AROMA-NT: Essential Oils and Wearable TENS Device for Chronic Nausea
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention 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.
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Ohio State University
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.
