Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients

NCT07434323 | Completed

• 1 other identifier: RS1496/21
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lavender; aromatherapy; preoperative anxiety; melanoma; non-melanoma skin cancer; randomized controlled trial

Outcome Measures

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)

  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 Outcomes (6)

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

  Baseline (pre-intervention).

• Postoperative Anxiety Level

  End of surgery (T2)

• Postoperative Complications

  From surgery completion up to 7 days postoperatively (T4)

• Change in systolic blood pressure (mmHg)

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

• Change in diastolic blood pressure (mmHg)

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

Study Arms (2)

Lavender aromatherapy

EXPERIMENTAL

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

Placebo (Physiological Saline)

PLACEBO COMPARATOR

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)

Interventions

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

Also known as: Inhalational Aromatherapy

Lavender 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

Also known as: Placebo Aromatherapy

Placebo (Physiological Saline)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Gallicano Dermatological Institute IRCCS: lead

Study Sites (1)

San Gallicano Dermatological Institute IRCCS

Roma, Italy, 00144, Italy

Location

Related Publications (7)

• Kao R, Wannemuehler T, Yates CW, Nelson RF. Outpatient management of cholesteatoma with canal wall reconstruction tympanomastoidectomy. Laryngoscope Investig Otolaryngol. 2017 Oct 31;2(6):351-357. doi: 10.1002/lio2.116. eCollection 2017 Dec.

  PMID: 29299507 BACKGROUND

• Ishio J, Komasawa N, Kido H, Minami T. Difficult airway management using Pentax-AWS Airwayscope with pediatric Intlock and tracheal tube introducer in Goldenhar syndrome patient. J Clin Anesth. 2016 Sep;33:223-4. doi: 10.1016/j.jclinane.2016.03.069. Epub 2016 May 4. No abstract available.

  PMID: 27555169 BACKGROUND

• Beyliklioglu A, Arslan S. Effect of Lavender Oil on the Anxiety of Patients Before Breast Surgery. J Perianesth Nurs. 2019 Jun;34(3):587-593. doi: 10.1016/j.jopan.2018.10.002. Epub 2019 Jan 16.

  PMID: 30660371 BACKGROUND

• Yang EJ, Lipner SR. Differences in price trends between branded and generic medications for onychomycosis. Dermatol Ther. 2020 Nov;33(6):e13928. doi: 10.1111/dth.13928. Epub 2020 Jul 13. No abstract available.

  PMID: 32602157 BACKGROUND

• Tofield A. Peace Plaque for the city of Barcelona. Eur Heart J. 2018 Feb 14;39(7):502. doi: 10.1093/eurheartj/ehy032. No abstract available.

  PMID: 29452414 BACKGROUND

• Whichello C, Bywall KS, Mauer J, Stephen W, Cleemput I, Pinto CA, van Overbeeke E, Huys I, de Bekker-Grob EW, Hermann R, Veldwijk J. An overview of critical decision-points in the medical product lifecycle: Where to include patient preference information in the decision-making process? Health Policy. 2020 Dec;124(12):1325-1332. doi: 10.1016/j.healthpol.2020.07.007. Epub 2020 Jul 30.

  PMID: 32839011 BACKGROUND

• Wainwright BJ, Zahn GL, Zushi J, Lee NLY, Ooi JLS, Lee JN, Huang D. Seagrass-associated fungal communities show distance decay of similarity that has implications for seagrass management and restoration. Ecol Evol. 2019 Sep 15;9(19):11288-11297. doi: 10.1002/ece3.5631. eCollection 2019 Oct.

  PMID: 31641473 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Emilia Migliano, Phd

  San Gallicano Dermatological Institute IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 25, 2026
• Study Start: November 2, 2021
• Primary Completion: December 16, 2021
• Study Completion: November 2, 2024
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)