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MelanomaLAPAMNCT07434323

Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients

A study testing Lavender Essential Oil in people with Melanoma and Non-Melanoma Skin Cancer, run by San Gallicano Dermatological Institute IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Lavender Essential Oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteItaly
Study dates
2 Nov 2021to 2 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • San Gallicano Dermatological Institute IRCCS

    Roma, Italy, 00144

Other trials in Italy

About this study

Official 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

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

Read the 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).

Being tested
Lavender Essential Oil, Physiological saline solution (as placebo)
Keywords
lavender, aromatherapy, preoperative anxiety, melanoma, non-melanoma skin cancer, randomized controlled trial
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lavender Essential OilDrug

    Also called Inhalational Aromatherapy

    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

  • Physiological saline solution (as placebo)Drug

    Also called Placebo Aromatherapy

    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

Study groups in NCT07434323
Study groupRoleWhat they receive
Lavender aromatherapyExperimentalParticipants 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.
Receives: Drug: Lavender Essential Oil
Placebo (Physiological Saline)Placebo comparatorParticipants 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.
Receives: Drug: Physiological saline solution (as placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (6)

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

    Trait anxiety score assessed using the State-Trait Anxiety Inventory, Form Y-2 (STAI Y-2), evaluated at baseline prior to aromatherapy.

    Measured: Baseline (pre-intervention).

  2. Postoperative Anxiety Level

    Anxiety level assessed using the State-Trait Anxiety Inventory, Form Y-1 (STAI Y-1), after completion of the surgical procedure.

    Measured: End of surgery (T2)

  3. Postoperative Complications

    Incidence of postoperative complications assessed through clinical evaluation.

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

  4. Change in systolic blood pressure (mmHg)

    Change in systolic blood pressure measured before and after aromatherapy

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

  5. Change in diastolic blood pressure (mmHg)

    Change in diastolic blood pressure measured before and after aromatherapy.

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

  6. Change in heart rate (beats per minute)

    Change in heart rate measured before and after aromatherapy.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start2 Nov 2021
  3. Primary completion16 Dec 2021
  4. Study completion2 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07434323
Sponsor's protocol ID
RS1496/21
Acronym
LAPAM
Status last verified
Feb 2026
First submitted
3 Feb 2026
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • 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.

    PubMed 29299507

  • 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.

    PubMed 27555169

  • 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.

    PubMed 30660371

  • 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.

    PubMed 32602157

  • 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.

    PubMed 29452414

  • 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.

    PubMed 32839011

  • 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.

    PubMed 31641473

Questions about this trial

What is this clinical trial studying?

A study testing Lavender Essential Oil in people with Melanoma and Non-Melanoma Skin Cancer, run by San Gallicano Dermatological Institute IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07434323, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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