Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients (LAPAM)

February 19, 2026 updated by: San Gallicano Dermatological Institute IRCCS

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Roma, Italy, Italy, 00144
        • San Gallicano Dermatological Institute IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lavender aromatherapy
Participants receive inhalational lavender essential oil aromatherapy for 15 minutes in the preoperative ward using a dedicated diffuser, prior to surgery for melanoma or non-melanoma skin cancer. Anxiety levels are assessed using validated psychometric scales and physiological parameters at predefined time points.
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
Other Names:
  • Inhalational Aromatherapy
Placebo Comparator: Placebo (Physiological Saline)
Participants receive inhalational physiological saline for 15 minutes in the preoperative ward using an identical diffuser, prior to surgery for melanoma or non-melanoma skin cancer. Anxiety levels are assessed using validated psychometric scales and physiological parameters at predefined time points.
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
Other Names:
  • Placebo Aromatherapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trait anxiety score measured by the State-Trait Anxiety Inventory (STAI Form Y-2), score range 20-80 (higher scores indicate greater anxiety)
Time Frame: Baseline (pre-intervention).
Trait anxiety score assessed using the State-Trait Anxiety Inventory, Form Y-2 (STAI Y-2), evaluated at baseline prior to aromatherapy.
Baseline (pre-intervention).
Postoperative Anxiety Level
Time Frame: End of surgery (T2)
Anxiety level assessed using the State-Trait Anxiety Inventory, Form Y-1 (STAI Y-1), after completion of the surgical procedure.
End of surgery (T2)
Postoperative Complications
Time Frame: From surgery completion up to 7 days postoperatively (T4)
Incidence of postoperative complications assessed through clinical evaluation.
From surgery completion up to 7 days postoperatively (T4)
Change in systolic blood pressure (mmHg)
Time Frame: From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.
Change in systolic blood pressure measured before and after aromatherapy
From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.
Change in diastolic blood pressure (mmHg)
Time Frame: From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.
Change in diastolic blood pressure measured before and after aromatherapy.
From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.
Change in heart rate (beats per minute)
Time Frame: From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.
Change in heart rate measured before and after aromatherapy.
From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Gallicano Dermatological Institute IRCCS

Investigators

  • Principal Investigator: Emilia Migliano, Phd, San Gallicano Dermatological Institute IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2021

Primary Completion (Actual)

December 16, 2021

Study Completion (Actual)

November 2, 2024

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS1496/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared to ensure the confidentiality of patients' personal information. The results of the research will be owned by the UOSD Plastic Surgery ISG and the UOC Anaesthesia and Resuscitation. Findings will be disseminated exclusively through publications in specialized journals and presentations at national and international congresses

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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