Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Implementing a Nurse-Driven Aromatherapy Protocol to Decrease the Effect of Postoperative Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04822844
Recruitment Status : Completed
First Posted : March 30, 2021
Last Update Posted : July 2, 2021
Sponsor:
Collaborator:
HCA Houston Healthcare Southeast Hospital
Information provided by (Responsible Party):
Julie George, The University of Texas Health Science Center, Houston

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting (PONV) Other: Lavender Essential Oil Other: Ginger Essential Oil Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementing a Nurse-Driven Aromatherapy Protocol to Decrease the Effect of Postoperative Nausea and Vomiting
Actual Study Start Date : April 1, 2021
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Other: Lavender 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.

Other: Ginger 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Post-Operative Nausea and Vomiting Episodes While in the PACU [ Time Frame: during stay in PACU (about 45-60 minutes) ]

Secondary Outcome Measures :
  1. 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.

  2. Number of Participants Who Use Antiemetics While in the PACU [ Time Frame: during stay in PACU (about 45-60 minutes) ]
  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04822844


Locations
Layout table for location information
United States, Texas
HCA Houston Healthcare Southeast Hospital
Pasadena, Texas, United States, 77504
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
HCA Houston Healthcare Southeast Hospital
Investigators
Layout table for investigator information
Principal Investigator: Julie George, RN, MSN The University of Texas Health Science Center, Houston
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Julie George, Director of Surgical Services, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04822844    
Other Study ID Numbers: HSC-SN-20-1306
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie George, The University of Texas Health Science Center, Houston:
aromatherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Nausea
Vomiting
Postoperative Nausea and Vomiting
 Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes