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Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients

NCT07434323 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-02-25

No results posted yet for this study

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

Conditions

  • Melanoma
  • Non-Melanoma Skin Cancer
  • Preoperative Anxiety
  • pT1a

Interventions

DRUG

Lavender Essential Oil

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

DRUG

Physiological saline solution (as placebo)

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

Sponsors & Collaborators

  • San Gallicano Dermatological Institute IRCCS

    lead OTHER

Principal Investigators

  • Emilia Migliano, Phd · San Gallicano Dermatological Institute IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2021-12-16
Completion
2024-11-02

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07434323 on ClinicalTrials.gov