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
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- San Gallicano Dermatological Institute IRCCS
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 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)
概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lavender aromatherapy
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.
干预措施: Lavender Essential Oil (Drug)
Placebo (Physiological Saline)
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.
干预措施: Physiological saline solution (as placebo) (Drug)
结局指标
主要结局
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)
时间窗: 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).
次要结局
- 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.)
- Change in heart rate (beats per minute)(From baseline (pre-intervention) to immediately after aromatherapy, upon arrival in the operating block.)