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| Name | Class |
|---|---|
| University Health | UNKNOWN |
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Use of inhaled essential oils to reduce the symptoms of pain or nausea, enabling a patient to have increase participation with PT or OT, thereby minimizing hospitalization-related risks and potentially reducing the length of stay in the hospital.
The study intervention consists of 3 essential oils: lavender, mandarin and peppermint administered on an inhalation patch affixed in the chest region of the participant gown. The inhalation patch consists of hydrogel cast onto polyester film, supported by non-woven polyester fabric, covered with a polyethylene film. The proprietary foil-backed lamination on the patch is used to provide an occlusive barrier that prevents any essential oil from being absorbed through the skin. The placebo will consist of a comparable sized felt patch with adhesive backing with no essential oil applied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Symptoms Arm | Experimental | Subjects who will receive physical or occupational therapy experiencing pain prior to therapy session. |
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| Nausea Symptom Arm | Experimental | Subjects who will receive physical or occupational therapy experiencing nausea prior to therapy session. |
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| Placebo Group | Placebo Comparator | Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session. |
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| Standard of Care Group | No Intervention | Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session that decline the option to use an aromatherapy patch. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavender Oil | Drug | A hydrogel lavender oil infused aromatherapy patch |
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| Measure | Description | Time Frame |
|---|---|---|
| Completion of PT/OT session | The number of subjects who successfully completed physical or occupational therapy session | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain/Nausea Scale | A scale with ranks the pain or nausea from 0 to 10 with a 0 being no pain or nausea and 10 being the worst pain | Baseline to post therapy follow-up (30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in participation in PT and OT sessions | An exploratory measure to compare whether the use of aromatherapy changes the number of participants in PT or OT. | 30 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bianca Gonzales, OTR, CNT, EdD, MOT | University Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bianca Gonzales | San Antonio | Texas | 78253 | United States |
The study will be registered on ClinicalTrials.gov and will be conducted in accordance with the ICMJE publication and data sharing policies and regulations.
Data will become available once analyzed and published
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| C045718 | lavender oil |
| C015424 | peppermint oil |
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Three interventional and one control arm
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Subjects will be assigned to an arm based upon the symptoms they are experiencing prior to their therapy session. If a patient reports nausea symptom, they will be assigned to the peppermint fragrance or a placebo. The randomization will be conducted in a 1:2 ratio, one placebo to two experimental. If a patient reports pain symptom, they will be assigned to the lavender or mandarin fragrance or placebo. The randomization will be conducted in a 1:2 ratio, one placebo to two experimental. The experimental group will then be randomized to a 1:1 ratio between lavender and mandarin. For those that refuse the aromatherapy patch will be asked to serve as a control and receive usual care with no patch.
| Mandarin Oil | Drug | A hydrogel mandarin oil infused aromatherapy patch |
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| Peppermint oil | Drug | A hydrogel peppermint oil infused aromatherapy patch |
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| Placebo | Other | A placebo patch containing no aromatherapy oil |
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