NCT07586761

Brief Summary

This randomized, placebo-controlled clinical trial aims to evaluate the acute effects of lemon essential oil inhalation on sustained attention and visual memory in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). Fifty-two medication-naive children aged 9-16 were randomized to receive either lemon oil or placebo inhalation before cognitive assessments. Primary outcome was sustained attention performance. The study found significant improvements in attention scores in the lemon oil group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
Last Updated

May 14, 2026

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

December 24, 2025

Last Update Submit

May 8, 2026

Conditions

Keywords

Pediatric NeuropsychologyNon-Pharmacological InterventionsAttention Deficit Disorder with Hyperactivitiy (ADHD)AromatherapyEssential Oils

Outcome Measures

Primary Outcomes (1)

  • Change in D2 Attention Test Total Performance Score (TN-E)

    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.

    Baseline and Day 30 (after intervention)

Secondary Outcomes (1)

  • Change in Benton Visual Retention Test (BVRT) Score

    Baseline and Day 30 (after intervention)

Study Arms (2)

Lemon Essential Oil Inhalation (LEO)

EXPERIMENTAL

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.

Other: Lemon Essential Oil Inhalation

Placebo Inhalation (Distilled Water)

PLACEBO COMPARATOR

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.

Other: placebo inhalation

Interventions

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.

Also known as: Citrus limon aroma, LEO
Lemon Essential Oil Inhalation (LEO)

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.

Placebo Inhalation (Distilled Water)

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study employed a randomized, single-blind, parallel-group design with two arms: one group received inhalation of lemon essential oil (LEO), and the other received placebo (distilled water). Participants were randomly assigned to either group, and the intervention was administered individually. Both groups underwent baseline and post-intervention neuropsychological testing using standardized assessments. The study assessed the acute effects of a single-session inhalation intervention.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2025

First Posted

May 14, 2026

Study Start

February 15, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

May 14, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared for this study due to ethical considerations, privacy protection regulations involving minors, and the absence of prior consent for data sharing beyond the scope of this trial. Additionally, the study was conducted with a small sample size from a single center, limiting the generalizability and reuse of anonymized data for broader analysis.

Locations