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

Phase 1

• Conditions: Nausea; Suffering, Physical
• Interventions: Drug: Lavender Oil; Other: Placebo; Drug: Peppermint oil; Drug: Mandarin Oil

• Registration Number: NCT05282706
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Study Start: 2022-05-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Symptoms Arm	Mandarin Oil	Subjects who will receive physical or occupational therapy experiencing pain prior to therapy session.
Pain Symptoms Arm	Lavender Oil	Subjects who will receive physical or occupational therapy experiencing pain prior to therapy session.
Placebo Group	Placebo	Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session.
Nausea Symptom Arm	Peppermint oil	Subjects who will receive physical or occupational therapy experiencing nausea prior to therapy session.

Primary Outcome Measures

Name	Time	Method
Completion of PT/OT session	30 minutes	The number of subjects who successfully completed physical or occupational therapy session

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bianca Gonzales; 🇺🇸 San Antonio, Texas, United States