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

NCT ID: NCT05282706

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-16

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Suffering, Physical Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three interventional and one control arm
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Pain Symptoms Arm

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

Group Type EXPERIMENTAL

Lavender Oil

Intervention Type DRUG

A hydrogel lavender oil infused aromatherapy patch

Mandarin Oil

Intervention Type DRUG

A hydrogel mandarin oil infused aromatherapy patch

Nausea Symptom Arm

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

Group Type EXPERIMENTAL

Peppermint oil

Intervention Type DRUG

A hydrogel peppermint oil infused aromatherapy patch

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A placebo patch containing no aromatherapy oil

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lavender Oil

A hydrogel lavender oil infused aromatherapy patch

Intervention Type DRUG

Mandarin Oil

A hydrogel mandarin oil infused aromatherapy patch

Intervention Type DRUG

Peppermint oil

A hydrogel peppermint oil infused aromatherapy patch

Intervention Type DRUG

Placebo

A placebo patch containing no aromatherapy oil

Intervention Type OTHER

Other Intervention Names

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Lavender Aromatherapy Patch Mandarin Aromatherapy Patch Peppermint Aromatherapy Patch Placebo patch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bianca Gonzales, OTR, CNT, EdD, MOT

Role: PRINCIPAL_INVESTIGATOR

University Health

Locations

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Bianca Gonzales

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC20210769H

Identifier Type: -

Identifier Source: org_study_id

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