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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07720336
Status
Recruiting
Apply to this trial

Conditions

  • Anxiety
  • Chronic Nausea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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

Key Dates

First listed
Jul 22, 2026
Start date
May 17, 2024
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Change in Anxiety Severity as a Potential Mechanism of Chronic Nausea [ Time Frame: Baseline through 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Wexner Medical CenterColumbusOhio43210
Subhankar Chakraborty, MD, Ph.D.
[email protected]
614-293-6255'

Find similar trials in Columbus, OH

By research site
Ohio State University Wexner Medical Center· Columbus, OH

Related Studies