NCT04822844

Brief Summary

This is a quality improvement project that aims to assess the effect of nurse-driven administration of essential oil aromatherapy on postoperative nausea and vomiting (PONV) in patients while in the post-anesthesia care unit (PACU) after general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

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

First Submitted

Initial submission to the registry

March 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

March 25, 2021

Last Update Submit

June 30, 2021

Conditions

Postoperative Nausea and Vomiting (PONV)

Keywords

aromatherapy

Outcome Measures

Primary Outcomes (1)

  • Number of Post-Operative Nausea and Vomiting Episodes While in the PACU

    during stay in PACU (about 45-60 minutes)

Secondary Outcomes (3)

  • PACU Length of Stay

    time between PACU admission and PACU discharge (about 45-60 minutes)

  • Number of Participants Who Use Antiemetics While in the PACU

    during stay in PACU (about 45-60 minutes)

  • Patient Satisfaction as Assessed by the Press Ganey Patient Satisfaction Survey

    at discharge (about 1 hour after PACU admission)

Study Arms (1)

Aromatherapy with Essential Oil

EXPERIMENTAL

Within 5 minutes of arrival at the PACU, the PACU nurse will proactively offer the patient a 2x2 gauze with two drops of essential oil (patient's choice of ginger or lavender essential oil) for all patients who have opted to participate, regardless of their nausea and vomiting status. Participating patients will continue to use the essential oil during their stay in the PACU, which is typically 45-60 minutes.

Other: Lavender Essential OilOther: Ginger Essential Oil

Interventions

Lavender Essential OilOTHER

Within 5 minutes of arrival at the PACU, the PACU nurse will proactively offer the patient a 2x2 gauze with two drops of essential oil (patient's choice of ginger or lavender essential oil) for all patients who have opted to participate, regardless of their nausea and vomiting status. Participating patients will continue to use the essential oil during their stay in the PACU, which is typically 45-60 minutes.

Aromatherapy with Essential Oil
Ginger Essential OilOTHER

Within 5 minutes of arrival at the PACU, the PACU nurse will proactively offer the patient a 2x2 gauze with two drops of essential oil (patient's choice of ginger or lavender essential oil) for all patients who have opted to participate, regardless of their nausea and vomiting status. Participating patients will continue to use the essential oil during their stay in the PACU, which is typically 45-60 minutes.

Aromatherapy with Essential Oil

Eligibility Criteria

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

You may qualify if:

  • PACU patients who are in the main PACU setting at HCA Houston Healthcare Southeast Hospital after having undergone general anesthesia for a surgical procedure

You may not qualify if:

  • patients with allergies or sensitivity to ginger or lavender essential oils
  • patients who wish to be excluded from the project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCA Houston Healthcare Southeast Hospital

Pasadena, Texas, 77504, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

lavender oil

Condition Hierarchy (Ancestors)

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

Study Officials

  • Julie George, RN, MSN

    The University of Texas Health Science Center, Houston

    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
PRINCIPAL INVESTIGATOR
PI Title
Director of Surgical Services

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 30, 2021

Study Start

April 1, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)