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Outpatient Oncology Aromatherapy for Symptom Management

Primary Purpose

Anxiety, Nausea

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Young Living Lavender Essential Oil
Sponsored by
Central DuPage Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

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

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

Sites / Locations

  • Central DuPage

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peppermint and Lavender Essential Oil

Arm Description

Young Living Essential oil of Peppermint and Lavender will be used to patients who meet the inclusion criteria.

Outcomes

Primary Outcome Measures

Post Intervention Interview From
After the patients' infusion they will be asked questions from this form

Secondary Outcome Measures

Full Information

First Posted
June 12, 2020
Last Updated
June 25, 2020
Sponsor
Central DuPage Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04449315
Brief Title
Outpatient Oncology Aromatherapy for Symptom Management
Official Title
Outpatient Oncology Aromatherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central DuPage Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peppermint and Lavender Essential Oil
Arm Type
Experimental
Arm Description
Young Living Essential oil of Peppermint and Lavender will be used to patients who meet the inclusion criteria.
Intervention Type
Other
Intervention Name(s)
Young Living Lavender Essential Oil
Other Intervention Name(s)
Young Living Peppermint Essential Oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post Intervention Interview From
Description
After the patients' infusion they will be asked questions from this form
Time Frame
Immediately upon Completion of the patient's infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorraine Mack, MSN
Phone
630-315-6025
Email
lorraine.mack@nm.org
First Name & Middle Initial & Last Name or Official Title & Degree
Megha Shah, BSN
Email
megha.shah@nm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorraine Mack, MSN
Organizational Affiliation
Central DuPage Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central DuPage
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorraine Mack, MSN
Phone
630-315-6025
Email
lorraine.mack@nm.org
First Name & Middle Initial & Last Name & Degree
Lorraine Mack, MSN

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Outpatient Oncology Aromatherapy for Symptom Management

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