AROMA-NT: Essential Oils and Wearable TENS Device for Chronic Nausea (AROMA-NT)
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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：SUBHANKAR CHAKRABORTY, M.D., Ph.D.
- 电话号码：614-293-6255'
- 邮箱：Subhankar.chakraborty@osumc.edu
学习地点
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Ohio
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Columbus、Ohio、美国、43210
- 招聘中
- Ohio State University Wexner Medical Center
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接触：
- Subhankar Chakraborty, MD, Ph.D.
- 电话号码：614-293-6255'
- 邮箱：subhankar.chakraborty@osumc.edu
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
其他名称：
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Anxiety Severity as a Potential Mechanism of Chronic Nausea
大体时间：Baseline through 3 months
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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
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Baseline through 3 months
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Change in Anxiety Severity as a Potential Mechanism of How TENS Units Affect Chronic Nausea
大体时间：Change from 2nd baseline to 3 months after using TENS unit
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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
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Change from 2nd baseline to 3 months after using TENS unit
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Autonomic Symptom Burden as a Potential Mechanism by which Inhaled Essential Oils Affect Chronic Nausea
大体时间：Baseline to 3 months
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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.
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Baseline to 3 months
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Change in Autonomic Symptom Burden as a Potential Mechanism by which TENS units Affect Chronic Nausea
大体时间：Second Baseline to 3 months after using TENS unit
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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.
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Second Baseline to 3 months after using TENS unit
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合作者和调查者
调查人员
- 首席研究员：Subhankar CHAKRABORTY, MD, Ph.D.、Ohio State University
出版物和有用的链接
一般刊物
- Hines S, Steels E, Chang A, Gibbons K. Aromatherapy for treatment of postoperative nausea and vomiting. Cochrane Database Syst Rev. 2018 Mar 10;3(3):CD007598. doi: 10.1002/14651858.CD007598.pub3.
- White PF, Issioui T, Hu J, Jones SB, Coleman JE, Waddle JP, Markowitz SD, Coloma M, Macaluso AR, Ing CH. Comparative efficacy of acustimulation (ReliefBand) versus ondansetron (Zofran) in combination with droperidol for preventing nausea and vomiting. Anesthesiology. 2002 Nov;97(5):1075-81. doi: 10.1097/00000542-200211000-00008.
- Safajou F, Soltani N, Taghizadeh M, Amouzeshi Z, Sandrous M. The Effect of Combined Inhalation Aromatherapy with Lemon and Peppermint on Nausea and Vomiting of Pregnancy: A Double-Blind, Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2020 Sep 1;25(5):401-406. doi: 10.4103/ijnmr.IJNMR_11_19. eCollection 2020 Sep-Oct.
- Bertone AC, Dekker RL. Aromatherapy in Obstetrics: A Critical Review of the Literature. Clin Obstet Gynecol. 2021 Sep 1;64(3):572-588. doi: 10.1097/GRF.0000000000000622.
- Reis D, Jones T. Aromatherapy: Using Essential Oils as a Supportive Therapy. Clin J Oncol Nurs. 2017 Feb 1;21(1):16-19. doi: 10.1188/17.CJON.16-19.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2023H0304
计划个人参与者数据 (IPD)
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IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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