- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07586761
The Effects of Lemon Essential Oil Inhalation on Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Lemon Essential Oil Inhalation Improves Sustained Attention in Children With Attention-Deficit/Hyperactivity Disorder: A Placebo-Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized, placebo-controlled, single-blind clinical trial investigates the acute effects of lemon essential oil (LEO) inhalation on sustained attention and visual memory in children with attention-deficit/hyperactivity disorder (ADHD). Essential oils, particularly those rich in monoterpenes such as limonene, have demonstrated neuroactive properties through cholinergic modulation and limbic-prefrontal engagement via the olfactory pathway.
Fifty-two children aged 9-16 years, newly diagnosed with ADHD and not receiving any pharmacological treatment, were randomized to either the LEO group or the placebo group. Participants in the LEO group inhaled 5 drops of 100% pure Citrus limon essential oil via a cotton pad for five minutes prior to cognitive testing. The placebo group received an identical application with odorless distilled water.
Cognitive performance was assessed at baseline and 30 days later using the D2 Attention Test (primary outcome) and the Benton Visual Memory Test (secondary outcome). The entire intervention was conducted under standardized conditions, with blinded outcome assessment and strict adherence to procedural fidelity.
This study is the first to evaluate the short-term cognitive effects of lemon essential oil inhalation in children with clinical ADHD and aims to provide evidence for potential non-pharmacological support strategies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Basaksehir Cam ve Sakura City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 9 to 16 years
- Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) based on DSM-5 criteria
- Medication-naive (not currently using or previously treated with pharmacological agents for ADHD)
- No chronic medical or psychiatric comorbidities
- Capable of completing standardized cognitive assessments (e.g., D2 Attention Test, Benton Visual Memory Test)
- Written informed consent obtained from a parent or legal guardian
- Written assent obtained from the child
Exclusion Criteria:
- Lack of written parental consent or child assent
- Inability to comply with the study protocol (e.g., refusal to complete cognitive testing or intervention procedure)
- Current or prior use of ADHD medication
- Presence of moderate-to-severe ADHD symptoms requiring immediate pharmacological treatment (based on AACAP 2020 and NICE 2019 guidelines)
- Presence of any chronic medical or psychiatric comorbid condition
- Diagnosis not confirmed by a board-certified child and adolescent psychiatrist
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Lemon Essential Oil Inhalation (LEO)
Participants in this arm received a single-session inhalation of 100% pure lemon essential oil (Citrus limon) via a sterile cotton pad.
Five drops of essential oil were applied to the pad, which was held approximately 5 cm from the participant's nose.
The child inhaled the scent for 5 minutes under supervision in a clinical setting.
Neuropsychological testing (D2 Attention Test and Benton Visual Memory Test) followed immediately after inhalation.
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This intervention consists of a single-session, short-term olfactory exposure to 100% pure lemon essential oil (Citrus limon, ISO 9235 compliant, GC-MS confirmed composition: limonene 67.2%, β-pinene 12.3%, γ-terpinene 9.8%).
Five drops were applied to a sterile cotton pad and held approximately 5 cm from the participant's nose.
Participants inhaled the aroma for 5 minutes under direct supervision in a quiet, odor-free clinical setting.
This intervention was administered immediately prior to standardized neuropsychological assessments measuring attention and visual memory.
No ingestion or topical application occurred.
Other Names:
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Placebo Comparator: Placebo Inhalation (Distilled Water)
Participants in this arm received a single-session inhalation of distilled water as placebo.
Five drops of distilled water were applied to a sterile cotton pad, which was held approximately 5 cm from the participant's nose.
The child inhaled the scentless solution for 5 minutes under supervision.
Neuropsychological testing (D2 Attention Test and Benton Visual Memory Test) followed immediately after inhalation.
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The placebo condition involved the same protocol as the intervention group, using five drops of distilled water applied to a sterile cotton pad.
The pad was held approximately 5 cm from the participant's nose, and inhalation lasted for 5 minutes.
The procedure was designed to mimic the intervention without olfactory stimulation, ensuring consistency in timing, setting, and administration method.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in D2 Attention Test Total Performance Score (TN-E)
Time Frame: Baseline and Day 30 (after intervention)
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The D2 Attention Test evaluates sustained attention and concentration performance.
The TN-E (Total Number of Correct Items minus Errors) score reflects attentional capacity.
A higher post-intervention TN-E score indicates improved attention.
The difference between baseline and Day 30 scores will be compared between the lemon essential oil group and placebo group.
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Baseline and Day 30 (after intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Benton Visual Retention Test (BVRT) Score
Time Frame: Baseline and Day 30 (after intervention)
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The Benton Visual Retention Test assesses visual memory and visuospatial construction skills.
Scores range based on correct reproductions of geometric figures.
The change in BVRT scores from baseline to Day 30 will be analyzed to assess the impact of lemon essential oil inhalation versus placebo.
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Baseline and Day 30 (after intervention)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10.06.2021-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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