Use of Aromatherapy to Reduce Symptom Burden in Patients Receiving Stem Cell Transplantation
Overview
- Phase
- Phase 2
- Intervention
- Essential oils
- Conditions
- Anxiety
- Sponsor
- Indiana University
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Monica Bates
Registered Nurse
Indiana University
Eligibility Criteria
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
Arms & Interventions
Intervention - nausea/vomiting
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).
Intervention: Essential oils
Intervention - anxiety
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.
Intervention: Essential oils
Control - nausea/vomiting
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.
Intervention: Placebo
Control - anxiety
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: Placebo
Outcomes
Primary Outcomes
Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours
Time Frame: 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
Time Frame: 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 Outcomes
- Inpatient Fall Events at Baseline and During Intervention(baseline (December 2020-February 2022) and during intervention (March 2022-June 2023))
- Patient Satisfaction at 48 Hours(post-intervention (48 hours))
- Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe(48 hour intervention timeframe)