A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reduction in anxiety as measured by the change in baseline STAI scores
研究概览
简要总结
The purpose of this study is to determine the effects of lavender aromatherapy on preoperative anxiety by measuring changes in pulse rate and anxiety core using Spielberger State-Trait Anxiety Index questionnaires and on postoperative pain medicine usage. Study participants will then be randomized into one of four groups; either they will receive 2 drops of lavender (Lavandula Angustifolia) oil (LO) or 2 drops of Michelia Alba Leaf oil (MA) or 2 drops of unscented Almond oil (AO) or two drops water on the inside of an oxygen face mask for 15 minutes. Linalool makes up ~30% of Lavandula Angustifolia oil and is believed to be its most active anti-anxiety component. Before and after treatment, anxiety level will be measured using the Spielberger State-Trait Anxiety Inventory.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, older than 18, American Society of Anesthesiologists (ASA) classification I-III, undergoing elective breast surgery on Tisch 10th floor Day Surgery. Cancer patients are included.
排除标准
- •History of asthma, bronchitis, COPD, contact dermatitis to cosmetic fragrances, positive patch test, pregnancy, and significant laboratory abnormalities.
研究组 & 干预措施
Lavandula Angustifolia oil (LO)
2 Drops in Oxygen Mask
干预措施: Lavandula Angustifolia oil (LO) (Other)
Michelia Alba Leaf oil (MA)
2 Drops in Oxygen Mask
干预措施: Michelia Alba Leaf oil (MA) (Other)
Almond oil (AO)
2 Drops in Oxygen Mask
干预措施: Almond oil (AO) (Other)
Water
2 Drops in Oxygen Mask
干预措施: Water (Other)
结局指标
主要结局
Reduction in anxiety as measured by the change in baseline STAI scores
时间窗: 20 Minutes
Spielberger State-Trait Anxiety Inventory (STAI) is a self-reported instrument. It was designed to assess levels of state anxiety and traint anxiety, through 40 items scored by a likert-scale. State anxiety can be defined as a transient momentary emotional status that results from situational stress.
次要结局
未报告次要终点