Trial Outcomes & Findings for Use of Aromatherapy to Reduce Symptom Burden (NCT NCT05251337)
NCT ID: NCT05251337
Last Updated: 2024-05-16
Results Overview
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),
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
baseline (0 hours) and post-intervention (24, 48 hours)
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
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).
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.
|
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.
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.
|
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.
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).
|
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.
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
26
|
21
|
|
Overall Study
COMPLETED
|
19
|
15
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Aromatherapy to Reduce Symptom Burden
Baseline characteristics by cohort
| Measure |
Intervention - Nausea/Vomiting
n=24 Participants
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).
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
|
Intervention - Anxiety
n=21 Participants
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.
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.
|
Control - Nausea/Vomiting
n=26 Participants
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.
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).
|
Control - Anxiety
n=21 Participants
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.
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).
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55 Years
n=99 Participants
|
51 Years
n=107 Participants
|
52 Years
n=206 Participants
|
51 Years
n=7 Participants
|
52 Years
n=31 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native American or American Indian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White/Non-Hispanic
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
78 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Prefer Not to Say
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Transplant Type
Allogenic
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Transplant Type
Autologous
|
23 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
|
Cancer Type
Leukemia
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Cancer Type
Dendritic Cell
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Cancer Type
Germ Cell Tumor
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Cancer Type
Hodgkin's Disease
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Cancer Type
Myelodysplastic Syndromes
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Cancer Type
Multiple Myeloma
|
20 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Cancer Type
Non-Hodgkin's Lymphoma
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Chemotherapy Regimen
BEAM
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Chemotherapy Regimen
Etoposide/Carboplatin
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Chemotherapy Regimen
Fludarabine/Cytoxan/Total Body Irradiation
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Chemotherapy Regimen
Fludarabine/Cytoxan
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Chemotherapy Regimen
Melphalan
|
20 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Chemotherapy Regimen
Thiotepa/Cytoxan
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Chemotherapy Regimen
Triptycene/Cytoxan/Fludarabine
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: baseline (0 hours) and post-intervention (24, 48 hours)Population: Outcome measure was pre-specified to analyze data only from the "Intervention-Nausea/Vomiting" and "Control-Nausea/Vomiting" Arms
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),
Outcome measures
| Measure |
Intervention - Nausea/Vomiting
n=24 Participants
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).
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.
|
Control - Nausea/Vomiting
n=26 Participants
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.
|
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.
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).
|
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.
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)
|
|---|---|---|---|---|
|
Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours
Baseline
|
9.6 score on a scale
Standard Deviation 4.6
|
8.5 score on a scale
Standard Deviation 4.4
|
—
|
—
|
|
Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours
24 hours
|
5.2 score on a scale
Standard Deviation 3.1
|
4.9 score on a scale
Standard Deviation 3.5
|
—
|
—
|
|
Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours
48 hours
|
3.9 score on a scale
Standard Deviation 3.5
|
4.4 score on a scale
Standard Deviation 4.4
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline (0 hours) and post-intervention (24, 48 hours)Population: Outcome measure was pre-specified to analyze data only from the "Intervention-Anxiety" and "Control-Anxiety" Arms/Groups
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.
Outcome measures
| Measure |
Intervention - Nausea/Vomiting
n=21 Participants
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).
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.
|
Control - Nausea/Vomiting
n=21 Participants
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.
|
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.
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).
|
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.
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)
|
|---|---|---|---|---|
|
Anxiety Symptoms at Baseline 24 Hours, and 48 Hours
Baseline
|
14.4 score on a scale
Standard Deviation 3.7
|
15.4 score on a scale
Standard Deviation 4.1
|
—
|
—
|
|
Anxiety Symptoms at Baseline 24 Hours, and 48 Hours
24 hours
|
10.9 score on a scale
Standard Deviation 3.3
|
13.3 score on a scale
Standard Deviation 3.5
|
—
|
—
|
|
Anxiety Symptoms at Baseline 24 Hours, and 48 Hours
48 hours
|
10.5 score on a scale
Standard Deviation 3.4
|
12.9 score on a scale
Standard Deviation 4.1
|
—
|
—
|
SECONDARY outcome
Timeframe: post-intervention (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).
Outcome measures
| Measure |
Intervention - Nausea/Vomiting
n=21 Participants
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).
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.
|
Control - Nausea/Vomiting
n=15 Participants
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.
|
Control - Nausea/Vomiting
n=20 Participants
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.
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).
|
Control - Anxiety
n=18 Participants
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.
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)
|
|---|---|---|---|---|
|
Patient Satisfaction at 48 Hours
Rating = 8
|
5 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Patient Satisfaction at 48 Hours
Rating = 9
|
8 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Patient Satisfaction at 48 Hours
Rating =10
|
5 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
|
Patient Satisfaction at 48 Hours
Rating = 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction at 48 Hours
Rating = 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction at 48 Hours
Rating = 3
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Patient Satisfaction at 48 Hours
Rating = 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction at 48 Hours
Rating = 5
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction at 48 Hours
Rating = 6
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Patient Satisfaction at 48 Hours
Rating = 7
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 hour intervention timeframePopulation: Outcome measure was pre-specified to collect data only from the "Intervention-Nausea/Vomiting" and "Control-Nausea/Vomiting" Arms/Groups
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.
Outcome measures
| Measure |
Intervention - Nausea/Vomiting
n=24 Participants
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).
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.
|
Control - Nausea/Vomiting
n=26 Participants
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.
|
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.
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).
|
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.
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)
|
|---|---|---|---|---|
|
Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe
|
10.0 Medications Administered
Standard Deviation 5.0
|
7.1 Medications Administered
Standard Deviation 5.3
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline (December 2020-February 2022) and during intervention (March 2022-June 2023)Population: Data were pre-specified to be analyzed across participating hospital units, rather than study arms.
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.
Outcome measures
| Measure |
Intervention - Nausea/Vomiting
n=2 Hospital Units
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).
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.
|
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.
|
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.
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).
|
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.
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)
|
|---|---|---|---|---|
|
Inpatient Fall Events at Baseline and During Intervention
Baseline
|
32 Fall Events
|
—
|
—
|
—
|
|
Inpatient Fall Events at Baseline and During Intervention
Post
|
31 Fall Events
|
—
|
—
|
—
|
Adverse Events
Intervention - Nausea/Vomiting
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Intervention - Anxiety
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention - Nausea/Vomiting
n=24 participants at risk
Participants indicating that nausea/vomiting was their primary symptom of concern and were randomized to receive intervention were allocated to the intervention - nausea/vomiting arm. This arm received peppermint inhaled aromatherapy patches (or mandarin as an alternative if they had a peppermint sensitivity).
|
Intervention - Anxiety
n=21 participants at risk
Participants indicating that anxiety was their primary symptom of concern and were randomized to receive intervention were allocated to the intervention - anxiety arm. This arm received lavender inhaled aromatherapy patches.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/24 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
4.8%
1/21 • Number of events 1 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/24 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
4.8%
1/21 • Number of events 1 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
Other adverse events
| Measure |
Intervention - Nausea/Vomiting
n=24 participants at risk
Participants indicating that nausea/vomiting was their primary symptom of concern and were randomized to receive intervention were allocated to the intervention - nausea/vomiting arm. This arm received peppermint inhaled aromatherapy patches (or mandarin as an alternative if they had a peppermint sensitivity).
|
Intervention - Anxiety
n=21 participants at risk
Participants indicating that anxiety was their primary symptom of concern and were randomized to receive intervention were allocated to the intervention - anxiety arm. This arm received lavender inhaled aromatherapy patches.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
9.5%
2/21 • Number of events 2 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/24 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
14.3%
3/21 • Number of events 3 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • Number of events 1 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
9.5%
2/21 • Number of events 2 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Gastrointestinal disorders
Abdominal Cramps
|
8.3%
2/24 • Number of events 2 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
0.00%
0/21 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
9.5%
2/21 • Number of events 2 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
2/24 • Number of events 2 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
0.00%
0/21 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
4/24 • Number of events 4 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
4.8%
1/21 • Number of events 1 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • Number of events 3 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
4.8%
1/21 • Number of events 1 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Gastrointestinal disorders
Diarrhea
|
20.8%
5/24 • Number of events 5 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
19.0%
4/21 • Number of events 4 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Infections and infestations
Mucositis
|
25.0%
6/24 • Number of events 6 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
14.3%
3/21 • Number of events 3 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
General disorders
Fatigue
|
12.5%
3/24 • Number of events 3 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
28.6%
6/21 • Number of events 6 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Immune system disorders
Neutropenic Fever
|
20.8%
5/24 • Number of events 5 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
14.3%
3/21 • Number of events 3 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
Immune system disorders
Pancytopenia
|
25.0%
6/24 • Number of events 6 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
19.0%
4/21 • Number of events 4 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
|
General disorders
Orthostasis
|
12.5%
3/24 • Number of events 3 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
0.00%
0/21 • Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).
Adverse Event Definition Per Study Protocol: Any problematic medical occurrence/changes in medical condition, regardless of causality, in a study participant who received the intervention from enrollment - 72 hours post. Adverse events were not monitored for "Control-Nausea/Vomiting" or "Control-Anxiety" Arms/Groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place