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AROMA-NT: Essential Oils and Wearable TENS Device for Chronic Nausea (AROMA-NT)

2026年7月17日 更新者：Subhankar Chakraborty、Ohio State University

AROMA-NT: Assessment of the Mechanisms of Action of Inhaled Essential Oils and Wearable TENS Unit Device on Nausea

This study will investigate how two inhaled essential oil products (QueaseEASE and STILL) and a wearable transcutaneous electrical nerve stimulation (TENS) device (ReliefBand) affect chronic nausea and anxiety in adults with longstanding nausea. The goal is to better understand the mechanisms by which these non-prescription therapies may influence nausea, anxiety, sleep, pain, autonomic symptoms, and bowel-related symptoms.

Participants will first complete a 2-week baseline period during which nausea and other symptoms are assessed through questionnaires. Participants will then use the inhaled essential oil products as needed for 12 weeks while completing symptom surveys. Afterward, participants will use the ReliefBand wearable TENS device as needed for an additional 12 weeks and continue completing surveys. Researchers will compare symptom changes during the intervention periods with baseline measurements to better understand factors that contribute to chronic nausea and how these therapies may provide relief. Up to 250 participants may be enrolled to achieve approximately 100 participants completing both intervention phases

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Chronic nausea is a complex symptom that may be influenced by multiple factors, including anxiety, stress, sleep disturbance, pain, autonomic nervous system function, and bowel-related symptoms. Although inhaled essential oil products and wearable transcutaneous electrical nerve stimulation (TENS) devices are used by individuals experiencing nausea, the mechanisms through which these interventions may affect nausea and related symptoms are not well understood.

The primary purpose of this prospective study is to investigate the mechanisms by which inhaled essential oils and a wearable TENS device influence nausea in adults with chronic nausea and anxiety. Rather than evaluating treatment efficacy, the study is designed to examine whether use of these interventions is associated with changes in potential contributors to nausea, including anxiety, stress, sleep disturbance, pain, autonomic symptoms, and bowel-related symptoms.

Participants will complete a 2-week baseline assessment period followed by a 12-week inhaled essential oil phase and a 12-week wearable TENS device phase. Throughout the study, participants will complete patient-reported assessments of nausea and related symptoms. Changes in symptom domains during the intervention periods will be compared with baseline measurements to identify potential pathways through which these interventions may influence the experience of chronic nausea.

A secondary objective is to evaluate the relationship between changes in nausea severity and changes in fatigue, appetite, and quality of life. Findings from this study are expected to improve understanding of the biological and symptom-based factors associated with chronic nausea and to provide insight into how inhaled essential oils and wearable TENS therapy may affect these factors.

研究の種類

介入

入学 (推定)

250

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Ohio
      • Columbus、Ohio、アメリカ、43210
        • 募集
        • Ohio State University Wexner Medical Center
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

Age 18 years or older. Chronic nausea for more than 6 months. Nausea on 3 or more days during the previous week. Severe or very severe nausea. At least moderate anxiety as defined by a Generalized Anxiety Disorder-7 (GAD-7) score of 10 or greater.

Able to read and understand English. Willing and able to complete study procedures and questionnaires

Exclusion Criteria:

Currently receiving treatment for cancer. Decompensated cirrhosis, including cirrhosis with ascites, variceal bleeding, or hepatic encephalopathy.

Currently receiving dialysis. Gastrointestinal surgery within the previous 3 months. Stroke within the previous 3 months. Currently pregnant (self-reported). Symptoms consistent with carpal tunnel syndrome based on the Kamath-Stothard questionnaire.

Inflammation, irritation, infection, or other significant skin disease near the wrist at the intended site of ReliefBand application.

Latex allergy, due to natural rubber latex contained in the ReliefBand wrist strap

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Sequential Essential Oil and TENS Intervention
All participants complete a 2-week baseline assessment period followed by 12 weeks of use of inhaled essential oil products (QueaseEASE for nausea and STILL for stress or anxiety) as needed. Participants then complete 12 weeks of use of a wearable transcutaneous electrical nerve stimulation (TENS) device (ReliefBand) as needed for nausea. The study is designed to evaluate changes in factors that may contribute to chronic nausea, including anxiety, stress, sleep disturbance, pain, autonomic symptoms, and bowel-related symptoms. Participants serve as their own controls through comparison with baseline assessments.
他の：Inhaled Essential Oils
Participants will use two commercially available inhaled essential oil products during a 12-week intervention period. QueaseEASE, containing peppermint, ginger, lavender, and spearmint essential oils, will be used as needed for nausea. STILL, containing sweet orange, ylang ylang, lavender, and bergamot essential oils, will be used as needed for stress or anxiety. Participants may use either or both products according to their symptoms. The intervention is being studied to evaluate potential mechanisms through which inhaled essential oils may influence nausea and related symptom domains, including anxiety, stress, sleep disturbance, pain, autonomic symptoms, and bowel-related symptoms.
他の名前：
  • QueaseEASE
  • STILL
デバイス：Wearable TENS Device
participants will use the ReliefBand wearable transcutaneous electrical nerve stimulation (TENS) device during a 12-week intervention period following completion of the inhaled essential oil phase. The device is worn on the wrist and delivers electrical stimulation to the median nerve. Participants will use the device as needed for nausea and will not use the inhaled essential oil products during this phase. The intervention is being studied to evaluate potential mechanisms through which wearable TENS therapy may influence nausea and related symptom domains, including anxiety, stress, sleep disturbance, pain, autonomic symptoms, and bowel-related symptoms.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Anxiety Severity as a Potential Mechanism of Chronic Nausea
時間枠：Baseline through 3 months
Change in anxiety severity from baseline during inhaled essential oil use assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Modulation of anxiety severity is hypothesized as a mechanism by which Inhaled essential oils affect chronic Nausea
Baseline through 3 months
Change in Anxiety Severity as a Potential Mechanism of How TENS Units Affect Chronic Nausea
時間枠：Change from 2nd baseline to 3 months after using TENS unit
Change in anxiety severity from baseline during wearable TENS device use, assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Modulation of anxiety severity is hypothesized as a mechanism by which TENS units affect chronic Nausea
Change from 2nd baseline to 3 months after using TENS unit

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Autonomic Symptom Burden as a Potential Mechanism by which Inhaled Essential Oils Affect Chronic Nausea
時間枠：Baseline to 3 months
Change in autonomic symptom severity from baseline during inhaled essential oil use assessed using the COMPASS-31 questionnaire. This will evaluate if the change in autonomic symptoms from baseline could be a mechanism by which inhaled essential oils can affect chronic nausea.
Baseline to 3 months
Change in Autonomic Symptom Burden as a Potential Mechanism by which TENS units Affect Chronic Nausea
時間枠：Second Baseline to 3 months after using TENS unit
Change in autonomic symptom severity from baseline during TENS unit use assessed using the COMPASS-31 questionnaire. This will evaluate if the change in autonomic symptoms from baseline could be a mechanism by which TENS units can affect chronic nausea.
Second Baseline to 3 months after using TENS unit

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ohio State University

捜査官

  • 主任研究者：Subhankar CHAKRABORTY, MD, Ph.D.、Ohio State University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年5月17日

一次修了 (推定)

2027年5月31日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2026年7月17日

QC基準を満たした最初の提出物

2026年7月17日

最初の投稿 (実際)

2026年7月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月22日

QC基準を満たした最後の更新が送信されました

2026年7月17日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2023H0304

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Due to privacy concerns, we cannot share IPD with other researchers

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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