Dental AnxietyNCT07367594
Lavender vs Bitter Orange Aromatherapy to Reduce Anxiety and Pain in Pediatric Local Anesthesia
A study testing Lavender essential oil in the inhaler and Bitter Orange essential oil in the inhaler in people with Dental Anxiety and Local Anesthesia, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dental Anxiety, Local Anesthesia
- What is being tested?
- Lavender essential oil in the inhaler and Bitter Orange essential oil in the inhaler
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to 1 Apr 2026
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
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
October University for Modern Science and Art
Giza, Giza Governorate, 12611
Menna Tallah Khaled Saied Mohamed, bachelor degree, 00201113646363, Mennatallah.khaled@msa.edu.eg
About this study
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)
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.
Read the 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
- Conditions
- Dental Anxiety, Local Anesthesia
- Being tested
- Lavender essential oil in the inhaler, Bitter Orange essential oil in the inhaler, Epmty inhaler (Placebo)
- Keywords
- aromatherapy, local anesthesia injection, lavender essential oil, bitter orange essential oil, dental anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender essential oil in the inhalerBehavioural
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.
Bitter Orange essential oil in the inhalerBehavioural
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.
Epmty inhaler (Placebo)Behavioural
The children will be asked to inhale from an empty inhaler for 2 minutes before local anesthetic agent injection.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo | Experimental | In 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. Receives: Behavioral: Lavender essential oil in the inhaler; Behavioral: Bitter Orange essential oil in the inhaler; Behavioral: Epmty inhaler (Placebo) |
| Arm B: Bitter Orange essential oil then Lavender essential oil then Placebo | Experimental | In 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. Receives: Behavioral: Lavender essential oil in the inhaler; Behavioral: Bitter Orange essential oil in the inhaler; Behavioral: Epmty inhaler (Placebo) |
| Arm C: Placebo then Lavender essential oil then Bitter Orange essential oil | Active comparator | In 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. Receives: Behavioral: Lavender essential oil in the inhaler; Behavioral: Bitter Orange essential oil in the inhaler; Behavioral: Epmty inhaler (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level (objective)
tool: pulse oximeter unit: beats per minute
Measured: baseline (5 minutes before session), during injection (real time), and immediately post injection (within 5 minutes)
Secondary outcomes (2)
anxiety level (objective)
tool: digital blood pressure monitor, unit: systolic/diastolic mmhg
Measured: immediately before the injection (baseline), immediately after the injection (post injection)
pain assessment
assessment of pain by FLACC (face-leg-activity-cry-consolability) scale score (0-2) (0 is the best outcome) (2 is the worst)
Measured: during the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Khaled, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367594
- Sponsor's protocol ID
- Menna MSA University
- Status last verified
- Nov 2025
- First submitted
- 17 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07367594
- Acronym / sponsor ID
- Menna MSA University
- Conditions
- Dental Anxiety, Local Anesthesia
- Keywords
- aromatherapy, local anesthesia injection, lavender essential oil, bitter orange essential oil, dental anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo | Experimental | Behavioral: Lavender essential oil in the inhaler, Behavioral: Bitter Orange essential oil in the inhaler, Behavioral: Epmty inhaler (Placebo)In 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 | Experimental | Behavioral: Lavender essential oil in the inhaler, Behavioral: Bitter Orange essential oil in the inhaler, Behavioral: Epmty inhaler (Placebo)In 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 comparator | Behavioral: Lavender essential oil in the inhaler, Behavioral: Bitter Orange essential oil in the inhaler, Behavioral: Epmty inhaler (Placebo)In 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
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 in the inhalerThe 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. | Behavioural | Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo, Arm B: Bitter Orange essential oil then Lavender essential oil then Placebo, Arm C: Placebo then Lavender essential oil then Bitter Orange essential oil |
| Bitter Orange essential oil in the inhalerThe 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. | Behavioural | Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo, Arm B: Bitter Orange essential oil then Lavender essential oil then Placebo, Arm C: Placebo then Lavender essential oil then Bitter Orange essential oil |
| Epmty inhaler (Placebo)The children will be asked to inhale from an empty inhaler for 2 minutes before local anesthetic agent injection. | Behavioural | Arm A: Lavender essential oil then Bitter Orange essential oil then Placebo, Arm B: Bitter Orange essential oil then Lavender essential oil then Placebo, Arm C: Placebo then Lavender essential oil then Bitter Orange essential oil |
Primary outcome
Anxiety level (objective)
Time frame: baseline (5 minutes before session), during injection (real time), and immediately post injection (within 5 minutes)
tool: pulse oximeter unit: beats per minute
2 secondary outcomes
anxiety level (objective)
Time frame: immediately before the injection (baseline), immediately after the injection (post injection)
pain assessment
Time frame: during the injection
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 28 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender essential oil in the inhaler and Bitter Orange essential oil in the inhaler in people with Dental Anxiety and Local Anesthesia, run by October University for Modern Sciences and Arts 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 5 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: opening soon, as of the sponsor's last update on 28 Jan 2026. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (objective) (time frame: baseline (5 minutes before session), during injection (real time), and immediately post injection (within 5 minutes)). 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 28 Jan 2026.