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

NCT07720336 | Recruiting FDA Device

• 1 other identifier: 2023H0304
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Chronic Nausea; Anxiety

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

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline through 3 months

• 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

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

Secondary Outcomes (2)

• Change in Autonomic Symptom Burden as a Potential Mechanism by which Inhaled Essential Oils Affect Chronic Nausea

  Baseline to 3 months

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

  Second Baseline to 3 months after using TENS unit

Study Arms (1)

Sequential Essential Oil and TENS Intervention

EXPERIMENTAL

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.

Other: Inhaled Essential Oils; Device: Wearable TENS Device

Interventions

Wearable TENS Device 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.

Sequential Essential Oil and TENS Intervention

Inhaled Essential Oils OTHER

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.

Also known as: QueaseEASE, STILL

Sequential Essential Oil and TENS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 33344211 BACKGROUND

• 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.

  PMID: 33927109 BACKGROUND

• 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.

  PMID: 28107335 BACKGROUND

• 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.

  PMID: 29523018 BACKGROUND

• 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.

  PMID: 12411789 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Primary Dysautonomias; Parasomnias; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Autonomic Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Subhankar CHAKRABORTY, MD, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

614-293-6255'; Subhankar.chakraborty@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Clinical)

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: May 17, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)