Use of Aromatherapy to Reduce Symptom Burden

Anxiety Clinical Trial

Official title:

Use of Aromatherapy to Reduce Symptom Burden in Patients Receiving Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251337
• Other study ID #: 11973
• Status: Completed
• Phase: Phase 2
• Start date: March 7, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Essential oils
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
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).

Locations

Country	Name	City	State
United States	Indiana University Health, University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Patient Satisfaction at 48 Hours	An investigator-developed questionnaire was administered at the 48-hour study completion to evaluate patient satisfaction. Participants rated their satisfaction with the intervention on a 1-10 rating scale, with 10 being extremely satisfied (e.g., higher score means higher satisfaction).	post-intervention (48 hours)
Secondary	Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe	Medications administered for nausea/vomiting indication (scopolamine, lorazepam, promethazine, prochlorperazine, olanzapine, dexamethasone, Marinol, ondansetron). Medications administered for nausea/vomiting symptom indication were extracted from the electronic medical record for participants in the nausea/vomiting symptom group.	48 hour intervention timeframe
Secondary	Inpatient Fall Events at Baseline and During Intervention	Fall numbers using total number of falls reported to the National Database of Nurse Quality Indicators. Data were extracted from the bone marrow transplant and hematology/oncology units for baseline (December 2020-March 2022) and intervention (March 2022-June 2023) timeframes.	baseline (December 2020-February 2022) and during intervention (March 2022-June 2023)