Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients

San Gallicano Dermatological Institute IRCCS66 enrolled

Overview

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

Patients admitted to the Plastic, Reconstructive and Regenerative Surgery Unit who meet inclusion criteria will be randomly assigned (1:1) to the experimental group (lavender essential oil inhalation for 15 minutes via dedicated diffuser) or to the placebo group (physiological saline inhalation for 15 minutes). Assessments occur at T0 (ward admission before aromatherapy), T1 (arrival in operating block after aromatherapy, before surgery), T2 (end of surgical procedure), T3 (48 hours post-surgery), and T4 (7 days post-surgery for complications). Primary psychometric assessments include STAI Y-1 and STAI Y-2; additional measures include DASS-21 and vital signs. Randomization is centralized and computer-generated; allocation is concealed. Estimated data collection period: approximately six months. Sample size: 33 subjects per arm (66 total).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Melanoma

Interventions

Lavender Essential OilDRUG

Patients will receive aromatherapy treatment based on lavender essential oil administered through a dedicated diffuser for 15 minutes prior to the surgical procedure. During administration, access to the room is restricted to maintain the concentration of active substances

Physiological saline solution (as placebo)DRUG

Patients will receive a placebo treatment consisting of a physiological saline solution administered through a dedicated diffuser for 15 minutes prior to surgery. This procedure mirrors the experimental group to maintain the study's double-blind integrity

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Change in state anxiety score assessed using the State-Trait Anxiety Inventory, Form Y-1 (STAI Y-1), comparing baseline assessment prior to aromatherapy (T0) with assessment immediately after aromatherapy upon arrival in the operating block, before induction of anesthesia (T1).

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

Secondary Outcomes

Trait anxiety score measured by the State-Trait Anxiety Inventory (STAI Form Y-2), score range 20-80 (higher scores indicate greater anxiety)

Trait anxiety score assessed using the State-Trait Anxiety Inventory, Form Y-2 (STAI Y-2), evaluated at baseline prior to aromatherapy.

Time frame: Baseline (pre-intervention).

Postoperative Anxiety Level

Anxiety level assessed using the State-Trait Anxiety Inventory, Form Y-1 (STAI Y-1), after completion of the surgical procedure.

Time frame: End of surgery (T2)

Postoperative Complications

Incidence of postoperative complications assessed through clinical evaluation.

Time frame: From surgery completion up to 7 days postoperatively (T4)

Change in systolic blood pressure (mmHg)

Change in systolic blood pressure measured before and after aromatherapy

Time frame: From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.

Change in diastolic blood pressure (mmHg)

Change in diastolic blood pressure measured before and after aromatherapy.

Time frame: From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.

Change in heart rate (beats per minute)

Change in heart rate measured before and after aromatherapy.

Time frame: From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.

Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes