Evaluation of Aromatic Essential Oils in Conditions of Stress and Relaxation - A Double-Blind, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) Stress Area Under the Curve (AUC)
研究概览
简要总结
This randomized, double-blind, placebo-controlled study evaluates the acute physiological and subjective responses to essential oil inhalation in healthy adults. Participants are assigned to inhale either an essential oil or a placebo via an aroma stick during standardized laboratory procedures designed to induce temporary psychosocial stress (Trier Social Stress Test - Group version) and during a guided relaxation session.
Physiological responses, including heart rate, heart rate variability, and electrodermal activity, are measured using a wearable sensor. Subjective stress and affect are assessed using validated questionnaires and visual analog scales. The purpose of this study is to characterize short-term autonomic and self-reported responses associated with essential oil inhalation under controlled experimental conditions. This study is exploratory and is not intended to diagnose, treat, or prevent any medical condition.
详细描述
Essential oils and essential oil blends are widely used in non-clinical settings; however, objective data describing short-term physiological and subjective responses to inhalation under controlled experimental conditions remain limited. This study is designed to evaluate acute autonomic and self-reported responses to essential oil inhalation during standardized laboratory procedures involving psychosocial stress and guided relaxation.
This is a randomized, double-blind, placebo-controlled, parallel-group study conducted in healthy adults aged 18-45 years. Participants are assigned to inhale either an essential oil (or essential oil blend) or a placebo comparator administered via an identical aroma stick. Inhalation occurs at standardized time points during two study visits.
During Study Visit 1, participants undergo the Trier Social Stress Test - Group version (TSST-G), a validated laboratory paradigm designed to induce temporary psychosocial stress through public speaking and mental arithmetic tasks performed under observation. Inhalation occurs during baseline, preparation, stress, and recovery phases. During Study Visit 2, participants undergo a structured guided meditation session under controlled environmental conditions, with inhalation occurring at standardized intervals.
Physiological measures are collected continuously using a wrist-worn wearable device capable of measuring heart rate, heart rate variability (HRV), and electrodermal activity (EDA). Subjective responses are assessed using validated instruments including visual analog scales for stress and calm, PROMIS Anxiety, GAD-7, and PANAS. The primary outcome is change in stress response as measured by area under the curve (AUC) for visual analog scale stress scores across the stress and recovery period.
The study employs an adaptive design with an initial planned enrollment of 100 participants (50 per arm) and a prespecified interim analysis for potential expansion to a maximum of 200 participants. Statistical analyses include comparison of stress and physiological responses between groups using baseline-adjusted models.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years, inclusive
- •Able to read, write, and understand English
- •Willing and able to provide informed consent
- •Willing to attend two in-person study visits
- •Generally healthy, as determined by medical history and screening review
排除标准
- •Known asthma, chronic obstructive pulmonary disease (COPD), significant lung disease, heart disease, or other medical condition that may compromise safety or data integrity
- •Pregnancy or pregnancy within the past 90 days
- •Known allergy or sensitivity to essential oils or study placebo materials
- •Current smoking, vaping, chewing tobacco, or use of recreational drugs
- •Regular use of essential oils applicable to the study phase (>3 times per week for ≥2 weeks within the past month) without a minimum 1-month washout
- •Unwillingness to abstain from alcohol for at least 72 hours prior to each study visit
- •Failure to meet inclusion criteria
研究组 & 干预措施
Essential Oil Inhalation
Participants inhale an essential oil or essential oil blend via an individual aroma stick during standardized stress induction (TSST-G) and guided relaxation procedures across two study visits.
干预措施: Essential Oil Inhalation (Other)
Placebo Inhalation
Participants inhale a placebo aroma stick matched in appearance and delivery method but without active essential oil components during identical stress and relaxation procedures.
干预措施: Placebo Aroma Stick (Other)
结局指标
主要结局
Change in Visual Analog Scale (VAS) Stress Area Under the Curve (AUC)
时间窗: Baseline through 30 minutes post-stressor recovery (Study Visit 1)
Area under the curve (AUC) for self-reported stress measured using a Visual Analog Scale (VAS) across baseline, stress induction (Trier Social Stress Test - Group version), and post-stressor recovery periods. The VAS-stress scale ranges from low stress to high stress, with higher scores indicating greater perceived stress.
次要结局
未报告次要终点