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Use of Aromatherapy to Reduce Symptom Burden

Primary Purpose

Anxiety, Chemotherapy-induced Nausea and Vomiting

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Essential oils
Placebo
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring stem cell transplant, anxiety, chemotherapy-induced nausea and vomiting, aromatherapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Indiana University Health, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Intervention - nausea/vomiting

Intervention - anxiety

Control - nausea/vomiting

Control - anxiety

Arm 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).

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.

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 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.

Outcomes

Primary Outcome Measures

Change in chemotherapy-induced nausea, vomiting and retching symptoms
Rhodes Index of Nausea, Vomiting and Retching (INVR)
Change in anxiety symptoms
shortened version of Spielberger's State Anxiety Inventory (SAI)

Secondary Outcome Measures

Patient satisfaction
Aromatherapy satisfaction questionnaire
Antiemetic administration
Antiemetic medication (dose, route, frequency) administration documented in the medical record
Inpatient falls
Number and incidence of unit falls

Full Information

First Posted
February 3, 2022
Last Updated
July 18, 2023
Sponsor
Indiana University
Collaborators
Indiana University Health
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1. Study Identification

Unique Protocol Identification Number
NCT05251337
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
June 22, 2023 (Actual)
Study Completion Date
June 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Indiana University Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Chemotherapy-induced Nausea and Vomiting
Keywords
stem cell transplant, anxiety, chemotherapy-induced nausea and vomiting, aromatherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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).
Masking
Participant
Masking Description
Participants will not be informed of assignment to intervention or control; however, the blank aromatherapy patch (control group) will not have a scent and the essential oil infused aromatherapy patch (intervention group) will. Thus, it may be obvious to participants what group they are randomized to.
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention - nausea/vomiting
Arm Type
Experimental
Arm 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).
Arm Title
Intervention - anxiety
Arm Type
Experimental
Arm 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.
Arm Title
Control - nausea/vomiting
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Control - anxiety
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Essential oils
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in chemotherapy-induced nausea, vomiting and retching symptoms
Description
Rhodes Index of Nausea, Vomiting and Retching (INVR)
Time Frame
baseline (0 hours) and post-intervention (48 hours)
Title
Change in anxiety symptoms
Description
shortened version of Spielberger's State Anxiety Inventory (SAI)
Time Frame
baseline (0 hours) and post-intervention (48 hours)
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Aromatherapy satisfaction questionnaire
Time Frame
post-intervention (48 hours)
Title
Antiemetic administration
Description
Antiemetic medication (dose, route, frequency) administration documented in the medical record
Time Frame
48 hour intervention timeframe
Title
Inpatient falls
Description
Number and incidence of unit falls
Time Frame
baseline (12 months prior to intervention) and during intervention (12 months during study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Indiana University Health, University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Aromatherapy to Reduce Symptom Burden

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