Recruiting

QueaseEASE, STILL, ReliefBand

Sponsor:

Ohio State University

Code:

NCT07720336

Conditions

Chronic Nausea

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inhaled Essential Oils

Wearable TENS Device

Study Details

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

Study ID

NCT07720336

Start date

May 17, 2024

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

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.

Primary outcome measure

  • Change in Anxiety Severity as a Potential Mechanism of Chronic Nausea [ Time Frame: Baseline through 3 months ]
  • Change in Anxiety Severity as a Potential Mechanism of How TENS Units Affect Chronic Nausea [ Time Frame: Change from 2nd baseline to 3 months after using TENS unit ]

Central Contacts and Locations

Central contacts

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

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

Locations

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Subhankar Chakraborty, MD, Ph.D.

614-293-6255'subhankar.chakraborty@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-22.