- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04822844
Implementing a Nurse-Driven Aromatherapy Protocol to Decrease the Effect of Postoperative Nausea and Vomiting
June 30, 2021 updated by: Julie George, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this three-month quality improvement project, nurse-driven aromatherapy will be offered to all patients in the main PACU setting at the Hospital Corporation of America (HCA) Houston Healthcare Southeast Hospital after they have undergone surgical procedures with general anesthesia, with the exception of patients who report allergies or sensitivity to ginger or lavender essential oils (EO) and patients who wish to be excluded from the project.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Pasadena, Texas, United States, 77504
- HCA Houston Healthcare Southeast Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- PACU patients who are in the main PACU setting at HCA Houston Healthcare Southeast Hospital after having undergone general anesthesia for a surgical procedure
Exclusion Criteria:
- patients with allergies or sensitivity to ginger or lavender essential oils
- patients who wish to be excluded from the project
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aromatherapy with Essential Oil
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Post-Operative Nausea and Vomiting Episodes While in the PACU
Time Frame: during stay in PACU (about 45-60 minutes)
|
during stay in PACU (about 45-60 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PACU Length of Stay
Time Frame: time between PACU admission and PACU discharge (about 45-60 minutes)
|
PACU length of stay is the time between PACU admission and PACU discharge, measured in minutes.
|
time between PACU admission and PACU discharge (about 45-60 minutes)
|
|
Number of Participants Who Use Antiemetics While in the PACU
Time Frame: during stay in PACU (about 45-60 minutes)
|
during stay in PACU (about 45-60 minutes)
|
|
|
Patient Satisfaction as Assessed by the Press Ganey Patient Satisfaction Survey
Time Frame: at discharge (about 1 hour after PACU admission)
|
The Press Ganey Patient Satisfaction Survey is scored from 0 to 100, with a higher score indicating greater satisfaction.
|
at discharge (about 1 hour after PACU admission)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Julie George, RN, MSN, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
March 25, 2021
First Submitted That Met QC Criteria
March 25, 2021
First Posted (Actual)
March 30, 2021
Study Record Updates
Last Update Posted (Actual)
July 2, 2021
Last Update Submitted That Met QC Criteria
June 30, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SN-20-1306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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