Effects of Aromatherapy on Nausea Levels
Primary Purpose
Nausea, Postoperative
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
QUEASEEase aromatherapy quick tab
Placebo product
Sponsored by
About this trial
This is an interventional treatment trial for Nausea, Postoperative
Eligibility Criteria
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.
Sites / Locations
- Inova Fair Oaks Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Actual aromatherapy product
Placebo product
Arm Description
QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization
Placebo product (normal saline) 50% chance of participant receiving based on randomization
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS) from 0-3
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.
Secondary Outcome Measures
Total post operative anti-emetic usage
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.
Full Information
NCT ID
NCT04882501
First Posted
May 6, 2021
Last Updated
October 7, 2022
Sponsor
Inova Health Care Services
1. Study Identification
Unique Protocol Identification Number
NCT04882501
Brief Title
Effects of Aromatherapy on Nausea Levels
Official Title
Effects of Aromatherapy in Decreasing Nausea Levels in the Post-operative Bariatric Patient Population on a Surgical Unit
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blinded, parallel arm, placebo- controlled, randomized clinical trial.
Masking
Participant
Masking Description
If you agree to participate in the study you will be randomized (assigned by chance) to a product group (product A or product B) and will receive either the active intervention or placebo. There is a 50% or 1 in 2 chance of you receiving either product A or product B upon your initial complaint of nausea when on the Surgical Unit. You will receive a one-time dose for your nausea using either product A or product B based on trial randomization.
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Actual aromatherapy product
Arm Type
Active Comparator
Arm Description
QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization
Arm Title
Placebo product
Arm Type
Placebo Comparator
Arm Description
Placebo product (normal saline) 50% chance of participant receiving based on randomization
Intervention Type
Other
Intervention Name(s)
QUEASEEase aromatherapy quick tab
Intervention Description
Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
Intervention Type
Other
Intervention Name(s)
Placebo product
Intervention Description
Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) from 0-3
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Total post operative anti-emetic usage
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Ann Friesen, PhD, RN
Organizational Affiliation
IHS
Official's Role
Study Director
Facility Information:
Facility Name
Inova Fair Oaks Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Aromatherapy on Nausea Levels
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