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

NCT05282706 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: HSC20210769H
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Suffering, Physical; Nausea

Keywords

Acute Care; Physical Therapy; Occupational Therapy; Aromatherapy

Outcome Measures

Primary Outcomes (1)

• Completion of PT/OT session

  The number of subjects who successfully completed physical or occupational therapy session

  30 minutes

Secondary Outcomes (1)

• Change in Pain/Nausea Scale

  Baseline to post therapy follow-up (30 minutes)

Other Outcomes (1)

• Increase in participation in PT and OT sessions

  30 minutes

Study Arms (4)

Pain Symptoms Arm

EXPERIMENTAL

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

Drug: Lavender Oil; Drug: Mandarin Oil

Nausea Symptom Arm

EXPERIMENTAL

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

Drug: Peppermint oil

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Standard of Care Group

NO INTERVENTION

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.

Interventions

Lavender Oil DRUG

A hydrogel lavender oil infused aromatherapy patch

Also known as: Lavender Aromatherapy Patch

Pain Symptoms Arm

Mandarin Oil DRUG

A hydrogel mandarin oil infused aromatherapy patch

Also known as: Mandarin Aromatherapy Patch

Pain Symptoms Arm

Peppermint oil DRUG

A hydrogel peppermint oil infused aromatherapy patch

Also known as: Peppermint Aromatherapy Patch

Nausea Symptom Arm

Placebo OTHER

A placebo patch containing no aromatherapy oil

Also known as: Placebo patch

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• University Health: collaborator

Study Sites (1)

Bianca Gonzales

San Antonio, Texas, 78253, United States

Location

MeSH Terms

Conditions

Pain; Nausea

Interventions

lavender oil; peppermint oil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Bianca Gonzales, OTR, CNT, EdD, MOT

  University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be assigned to an arm based upon the symptoms they are experiencing prior to their therapy session. If a patient reports nausea symptom, they will be assigned to the peppermint fragrance or a placebo. The randomization will be conducted in a 1:2 ratio, one placebo to two experimental. If a patient reports pain symptom, they will be assigned to the lavender or mandarin fragrance or placebo. The randomization will be conducted in a 1:2 ratio, one placebo to two experimental. The experimental group will then be randomized to a 1:1 ratio between lavender and mandarin. For those that refuse the aromatherapy patch will be asked to serve as a control and receive usual care with no patch.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three interventional and one control arm

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: May 16, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available once analyzed and published

Locations

US (1)