Use of Aromatherapy to Reduce Symptom Burden

NCT05251337 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 11973
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Chemotherapy-induced Nausea and Vomiting

Keywords

stem cell transplant; anxiety; chemotherapy-induced nausea and vomiting; aromatherapy

Outcome Measures

Primary Outcomes (2)

• Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 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),

  baseline (0 hours) and post-intervention (24, 48 hours)

• Anxiety Symptoms at Baseline 24 Hours, and 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.

  baseline (0 hours) and post-intervention (24, 48 hours)

Secondary Outcomes (3)

• Patient Satisfaction at 48 Hours

  post-intervention (48 hours)

• Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe

  48 hour intervention timeframe

• Inpatient Fall Events at Baseline and During Intervention

  baseline (December 2020-February 2022) and during intervention (March 2022-June 2023)

Study Arms (4)

Intervention - nausea/vomiting

EXPERIMENTAL

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).

Drug: Essential oils

Intervention - anxiety

EXPERIMENTAL

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.

Drug: Essential oils

Control - nausea/vomiting

PLACEBO COMPARATOR

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.

Drug: Placebo

Control - anxiety

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Essential oils DRUG

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 - anxiety; Intervention - nausea/vomiting

Placebo DRUG

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).

Control - anxiety; Control - nausea/vomiting

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Indiana University Health, University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Vomiting

Interventions

Oils, Volatile

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Results Point of Contact

• Title: Alyson Keen
• Organization: Indiana University Health

akeen2@iuhealth.org

3173413060

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Model Details: 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).

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 22, 2022
• Study Start: March 7, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)