Utility of Aromatherapy in Reducing Burnt Flesh Smell, Decreasing Intraoperative Anxiety, and Improving the Patient's Overall Experience During Cutaneous Surgical Procedures: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Patient reported anxiety State-Trait Anxiety Inventory (STAI-6)
研究概览
简要总结
The purpose of this study is to assess whether essential oil aromatherapy could improve or eliminate the smell of burnt flesh from electrocautery and subsequently mitigate patient anxiety and discomfort during dermatologic skin surgery.
This is a randomized clinical trial. Approximately 210 electrocautery participants will be randomized to receive sham control/no aromatherapy or aromatherapy. Patients will be asked to complete a questionnaire after completion of the procedure to assess their experience. This study was a pilot study designed to determine the feasibility of this procedure.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years of age
- •Receiving same day cutaneous surgical procedure that requires electrocautery per protocol
- •In good general health as assessed by the investigator
- •Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
排除标准
- •Surgery site incompatible with the patient holding a handheld aromatherapy device (physician discretion)
- •Subject unwilling to sign an IRB approved consent form
- •Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
研究组 & 干预措施
Aromatherapy
干预措施: Essential Oil (Other)
Sham
干预措施: No Essential Oil (Other)
结局指标
主要结局
Patient reported anxiety State-Trait Anxiety Inventory (STAI-6)
时间窗: Immediately after surgery
Patient perioperative anxiety will be reported on the 6-item shortform of the State-Trait Anxiety Inventory (STAI-6) directly after procedure
Self-reported perceptions of cautery smell on a 4-point likert scale
时间窗: Immediately after surgery
This is a patient-reported questionnaire about perceptions of smell.
次要结局
未报告次要终点
研究者
Murad Alam
Professor of Dermatology
Northwestern University