NCT03577496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

January 9, 2019

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 23, 2018

Last Update Submit

January 7, 2019

Conditions

Nausea, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Decrease incidence of postoperative nausea and vomiting (PONV)

    Decreased severity of PONV rating with peppermint aromatherapy

    Patients will be monitored for up to one hour after surgery to test effectiveness of peppermint oil at decreasing PONV.

Study Arms (1)

Peppermint oil

EXPERIMENTAL

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.

Other: Peppermint oil

Interventions

Peppermint oilOTHER

A cotton ball with three drops of peppermint oil will be waved under the patient's nares.

Peppermint oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

peppermint oil

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Michelle S Karsten, RN, BSN

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2018

First Posted

July 5, 2018

Study Start

June 15, 2018

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

January 9, 2019

Record last verified: 2018-06

Locations

US(1)