Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Effect of lavender aromatherapy on anxiolysis
研究概览
简要总结
The purpose of this study is to assess the validity of lavender aromatherapy as a method of anxiolysis prior to a cataract surgery, and to see if this effect will extend intraoperatively to minimize patients' intraoperative medication requirements. The study team plans on enrolling 186 participants.
The investigator team hypothesizes that:
- Participants will have a lower anxiety score after the intervention
- Participants will require less intraoperative sedation medication compared to participants that did not have the lavender intervention.
- A decrease in intraoperative medication requirements will lead to a faster discharge time
详细描述
All participants will arrive at the Hutchinson Campus on the morning of surgery. After nursing intake, participants will be consented into the study. Vital signs will be recorded, as is part of the typical nursing intake. After the consent is completed, participants will receive the visual analogue scale (VAS) anxiety questionnaire. Participants that are part of the experimental group will then have the Bioesse lavender patch placed on the chest, according to manufacturer recommendations. After the lavender has been in place for 5 minutes, the same VAS anxiety questionnaire will be provided for completion. The control subjects will only receive the initial VAS questionnaire.
After this, all participants will receive the same premedication, including fentanyl and midazolam prior to cataract surgery, and will have monitored anesthesia care (MAC) during the case.
In the second phase of the study, chart review will be completed to monitor the patients' intraoperative sedation requirements . Additionally, demographic data will be taken at this time, including age, race, and sex.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over the age of 18
- •ASA (American Society of Anesthesiology) score <=3
- •Patients must be able to consent to participating in the study
排除标准
- •ASA score >4
- •Patients with a psychiatric diagnosis or who are on psychiatric medication
- •Patients with a history of asthma
- •Patients with an allergy to lavender
- •Patients under an anesthetic plan that has been switched from local anesthesia with sedation to general anesthesia
- •VAS score > 60 pre-operatively (high anxiety score)
结局指标
主要结局
Effect of lavender aromatherapy on anxiolysis
时间窗: Based on intra-operative time
Patient intra-operative data will be assessed to check dosage of midazolam and fentanyl between the placebo and intervention groups to see if lavender aromatherapy provides intra-operative anxiolysis cataracts surgery
次要结局
未报告次要终点