Use of Aromatherapy to Reduce Symptom Burden
Condition: Anxiety; Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): Essential oils; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Wyndmere Naturals, Inc. aromatherapy patches. The hydrogel adhesive patches are infused with essential oil for inhaled aromatherapy treatment. The aromatherapy patches provide an occlusive barrier that is hypoallergenic, allowing essential oils to be inhaled without coming in direct contact with the skin. Participants indicating nausea/vomiting is their symptom of concern will receive peppermint aromatherapy patches (or mandarin if peppermint sensitivity). Participants indicating anxiety is their symptom of concern will receive lavender aromatherapy patches.; Patients assigned to either control group (nausea/vomiting or anxiety) will receive Wyndmere Naturals non-scented patches (i.e., blank hydrogel adhesive patches without essential oil infusion).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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).
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: stem cell transplant; anxiety; chemotherapy-induced nausea and vomiting; aromatherapy