Effects of Aromatherapy in Decreasing Nausea Levels in the Post-operative Bariatric Patient Population on a Surgical Unit
Phase: NA
Conditions: Nausea, Postoperative
Sponsor: Inova Health Care Services

Laura McNicholl, MS, RN-BC, CNS-BC 
3600 Joseph Siewick Drive 
Fairfax VA, 22033 
Laura.mcnicholl@inova.org 
Nov 21, 2024 
Dear Clinical Trials, 
Please see attachments regarding the Study Protocol, Statistical Analysis Plan (SAP) 
and Informed Consent Form (ICF) 
ClinicalTrials.gov ID: NCT04882501 
Unique Protocol ID; U19-07-3670 
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 
Document dates:  
Protocol, SAP, ICF: June 13, 2023 
Fair Oaks Hospital

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IRB #U19-07-3670 The Use of Aromatherapy in Decreasing Nausea 
Levels in the Post-Operative Bariatric Patient Population on a 
Surgical Unit 
 
 
 
Principal Investigator: 
Laura McNicholl, MS, RN, CNS-BC, RN-BC 
 
 
Sub-Investigator: 
Carmen Spencer, BSN, RN, CBN  
Kimberley Hohenadel, MSN, NP-BC 
Colleen Jurgens, MSN, NP-BC 
Therese Findjieu, BSN, RN 
Liliana Suchicital, BSN, RN-BC 
Frances Collins, MSN, CCRN-K, RN 
Cathleen Cowden, Pharm D 
Audra Gollenberg, PhD 
 
 
Study Coordinators: 
Mary Ann Friesen, PhD, RN, CPHQ 
Jennifer McCaughey, MSN, RN, RNC-MNN, CCE 
Anne-Marie O’Brien PhD, RN, WHNP-BC 
 
 
Sponsor: 
Inova Health System 
 
 
Site of Investigation: 
Inova Fair Oaks Hospital 
 
 
Date of Protocol 
 March 8, 2021 
Amendment June 13, 2023 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
Abstract 
3 
Specific Aims 
4 
Hypothesis  
5 
Background and Significance 
5 
Preliminary Studies 
7 
Study Design and Subject Selection 
7 
Study Methods and Procedures 
9 
Statistical Considerations and Data Analysis 
4, 10 
Human Subjects Protection (Risks / Benefits / Alternatives) 
11 
Subject Compensation 
11 
Adverse Event Reporting 
11 
Funding 
11 
Conflicts of Interest 
12 
Facilities and Equipment 
12 
Outside Consultants / Collaborators 
12 
Contractual Agreements 
12 
References 
12, 13 
Appendices: 
15-30 
     A: IMG office flyer 
15 
     B: Interested patient form 
16 
   C: Patient Consent (C1); HIPAA (C2) 
17-22 
   D: Data Collection Form A 
23 
     E: Data Collection Form B 
24 
     F: Aromatherapy patient education sheet 
25 
     G: Study recruitment script 
26 
     H: Demographic/Outcome data 
27-28 
I: Study timetable 
29 
J: Soothing Scents Disclaimer 
30 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABSTRACT 
 
Title: Effects of Aromatherapy in Decreasing Nausea Levels in the Post-operative Bariatric Patient Population on a Surgical 
Unit 
 
Short Title: Effects of Aromatherapy on Nausea Levels 
 
Rationale: 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. 
 
Purpose: 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. 
 
Objectives: Hypotheses include the following: 1) Patients using aromatherapy with the initial episode of nausea on the 
surgical unit will have a greater decrease in mean nausea levels compared to control group.  2) The use of aromatherapy will 
decrease the utilization of antiemetic medication in the first 24 hours in the post-operative bariatric patient population.  
 
Study Type: Single blinded, parallel arm, placebo- controlled, randomized clinical trial.  
 
Study Design: Inclusion criteria includes:  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 include: 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.  The study location is the Surgical Unit at Inova Fair Oaks Hospital.  
The proposed sample size is 180 subjects. 
Hypotheses include the following: 1) Patients using aromatherapy with the initial episode of nausea on the surgical unit will 
have a greater decrease in mean nausea levels compared to control group per the visual analog scale (VAS) from 0-3.  The 0-
3 VAS was used in prior aromatherapy research (Dienemann,2012; & Hunt,2013).  2).  The use of aromatherapy will 
decrease the utilization of antiemetic medication in the first 24 hours in the post-operative bariatric patient population.  
 
Study Methodology:   
Subjects will be provided with information about this research study by the following means: a member of the research team 
(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). 

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On day of discharge a member of the research team will ask the patient  the following questions regarding the Aromatherapy 
QueaseEASE™ product (refer to appendix E: Data Collection Form B).  
The study will occur Monday through Thursday. 
 
 
Did you use the QueaseEASE™ product? 
 
Yes 
No 
 
If yes: 
How beneficial was the aromatherapy?  
 
0    1    2    3    4    5     
 no benefit       
          very beneficial 
 
 
Would you consider using QueaseEASE™ in the future for nausea? 
 
Yes/No 
Would you recommend QueaseEASE™ to family / friend?   
 
 
Yes/No 
Did the participant experience any side effects from the product?  
 
Yes/No 
If yes, what side effect (s):  
Dizziness         Lightheadedness 
    Headache          Other_______ 
 
Primary outcome will be an improved patient reported nausea level after receiving the aromatherapy intervention with 
QueaseEASE™.  Secondary outcome will be a decrease in the utilization of antiemetic medication in the first 24 hours in 
the post-operative bariatric patient population on the surgical unit.   Tertiary outcome will be a determination if 
aromatherapy is more effective for a particular type of bariatric surgery over another (sleeve gastrectomy, Roux-En-Y, 
revisional bariatric surgery) with post-operative nausea. 
 
Statistical Methodology:  
Data will be presented as mean ± SD or frequency (percent), where appropriate.  Group differences will be compared using 
Student’s t-test, or chi-square tests of association, where appropriate.  Data will be assessed for departures from normality 
with group comparisons adjusted accordingly.  The primary hypothesis efficacy endpoint is the incidence rate of nausea 
following surgery.  Rates of nausea and 95% confidence intervals will be presented and group comparison will be via chi-
square tests.  The primary efficacy analysis will only include surgery groups sleeve gastrectomy and Roux-En-Y.  However, 
to expand our knowledge regarding the effect of aromatherapy, we will recruit patients undergoing revisional bariatric 
surgery but these patients will only be considered for secondary analyses.  As this is an RCT, we anticipate potential 
cofounders (e.g., gender, type of surgery, etc ) and effect modifiers to be distributed equally.  However, in the event of a 
failed distribution of clinical or demographic characteristics, mixed effects modeling will be substituted to test the primary 
hypothesis.  All analyses will be conducted using SAS (Ver.9.4, Carey, NC) with statistical significance considered as 
p≤0.05, two-tailed. 
 
1. INTRODUCTION 
 
1.1 Specific Aims  
The use of integrative approaches to health and wellness has grown within care settings across the United States.  
Integrative health is when complementary approaches are utilized in mainstream health care (National Center for 
Complementary and Integrative Health (www.nccih.nih.gov; Downloaded  2/7 /19, Complementary, Alternative, or 
Integrative Health: What’s In a Name).   
 
Aromatherapy is one type of complementary approach.  It is the use of essential oils for the purposes of healing.  It has 
been used for years to relieve pain, promote healing, kill bacteria, and maintain health.  It has been accepted as a part of 
nursing in many countries but only recently has been a part of nursing in the United States.  Clinical aromatherapy is the 
use of essential oils for specific, measurable outcomes (Kreitzer 2014 - book).  Certain essential oils (lavender, 
lavandin, mandarin, rose, bergamot, and frankincense) have their own relaxing properties and all have been shown their 
potential to reduce stress (Buckle, 2015).   
 
Primary Aim: 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.   
 

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Secondary Aim: To determine if aromatherapy utilization for the treatment of post-operative nausea is more effective with 
a particular post-operative bariatric patient population (sleeve gastrectomy , Roux-En-Y, revisional bariatric surgery) on a 
surgical unit than with another.   
 
 
1.2 Hypothesis  
(1) Patients using aromatherapy with the initial episode of nausea on the surgical unit will have a greater decrease in mean 
nausea levels compared to control group and (2) The use of aromatherapy will decrease the utilization of antiemetic 
medication in the first 24 hours for the post-operative bariatric patient population on the surgical unit. 
 
1.3 Background and Significance  
 
Inova Fair Oaks Hospital performs over 550 bariatric surgeries per year.  These surgeries consist of laparoscopic sleeve 
gastrectomy and laparoscopic Roux-En-Y bypass.  These patients receive general anesthesia and insufflation of gas in 
the peritoneal cavity for surgical visualization.  According to Brown and colleagues (2018) general anesthesia causes an 
increased risk for post- operative nausea and vomiting (PONV) when compared with regional anesthesia.  In addition, 
the nursing literature states that laparoscopic surgeries are associated with a higher incidence of PONV.   
 
PONV occurs in one-third of post-operative patients (Ferruggiari, 2012; O’Malley 2016 & Stalling-Welden 2018). 
According to Adib-Hajbaghert and Hosseini, F. (2015) “patients who experience PONV describe it as one of the most 
stressful complications of surgery and prefer postoperative pain over it” (p. 827).  PONV can result in discomfort, fluid 
and electrolyte imbalance, dehydration, increased blood pressure, strain on the surgical site, reduced patient satisfaction 
and delayed discharge (Abid-Hajbaghery, 2015; Brown, 2018; Hodge, 2014; Lee, 2017; O’Malley, 2016; Asay, 2018). 
 
Traditionally, PONV is treated with the administration of antiemetic medications.  However antiemetic medications 
have the following side effects: hypotension, dry mouth, excessive sedation, restlessness, fatigue, extrapyramidal 
reactions and limited dosing (Hodge, 2014; Adib-Hajbaghery, 2015; Karaman, 2019).  Many patients would like the 
option of a non-pharmacological intervention for PONV.  The American Society of Peri-Anesthesia Nurses (2006) 
developed clinical practice guidelines for the prevention and management of PONV.  These guidelines cite 
aromatherapy as an intervention to consider for PONV in the post anesthesia care unit (Stalling-Welden, 2018).  
According, to O’Malley (2016) “aromatherapy provides an alternative therapy to manage nausea, one which is free of 
medication side effects and sedation” (p. 318). 
 
Aromatherapy is the use of essential oils for the purposes of healing.  It has been used for centuries to help relieve pain, 
kill bacteria, and promote health.  It has been accepted as a part of nursing in many countries but only recently in the 
United States.  Clinical aromatherapy is the controlled and therapeutic use of essential oils in the clinical setting for 
specific, measurable outcomes and is a natural therapy that is being used during hospitalization to improve symptoms 
(Johnson, 2016).  According to Buckle (2009), “peppermint, spearmint, and ginger are the classic essential oils to inhale 
for nausea” (p. 402). 
 
Lua and Zakaria (2012) reviewed five research articles which included 328 subjects who received essential oils via 
inhalation for the alleviation of nausea and vomiting.  The results suggest that inhaled vapors of peppermint or ginger 
essential oils did reduce the incidence and severity of nausea and vomiting, decreased the utilization of antiemetic 
medication and improved patient satisfaction.   Peppermint oil has been shown to be effective in the treatment of 
morning sickness, dyspepsia, gastrointestinal complaints due to its antispasmodic properties (Buckle, 2015 & Lua, 
2012).  Ginger has shown to be effective with motion sickness, pregnancy induced nausea and post-operative nausea 
(Buckle, 2015 & Lua, 2012). 
 
A prospective exploratory study in 2015 utilized the produce QueaseEASE™ for the treatment of post-discharge nausea 
in same day abdominal surgery patients (n=25).   Ninety- six percent of participants had either a laparoscopic 
cholecystectomy or hernia repair.  Fourty-seven episodes of post-discharge nausea was reported, and all of the subjects 
had a decrease in their nausea scale (0-10) after using the product and  22 of those 47 episodes  ( 47%) reported a  
nausea scale of 0 after using the product.  The mean decrease in nausea scale for the 25 participants was 4.78 (+ 2.12) 

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after using the QueaseEASE™ product (Mcilvoy, 2015).  This study found that aromatherapy was an effective 
treatment for post-discharge nausea in same day abdominal surgery patients. 
 
Lee and Shin (2017) conducted a quasi-experimental study with nonequivalent control group utilizing ginger essential 
oil and normal saline (NS) via an aromatherapy necklace.  Sample size was 60, 30 subjects received ginger and 30 
subjects received NS.  The purpose of the study was to examine the effectiveness of aromatherapy with ginger essential 
oil on nausea and vomiting in abdominal surgery patients.  The mean post-operative nausea and vomiting (PONV) 
scores in the experimental group (ginger) decreased significantly to an average of 1.14 (scale 2-32, the higher the score 
the more severe the nausea), while those in the control group (NS) had an average of 8.91. 
 
Another study by Adib-Hajbaghery (2015) examined the effect of ginger essence of post-nephrectomy patients and 
PONV.  This study was a randomized controlled trial study with a convenience sample of 120 patients utilizing ginger 
essence and normal saline. The mean nausea intensity in the treatment group was significantly lower than the control 
group (p<0.001) and the differences between the two groups regarding the number of vomiting episodes was also 
statistically significant (p<0.001).  Adib-Hajbaghery (2015), states that the main ingredients in ginger are gingerol and 
shagoal.  These “ingredients have antiemetic, antipyretic, antitussive and anti-inflammatory effects and can relieve 
gastrointestinal disorders as well as limit gastric contractions” (p. 828).  This study supported that inhaling ginger 
essence had a positive effect on PONV in the post-operative nephrectomy patient population. 
 
A 2014 prospective randomized two group design study conducted by Hodge, McCarthy, & Pierce compared the use of 
QueaseEASE™ versus an unscented inhalant in relieving PONV on a surgical unit for the first 24 hours.  Three hundred 
and thirty nine patients were enrolled and 112 patients experienced PONV, the 112 subjects were randomized into the 
treatment group (QueaseEASE™ inhaler) and control group (placebo inhaler).  Findings were the following: perceived 
effectiveness of aromatherapy was significantly higher in the treatment group (p<0.001) and there was a significant 
difference between the two groups (p=0.03). Hodge and colleagues (2014) noted that the nurse is not always able to 
respond as promptly as the patient desires in regards to the administration of antiemetic medication.  The aromatherapy 
device is immediately available for the patient and if it does not completely relieve PONV, it may help the patient 
during the waiting time for the antiemetic to be administered.  Asay (2018) conducted a systematic review of the 
literature regarding the use of aromatherapy in postoperative nausea and vomiting, and the synthesis of evidence did 
support the use of aromatherapy for PONV. Asay and colleagues stated the following “aromatherapy has a positive 
effect on PONV, and therefore should be considered as a complementary therapy or as an adjunct to antiemetic 
medications” (p. 1).   
 
Hudgen, Hunt, Dienemann, Norton and Hartley (2013) conducted a randomized control trial of three aromatherapy 
agents (ginger, isopropyl alcohol and a blend of essential oils).   Normal Saline was used as the control. The purpose of 
the study was to investigate the effectiveness of aromatherapy agents on the treatment of PONV for patients after 
surgery.  Sample size was 301 subjects, who were randomly given one of the four agents upon initial complains of 
PONV via a gauze pad and instructed to inhale the aroma.  Findings included: change in nausea was most significant for 
the aromatherapy blend agent (p=0.0001), then the ginger agent (p=0.0006) and there was no significant finding for 
isopropyl alcohol compared to NS.  The number of antiemetic medication that was requested after the blended 
aromatherapy intervention was reduced. 
 
Hines, Steels, Chang and Gibbons (2018) conducted a systematic review regarding the use of aromatherapy for the 
treatment of postoperative nausea and vomiting, this review included sixteen studies with a total of 1036 participants.  
The time points at which data was collected varied in the studies from 2 minutes to discharge from the Post Anesthesia 
Care Unit or Same Day Surgery Unit. According to Hines et al (2018) “aromatherapy was not effective in reducing 
nausea severity at greater than three minutes after treatment in comparison to saline, water or controlled breathing 
placebo (6 studies with 241 participants) but more participants who received aromatherapy were nausea free at the end 
of the treatment (4 studies, 193 participants) and fewer participants who received aromatherapy required anti-nausea 
medications (7 studies with 609 participants) (p. 4)”. 
 
In 2018, Karaman conducted a randomized 4-armed placebo controlled study with 184 subjects.  This study studied the 
effects of water (placebo), ginger, lavender and rose with PONV in the recovery room.  Results showed that ginger and 

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lavender essential oils were superior to water and rose oil in decreasing nausea scores.  There were also statistically 
significant findings between the groups in regards to vomiting and antiemetic medication administration (p=0.00).   
 
Several studies have been conducted using a variety of aromatherapy agents for the treatment of PONV. The results for 
this type of intervention are positive, yet there is no consensus on which aromatherapy agent/product is most effective at 
reducing PONV in the bariatric post–operative patient population.  Additional nursing research is also needed to 
validate if aromatherapy using the QueaseEASE™ product is evidence based practice for the treatment of PONV 
particularly in the post-operative bariatric patient population.  Nursing practice would also benefit from additional 
research regarding the effectiveness of aromatherapy to help promote its use and gain acceptance as an efficacious 
complementary therapy. 
 
 
1.4 Preliminary Studies 
The principal investigator has been in involved in another complementary/ integrative therapy research at Inova.  This 
study utilized the aromatherapy product Calm Essential Oil Blend AethereoStick as an intervention to help decrease 
pain and anxiety scores in adult patients admitted to a community hospital on the Medical Unit or Telemetry Unit (pilot 
study concluded in August 2018).  Findings from this pilot study were the following: ninety-six percent of the 
participants would use aromatherapy if offered again, would use in in the future, and would recommend its use to 
family and friends.  Pain and anxiety levels were assessed prior to administration of a medication, within 60 minutes of 
receiving pain medication, and within 60 minutes of receiving aromatherapy.  Both pain and anxiety improved after the 
aromatherapy with a p value of <0.001.  Manuscript accepted and published in 2019 (Lindgren, V., McNicholl, L., et 
al). 
 
 
2 STUDY DESIGN AND SUBJECT SELECTION  
 
2.1 Study Type 
Single blind, parallel arm, placebo- controlled, randomized clinical trial. 
 
2.2 Setting/Location 
Participants will be recruited from the Bariatric IMG during their second preoperative visit and/or via MyChart 
portal.  Consents will be obtained when the patient is in pre-operative bay on the day of surgery by a member 
of the research team, excluding the IMG Nurse Practitioners. Inova Fair Oaks Hospital is a top-ranked 182-bed 
acute care community hospital serving the rapidly growing suburbs of Northern Virginia. Inova Weight Loss 
Surgery Program is a nationally recognized weight loss (bariatric) surgery program designed to meet each 
patient’s unique needs.  Located at Inova Fair Oaks Hospital, it is a fully accredited Comprehensive Center for 
Bariatric Surgery since 2006.  Inova Fair Oaks Hospital is committed to providing safe care, excellent service 
and is continuously striving to improve each patient's unique experience.   
 
2.3 Duration of Study 
Participants in the study will receive a one-time one aromatherapy encounter utilizing either QueaseEASE™ 
inhaler product A or product B for post-operative nausea on the surgical unit.  Product A will be the actual 
product that contains peppermint, spearmint, lavender and ginger.  Product B will be the placebo product that 
contains distilled water. The participant will be instructed on self-administration with the aromatherapy inhaler 
product after reviewing standardized printed instructions with them (refer to appendix F: Aromatherapy patient 
education sheet).  The aromatherapy product A or B, based on randomization scheme will be offered to the 
consented patient upon their initial complaint of nausea on the Surgical Unit by the direct care nurse or a 
member of the research team.  The direct care nurse or a member of the research team will ask the participant 
pre and post nausea levels and collect this data on the data collection form (see Appendix D: Data Collection 
Form A). Questions regarding the product will be asked on day of discharge (see Appendix E: Data Collection 
Form B) by a member of the research team. 
 
2.4 Number of Subjects  
Total number of subjects is 180.   

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2.5 Study Population 
2.5.1 
Gender of Subjects 
Both men and women will be included in the proposed study.   
 
2.5.2 
Age of Subjects 
Study participants will be 18 years of age or older.   
 
2.5.3 
Racial and Ethnic Origin  
The study does not include any racial or ethnic enrollment restrictions.  Persons of diverse racial/ethnic 
backgrounds will be recruited equitably.   
 
2.5.4 
Vulnerable Populations 
The following groups will be excluded from the study: children, pregnant women, prisoners, and persons with 
decisional incapacity.   
 
2.6 Recruitment  
All members of the research team will collaborate with one another Monday to Thursday in order to identify 
potential participants.  Other members of the research team who have undergone the required training to obtain 
consent will approach potential participants and advise them of the study.  Consent will be obtained from the 
patients after they have been provided an informed consent form to view, read, and have any questions answered.  
The study will be explained using the script below:  
 
 
Study Recruitment Script: 
 
“I am collaborating with nurse researchers at Inova on a research study to explore the effects of an investigational 
aromatherapy on nausea in the post-operative bariatric patient population on the Surgical Unit.  Aromatherapy is the 
therapeutic use of essential oils from plants.  
 
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.  
This intervention will be in addition to your usual care and also not interfere with your care.   
 
In order to participate in this study, you will need to provide informed consent. I am happy to answer any questions you 
may have about the study and review the consent form with you.” 
  
Study Recruitment Script: See Appendix G  
 
2.7 Inclusion Criteria 
Inclusion criteria includes:  patients ≥ 18 years of age admitted to the Surgical Unit who are experiencing an 
initial episode of nausea status post laparoscopic sleeve gastrectomy or laparoscopic Roux-En-Y (RNY) 
surgery and/or revisional bariatric surgery; must be able to read and speak English; able to follow directions; 
not allergic to peppermint, spearmint, ginger and/or lavender; bariatric surgeon is part of IMG group and 
patient is an inpatient. 
 
2.8 Exclusion Criteria 
Exclusion criteria include: 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, music therapy) or presently enrolled in another research study.   
 

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3 STUDY METHODS AND PROCEDURES 
 
3.1 Study Treatment/Intervention 
Once consent is obtained, the licensed prescriber will enter an order into the patient’s electronic medical record 
(EMR) for the aromatherapy product.  It will be a one-time order to administer the aromatherapy product for 
complaints of nausea while on the surgical unit for the first 24 hours post-operatively.  This order will appear 
on the medication administration record (MAR) in the EMR. 
 
 
Pharmacy will review and release the aromatherapy order.  Pharmacy will be provided with the study Subject 
Identification (SID) number, a copy of the patient’s research consent and randomization scheme generated by 
SAS which will determine the protocol drug (aromatherapy product A or B).  Pharmacy will apply a patient 
label to study drug and one label on the delivery sheet. The pharmacy will dispense the study drug to the 
Surgical Unit. The study drug will be placed in the patient’s medication bin in the medication room closet to 
the patient’s room.  Pharmacy will maintain all delivery sheets in a secure location. 
 
If the enrolled post-operative bariatric patient complains of nausea for first time (initial) while on the surgical 
unit within the first 24 hours post-operatively, the participant will be offered a one-time aromatherapy 
intervention with either product A or product B (based on the randomization scheme) for their nausea 
treatment. A member of the research team will instruct the patient on the use of the QueaseEASE™ 
aromatherapy product (A or B) and also provide them with the educational handout (refer to appendix F: 
Aromatherapy patient education sheet).  The instructions to use are the same for product A as product B. 
 
The direct care nurse will assess the patient’s nausea level prior to the intervention. The direct care nurse will 
provide the patient with their randomized product, and the patient can utilize the product for up to 5 minutes. 
The nurse will document this one time aromatherapy administration via the MAR.  The nurse or a member of 
the research team will then reassess the patient’s nausea level at 5 minutes. 
After the aromatherapy intervention the nurse will remove and discard the patient label from the study drug 
and dispose of the study drug in the appropriate receptacle. 
If the patient still complains of nausea following the one-time aromatherapy intervention with QueaseEASE™ 
product A or product B, an antiemetic medication will be offered. The direct care nurse will complete the data 
collection form A (refer to appendix D: Data Collection Form A). The PI/SI will collect the completed data 
collection form A and store in a secure locked location.  On day of discharge, a member of the research team 
will query the patients on the aromatherapy session using form B (refer to appendix E: Data Collection Form 
B).  The PI/SI will collect and securely store the data collection form B once completed.   
A member of the research team will complete the demographic /outcomes sheet (refer to Appendix H:  
demographic/outcomes sheet) and the PI/SI will collect the completed demographic/outcomes sheet and store 
in a secure locked location. 
 
Refer to Appendix I --for tentative time table for this study.   
 
3.2 Control Group  
Consented patients will be randomized into the control group and will receive aromatherapy product B.   Pre 
and post nausea levels will be assessed and if the nausea level is not decreased an antiemetic will be 
administered as ordered. 
 
 
 

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3.3 Randomization  
Upon enrollment in the trial, each subject will be randomized to one of two treatment groups: Product A 
(aromatherapy inhaler product), Product B (Placebo product: inhaler with distilled water).  Each product will 
look the same. SAS will be used to generate the randomization table using random numbers to determine 
which treatment subject #1 will receive; subject #2 will receive, etc., resulting in a total of 90 subjects for each 
treatment group.  The randomization scheme will be located in a secured location in the pharmacy department 
and access will be granted to Pharmacy and designated research team members.  
 
3.4 Endpoints/Outcomes Measurements 
3.4.1 
Primary outcome. 
Primary end-point: Post-operative bariatric patients that use aromatherapy will have a greater decrease in mean  
nausea levels compared to control group. 
 
3.4.2 
Secondary outcomes 
Secondary end-points: A decrease in the use of antiemetic medication administration in the post-operative bariatric 
patient population; determine if aromatherapy utilization for nausea is more beneficial with a particular post-
operative bariatric patient population (sleeve gastrectomy, Roux-En-Y, revisional bariatric surgery).   
 
3.5    Consent/Assent 
Informed written consent will be obtained by either the PI or SI.  The PI or SI will provide consent document 
to all willing participants after they have met the inclusion criteria listed above and have not met any exclusion 
criteria.  The participant will have an opportunity to view the consent, read the contents, and have time to ask 
any questions.  If they are willing to be a participant in the study the consent will be signed and witnessed by 
the PI or SI.  See attached Informed Consent Document from potential participants (refer to appendix C: 
Consent). 
 
3.6   Monitoring Subjects and Criteria for Withdrawal of Subjects from the Study.    
Participants may withdraw from the study at any time, as desired.   
 
4 STATISTICAL CONSIDERATIONS/DATA ANALYSIS 
4.1   Sample Size   
To test the primary hypothesis that aromatherapy will lead to a decrease in post-operative nausea among 
patients undergoing laparoscopic/robotic sleeve gastrectomy, Roux-En-Y, and/or revisional bariatric surgery we 
will use a Pearson Chi-Square test for proportion difference.  Assuming an expected incidence of nausea among 
controls of 80%, an alpha level of 5 percent, and a 1:1 treatment to control group ratio, we anticipate  90 subjects 
per group (n= 180 total) provides at least 80% power will to detect a statistically significant 20% reduction in the 
incidence of nausea among aromatherapy patients.  The randomization scheme was calculated with SAS (ver.9.4., 
Cary, NC) using a two-group (treatment vs. placebo), simple randomization block (n=15) design.  The total 
randomization scheme was increased to 180 (15 blocks of 12 patients) to allow for drop out and screen failures.  
Sample size will be increased to 180 subjects, this allows for a 20% (n=30) adm/screen fail/etc. error.   
 
4.2 Method of Data Analysis  
Data will be presented as mean ± SD or frequency (percent), where appropriate.  Group differences will be 
compared using Student’s t-test, or chi-square tests of association, where appropriate.  Data will be assessed for 
departures from normality with group comparisons adjusted accordingly.  The primary hypothesis efficacy 
endpoint is incidence rate of nausea following surgery.  Rates of nausea and 95% confidence intervals will be 
presented and group comparison will be via chi-square tests.  The primary efficacy analysis will only include 
surgery groups sleeve gastrectomy and Roux-En-Y.  However, to expand our knowledge regarding the effect of 
aromatherapy, we will recruit patients undergoing revisional bariatric surgery but these will only be considered for 
secondary analyses.  As this is an RCT, we anticipate potential cofounders (e.g., gender, type of surgery, etc.) and 
effect modifiers to be distributed equally.  However, in the event of a failed distribution of clinical or demographic 
characteristics, mixed effects modeling will be substituted to test the primary hypothesis.  All analyses will be 
conducted using SAS (Ver.9.4, Carey, NC) with statistical significance considered as p≤0.05, two-tailed. 
 

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4.3   Data Storage 
Data will be stored in a secure area in a locked cabinet.  All electronic data will be stored on a password 
protected, secure server.  All computers will be password protected.  REDCap, a HIPAA compliant, secure 
web-based application for building and managing online surveys and databases will be used to store the data. 
 
4.3.1 
Data Management 
Information about study subjects will be kept confidential and managed according to the requirements of the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Privacy and confidentiality of all 
enrolled participants will be maintained.  Participants will be de-identified using an ID# that will only be 
accessible to the research team.  The key to the PIN will be kept separate from the collection data and secured 
in a locked cabinet.  All data will be stored on a password protected secure server.  REDCap will be used.   
A Data Usage Agreement (DUA) will be executed by Inova to an external consultant in order to ensure the 
privacy and protection of data. 
 
4.3.2 
  Records Retention 
Data will be stored for three years and then will be destroyed.   
 
5 HUMAN SUBJECTS PROTECTION (RISKS, BENEFITS, AND    ALTERNATIVES) 
5.1 Risks 
Minimal risks, if any, are anticipated.  Participants may experience dizziness, lightheadedness and/or headache. 
 
5.2 Benefits   
There is potential for participants in this study to receive direct benefits from participating in the study by 
decreasing nausea levels.   
 
5.3  Alternatives 
The alternative is to not be a participant in the study.   
 
5.4 Confidentiality 
Confidentiality of the data will be ensured as follows: 
• 
All study data will be coded with a PIN.  The PIN will be used in lieu of any identifiable information 
to ensure confidentiality. 
• 
Only the research team will have access to hardcopy study data.  Hardcopy study data will be kept in 
a locked file cabinet or locked area. 
• 
Only the research team will have access to electronic databases with the study data.  The electronic 
database will be held on a password protected computer.  REDCap will be used. 
• 
Data will be made available only to the investigators and staff working on the study. 
• 
Data will be reported in aggregate.   
 
6 SUBJECT COMPENSATION    
6.1 Costs 
There are no costs to participants.   
 
6.2 Payment  
There will be no payment for participation.   
 
7 ADVERSE EVENT REPORTING   
There are no known anticipated potential adverse events as a result of this study.  However, any adverse events 
will be reported to the IRB.  Protocol deviations will also be reported as required.   
 
8 FUNDING 
This proposed study is non-funded.  

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The company Soothing Scents will be donating the QueaseEASE™ aromatic inhalers and placebo inhalers free 
of charge under the Ease the Quease product evaluation program.  Disclaimer states: “enrollment in this 
program in no way obligates your facility to purchase any product or pay any fees to soothing scents (product 
costs, set-up cost, shipping & handling, etc.).  You can stop the program at any time.  Soothing Scents also 
reserves the right to cancel the program at any time” (refer to appendix J: Soothing Scents Disclaimer).   
 
9 CONFLICTS OF INTEREST  
There are no conflicts of interest.  Refer to disclaimer from Soothing Scents (refer to appendix J: Soothing 
Scents Disclaimer). 
 
10   FACILITIES AND EQUIPMENT  
The Surgical Unit at Inova Fair Oaks Hospital will be the study site.  No extra equipment or investigational 
equipment is needed for this study.   
 
11   OUTSIDE CONSULTANTS/COLLABORATORS   
All members of the research team have completed CITI or WCG training and are Inova employees. 
 
12 CONTRACTURAL AGREEMENTS     
There are no contractual agreements.   
 
13 CLINICAL TRIALS 
A description of this clinical trial will be available on https://www.clinicaltrials.gov/ as required by U.S. law. 
 
14   REFERENCES 
 
 
Adib-Hajbaghery, M., & Hosseini, F. (2015).  Investigating the effects of inhaling ginger essence on post-nephrectomy 
nausea and vomiting.  Complementary therapies in medicine 23, 827-831. http://dx.doi.org/10.1016/j.ctim.2015.10.002 
 
Asay, K., Olson, C., Donnelley, J., & Perlman, E., (2018).  The use of aromatherapy in postoperative nausea and vomiting: 
a systematic review.  Journal of perianesthesia nursing.  Article in press.  http://doi.org/10.1016/j.jopan.2018.08.006 
 
ASPAN (2006).   ASPAN’s evidence-based clinical practice guideline for the prevention and/or management of 
PONV/PDNV. Journal of perianesthesia nursing 21 (4), 230-250.   
 
Brown, L., Danda, L., & Fahery, T.  (2018).  A quality improvement project to determine the effects of aromatherapy on 
postoperative nausea and vomiting in a short-stay surgical population.  Association of perioperative registered nurses 
108 (4), 361-369. http://doi.org/10/1002/aorn.12366 
Buckle J.  (2015). Aromatherapy for stress in patients and hospital staff.  Alternative and Complementary Therapies. 21 
(5), 210-213. 
Dienemann, J., Hudgens, A., Martin, D., Jones, H., Hunt, R., Blackwell, R., Norton, J., & Divine, G.  (2012).  Risk 
factors of patients with and without postoperative  nausea (PON).  Journal of perianesthesia nursing 27, 252-258. 
http://dx.doi.org/10.1016/j.jopan.2012.05.011 
Ferruggiari, L., Ragione, B., Rich, E., & Lock, K. (2012). The effects of aromatherapy on postoperative nausea in women 
undergoing 
surgical 
procedures. 
 
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Hines, S., Steels, E., Chang, A., & Gibbons. K.  (2018). Aromatherapy for treatment of postoperative nausea and vomiting. 
Cochrane Library. https:/doi.org/10.1002/14651858.CD007598.pub3 
 

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Hodge, N., McCarthy, M., & Pierce, R.  (2014). A prospective randomized study of the effectiveness of aromatherapy for 
relief 
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vomiting. 
 
Journal 
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5-11. 
http://dx.doi.org/10.1016/j.jopan.20212.12.004 
 
Hudgens, A., Hunt, R., Dienemann, J., Norton, J., & Hartley, W. (2013). Postoperative nausea and vomiting rescue using 
aromatherapy.  ASPAN National Conference Abstracts. Journal of perianesthesia nursing 28, 46-47. 
http://dx.doi.org/10.1213/ANE.0b013e31824a0b1c 
 
Hunt, R., Dienemann, J., Norton, J., Hartley, W., Hudgens, A., Stern, T., & Divine, G.  (2013). Aromatherapy as treatment 
for postoperative nausea: a randomized trial.  Anesthesia-analgesia 117 (3), 597-604.   
 
Johnson, J., Rivard, R., Griffin, K., Kolste, A., Joswiak, D., Kinney, M., & Dusek, J.  (2016). The effectiveness of nurse-
delivery aromatherapy in an acute care setting.  Complementary therapies in medicine 25, 164-169.  
http://dx.doi.org/10.1016/j.ctim.2016.03.006 
 
Karaman, S., Karaman, T., Tapar, H., Dogru, S., & Suren, M.  (2019).  A randomized placebo-controlled study of 
aromatherapy for the treatment of postoperative nausea and vomiting.  Complementary therapies in medicine 42, 417-
421. http://doi.org/10.1016/j.ctim.2018.12.019 
 
Lee, Y., & Shin, H.  (2017). Effectiveness of ginger essential oil on postoperative nausea and vomiting in abdominal 
surgery 
patients. 
 
The 
journal 
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alternative 
and 
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23 
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196-200. 
http://dx.doi.org/10/1089/acm.2015.0328 
 
Lindgren, V., McNicholl, L., Friesen, MA., Barnett, S., & Collins, F. (2019). Effects of aromatherapy on patient and 
anxiety score in patients admitted to a community hospital on the medical unit or telemetry unit.  Holistic Nursing 
Practice, 33 (6), 3446-353. 
 
Lua, P., Zakaria, S.  (2012). A brief review of current scientific evidence involving aromatherapy use for nausea and 
vomiting.  The journal of alternative and complementary medicine 18 (6), 534-540. 
http://dx.doi.org/10.1089/acm.2010.0862 
Mcilvoy, L., Richmer,L., Kramer, D., Jackson, R., Shaffer, L., Lawrence, J.,& Inman, K (2015).The efficacy of 
aromatherapy in the treatment of post-discharge nausea in patients undergoing outpatient abdominal surgery.  Journal of 
perianesthesia nursing 30 (5), 383-388. http://dx.doi.org/10.1016/j.jopan.2014.10.004 
O’Malley, P.  (2016).  Aromatherapy for postoperative nausea in acute care-evidence and future opportunities.  Clinical 
nurse specialist.  November/December, 318-320. http://dx.doi.org/10.1097/NUR.000000000000254 
 
Stallings-Welden, L., Doerner, M., Ketchem, E., Benkert, L., Alka, S., & Stallings, J.  (2018).  A comparison of 
aromatherapy to standard care for relief of PONV and PDNV in ambulatory surgical patients.  Journal of perianesthesia 
nursing 33 (2), 116-128. http://dx.doi.org/10/1016/j.jopan.2016.09.001 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDICES 
 
Appendix A: IMG office flyer 
Appendix B: Interested patient card 
Appendix C: Patient Consent (C1) and HIPAA (C2) 
Appendix D: Data Collection Form A 
Appendix E: Data Collection Form B 
Appendix F: Aromatherapy patient education sheet 
Appendix G: Study recruitment script 
Appendix H: Demographic/outcomes data 
Appendix I: Study timetable 
Appendix J: Soothing Scents Disclaimer 
 
 

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Appendix A 
 
 
 
 
 
 

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Appendix B 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix C1 
 
 

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Appendix C2 

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Appendix D 
 
 
 

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Appendix E 
 
 
 
 
 
 
 
 

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Appendix F 
 
 
 
 

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Appendix G 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix H 
 
 
 
 
 
 

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Appendix I 
 
 
 
 
 
 
 
 
 
 

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Appendix J