跳至主要内容
临床试验/NCT07328412
NCT07328412已完成不适用

Aromatherapy to Address Psychological Distress in Emergency Department Patients.

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月2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
60
试验地点
1
主要终点
Acceptability of intervention via AIM

研究概览

简要总结

The goal of this clinical trial is to understand the feasibility and acceptability of a brief aromatherapy session for reducing stress, anxiety, and improving patient satisfaction among emergency department patients. The main question the study aims to answer is: Is the intervention acceptable and feasible? Participants in the intervention group will receive a lavender-scented tube and smell it for about 5 minutes. Participants in the control group will receive an unscented tube and follow the same instructions.

详细描述

Stress and anxiety are frequently experienced by patients during emergency department (ED) visits, often due to diagnostic uncertainty, prolonged wait times, and environmental factors such as noise and bright lighting. These psychological stressors can trigger physiological responses, including elevated cortisol levels, increased blood pressure, and disrupted sleep, which may negatively impact patients' experiences and overall health outcomes. Aromatherapy has emerged as a promising non-pharmacologic intervention for reducing stress and anxiety in various settings.

This pilot randomized controlled trial will be conducted to assess the feasibility and acceptability of a brief aromatherapy session for ED patients. Research staff will pre-screen potential participants admitted to the ED Observation Unit at Brigham and Women's Hospital (BWH) using information from the electronic medical record. After obtaining approval from the treating medical team, staff will approach and invite potential participants to participate in the study. Once consented and screened eligible, participants will complete a baseline assessment and be randomized in a 1:1 ratio to either the aromatherapy group or the control group. Participants in the aromatherapy group will receive a lavender-scented tube and be instructed to inhale it for about 5 minutes. Participants in the control group will receive an unscented tube and follow the same instructions. After the session, participants will complete a post-experiment assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Adults ≥18 years of age
  • Admitted to the BWH Emergency Department (ED) Observation Unit
  • Able to provide written informed consent
  • Willing to participate in a 1-hour aromatherapy session

排除标准

  • Acutely ill and unable to be approached for research, as determined by the treating medical team and/or physician investigator
  • Active gastrointestinal problems at the time of enrollment (e.g., nausea, vomiting, abdominal cramping, diarrhea), as determined by the treating team and/or physician investigator.
  • Pregnancy or breastfeeding
  • Current or planned treatment using sedating medications
  • History of, or current presentation with, significant cognitive impairment or acute delirium that would preclude informed consent or participation
  • Currently receiving supplemental oxygen
  • Acute exacerbation of asthma or COPD
  • Admission for an acute upper or lower respiratory tract illness (e.g., pneumonia, bronchitis, influenza, COVID-19)
  • Known allergy or sensitivity to lavender
  • Documented history of anosmia (loss of smell)
  • Documented hypotension during current ED presentation, defined as systolic blood pressure <90 mmHg
  • Assigned clinical staff (physician, nurse, or other healthcare provider) with fragrance sensitivity prior to consent
  • Concurrent enrollment in another interventional drug or behavioral trial
  • Any condition that, in the judgment of the treating team or physician investigator, would make study participation unsafe or inappropriate.

研究组 & 干预措施

Aromatherapy Group

Experimental

Participants will receive a lavender-scented tube to inhale for 5 minutes.

干预措施: Lavender Aromatherapy (Other)

Control Group

Active Comparator

Participants will receive an unscented tube to inhale for 5 minutes.

干预措施: Unscented Aromatherapy (Other)

结局指标

主要结局

Acceptability of intervention via AIM

时间窗: day 1

Acceptability will be assessed via the Acceptability of Intervention Measure (AIM). AIM is a 4-item Likert agreeability scale ranging from 1 (Completely disagree) to 5 (Completely agree). A mean score is calculated, resulting in a continuous score with higher scores indicating greater intervention acceptability.

Usability of intervention via SUS

时间窗: day 1

Usability will be assessed via an adapted, validated 2-item version of the System Usability Scale (SUS). Each item is rated on a 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). The mean score of each item will be calculated and entered into a validated regression equation to estimate the full SUS score, which ranges from 0 to 100, with higher scores indicating greater usability.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter R Chai MD

Associate Professor

Brigham and Women's Hospital

研究点 (1)

Loading locations...

相似试验

Aromatherapy to Address Psychological Distress in... | 临床试验