Efficacy Of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Change in visual analog scale anxiety, measured on a 10 cm scale
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of lavender aromatherapy in adult patients undergoing awake otolaryngologic procedures in the outpatient clinic setting. The main questions it aims to answer are:
- Does lavender aromatherapy help reduce anxiety and/or pain, and improve patient comfort during awake otolaryngologic procedures in the clinic?
- Do patients subjectively find aromatherapy relaxing and/or beneficial during the procedure?
Researchers will compare lavender aromatherapy to placebo (an odorless liquid) to see if lavender aromatherapy helps improve patient comfort during their awake procedure
Participants will:
- Have their scheduled procedure performed with lavender aromatherapy or placebo during the duration of the procedure
- Take a short, less than 1 minute questionnaire both before and after the procedure, describing their levels of anxiety, pain and subjective impressions of the aromatherapy
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥18 years old undergoing awake otolaryngologic procedures in the outpatient clinic
- •Able to provide informed consent
排除标准
- •Hypersensitivity to fragrances
- •Taking systemic NSAIDs or other systemic pain-relieving medications within 48 hours
- •Taking anxiolytics, hypnotics, sedating antihistamines, antidepressants on regular basis within 4 weeks
- •Pregnant or breastfeeding
- •Participation in another clinical research study within the prior 30 days
结局指标
主要结局
Change in visual analog scale anxiety, measured on a 10 cm scale
时间窗: Baseline, Periprocedural and Immediately after the procedure
A 10 cm visual analog scale is widely utilized to measure procedural anxiety, rated from 0 to 10, with 10 being the highest level of anxiety. The patient will provide a vertical mark above their level of anxiety. This number measured in mm (0-100) will be recorded both immediately before the procedure, and after the procedure, where the patient will record their average level of anxiety during the procedure. The change between pre-procedure, and post-procedure, will be recorded for each patient and compared between the lavender aromatherapy and placebo groups. The mean and median pre-procedure and post-procedure values will also be compared between the groups.
Likert scale subjective improvement with pain, measured on scale of 1-5
时间窗: Immediately after the procedure
Patients will be asked in post-procedural questionnaire if they felt the aromatherapy helped with pain during the procedure, on a scale of 1 (strongly disagree) to 5 (strongly agree)
Likert scale of pain, measured on a scale of 0-10
时间窗: Immediately after the procedure
Patients will be asked to rate their your average level of pain on a scale of 0 (no pain) to 10 (worst possible pain) on a post-procedural questionnaire
次要结局
- Subjective Impressions of Lavender Aromatherapy, measured on Likert scale and in Yes/No format in post-procedural questionnaire(Immediately after the procedure)
研究者
Ankona Ghosh
Principal Investigator
Cedars-Sinai Medical Center