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

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05282706
Collaborator
University Hospital (Other)
200
Enrollment
1
Location
4
Arms
35.5
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lavender Oil
  • Drug: Mandarin Oil
  • Drug: Peppermint oil
  • Other: Placebo
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three interventional and one control armThree interventional and one control arm
Masking:
Single (Participant)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
A Placebo-controlled Clinical Trial Investigating the Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting
Actual Study Start Date :
May 16, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Completion of PT/OT session [30 minutes]

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

    Secondary Outcome Measures

    1. 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

    Other Outcome Measures

    1. Increase in participation in PT and OT sessions [30 minutes]

      An exploratory measure to compare whether the use of aromatherapy changes the number of participants in PT or OT.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Systems San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio
    • University Hospital

    Investigators

    • Principal Investigator: Elizabeth Koyle, PT, DPT, RN, BSN, PhD, University Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    A. Elizabeth Koyle, Executive Director, Rehab Therapy Programs University Hospital, The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT05282706
    Other Study ID Numbers:
    • HSC20210769H
    First Posted:
    Mar 16, 2022
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by A. Elizabeth Koyle, Executive Director, Rehab Therapy Programs University Hospital, The University of Texas Health Science Center at San Antonio
    Acute Care
    Physical Therapy
    Occupational Therapy
    Aromatherapy
    Additional relevant MeSH terms:
    Pain
    Peppermint oil

    Study Results

    No Results Posted as of May 25, 2022