Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients (NCT07434323) | Clinical Trial Compass
CompletedNot Applicable
Lavender Aromatherapy for Preoperative Anxiety in Melanoma and Epithelioma Patients
Italy66 participantsStarted 2021-11-02
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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)
Timeframe: From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block, prior to induction of anesthesia.
Trial details
NCT IDNCT07434323
SponsorSan Gallicano Dermatological Institute IRCCS