Use of Aromatherapy to Reduce Symptom Burden

Last updated: April 19, 2024
Sponsor: Indiana University
Overall Status: Completed

Phase

2

Condition

Vomiting

Colic

Lactose Intolerance

Treatment

Placebo

Essential oils

Clinical Study ID

NCT05251337
11973
  • Ages 18-100
  • All Genders

Study Summary

The purpose of this study is to evaluate the effect of inhaled aromatherapy on symptoms of nausea/vomiting and anxiety in patients who have received a stem cell transplant. Aromatherapy involves essential oils from aromatic plants that can be absorbed into the body in different ways. Our study will be using inhaled aromatherapy, which has been found helpful for symptoms such as nausea/vomiting and anxiety.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients from a bone marrow transplant unit or hematology/oncology unit within anadult academic health center in the Midwest.

  • Adult stem cell transplant inpatients that have received autologous or allogeneictransplant and are actively going through therapy.

  • Patients must also be alert and oriented, able to interact with the study team, andable to read and write English.

Exclusion

Exclusion Criteria:

  • Under 18 years of age

  • Intubation

  • Medical sedation

  • Receipt of chimeric antigen receptor T (CAR-T) cells

  • History of atrial fibrillation

  • History of seizures/epilepsy

  • Adhesive allergy or sensitivity

  • Currently pregnant

  • Prisoner

Study Design

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 07, 2022
Estimated Completion Date:
June 22, 2023

Study Description

The purpose of this study is to evaluate the efficacy of aromatherapy on symptoms of chemotherapy-induced nausea, vomiting, and retching (CINVR) and anxiety for patients hospitalized for hematopoietic stem cell transplant. The primary aim will be to evaluate the effect of inhaled aromatherapy on CINVR and anxiety symptoms compared to control for 48 hours. Secondary aims include (1) Evaluating patient satisfaction with aromatherapy at completion of study; (2) Evaluating the antiemetic administration between intervention and control groups during the 48-hour intervention time span; (3) Evaluating the number and incidence of unit falls pre and post intervention.

This study will be a randomized controlled trial. Prior to randomization, participants will be asked which symptom, nausea/vomiting or anxiety, is most burdensome for them. Participants will be stratified based on their identified symptom of burden (nausea/vomiting or anxiety) and will then be randomized to either the intervention or control group, with a target of 50 participants in the nausea/vomiting symptom group (25 intervention and 25 control) and 50 participants in the anxiety symptom group (25 intervention and 25 control). Intervention and control groups will receive Wyndmere Naturals, Inc. aromatherapy patches and a symptom diary. Participants in the intervention group indicating that nausea/vomiting is the primary symptom of concern will receive peppermint inhaled aromatherapy patches (or mandarin if peppermint intolerance indicted). Participants in the intervention group indicating that anxiety is the primary symptoms of concern with receive lavender inhaled aromatherapy patches. The control group will receive non-scented aromatherapy patches (i.e., blank hydrogel adhesive patches without essential oil infusion), so it will not be feasible to blind participants to group assignment. The control group will have the same interactions with the study team as the intervention group and will complete patch changes and a symptom diary to serve as an attention control.

Connect with a study center

  • Indiana University Health, University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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