Does Aromatherapy Decrease Postoperative Nausea and Vomiting?
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| ClinicalTrials.gov Identifier: NCT03577496 |
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Recruitment Status :
Completed
First Posted : July 5, 2018
Last Update Posted : January 9, 2019
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Sponsor:
The University of Texas Medical Branch, Galveston
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nausea, Postoperative | Other: Peppermint oil | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Does Aromatherapy Decrease Postoperative Nausea and Vomiting? |
| Actual Study Start Date : | June 15, 2018 |
| Actual Primary Completion Date : | December 15, 2018 |
| Actual Study Completion Date : | December 15, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Nausea and Vomiting
Drug Information available for:
Peppermint oil
| Arm | Intervention/treatment |
|---|---|
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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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Other: Peppermint oil
A cotton ball with three drops of peppermint oil will be waved under the patient's nares. |
Primary Outcome Measures :
- 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. ]Decreased severity of PONV rating with peppermint aromatherapy
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577496
Locations
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555 | |
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
| Principal Investigator: | Michelle S Karsten, RN, BSN | University of Texas |
| Responsible Party: | The University of Texas Medical Branch, Galveston |
| ClinicalTrials.gov Identifier: | NCT03577496 |
| Other Study ID Numbers: |
18-0058 |
| First Posted: | July 5, 2018 Key Record Dates |
| Last Update Posted: | January 9, 2019 |
| Last Verified: | June 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Postoperative Complications Pathologic Processes Peppermint oil |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Parasympatholytics |