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临床试验/NCT03328143
NCT03328143已完成1 期

Feasibility of Aromatherapy in an Awake Craniotomy Environment

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Number of Consented Patients

研究概览

简要总结

Awake craniotomy for tumor surgery allows for mapping of speech, motor and sensory function during tumor resection. Awake craniotomy is increasingly utilized as it has several advantages over a traditional general anesthetic technique. Though many patients tolerate awake cranial surgery well, recent studies found that roughly 30% of patients experience moderate to severe pain and anxiety, while 50% report moderate fear and 11% report severe fear. Therefore, alternative methods to mitigate pain, anxiety, and fear are needed. In this study, the investigators will employ lavender aromatherapy to reduce anxiety and improve the satisfaction with pain control.

详细描述

The lavender aromatherapy trial protocol was developed in conjunction with the Aurora Health Care (AHC) Integrative Medicine Department and Certified Clinical Aromatherapy Practitioners (CCAP). Participating patients received standard of care intraoperative analgesic and anxiolytic management plus lavender aromatherapy. Lavender scent was administered via nasal inhaler. The lavender essential oil, base oil, and nasal inhaler were provided by AHC Integrative Medicine Department to ensure standardization across all patients. The nasal inhaler was prepared with 15 gtts (drops) of lavender essential oil and 4 gtts (drops) of the base oil (grapeseed oil). A CCAP from Integrative Medicine provided training on the delivery of lavender aromatherapy to all study team members. This person consulted on the participation of the first three subjects and was present in the operating room (OR) to oversee administration of lavender aromatherapy. The CCAP was also available for consultation during the course of the study, as needed.

A dedicated OR nurse, neuropsychologist, or neuropsychometrist oversaw administration of lavender aromatherapy to subjects. They monitored the subject during study participation and were prepared to discontinue the trial if they felt continued participation was detrimental to the patient. Lavender aromatherapy was administered for up to five minutes using the nasal inhaler at designated time points (preoperative, induction) and every 30 minutes during the surgery. Although the majority of the time OR personnel administered the aromatherapy, some patients were able to and chose to self-administer. Additional lavender aromatherapy treatments were provided at any time upon request. During non-use periods, the nasal inhaler was capped and sealed. If the subject was unable to verbally request the research team member to hold the nasal inhaler under their nose, the subject's participation in the study was terminated. Additionally, subjects were free to discontinue administration of aromatherapy at any time during their participation in the study. The timing and reason of discontinuation of lavender aromatherapy was recorded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any adult patient aged 18 and older undergoing awake cranial neurosurgery

排除标准

  • Allergy or sensitivity to the aromatherapy agent (Lavender)
  • Aversion to lavender scent
  • History of asthma, chronic obstructive pulmonary disease (COPD)
  • History of contact dermatitis following exposure to cosmetic fragrances
  • Pregnancy

研究组 & 干预措施

Treatment with Lavender

Experimental

Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler.

干预措施: Lavender (Lavandula angustifolia) (Drug)

结局指标

主要结局

Number of Consented Patients

时间窗: From recruitment to end of enrollment period

Determine the number of eligible patients enrolled and consented

Protocol Completion

时间窗: From the preoperative evaluation through the post operative evaluation in the Neurosurgical Intensive Care Unit (NICU)

Determine the number of consented patients completing the trial protocol

次要结局

  • Validation of Visual Analogue Scale for Anxiety (VAS-A)(8 hours)
  • Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall.(8 hours)
  • Validation of Visual Analogue Scale for Pain (VAS-P)(8 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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