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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nausea; Suffering, Physical
• Intervention / Treatment: Drug: Lavender Oil; Drug: Mandarin Oil; Drug: Peppermint oil; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78253
      • Bianca Gonzales

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in participation in PT and OT sessions	An exploratory measure to compare whether the use of aromatherapy changes the number of participants in PT or OT.	30 minutes

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: University Health
• Investigators: Principal Investigator: Bianca Gonzales, OTR, CNT, EdD, MOT, University Health

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Physical Therapy; Occupational Therapy; Aromatherapy; Acute Care
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain; Physiological Effects of Drugs; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Parasympatholytics; Peppermint oil
• Other Study ID Numbers: HSC20210769H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study will be registered on ClinicalTrials.gov and will be conducted in accordance with the ICMJE publication and data sharing policies and regulations.
• IPD Sharing Time Frame: Data will become available once analyzed and published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No