Nausea, PostoperativeNCT04882501
Effects of Aromatherapy on Nausea Levels
A study testing QUEASEEase aromatherapy quick tab in people with Nausea, Postoperative, run by Inova Health Care Services at 1 site in United States.
Trial summary
Aromatherapy is the therapeutic use of essential oils from plants for the improvement of physical, emotional, and spiritual well-being. Healthcare providers play an important role in improving the care of patients with nausea. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea, Postoperative
- What is being tested?
- QUEASEEase aromatherapy quick tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age admitted to the Surgical Unit who are experiencing an initial episode of nausea status post laparoscopic/ robotic sleeve gastrectomy, and/or laparoscopic/robotic Roux-En-Y (RNY) surgery, and/or revisional bariatric surgery; must be able to read and speak English; able to follow directions; bariatric surgeon is part of Inova Medical Group (IMG) and patient is an inpatient.
Who cannot join
- Patients < 18 years of age; non-English speaking; not able to follow directions; inability to smell (anosmia); allergy to peppermint, spearmint, ginger and/or lavender; receiving bariatric surgery for gastroparesis; pregnant or breastfeeding; vulnerable subjects; receiving complementary therapy (healing touch and/or music therapy) or presently enrolled in another research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aromatherapy in Decreasing Nausea Levels in the Post-operative Bariatric Patient Population on a Surgical Unit
Aromatherapy is the therapeutic use of essential oils from plants for the improvement of physical, emotional, and spiritual well-being. Healthcare providers play an important role in improving the care of patients with nausea. Aromatherapy is a complementary therapy that may help with post-operative nausea in the adult post-operative bariatric patient population.
The purpose of this study is to evaluate the effects of aromatherapy intervention on nausea levels with post-operative bariatric patients once they are on the surgical unit.
Read the detailed description
Subjects will be provided with information about this research study by the following means: a member of the research team- Inova Medical Group (IMG) Nurse Practitioners will discuss the research study during the patient's second pre-operative visit; study information will be uploaded to their MyChart portal; and flyers will be available in the IMG office (refer to appendix A: IMG office flyer). Interested patients will be able to fill out a brief form (refer to appendix B: Interested patient card) requesting to be contacted for further information, this form will be placed in a secure box at the reception desk or the patients can indicate interest by contacting one of the research team members. A member of the research team may need to access medical record information in order to confirm potential patient's phone number and or email address for further contact. A member of the research team will contact any interested patients and answer any questions regarding the research study. Consent will be obtained while the patient is in the peri-operative holding area on day of surgery by a member of the research team, excluding the IMG Nurse Practitioners. The research team member will determine if the patient is eligible for the study, discuss the study, answer any questions, and obtain consent (refer to appendix C: Consent). All members of the research team have completed Informed Consent Training. Once the consented post-operative bariatric patient complains of initial nausea on the Surgical Unit, the direct care nurse or research team member will ask the patient to rate their nausea level using a VAS on a 0-3 scale. Patients will be provided with either product A or B based on randomization scheme calculated by SAS (ver.9.4, Cary, NC). The patient will receive a one-time aromatherapy intervention. Nausea levels will be reassessed 5 minutes after the aromatherapy intervention. If the nausea level does not improve after the study drug intervention an antiemetic medication will be offered (refer to appendix D: Data Collection Form A).
- Conditions
- Nausea, Postoperative
- Being tested
- QUEASEEase aromatherapy quick tab, Placebo product
- 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.
QUEASEEase aromatherapy quick tabOther
Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
Placebo productOther
Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
| Study group | Role | What they receive |
|---|---|---|
| Actual aromatherapy product | Active comparator | QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization Receives: Other: QUEASEEase aromatherapy quick tab |
| Placebo product | Placebo comparator | Placebo product (normal saline) 50% chance of participant receiving based on randomization Receives: Other: Placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Measured participants self reported nausea level pre ( Baseline) and post intervention VAS 0 - no nausea VAS 1- Mild Nausea VAS 2- Moderate Nausea VAS 3 - Severe nausea
Measured: Up to 24 hours post operatively
Secondary outcomes (1)
Total Number of Participants Who Received an Anti-emetic Post Study Intervention.
This the number of patients who received an anti- emetic for nausea after receiving post study intervention.
Measured: Up to 24 hours post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start19 Apr 2021
- Primary completion22 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nausea, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded, parallel arm, placebo- controlled, randomized clinical trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Ann Friesen, PhD, RN, Study director, IHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882501
- Sponsor's protocol ID
- U19-07-3670
- Status last verified
- Nov 2024
- First submitted
- 6 May 2021
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aromatherapy in Decreasing Nausea Levels in the Post-operative Bariatric Patient Population on a Surgical Unit
- ClinicalTrials.gov ID
- NCT04882501
- Acronym / sponsor ID
- U19-07-3670
- Conditions
- Nausea, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aromatherapy is the therapeutic use of essential oils from plants for the improvement of physical, emotional, and spiritual well-being. Healthcare providers play an important role in improving the care of patients with nausea. Aromatherapy is a complementary therapy that may help with post-operative nausea in the adult post-operative bariatric patient population.
The purpose of this study is to evaluate the effects of aromatherapy intervention on nausea levels with post-operative bariatric patients once they are on the surgical unit.
Detailed description
Subjects will be provided with information about this research study by the following means: a member of the research team- Inova Medical Group (IMG) Nurse Practitioners will discuss the research study during the patient's second pre-operative visit; study information will be uploaded to their MyChart portal; and flyers will be available in the IMG office (refer to appendix A: IMG office flyer). Interested patients will be able to fill out a brief form (refer to appendix B: Interested patient card) requesting to be contacted for further information, this form will be placed in a secure box at the reception desk or the patients can indicate interest by contacting one of the research team members. A member of the research team may need to access medical record information in order to confirm potential patient's phone number and or email address for further contact. A member of the research team will contact any interested patients and answer any questions regarding the research study. Consent will be obtained while the patient is in the peri-operative holding area on day of surgery by a member of the research team, excluding the IMG Nurse Practitioners. The research team member will determine if the patient is eligible for the study, discuss the study, answer any questions, and obtain consent (refer to appendix C: Consent). All members of the research team have completed Informed Consent Training. Once the consented post-operative bariatric patient complains of initial nausea on the Surgical Unit, the direct care nurse or research team member will ask the patient to rate their nausea level using a VAS on a 0-3 scale. Patients will be provided with either product A or B based on randomization scheme calculated by SAS (ver.9.4, Cary, NC). The patient will receive a one-time aromatherapy intervention. Nausea levels will be reassessed 5 minutes after the aromatherapy intervention. If the nausea level does not improve after the study drug intervention an antiemetic medication will be offered (refer to appendix D: Data Collection Form A).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded, parallel arm, placebo- controlled, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Actual aromatherapy product | Active comparator | Other: QUEASEEase aromatherapy quick tabQUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization |
| Placebo product | Placebo comparator | Other: Placebo productPlacebo product (normal saline) 50% chance of participant receiving based on randomization |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥ 18 years of age admitted to the Surgical Unit who are experiencing an initial episode of nausea status post laparoscopic/ robotic sleeve gastrectomy, and/or laparoscopic/robotic Roux-En-Y (RNY) surgery, and/or revisional bariatric surgery; must be able to read and speak English; able to follow directions; bariatric surgeon is part of Inova Medical Group (IMG) and patient is an inpatient.
Key exclusion criteria (1 listed)
- Patients < 18 years of age; non-English speaking; not able to follow directions; inability to smell (anosmia); allergy to peppermint, spearmint, ginger and/or lavender; receiving bariatric surgery for gastroparesis; pregnant or breastfeeding; vulnerable subjects; receiving complementary therapy (healing touch and/or music therapy) or presently enrolled in another research study.
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 |
|---|---|---|
| QUEASEEase aromatherapy quick tabOnce patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. | Other | Actual aromatherapy product |
| Placebo productOnce patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed. | Other | Placebo product |
Primary outcome
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Time frame: Up to 24 hours post operatively
Measured participants self reported nausea level pre ( Baseline) and post intervention VAS 0 - no nausea VAS 1- Mild Nausea VAS 2- Moderate Nausea VAS 3 - Severe nausea
1 secondary outcome
Total Number of Participants Who Received an Anti-emetic Post Study Intervention.
Time frame: Up to 24 hours post operatively.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mary Ann Friesen, PhD, RN study director
IHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QUEASEEase aromatherapy quick tab in people with Nausea, Postoperative, run by Inova Health Care Services 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 1 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 29 Nov 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3 (time frame: Up to 24 hours post operatively). 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 29 Nov 2024.