Postoperative Nausea and Vomiting (PONV)NCT04822844
Implementing a Nurse-Driven Aromatherapy Protocol to Decrease the Effect of Postoperative Nausea and Vomiting
A study testing Lavender Essential Oil and Ginger Essential Oil in people with Postoperative Nausea and Vomiting (PONV), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV)
- What is being tested?
- Lavender Essential Oil and Ginger Essential Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PACU patients who are in the main PACU setting at HCA Houston Healthcare Southeast Hospital after having undergone general anesthesia for a surgical procedure
Who cannot join
- patients with allergies or sensitivity to ginger or lavender essential oils
- patients who wish to be excluded from the project
Trial locations and contacts
1 site in 1 country.
United States1 site
HCA Houston Healthcare Southeast Hospital
Pasadena, Texas, 77504
About this study
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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Being tested
- Lavender Essential Oil, Ginger Essential Oil
- Keywords
- aromatherapy
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lavender Essential Oil; Other: Ginger Essential Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Post-Operative Nausea and Vomiting Episodes While in the PACU
Measured: during stay in PACU (about 45-60 minutes)
Secondary outcomes (3)
PACU Length of Stay
PACU length of stay is the time between PACU admission and PACU discharge, measured in minutes.
Measured: time between PACU admission and PACU discharge (about 45-60 minutes)
Number of Participants Who Use Antiemetics While in the PACU
Measured: during stay in PACU (about 45-60 minutes)
Patient Satisfaction as Assessed by the Press Ganey Patient Satisfaction Survey
The Press Ganey Patient Satisfaction Survey is scored from 0 to 100, with a higher score indicating greater satisfaction.
Measured: at discharge (about 1 hour after PACU admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Apr 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and Vomiting (PONV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- HCA Houston Healthcare Southeast Hospital
- Responsible party
- Principal investigator, Julie George, The University of Texas Health Science Center, Houston
- Investigators
- Julie George, RN, MSN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822844
- Sponsor's protocol ID
- HSC-SN-20-1306
- Status last verified
- Jun 2021
- First submitted
- 25 Mar 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Nurse-Driven Aromatherapy Protocol to Decrease the Effect of Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT04822844
- Acronym / sponsor ID
- HSC-SN-20-1306
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Keywords
- aromatherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- HCA Houston Healthcare Southeast Hospital
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy with Essential Oil | Experimental | Other: Lavender Essential Oil, Other: Ginger Essential OilWithin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PACU patients who are in the main PACU setting at HCA Houston Healthcare Southeast Hospital after having undergone general anesthesia for a surgical procedure
Key exclusion criteria (2 listed)
- patients with allergies or sensitivity to ginger or lavender essential oils
- patients who wish to be excluded from the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender Essential OilWithin 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 | Aromatherapy with Essential Oil |
| Ginger Essential OilWithin 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 | Aromatherapy with Essential Oil |
Primary outcome
Number of Post-Operative Nausea and Vomiting Episodes While in the PACU
Time frame: during stay in PACU (about 45-60 minutes)
3 secondary outcomes
PACU Length of Stay
Time frame: 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)
Patient Satisfaction as Assessed by the Press Ganey Patient Satisfaction Survey
Time frame: at discharge (about 1 hour after PACU admission)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea and Vomiting (PONV)
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie George, RN, MSN principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Essential Oil and Ginger Essential Oil in people with Postoperative Nausea and Vomiting (PONV), run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Post-Operative Nausea and Vomiting Episodes While in the PACU (time frame: during stay in PACU (about 45-60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.