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

Official title

AROMA-NT: Assessment of the Mechanisms of Action of Inhaled Essential Oils and Wearable TENS Unit Device on Nausea

Overview

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

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.

Interventions

• Other 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 mech
• Device 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 wearabl

Primary outcome measures

• 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]

Secondary outcome measures (2)

• Change in Autonomic Symptom Burden as a Potential Mechanism by which Inhaled Essential Oils Affect Chronic Nausea [Time frame: Baseline to 3 months]
• Change in Autonomic Symptom Burden as a Potential Mechanism by which TENS units Affect Chronic Nausea [Time frame: Second Baseline to 3 months after using TENS unit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Ohio State University Wexner Medical Center — Columbus

Publications

• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07720336 · 2023H0304

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗