CompletedNot Applicable

Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients

Italy66 participantsStarted 2021-11-02

Plain-language summary

This double-blind, randomized, placebo-controlled trial evaluates whether a single 15-minute session of inhalational lavender aromatherapy, administered preoperatively, reduces anxiety in adult patients (ASA I-II) scheduled for surgical radicalization of pT1a melanoma or epithelioma. Physiological parameters (blood pressure, heart rate, respiratory rate) and validated psychometric scales (DASS-21, STAI Y-1 and Y-2) will be recorded at defined time points before and after the intervention. Total planned enrollment: 66 participants

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 to 80 years * Patients diagnosed with pT1a melanoma or non-melanoma skin cancer (epithelioma) * Scheduled for surgical radicalization under local anesthesia * American Society of Anesthesiologists (ASA) physical status classification I or II * Ability to understand and complete self-administered questionnaires (STAI Y-1, STAI Y-2, DASS-21) * Willingness and ability to provide written informed consent Exclusion Criteria * Known allergy or hypersensitivity to lavender or essential oils * Current use of anxiolytic, antidepressant, or psychotropic medications * History of psychiatric disorders or ongoing psychological treatment * Cognitive impairment or inability to complete questionnaires independently * Pregnancy or breastfeeding * Severe respiratory diseases (e.g., asthma, COPD) that could interfere with inhalational aromatherapy * ASA physical status classification ≥ III * Participation in another interventional clinical trial at the same time

What they're measuring

Change in state anxiety score measured by the State-Trait Anxiety Inventory (STAI Form Y-1), score range 20-80 (higher scores indicate greater anxiety)

Timeframe: From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block, prior to induction of anesthesia.

Trial details

NCT IDNCT07434323

SponsorSan Gallicano Dermatological Institute IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-16

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