Clinical trial NCT05282706: Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting
Official title: A Placebo-controlled Clinical Trial Investigating the Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Suffering, Physical
Nausea
Keywords: Acute Care
Physical Therapy
Occupational Therapy
Aromatherapy
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: University Health
First posted: 2022-03-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three interventional and one control arm
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion of PT/OT session
timeFrame: 30 minutes
Secondary outcomes:
measure: Change in Pain/Nausea Scale
timeFrame: Baseline to post therapy follow-up (30 minutes)
Other outcomes:
measure: Increase in participation in PT and OT sessions
timeFrame: 30 minutes
Locations:
city: San Antonio
country: United States
facility: Bianca Gonzales
state: Texas
Study officials:
affiliation: University Health
name: Bianca Gonzales, OTR, CNT, EdD, MOT
role: PRINCIPAL_INVESTIGATOR
References: