AROMA-NT: Essential Oils and Wearable TENS Device for Chronic Nausea (AROMA-NT)
AROMA-NT: Assessment of the Mechanisms of Action of Inhaled Essential Oils and Wearable TENS Unit Device on Nausea
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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: SUBHANKAR CHAKRABORTY, M.D., Ph.D.
- Telefonszám: 614-293-6255'
- E-mail: Subhankar.chakraborty@osumc.edu
Tanulmányi helyek
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Ohio
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Columbus, Ohio, Egyesült Államok, 43210
- Toborzás
- Ohio State University Wexner Medical Center
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Kapcsolatba lépni:
- Subhankar Chakraborty, MD, Ph.D.
- Telefonszám: 614-293-6255'
- E-mail: subhankar.chakraborty@osumc.edu
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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.
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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.
Más nevek:
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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Anxiety Severity as a Potential Mechanism of Chronic Nausea
Időkeret: Baseline through 3 months
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Change in anxiety severity from baseline during inhaled essential oil use assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire.
Modulation of anxiety severity is hypothesized as a mechanism by which Inhaled essential oils affect chronic Nausea
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Baseline through 3 months
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Change in Anxiety Severity as a Potential Mechanism of How TENS Units Affect Chronic Nausea
Időkeret: Change from 2nd baseline to 3 months after using TENS unit
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Change in anxiety severity from baseline during wearable TENS device use, assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire.
Modulation of anxiety severity is hypothesized as a mechanism by which TENS units affect chronic Nausea
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Change from 2nd baseline to 3 months after using TENS unit
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Autonomic Symptom Burden as a Potential Mechanism by which Inhaled Essential Oils Affect Chronic Nausea
Időkeret: Baseline to 3 months
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Change in autonomic symptom severity from baseline during inhaled essential oil use assessed using the COMPASS-31 questionnaire.
This will evaluate if the change in autonomic symptoms from baseline could be a mechanism by which inhaled essential oils can affect chronic nausea.
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Baseline to 3 months
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Change in Autonomic Symptom Burden as a Potential Mechanism by which TENS units Affect Chronic Nausea
Időkeret: Second Baseline to 3 months after using TENS unit
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Change in autonomic symptom severity from baseline during TENS unit use assessed using the COMPASS-31 questionnaire.
This will evaluate if the change in autonomic symptoms from baseline could be a mechanism by which TENS units can affect chronic nausea.
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Second Baseline to 3 months after using TENS unit
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Subhankar CHAKRABORTY, MD, Ph.D., Ohio State University
Publikációk és hasznos linkek
Általános kiadványok
- 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.
- 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.
- 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.
- 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.
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2023H0304
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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