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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-intervention). |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Emilia Migliano, Phd | San Gallicano Dermatological Institute IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Gallicano Dermatological Institute IRCCS | Roma | Italy | 00144 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29299507 | Background | 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. | |
| 27555169 | 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. |
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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
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C045718 | lavender oil |
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| 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 |
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| Postoperative Anxiety Level |
Anxiety level assessed using the State-Trait Anxiety Inventory, Form Y-1 (STAI Y-1), after completion of the surgical procedure. |
| End of surgery (T2) |
| Postoperative Complications | Incidence of postoperative complications assessed through clinical evaluation. | From surgery completion up to 7 days postoperatively (T4) |
| Change in systolic blood pressure (mmHg) | Change in systolic blood pressure measured before and after aromatherapy | From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block. |
| Change in diastolic blood pressure (mmHg) | Change in diastolic blood pressure measured before and after aromatherapy. | From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block. |
| Change in heart rate (beats per minute) | Change in heart rate measured before and after aromatherapy. | From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block. |
| 30660371 | 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. |
| 32602157 | 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. |
| 29452414 | 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. |
| 32839011 | 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. |
| 31641473 | 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. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |