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Completed

NCT Number: NCT07434323

Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Melanoma Skin Cancer Preoperative Anxiety Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases pT1a

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Gallicano Dermatological Institute IRCCS

Roma, Italy, 00144

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lavender Essential Oil

Drug

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

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

Other names: Placebo Aromatherapy

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. Postoperative Complications

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

    Incidence of postoperative complications assessed through clinical evaluation.

  4. 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

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

San Gallicano Dermatological Institute IRCCS

Other

Registry information

Official study title

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

Acronym: LAPAM

Important dates

Study start
2021
Primary completion
2021
Study completion
2024
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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