Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Placebo-controlled Clinical Trial Investigating the Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting

Conditions
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Suffering, Physical, Nausea

Intervention / Treatment
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* Drug: Lavender Oil
* Drug: Mandarin Oil
* Drug: Peppermint oil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients of acute care setting at University Health hospital Provision of a signed and dated informed consent form English or Spanish speaking Male or Female, aged 18 years and older Willing to comply with all study procedures Exclusion Criteria: Respiratory disorders, e.g., asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung cancer, cystic fibrosis, pneumonia, pleural effusion Cognitive impairment Unable to communicate Admitted to the closed access unit or to psychiatry Allergic to lavender, mandarin or peppermint oil Diseases that cause olfactory disorders such as: COVID-19, benign growths or polyps, congestion from a cold, sinus infection or allergy flare-up 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 Pregnant women (self-reported) Prisoner

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three interventional and one control arm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Symptoms Arm<br>Subjects who will receive physical or occupational therapy experiencing pain prior to therapy session. | Drug: Lavender Oil<br>* A hydrogel lavender oil infused aromatherapy patch<br>* Other names: Lavender Aromatherapy Patch;Drug: Mandarin Oil<br>* A hydrogel mandarin oil infused aromatherapy patch<br>* Other names: Mandarin Aromatherapy Patch;|
| Experimental: Nausea Symptom Arm<br>Subjects who will receive physical or occupational therapy experiencing nausea prior to therapy session. | Drug: Peppermint oil<br>* A hydrogel peppermint oil infused aromatherapy patch<br>* Other names: Peppermint Aromatherapy Patch;|
| Placebo Comparator: Placebo Group<br>Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session. | Other: Placebo<br>* A placebo patch containing no aromatherapy oil<br>* Other names: Placebo patch;|
| No Intervention: Standard of Care Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of PT/OT session | The number of subjects who successfully completed physical or occupational therapy session | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Care, Physical Therapy, Occupational Therapy, Aromatherapy