- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03130218
Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients
February 18, 2020 updated by: Lancaster General Hospital
Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Healthy weight management and use of essential oils and aromatherapy as natural interventions to manage health-related issues are significantly growing interests.
One frequent intervention for healthy weight management is bariatric surgery.
In the post-operative period following bariatric surgery, nausea is a common consequence.
Peppermint oil aromatherapy is an effective intervention for relieving nausea and other gastrointestinal symptoms in the bariatric and surgical population.
This study has multiple aims.
One is to determine effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population.
A second aim is to establish relative cost-effectiveness of peppermint oil aromatherapy versus traditional anti-emetic drug therapies.
A third is to determine whether peppermint oil aromatherapy increases patient satisfaction versus anti-emetic drug therapies.
This is a randomized study with control and experimental groups.
The control group will receive no peppermint oil aromatherapy and only traditional anti-emetics as needed.
The experimental group will receive peppermint oil aromatherapy and traditional anti-emetics as needed.
Study Type
Interventional
Enrollment (Actual)
204
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
-
-
Pennsylvania
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Lancaster, Pennsylvania, United States, 17604
- Lancaster General Hospital
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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
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Bariatric surgery candidate on 7-Lime at Lancaster General Hospital
- Scheduled for laparoscopic sleeve gastrectomy and laparoscopic Roux-En-Y (RNY) procedures
- Between ages of 18 and 70
- Surgical patient of either Dr. James Ku and Dr. Joseph McPhee
Exclusion Criteria:
- History of excessive sensitivity to peppermint oil, allergic response to peppermint oil and who state preference against aromatherapy
- Not alert and oriented or unable to follow directions will be excluded
- Severe reactive airway disease such as asthma or chronic obstructive pulmonary disease (COPD)
- Possible exclusion for severe hypertension or atrial fibrillation
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
Patients in the control group will not receive peppermint oil aromatherapy as a primary intervention for postoperative nausea and vomiting.
Primary therapy for postoperative nausea and vomiting would entail standard antiemetic drug therapies.
Patient monitoring and documentation would include the following: Patients in the control group will be assessed every 4 hours and as needed for nausea.
All aspects of care from physician, nursing and all disciplines will be consistent with current practices in care of postoperative bariatric surgical patients.
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|
EXPERIMENTAL: Intervention
Patients in the intervention group will receive peppermint oil aromatherapy as primary treatment for postoperative nausea.
Pharmacological therapy with anti-nausea drug therapies will be available as needed.
All other aspects of medical, surgical and nursing care will be standard practice for pre and post-operative care related to the bariatric surgical patient.
Patients in the intervention group will be assessed every 4 hours and as needed for nausea.
Post-intervention, the patient will be re-assessed for level of nausea after one hour.
In the event the patient refuses peppermint oil aromatherapy and requests anti-emetic drug therapies, they are able to do so.
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Aroma therapy with peppermint oil administered with presoaked diffuser and bag.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nausea Assessment and Treatment Scale
Time Frame: 4 Hours
|
Severity of post-operative nausea on a scale of 0-10
|
4 Hours
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Count of Antiemetic Drug Therapies
Time Frame: 4 Hours
|
Number of antiemetic drug therapies used in the post-operative period
|
4 Hours
|
Perception of Postoperative Nausea Management Survey
Time Frame: 24 Hours
|
Patient satisfaction with effectiveness of postoperative nausea management
|
24 Hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Anderson LA, Gross JB. Aromatherapy with peppermint, isopropyl alcohol, or placebo is equally effective in relieving postoperative nausea. J Perianesth Nurs. 2004 Feb;19(1):29-35. doi: 10.1016/j.jopan.2003.11.001.
- Tate S. Peppermint oil: a treatment for postoperative nausea. J Adv Nurs. 1997 Sep;26(3):543-9. doi: 10.1046/j.1365-2648.1997.t01-15-00999.x.
- Lane B, Cannella K, Bowen C, Copelan D, Nteff G, Barnes K, Poudevigne M, Lawson J. Examination of the effectiveness of peppermint aromatherapy on nausea in women post C-section. J Holist Nurs. 2012 Jun;30(2):90-104; quiz 105-6. doi: 10.1177/0898010111423419. Epub 2011 Oct 27.
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 8, 2017
Primary Completion (ACTUAL)
September 10, 2019
Study Completion (ACTUAL)
December 31, 2019
Study Registration Dates
First Submitted
April 21, 2017
First Submitted That Met QC Criteria
April 25, 2017
First Posted (ACTUAL)
April 26, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-74-LGH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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