Clinical trial NCT05251337: Use of Aromatherapy to Reduce Symptom Burden
Official title: Use of Aromatherapy to Reduce Symptom Burden in Patients Receiving Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Chemotherapy-induced Nausea and Vomiting
Keywords: stem cell transplant
anxiety
chemotherapy-induced nausea and vomiting
aromatherapy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Health
First posted: 2022-02-22
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

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
* Prisoner

Primary outcomes:
measure: Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours
timeFrame: baseline (0 hours) and post-intervention (24, 48 hours)
measure: Anxiety Symptoms at Baseline 24 Hours, and 48 Hours
timeFrame: baseline (0 hours) and post-intervention (24, 48 hours)
Secondary outcomes:
measure: Patient Satisfaction at 48 Hours
timeFrame: post-intervention (48 hours)
measure: Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe
timeFrame: 48 hour intervention timeframe
measure: Inpatient Fall Events at Baseline and During Intervention
timeFrame: baseline (December 2020-February 2022) and during intervention (March 2022-June 2023)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health, University Hospital
state: Indiana
Study officials:
References: