- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251337
Use of Aromatherapy to Reduce Symptom Burden
Use of Aromatherapy to Reduce Symptom Burden in Patients Receiving Stem Cell Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Health, University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
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.
|
Experimental: 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.
|
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.
|
Placebo Comparator: 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.
|
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).
|
Placebo Comparator: 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in chemotherapy-induced nausea, vomiting and retching symptoms
Time Frame: baseline (0 hours) and post-intervention (48 hours)
|
Rhodes Index of Nausea, Vomiting and Retching (INVR)
|
baseline (0 hours) and post-intervention (48 hours)
|
Change in anxiety symptoms
Time Frame: baseline (0 hours) and post-intervention (48 hours)
|
shortened version of Spielberger's State Anxiety Inventory (SAI)
|
baseline (0 hours) and post-intervention (48 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: post-intervention (48 hours)
|
Aromatherapy satisfaction questionnaire
|
post-intervention (48 hours)
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Antiemetic administration
Time Frame: 48 hour intervention timeframe
|
Antiemetic medication (dose, route, frequency) administration documented in the medical record
|
48 hour intervention timeframe
|
Inpatient falls
Time Frame: baseline (12 months prior to intervention) and during intervention (12 months during study)
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Number and incidence of unit falls
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baseline (12 months prior to intervention) and during intervention (12 months during study)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11973
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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