- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04449315
Outpatient Oncology Aromatherapy for Symptom Management
Outpatient Oncology Aromatherapy
The purpose of this research study is to determine whether using aromatherapy during chemotherapy infusion treatments in the outpatient Oncology setting promote relief of nausea and anxiety.
The objectives of this study are: 1. To promote relief of nausea using peppermint aromatherapy oil in an outpatient oncology setting. 2. To promote relief of anxiety using lavender aromatherapy oil in an outpatient oncology setting.
Study Overview
Status
Intervention / Treatment
Detailed Description
Subject Selection: Every outpatient oncology patient experiencing nausea and/or anxiety during an infusion visit will be offered hospital-approved aromatherapy of Peppermint oil or Lavender oil. If patient says yes, then they will be selected for the study and infusion nurse will notify the study co-investigators or principal investigator. Informed consent will then be obtained by co-investigators or principal investigator of the study. The consents as well as the data collection tool sheets will be numbered without identifying patient's personal information. Peppermint oil aromatherapy and/or lavender oil aromatherapy will then be administered to consented patients.
Method of Subject Identification and Recruitment: Every outpatient oncology patient experiencing nausea and/or anxiety during an infusion visit will be offered hospital- approved aromatherapy of Peppermint oil or Lavender oil. If patient says yes, then they will be selected for the study and infusion nurse will notify the study co-investigators or principal investigator. Informed consent will then be obtained by co-investigators or principal investigator of the study. The consents as well as the data collection tool sheets will be numbered without identifying patient's personal information. Peppermint oil aromatherapy and/or lavender oil aromatherapy will then be administered to consented patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Winfield, Illinois, United States, 60190
- Central DuPage
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All outpatient Oncology patients > 18 years of age
- Non pregnant
- Not cognitively impaired
- English speaking only
- Patients who report nausea and/or anxiety
Exclusion Criteria:
- All outpatient oncology patients <18 years of age
- Pregnant
- Cognitively impaired
- Non-English Speaking
- Patients who do not report nausea and/or anxiety
- Patients with a known allergy to peppermint and/or lavender aromatherapy oil
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peppermint and Lavender Essential Oil
Young Living Essential oil of Peppermint and Lavender will be used to patients who meet the inclusion criteria.
|
For qualified patients one to two drops of hospital approved essential oil will be placed on a 4X4 gauze and will be offered to the patient during their infusion visit.
This gauze will be placed in a sealable clear plastic bag and the patient will be instructed to use one sniff at a time.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post Intervention Interview From
Time Frame: Immediately upon Completion of the patient's infusion
|
After the patients' infusion they will be asked questions from this form
|
Immediately upon Completion of the patient's infusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lorraine Mack, MSN, Central DuPage Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CentralDuPage
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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