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

Primary Purpose

Suffering, Physical, Nausea

Status

Enrolling by invitation

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lavender Oil

Mandarin Oil

Peppermint oil

Placebo

About this trial

This is an interventional treatment trial for Suffering, Physical focused on measuring Acute Care, Physical Therapy, Occupational Therapy, Aromatherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Bianca Gonzales

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Pain Symptoms Arm

Nausea Symptom Arm

Placebo Group

Standard of Care Group

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

Completion of PT/OT session

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05282706

First Posted

March 7, 2022

Last Updated

June 12, 2023

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

University Health

1. Study Identification

Unique Protocol Identification Number

NCT05282706

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

May 16, 2022 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

University Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suffering, Physical, Nausea

Keywords

Acute Care, Physical Therapy, Occupational Therapy, Aromatherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Three interventional and one control arm

Masking

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.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pain Symptoms Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Nausea Symptom Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Standard of Care Group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Lavender Oil

Other Intervention Name(s)

Lavender Aromatherapy Patch

Intervention Description

A hydrogel lavender oil infused aromatherapy patch

Intervention Type

Drug

Intervention Name(s)

Mandarin Oil

Other Intervention Name(s)

Mandarin Aromatherapy Patch

Intervention Description

A hydrogel mandarin oil infused aromatherapy patch

Intervention Type

Drug

Intervention Name(s)

Peppermint oil

Other Intervention Name(s)

Peppermint Aromatherapy Patch

Intervention Description

A hydrogel peppermint oil infused aromatherapy patch

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo patch

Intervention Description

A placebo patch containing no aromatherapy oil

Primary Outcome Measure Information:

Title

Completion of PT/OT session

Description

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

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Change in Pain/Nausea Scale

Description

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

Time Frame

Baseline to post therapy follow-up (30 minutes)

Other Pre-specified Outcome Measures:

Title

Increase in participation in PT and OT sessions

Description

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

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bianca Gonzales, OTR, CNT, EdD, MOT

Organizational Affiliation

University Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bianca Gonzales

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78253

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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