Use of Aromatherapy to Reduce Symptom Burden

Indiana University

Status and phase: Completed; Phase 2

Conditions: Chemotherapy-induced Nausea and Vomiting; Anxiety

Treatments: Drug: Essential oils; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05251337

11973

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients from a bone marrow transplant unit or hematology/oncology unit within an adult academic health center in the Midwest.
• Adult stem cell transplant inpatients that have received autologous or allogeneic transplant and are actively going through therapy.
• Patients must also be alert and oriented, able to interact with the study team, and able to read and write English.

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 4 patient groups, including a placebo group

Intervention - nausea/vomiting

Experimental group

Description:

Patients indicating that nausea/vomiting is their primary symptom of concern and are randomized to receive intervention will be allocated to the intervention - nausea/vomiting arm. This arm will receive peppermint inhaled aromatherapy patches (or mandarin as an alternative if they have a peppermint sensitivity).

Treatment:

Drug: Essential oils

Intervention - anxiety

Experimental group

Description:

Patients indicating that anxiety is their primary symptom of concern and are randomized to receive intervention will be allocated to the intervention - anxiety arm. This arm will receive lavender inhaled aromatherapy patches.

Treatment:

Drug: Essential oils

Control - nausea/vomiting

Placebo Comparator group

Description:

Patients indicating that nausea/vomiting is their primary symptom of concern and are randomized to receive control will be allocated to the control - nausea/vomiting arm. This arm will receive blank (no essential oil infusion) aromatherapy patches.

Treatment:

Drug: Placebo

Control - anxiety

Placebo Comparator group

Description:

Patients indicating that anxiety is their primary symptom of concern and are randomized to receive control will be allocated to the control - anxiety arm. This arm will receive blank (no essential oil infusion) aromatherapy patches.

Treatment:

Drug: Placebo