[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648280":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":28,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":28,"enrollmentInfo":71,"targetDuration":28,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ohio State University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequential Essential Oil and TENS Intervention","EXPERIMENTAL","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.",[13,14],"Other: Inhaled Essential Oils","Device: Wearable TENS Device",[16,23],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],[21,22],"QueaseEASE","STILL",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"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 wearable TENS therapy may influence nausea and related symptom domains, including anxiety, stress, sleep disturbance, pain, autonomic symptoms, and bowel-related symptoms.",[9],null,[30],{"name":31,"affiliation":5,"role":32},"Subhankar CHAKRABORTY, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"SUBHANKAR CHAKRABORTY, M.D., Ph.D.","CONTACT","614-293-6255'","Subhankar.chakraborty@osumc.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ohio State University Wexner Medical Center","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-82.99879,39.96118,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":37,"phoneExt":28,"email":57},"Subhankar Chakraborty, MD, Ph.D.","subhankar.chakraborty@osumc.edu",{"type":32,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Subhankar Chakraborty","Associate Professor (Clinical)","100648280","aroma-nt-essential-oils-and-wearable-tens-device-for-chronic-nausea-100648280",false,"NCT07720336","AROMA-NT: Essential Oils and Wearable TENS Device for Chronic Nausea","AROMA-NT: Assessment of the Mechanisms of Action of Inhaled Essential Oils and Wearable TENS Unit Device on Nausea","AROMA-NT","Inclusion Criteria:\n\nAge 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.\n\nAble to read and understand English. Willing and able to complete study procedures and questionnaires\n\nExclusion Criteria:\n\nCurrently receiving treatment for cancer. Decompensated cirrhosis, including cirrhosis with ascites, variceal bleeding, or hepatic encephalopathy.\n\nCurrently 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.\n\nInflammation, irritation, infection, or other significant skin disease near the wrist at the intended site of ReliefBand application.\n\nLatex allergy, due to natural rubber latex contained in the ReliefBand wrist strap","ALL","18 Years",{"count":72,"type":73},250,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.\n\nParticipants 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",[79,80],"Chronic Nausea","Anxiety",[82,83,84,85,86,87,88,89,90,91,92,93,94],"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","2026-07-17",{"date":97,"type":98},"2026-07-22","ACTUAL",{"date":100,"type":98},"2024-05-17",{"date":102,"type":73},"2027-12-31",{"name":5,"class":6},1]