评估吸入 Shikuwasa(早田郁金香)精油对年轻女性成年人的放松效果:随机对照试验的研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Fumitake Yamaguchi , Naoki Yoshinaga , Miho Kuroki , Rie Nakasone , Hisanori Kenmotsu , Toshio Ueno , Yukihiro Yada , Michikazu Nakai , Yasuji Arimura
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引用次数: 0

摘要

引言 四葛(Citrus depressa Hayata)精油主要含有柠檬烯和γ-萜品烯,可用于压力管理和放松。然而,Shikuwasa 精油对人类的心理或生理放松效果仍然未知。本研究旨在调查 Shikuwasa 精油(研究较少的品种之一)与吸入无味空气相比对年轻女性成年人的短期放松效果:本研究是一项双臂、平行组、开放标签、随机对照的优效试验。40 名年轻女性成人将按 1:1 的分配比例被分配到吸入 Shikuwasa 精油组或吸入无味空气组。主要结果是主观紧张唤醒(威尔士科技大学情绪形容词检查表日语版的分量表)。次要结果包括客观测量:用于评估自律神经活动的瞳孔缩小率和外周皮肤温度,以及用于评估中枢神经活动的脑血流量(使用近红外光谱评估)。由于这些客观结果测量无法同时进行,我们将实验分为三个阶段,参与者将在每个实验中吸入样品瓶 2 分钟。我们还将评估个人对吸入样本的偏好/印象以及任何不良事件。伦理和传播本研究方案已通过宫崎大学医学系研究伦理委员会的审查和批准(参考编号:I-0074)。本研究的结果将通过在同行评审期刊上发表文章和在学术会议上发表演讲的方式向学术和专业受众传播,并通过公开讲座和媒体/新闻稿向更广泛的公众传播。所有研究结果,无论是负面的还是正面的,都将被报道。试验注册UMIN临床试验注册中心(UMIN-CTR),UMIN000053914。前瞻性注册日期为 2024 年 3 月 20 日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluating the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation in young female adults: Study protocol for a randomised controlled trial

Introduction

The essential oil of Shikuwasa (Citrus depressa Hayata) primarily contains limonene and γ-terpinene, which have potential applications in stress management and relaxation. However, the psychological or physiological relaxation effects of Shikuwasa essential oil on humans are still unknown. This study aims to investigate the short-term relaxation effects of Shikuwasa essential oil, one of the less-studied varieties, compared to inhaling odour-free air in young female adults.

Methods

and analysis: This study is a two-arm, parallel-group, open-label, randomised controlled superiority trial. Forty young female adults will be assigned with a 1:1 allocation ratio to either the Shikuwasa essential oil inhalation group or the odour-free air inhalation group. The primary outcome measure will be subjective tense arousal (subscale of the Japanese version of the University of Wales Institute of Science and Technology Mood Adjective Checklist). Secondary outcomes include objective measures: miosis rate and peripheral skin temperature for evaluating autonomic nervous activity, and cerebral blood flow (assessed using near-infrared spectroscopy) for evaluating central nervous activity. Since these objective outcome measures cannot be performed at the same time, we divide our experiment into three phases and participants will inhale sample vials for 2 min in each experiment. We will also evaluate individual preferences/impressions regarding inhaled samples and any adverse events.

Ethics and dissemination

The study protocol has been reviewed and approved by the Research Ethics Committee of the Faculty of Medicine, University of Miyazaki (reference no: I-0074). The findings of this study will be disseminated to academic and professional audiences via publications in peer-reviewed journals and presentations at academic conferences, and to the broader public via public talks and media/press releases. All study findings, whether negative or positive, will be reported.

Trial registration

UMIN Clinical Trials Registry (UMIN-CTR), UMIN000053914. Prospectively registered on March 20, 2024.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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