- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882501
Effects of Aromatherapy on Nausea Levels
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Fairfax, Virginia, United States, 22033
- Inova Fair Oaks Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Actual aromatherapy product
QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization
|
Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
Placebo Comparator: Placebo product
Placebo product (normal saline) 50% chance of participant receiving based on randomization
|
Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) from 0-3
Time Frame: 5 minutes
|
Post administration nausea levels will be the source of information for this measure To determine the effectiveness of using aromatherapy as a first line intervention in place of an antiemetic in post-operative bariatric patients who experience nausea on the surgical unit at IFOH. |
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total post operative anti-emetic usage
Time Frame: 24 hours
|
Medication administration record will be the source of information for this measure. effective with a particular post-operative bariatric patient population (sleeve gastrectomy , Roux-En-Y, revisional bariatric surgery) on a surgical unit than with another. |
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mary Ann Friesen, PhD, RN, IHS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U19-07-3670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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