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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05282706
• Other study ID #: HSC20210769H
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: May 16, 2022
• Est. completion date: May 2025

Study information

• Verified date: June 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Pain
• Suffering, Physical

Intervention

Drug:
• Lavender Oil
A hydrogel lavender oil infused aromatherapy patch
• Mandarin Oil
A hydrogel mandarin oil infused aromatherapy patch
• Peppermint oil
A hydrogel peppermint oil infused aromatherapy patch

Other:
• Placebo
A placebo patch containing no aromatherapy oil

Locations

Country	Name	City	State
United States	Bianca Gonzales	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	University Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Completion of PT/OT session	The number of subjects who successfully completed physical or occupational therapy session	30 minutes
Secondary	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)