- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577496
Does Aromatherapy Decrease Postoperative Nausea and Vomiting?
January 7, 2019 updated by: The University of Texas Medical Branch, Galveston
Aromatherapy has been proven to be effective for treating patients with postoperative nausea and vomiting (PONV) after surgery, but few studies analyze its effect on preventing PONV.
Most studies use aromatherapy once patients become nauseous, but this study will address a gap in the literature with relation to the effect of aromatherapy in the prevention of PONV.
Study Overview
Detailed Description
The purpose of this pilot study is to determine if aromatherapy will prevent postoperative nausea and vomiting (PONV).
Peppermint aromatherapy will be used preemptively to test for effectiveness, decreased PONV, and the ability to avoid anti-emetics.
This study will seek to demonstrate that peppermint aromatherapy is a simple, cost effective way to prevent PONV after anesthesia.
By decreasing the need for anti-emetics and incidence of PONV, patients may have a quicker recovery time and experience less side effects from anti-emetics, such as increased sedation.
This problem is significant to patients and society as it may demonstrate that the inhalation of peppermint can ease PONV and decrease costs due to anti-emetics, wound dehiscence, and prolonged hospital stay.
This study may lead to higher levels of patient satisfaction; if the patients are not nauseated they may be more satisfied with their care.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult surgical patients ages 18 and older.
- Patients deemed medically stable by their surgery team.
- Anesthesia and Surgeon faculty approval will be obtained prior to asking the patient for their consent.
Exclusion Criteria:
- Minors
- Unstable patients, such as ICU patients or intubated patients, pregnant women, and prisoners.
- Patients with a history of severe PONV or severe delirium on emergence from anesthesia will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peppermint oil
A cotton ball with three drops of peppermint oil will be waved under the patient's nares upon arrival to the recovery room.
The patients will be assessed for PONV for up to an hour in the post anesthesia care unit (PACU) or until their discharge, whichever is first.
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A cotton ball with three drops of peppermint oil will be waved under the patient's nares.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease incidence of postoperative nausea and vomiting (PONV)
Time Frame: Patients will be monitored for up to one hour after surgery to test effectiveness of peppermint oil at decreasing PONV.
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Decreased severity of PONV rating with peppermint aromatherapy
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Patients will be monitored for up to one hour after surgery to test effectiveness of peppermint oil at decreasing PONV.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michelle S Karsten, RN, BSN, University of Texas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2018
Primary Completion (Actual)
December 15, 2018
Study Completion (Actual)
December 15, 2018
Study Registration Dates
First Submitted
June 23, 2018
First Submitted That Met QC Criteria
July 3, 2018
First Posted (Actual)
July 5, 2018
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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