Suffering, Physical, Nausea
Conditions
Keywords
Acute Care, Physical Therapy, Occupational Therapy, Aromatherapy
Brief summary
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.
Detailed description
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.
Interventions
OTHERPlacebo
A placebo patch containing no aromatherapy oil
DRUGLavender Oil
A hydrogel lavender oil infused aromatherapy patch
DRUGMandarin Oil
A hydrogel mandarin oil infused aromatherapy patch
DRUGPeppermint oil
A hydrogel peppermint oil infused aromatherapy patch
Sponsors
University Health
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Three interventional and one control arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Inpatients of acute care setting at University Health hospital 2. Provision of a signed and dated informed consent form 3. English or Spanish speaking 4. Male or Female, aged 18 years and older 5. Willing to comply with all study procedures
Exclusion criteria
1. Respiratory disorders, e.g., asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung cancer, cystic fibrosis, pneumonia, pleural effusion 2. Cognitive impairment 3. Unable to communicate 4. Admitted to the closed access unit or to psychiatry 5. Allergic to lavender, mandarin or peppermint oil 6. Diseases that cause olfactory disorders such as: COVID-19, benign growths or polyps, congestion from a cold, sinus infection or allergy flare-up 7. Drugs that may cause loss of the ability to smell e.g., intranasal zinc products, decongestant nose sprays and certain oral drugs such as nifedipine and phenothiazines 8. Pregnant women (self-reported) 9. Prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of PT/OT session | 30 minutes | The number of subjects who successfully completed physical or occupational therapy session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain/Nausea Scale | Baseline to post therapy follow-up (30 minutes) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Increase in participation in PT and OT sessions | 30 minutes | An exploratory measure to compare whether the use of aromatherapy changes the number of participants in PT or OT. |
Countries
United States
Outcome results
None listed