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临床试验/NCT06400979
NCT06400979已完成不适用

Aromatherapy for Management of Pain, Anxiety, and Nausea in the Acute Care Setting

University of California, Davis2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
2
主要终点
Numerical Rating Pain Scale

研究概览

简要总结

The purpose of this interventional study is to investigate the effects of aromatherapy on an acute care unit and whether it is effective in decreasing physical or emotional stressors that occur as a hospitalized patient. This study aimed to expand the limited literature on aromatherapy use in hospitalized adults and its effectiveness in decreasing pain, anxiety, and nausea. The hypothesis was that use of aromatherapy would decrease pain, anxiety and nausea in hospitalized adults and increase patient satisfaction. While there is anecdotal evidence of its efficacy, few studies exist evaluating its effectiveness within peer-reviewed journals, specifically on acute care medical surgical units.

详细描述

The goal for the study was to collect a sample of one hundred adult patients admitted to an acute care medical surgical unit. A quasi-experimental study with a single-arm pre-/post-test design evaluated one-time use of inhaled aromatherapy on hospitalized adults on an acute care unit. Pre-test tools included a numeric pain rating scale, facial anxiety scale and Halpin's 0-5 nausea scale. Aromatherapy (Elequil aromatabs) was administered for 8 hours. Sleep, satisfaction, well-being, and concurrent medication use were assessed post-aromatherapy. Descriptive and inferential statistics were performed. These subjects had to be conscious, oriented, able to consent, and able to understand the purpose of the study. Exclusion criteria were otolaryngology free flap patients (as this was a study being conducted on an otolaryngology acute care unit and another study was occurring with this population), patients with known allergies to essential oils, those taking sleep medications, or who have an aroma/essential oil contraindication. The use of a pre and post survey was used to measure the effectiveness of aromatherapy on pain, anxiety, and nausea. A baseline assessment was made of these ailments via Qualtrix. Subjects chose the aromatherapy tab fragrance that best fit their chief complaint, which was placed on their gown. After eight hours, a post-application survey to assess pain, anxiety, nausea, sleep/relaxation, overall satisfaction, and overall wellbeing was administered via Qualtrix. A numeric pain scale from 0-10, a 0-5 Likert Anxiety scale and a 0-5 nausea scale were used to measure efficacy. Sleep, satisfaction, and wellbeing was assessed with yes/no. A chart review to determine any measurable benefits in the reduction of related medications while using aromatherapy was to be conducted once one hundred subjects were obtained. The period for this study was approximately fifteen months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Age 18 years or older,
  • Admission to Tower 4 for an anticipated inpatient stay >24 hours,
  • Alert and oriented,
  • Capable of using a visual scale to self-report symptoms,
  • Naïve to the use of aromatherapy for the use of decreasing pain, anxiety and/or nausea to participate,
  • Not on a pediatric service.

排除标准

  • Cognitively impaired,
  • Post-op from an otolaryngologic surgery (another study was being conducted concurrently with this patient population and we did not want to interfere with those results),
  • Known impaired olfactory function (limited or no sense of smell),
  • On any psychiatric holds (e.g., 5150's),
  • Known allergies to essential oils,
  • Sensitive or allergic to plants (specifically to lavender plants, orange blossoms, sandalwood trees, or peppermint leaves) as essential oils are natural aromas derived from plants,
  • Active participant of another Research Protocol,
  • Admitted as a "short stay" or on "observation" status,
  • Have a known history of Atrial Fibrillation. The use of peppermint has known effects on stimulating atrial fibrillation,
  • Is a prisoner,
  • Known pregnancy, or
  • Expected to be transferred out of Tower 4 and/or discharged from the hospital within twenty-four hours.

研究组 & 干预措施

Aromatherapy aromatab

Experimental

Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants

干预措施: Elequil aromatab (Device)

结局指标

主要结局

Numerical Rating Pain Scale

时间窗: Pre-Post Aromatherapy Administration (8 hours)

The Numerical Rating Pain Scale measures pain experienced right now based on a 11-point Likert scale with choices of 0 = no pain, 5 = Moderate pain, 10 = Worst possible pain.

Nausea Scale

时间窗: Pre-Post Aromatherapy Administration (8 hours)

Nausea Scale: 0-5 Nausea Scale. 0 - No nausea and 5 - severe nausea

Anxiety Likert Scale

时间窗: Pre-Post Aromatherapy Admin (8 hours)

This one-item scale consisted of five evenly spaced numbers each anchored to a level of anxiety (0 = not at all anxious, 2 = a little anxious, 3 = moderately anxious, 4 = very anxious, 5 = extremely anxious).

次要结局

  • Patient Satisfaction(8 hours)
  • Well-being(8 hours)
  • Increased Sleep(8 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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