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Chronic NauseaAROMA-NTNCT07720336

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

A study testing Inhaled Essential Oils and Wearable TENS Device in people with Chronic Nausea and Anxiety, run by Ohio State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Nausea, Anxiety
What is being tested?
Inhaled Essential Oils and Wearable TENS Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteUnited States
Study dates
17 May 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

SUBHANKAR CHAKRABORTY, M.D., Ph.D. contact

614-293-6255'

Subhankar.chakraborty@osumc.edu

United States1 site, 1 recruiting
  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Subhankar Chakraborty, MD, Ph.D., 614-293-6255', subhankar.chakraborty@osumc.edu

    Recruiting

Other trials in United States

About this study

Official title: 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

Read the detailed description

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.

Being tested
Inhaled Essential Oils, Wearable TENS Device
Keywords
chronic nausea, anxiety, aromatherapy, essential oil, inhaled essential oil, transcutaneous Electrical Nerve Stimulation, mechanism of action, autonomic dysfunction, sleep disturbance, stress, pain, bowel symptoms, quality of life
Medical subject headings
Anxiety Disorders, Primary Dysautonomias, Parasomnias, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled Essential OilsOther

    Also called QueaseEASE, STILL

    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.

  • Wearable TENS DeviceDevice

    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.

Study groups in NCT07720336
Study groupRoleWhat they receive
Sequential Essential Oil and TENS InterventionExperimentalAll 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.
Receives: Other: Inhaled Essential Oils; Device: Wearable TENS Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Anxiety Severity as a Potential Mechanism of Chronic Nausea

    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

    Measured: Baseline through 3 months

  2. Change in Anxiety Severity as a Potential Mechanism of How TENS Units Affect Chronic Nausea

    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

    Measured: Change from 2nd baseline to 3 months after using TENS unit

Secondary outcomes (2)
  1. Change in Autonomic Symptom Burden as a Potential Mechanism by which Inhaled Essential Oils Affect Chronic Nausea

    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.

    Measured: Baseline to 3 months

  2. Change in Autonomic Symptom Burden as a Potential Mechanism by which TENS units Affect Chronic Nausea

    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.

    Measured: Second Baseline to 3 months after using TENS unit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start17 May 2024
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Single-group, sequential-assignment design. All participants undergo a 2-week baseline assessment period followed by 12 weeks of inhaled essential oil use (QueaseEASE and STILL) and subsequently 12 weeks of wearable TENS device use (ReliefBand). Within-participant changes in symptom domains and potential mechanistic factors associated with chronic nausea are evaluated relative to baseline.
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07720336
Sponsor's protocol ID
2023H0304
Acronym
AROMA-NT
Status last verified
Jul 2026
First submitted
17 Jul 2026
Last updated
22 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Due to privacy concerns, we cannot share IPD with other researchers

Publications

  • 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.

    PubMed 33344211
  • 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.

    PubMed 33927109
  • 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.

    PubMed 28107335
  • 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.

    PubMed 29523018
  • 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.

    PubMed 12411789

Questions about this trial

What is this clinical trial studying?

A study testing Inhaled Essential Oils and Wearable TENS Device in people with Chronic Nausea and Anxiety, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SUBHANKAR CHAKRABORTY, M.D., Ph.D. (614-293-6255', Subhankar.chakraborty@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Anxiety Severity as a Potential Mechanism of Chronic Nausea (time frame: Baseline through 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07720336, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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