltayebUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dental anxiety is a common behavioral challenge in pediatric dentistry and can significantly influence the quality of dental care, potentially leading to avoidance of necessary treatments. One of the most anxiety-inducing procedures is the administration of local anesthesia. Excessive fear and pain perception can negatively impact the child's dental experience and long-term oral health behavior.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| lavender aromatherapy | Active comparator | Drug: lavender essential oil inhaled using face maskparticipants in this arm will receive lavender aromatherapy before local anesthesia administration |
| lemongrass aromatherapy | Active comparator | Drug: lemongrass essential oil inhaled using face maskparticipants in this arm will receive lemongrass aromatherapy before the local anesthesia administration |
| control | No intervention | –participants in this arm will not receive any aromatherapy before the local anesthesia administration |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lavender essential oil inhaled using face maskparticipants will inhale lavender essential oil via nebulizer before local anesthesia administration | Drug | lavender aromatherapy |
| lemongrass essential oil inhaled using face maskparticipants will inhale lemongrass essential oil via nebulizer before the local anesthesia administration | Drug | lemongrass aromatherapy |
Primary outcome
anxiety level
Time frame: salivary cortisol will be assessed by taking saliva samples at baseline, and within 30 minutes of the procedure
anxiety will be measured by measuring salivary cortisol levels after taking saliva samples
2 secondary outcomes
pain perception
Time frame: immediately after local anesthetic administration
physiological changes(heart rate)
Time frame: as baseline and 1 minute after local anesthetic administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No. Faculty of dentistry Ain Shams University research ethics committee, state that data will not be shared to preserve the confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ola Mohamed Abd El-geleel Associate Professor study director
Faculty of Dentistry, Ain Shams University.
Basma Gamal Awad Lecturer study director
Faculty of Dentistry, Ain Shams University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lavender essential oil inhaled using face mask and lemongrass essential oil inhaled using face mask in people with Dental Fear and Anxiety, run by Hiba Ahmed Eltayeb at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hiba AE suliman, master degree candidate (1119078420 ext. +20, hibaeltayeb@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety level (time frame: salivary cortisol will be assessed by taking saliva samples at baseline, and within 30 minutes of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.