NCT07434323

Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients

Benefits of Lavender Essential Oil Aromatherapy in the Management of Preoperative Anxiety in Patients Undergoing Surgical Excision of Melanoma or Epithelioma: A Prospective Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: San Gallicano Dermatological Institute IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

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).

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-02
• Primary completion: 2021-12-16
• Completion: 2024-11-02
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Italy