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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

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

52

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Istanbul, Tyrkia (Türkiye)
        • Basaksehir Çam Ve Sakura City Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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.
Andre navn:
  • Citrus limon aroma
  • LEO
Placebo komparator: 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.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in D2 Attention Test Total Performance Score (TN-E)
Tidsramme: Baseline and Day 30 (after intervention)
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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Benton Visual Retention Test (BVRT) Score
Tidsramme: Baseline and Day 30 (after intervention)
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.
Baseline and Day 30 (after intervention)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. februar 2022

Primær fullføring (Faktiske)

30. september 2023

Studiet fullført (Faktiske)

30. september 2023

Datoer for studieregistrering

Først innsendt

24. desember 2025

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2026

Sist bekreftet

1. desember 2025

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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