Nausea, Vomiting and Anxiety Associated With Medical Oncology PatientsNCT02163369
The Use of Aromatherapy for Symptom Management
A study testing Peppermint and Lavender Essential Oils in people with Nausea, Vomiting and Anxiety Associated With Medical Oncology Patients, run by Central DuPage Hospital at 1 site in United States.
Trial summary
The purpose of this pilot study is to introduce the use of aromatherapy/essential oils to medical oncology patients at Central DuPage Hospital to assess their perceived effectiveness to relieve symptoms of nausea or vomiting and/or anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea, Vomiting and Anxiety Associated With Medical Oncology Patients
- What is being tested?
- Peppermint and Lavender Essential Oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult hospitalized medical oncology patients admitted to Central DuPage Hospital.
- Age 18 years or greater.
- Able to understand and speak English.
- Women of non-childbearing potential or with childbearing potential with a negative pregnancy test documented during the hospital stay.
- Able to understand concept of aromatherapy for treatment of distressing symptoms.
Who cannot join
- Prisoners.
- Non-English speaking patients.
- Under the age of 18.
- Unable to comprehend the concept of aromatherapy.
- Severe cognitive impairment.
- Not experiencing the symptoms of nausea, vomiting or anxiety.
- Women with child-bearing potential who have not had a negative pregnancy test during the hospital stay.
- Patients with known allergy to lavender or peppermint.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Central DuPage Hospital
Winfield, Illinois, 60190
Mary Lyons, MSN, APN/CNS, RN-BC ONC, 630-933-6011
Lorraine Mack, RN, 630-933-3413
About this study
The purpose of this pilot study is to introduce the use of aromatherapy/essential oils to medical oncology patients at Central DuPage Hospital to assess their perceived effectiveness to relieve symptoms of nausea or vomiting and/or anxiety.
Peppermint oil will be used for nausea/vomiting and lavender oil will be used for anxiety. This study will involve administration of aromatherapy to a convenience sample of patients, who will then be asked to complete a brief questionnaire. The questionnaire will involve a simple likert scale to measure efficacy (in the opinion of the patient) and simple multiple-choice questions to determine patients' likeliness to use aromatherapy again.
- Being tested
- Peppermint and Lavender Essential Oils
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint and Lavender Essential OilsDrug
| Study group | Role | What they receive |
|---|---|---|
| Peppermint and Lavender Essential Oils | Experimental | Not described Receives: Drug: Peppermint and Lavender Essential Oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Intervention Patient Interview Form
Measured: 24hrs post aromatherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea, Vomiting and Anxiety Associated With Medical Oncology PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central DuPage Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Lyons, MSN, APN/CNS, RN-BC, ONC, Principal investigator, Central DuPage Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163369
- Sponsor's protocol ID
- 14-031-1
- Status last verified
- Feb 2015
- First submitted
- 11 Jun 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Aromatherapy for Symptom Management
- ClinicalTrials.gov ID
- NCT02163369
- Acronym / sponsor ID
- 14-031-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central DuPage HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (estimated)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to introduce the use of aromatherapy/essential oils to medical oncology patients at Central DuPage Hospital to assess their perceived effectiveness to relieve symptoms of nausea or vomiting and/or anxiety.
Peppermint oil will be used for nausea/vomiting and lavender oil will be used for anxiety. This study will involve administration of aromatherapy to a convenience sample of patients, who will then be asked to complete a brief questionnaire. The questionnaire will involve a simple likert scale to measure efficacy (in the opinion of the patient) and simple multiple-choice questions to determine patients' likeliness to use aromatherapy again.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peppermint and Lavender Essential Oils | Experimental | Drug: Peppermint and Lavender Essential Oils |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult hospitalized medical oncology patients admitted to Central DuPage Hospital.
- Age 18 years or greater.
- Able to understand and speak English.
- Women of non-childbearing potential or with childbearing potential with a negative pregnancy test documented during the hospital stay.
- Able to understand concept of aromatherapy for treatment of distressing symptoms.
Key exclusion criteria (8 listed)
- Prisoners.
- Non-English speaking patients.
- Under the age of 18.
- Unable to comprehend the concept of aromatherapy.
- Severe cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peppermint and Lavender Essential Oils | Drug | Peppermint and Lavender Essential Oils |
Primary outcome
Post Intervention Patient Interview Form
Time frame: 24hrs post aromatherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Lyons, MSN, APN/CNS, RN-BC, ONC principal investigator
Central DuPage Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peppermint and Lavender Essential Oils in people with Nausea, Vomiting and Anxiety Associated With Medical Oncology Patients, run by Central DuPage Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Lyons, MSN, APN/CNS, RN-BC, ONC (630-933-6011, mary.lyons@cadencehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Intervention Patient Interview Form (time frame: 24hrs post aromatherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.