Melanoma, Non-Melanoma Skin Cancer, Preoperative Anxiety, pT1a
Conditions
Keywords
lavender, aromatherapy, preoperative anxiety, melanoma, non-melanoma skin cancer, randomized controlled trial
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
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).
Interventions
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
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
Sponsors
San Gallicano Dermatological Institute IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | Trait anxiety score assessed using the State-Trait Anxiety Inventory, Form Y-2 (STAI Y-2), evaluated at baseline prior to aromatherapy. |
| Postoperative Anxiety Level | 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. |
| Postoperative Complications | From surgery completion up to 7 days postoperatively (T4) | Incidence of postoperative complications assessed through clinical evaluation. |
| Change in systolic blood pressure (mmHg) | From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block. | Change in systolic blood pressure measured before and after aromatherapy |
| Change in diastolic blood pressure (mmHg) | From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block. | Change in diastolic blood pressure measured before and after aromatherapy. |
| Change in heart rate (beats per minute) | From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block. | Change in heart rate measured before and after aromatherapy. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATOREmilia Migliano, Phd
San Gallicano Dermatological Institute IRCCS
Outcome results
None listed