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

The University of Texas System (UT)

Status and phase: Invitation-only; Phase 1

Conditions: Suffering, Physical; Nausea

Treatments: Drug: Lavender Oil; Drug: Mandarin Oil; Other: Placebo; Drug: Peppermint oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05282706

HSC20210769H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups, including a placebo group

Pain Symptoms Arm

Experimental group

Description:

Subjects who will receive physical or occupational therapy experiencing pain prior to therapy session.

Treatment:

Drug: Mandarin Oil

Drug: Lavender Oil

Nausea Symptom Arm

Experimental group

Description:

Subjects who will receive physical or occupational therapy experiencing nausea prior to therapy session.

Treatment:

Drug: Peppermint oil

Placebo Group

Placebo Comparator group

Description:

Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session.

Treatment:

Other: Placebo

Standard of Care Group

No Intervention group

Description:

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.