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Does Aromatherapy Decrease Postoperative Nausea and Vomiting?

Primary Purpose

Nausea, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peppermint oil
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peppermint oil

Arm Description

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.

Outcomes

Primary Outcome Measures

Decrease incidence of postoperative nausea and vomiting (PONV)
Decreased severity of PONV rating with peppermint aromatherapy

Secondary Outcome Measures

Full Information

First Posted
June 23, 2018
Last Updated
January 7, 2019
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03577496
Brief Title
Does Aromatherapy Decrease Postoperative Nausea and Vomiting?
Official Title
Does Aromatherapy Decrease Postoperative Nausea and Vomiting?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peppermint oil
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Peppermint oil
Intervention Description
A cotton ball with three drops of peppermint oil will be waved under the patient's nares.
Primary Outcome Measure Information:
Title
Decrease incidence of postoperative nausea and vomiting (PONV)
Description
Decreased severity of PONV rating with peppermint aromatherapy
Time Frame
Patients will be monitored for up to one hour after surgery to test effectiveness of peppermint oil at decreasing PONV.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle S Karsten, RN, BSN
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Does Aromatherapy Decrease Postoperative Nausea and Vomiting?

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