NCT07720336|RecruitingFDA Device
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
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AROMA-NT
AROMA-NT: Assessment of the Mechanisms of Action of Inhaled Essential Oils and Wearable TENS Unit Device on Nausea
Sponsor study identifier
interventional
250
1 country
1
Study Start
May 17, 2024
Actual (reported)Primary Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2024
Actual (reported)July 17, 2026
Actual (reported)July 22, 2026
Actual (reported)May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
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.
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
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.
Subhankar CHAKRABORTY, MD, Ph.D.
Ohio State University
First Submitted
July 17, 2026
First Posted
July 22, 2026
Study Start
May 17, 2024
Actual (reported)Effects of Virtual Reality Relaxation on the Anxiety Levels
Intervention Trial for Healthcare Workers With Anxiety
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
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.
Primary Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 22, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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