Use of Aromatherapy to Reduce Symptom Burden

Phase 2

Completed

Conditions: Anxiety
Chemotherapy-induced Nausea and Vomiting

Interventions: Drug: Essential oils
Drug: Placebo

Registration Number: NCT05251337

Lead Sponsor: Indiana University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention - nausea/vomiting	Essential oils	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).
Control - anxiety	Placebo	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.
Intervention - anxiety	Essential oils	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.
Control - nausea/vomiting	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours	baseline (0 hours) and post-intervention (24, 48 hours)	CINVR involves three gastrointestinal symptoms (nausea, vomiting, retching) influenced by administration of chemotherapy. Nausea is expressed as an unpleasant feeling in the throat/epigastrium that can result in expulsion of stomach content, known as vomiting. Retching is the effort to expel stomach contents without success. The Rhodes Index of Nausea, Vomiting and Retching (INVR) was used to measure CINVR and includes 8 Likert-type items on a 5-point scale. Items are scored from 0 (least amount of distress) to 4 (the most distress) and added after reverse coding items 1,3,6, and 7 to calculate an overall INVR score. The overall score ranges from 0 to 32, with higher scores indicating higher symptom burden. Subscales for symptom experience, occurrence, and distress for each symptom (nausea, vomiting, retching) are calculated by adding corresponding scale items for each subscale. The ranges for each subscale were as follows: nausea experience (0-12), vomiting experience (0-12),
Anxiety Symptoms at Baseline 24 Hours, and 48 Hours	baseline (0 hours) and post-intervention (24, 48 hours)	Anxiety is defined as excessive or persistent worry about aspects of life. Anxiety was measured using a shortened version of Spielberger's State Anxiety Inventory (SAI). The original SAI contains 20 items to measure state anxiety and items are scored using a 4-point Likert-type scale (almost never-almost always). The shortened SAI retains 6 items (from the original 20) and has evidence supporting good internal reliability consistency and strong construct validity. Items are scored from 1 (not at all) to 4 (very much so) and added after reverse coding anxiety absent items, with higher total scores indicating higher state anxiety. The shortened SAI total score ranges from a total score of 6-24.

Secondary Outcome Measures

Name	Time	Method
Inpatient Fall Events at Baseline and During Intervention	baseline (December 2020-February 2022) and during intervention (March 2022-June 2023)	Fall numbers using total number of falls reported to the National Database of Nurse Quality Indicators. Data were extracted from the bone marrow transplant and hematology/oncology units for baseline (December 2020-March 2022) and intervention (March 2022-June 2023) timeframes.
Patient Satisfaction at 48 Hours	post-intervention (48 hours)	An investigator-developed questionnaire was administered at the 48-hour study completion to evaluate patient satisfaction. Participants rated their satisfaction with the intervention on a 1-10 rating scale, with 10 being extremely satisfied (e.g., higher score means higher satisfaction).
Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe	48 hour intervention timeframe	Medications administered for nausea/vomiting indication (scopolamine, lorazepam, promethazine, prochlorperazine, olanzapine, dexamethasone, Marinol, ondansetron). Medications administered for nausea/vomiting symptom indication were extracted from the electronic medical record for participants in the nausea/vomiting symptom group.