Reducing Up-set Stomach and Vomiting After Surgery Using Essential Oils
Primary Purpose
Nausea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peppermint oil
Ginger oil
Sponsored by
About this trial
This is an interventional treatment trial for Nausea
Eligibility Criteria
Inclusion Criteria:
- post-op surgical patients at least 18 years of age or older
- the ability to understand and follow directions for use of essential oils
- the ability to understand and give informed consent to study
- the ability to understand, read and write English
- ambulatory or short-stay/23-hour patients
Exclusion Criteria:
- History of any pulmonary disease, including but not limited to: asthma, COPD, OSA, chronic bronchitis, pulmonary and ear, nose, throat (ENT) surgery patients
- Allergy to any of the ingredients in the essential oils
- Sensitivity to strong odors
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Peppermint oil
Ginger oil
Peppermint and ginger oil
Arm Description
post-op surgical patients
post-op surgical patients
post-op surgical patients
Outcomes
Primary Outcome Measures
Mean change in nausea score
Nausea will be score on a scale of 0-3 with zero indicated no nausea.
Secondary Outcome Measures
Full Information
NCT ID
NCT03370328
First Posted
December 7, 2017
Last Updated
August 31, 2018
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT03370328
Brief Title
Reducing Up-set Stomach and Vomiting After Surgery Using Essential Oils
Official Title
Essential Oils to Reduce Post-Operative Nausea and Vomiting
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to determine if aromatherapy (essential oil) is effective at reducing up-set stomach and vomiting after surgery and in reducing the need for up-set stomach medications
Detailed Description
If participants decide to take part in this study, they will be asked to use choose a small nasal inhaler from a bag, open the sealed package, and inhale from the nasal inhaler 3 times, inhaling through the nose and exhaling through the mouth, just prior to entering the operating room. During recovery in the Post-operative acute care unit (PACU), nausea severity will be rated using a 0-3 scale where zero indicates no nausea.
If your score is 1-3, participants will be instructed/assisted in using a nasal inhaler 3 times, inhaling through the nose and exhaling through the mouth. After 5 minutes, nausea scores will be collected again and if the score is the same or higher, participants will be asked to use the nasal inhaler again in the same manner as before. If their nausea has not resolved after the second use, they will be give anti-nausea medication that a surgeon ordered. This process will be repeated again whenever you complain of nausea, until they are discharged from the hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peppermint oil
Arm Type
Experimental
Arm Description
post-op surgical patients
Arm Title
Ginger oil
Arm Type
Experimental
Arm Description
post-op surgical patients
Arm Title
Peppermint and ginger oil
Arm Type
Experimental
Arm Description
post-op surgical patients
Intervention Type
Other
Intervention Name(s)
Peppermint oil
Intervention Description
The study product is a commercial essential oil product and nasal inhaler. It is to be prepared by a trained, independent individual who will add 4 drops of one of the three oils/oil combinations. The subject will be instructed to twist off the cap and position inhaler in such a way as to allow the subject to inhale the vapors; it can be reused for multiple administrations. Essential oils have been the subject of other studies in treating nausea. If nausea is unrelieved, treatment will progress to the ordered antiemetic.
Intervention Type
Other
Intervention Name(s)
Ginger oil
Intervention Description
The study product is a commercial essential oil product and nasal inhaler. It is to be prepared by a trained, independent individual who will add 4 drops of one of the three oils/oil combinations. The subject will be instructed to twist off the cap and position inhaler in such a way as to allow the subject to inhale the vapors; it can be reused for multiple administrations. Essential oils have been the subject of other studies in treating nausea. If nausea is unrelieved, treatment will progress to the ordered antiemetic.
Primary Outcome Measure Information:
Title
Mean change in nausea score
Description
Nausea will be score on a scale of 0-3 with zero indicated no nausea.
Time Frame
baseline to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
post-op surgical patients at least 18 years of age or older
the ability to understand and follow directions for use of essential oils
the ability to understand and give informed consent to study
the ability to understand, read and write English
ambulatory or short-stay/23-hour patients
Exclusion Criteria:
History of any pulmonary disease, including but not limited to: asthma, COPD, OSA, chronic bronchitis, pulmonary and ear, nose, throat (ENT) surgery patients
Allergy to any of the ingredients in the essential oils
Sensitivity to strong odors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxine Fearrington, MS
Organizational Affiliation
University of Rochester, Strong Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Reducing Up-set Stomach and Vomiting After Surgery Using Essential Oils
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