Aromatherapy for Management of Pain, Anxiety, and Nausea in the Acute Care Setting
Phase: NA
Conditions: Effectiveness of Aromatherapy
Sponsor: University of California, Davis

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1) Protocol Title 
Title:  Aromatherapy for management of pain, anxiety, and nausea in 
the acute care setting 
Protocol Version Date: 2/20/20 
2) Objectives 
The purpose of the study is to investigate the effects of aromatherapy on pain, 
anxiety, and nausea in patients on an acute care unit. The primary objective of 
this project is to determine whether Elequil aromatherapy tabs show a 
measurable benefit in reducing patient reported pain, anxiety, and nausea, thus 
reducing the use of anxiolytic, antiemetic, or opioid medications. The 
secondary objective is to identify the effectiveness of aromatherapy on 
improved sleep and improved patient satisfaction and well-being. 
Aromatherapy has been studied and shown effective for the decreased effects 
of pain, anxiety, and nausea. We are hypothesizing that the use of 
aromatherapy has a positive effect in decreasing patient-reported pain, 
anxiety, and nausea, and increasing sleep and overall patient satisfaction. 
3) Background 
People are hospitalized every day, with many of them experiencing ailments 
such as pain, nausea, and anxiety, on top of the symptoms that are related to 
their admitting diagnoses. As nurses, the primary responsibilities are to 
function as a caregiver to help manage physical conditions, treat illness, and 
educate to prevent further worsening of health conditions. Assessing, 
managing, and treating uncomfortable symptoms is an integral part of nursing 
care. Interventions for these primarily include pharmaceutical interventions. 
The use of aromatherapy is an alternative treatment that can be used in 
addition to medications. Clinical aromatherapy is the controlled and 
therapeutic use of essential oils in the clinical setting for specific, measurable 
outcomes and is a natural therapy increasingly being used to improve 
symptoms and maintain health and well-being during a hospital stay.1 
The encouragement of alternative, non-pharmaceutical means to decrease 
symptoms is not a wide-spread practice. Hospitals do not necessarily see the 
use of essential oils as an effective means to decrease somatic complaints. 
This study will try to expand upon the limited literature and studies regarding 
the use of aromatherapy and its effectiveness in decreasing the presence of 
pain, nausea, and anxiety in the hospital setting. 
There is limited evidence that shows that the use of aromatherapy is effective 
 
1 Buckle, J. The role of aromatherapy in nursing care. Nurs Clin North Am. 2001;36(1):57-72. 

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in decreasing somatic complaints. One study concluded that essential oils 
generally resulted in significant clinical improvements based on their intended 
use.2  Cho found that aromatherapy use resulted in reduced anxiety, increased 
sleep, and stabilized blood pressure.3  Moeini and colleagues demonstrated 
that the use of aromatherapy significantly improved the quality of sleep with 
the use of essential oils.4 While the majority of aromatherapy studies were 
done in the intensive care unit (ICU) setting, or outpatient setting, all 
concluded that further studies needed to be done. In an effort to provide non-
pharmacologic adjunctive treatments for symptom management, 
aromatherapy has been explored in the inpatient setting. 
We will be using Elequil aromatabs® to determine the effectiveness of 
aromatherapy in the hospital setting. The following scents, their common uses 
and estimated aromatab® duration of use are: 
• Lavendar: Promotes relaxation, comfort, and sleep.  Lasts 8 hours. 
• Lavendar-Sandalwood: Promotes relaxation, comfort, and sleep.  Lasts 
8 hours or more. 
• Lavendar-peppermint:  Promotes relaxation during pain, calm 
anxiousness, and soothe queasiness. Lasts 8 hours. 
• Orange-Peppermint: Uplifts, energizes, and soothes queasiness. Lasts 
8 hours.5 
The chosen essential oils will be inhaled by the patient when the aromatherapy 
tab is opened and affixed to their hospital gown. 
4) Inclusion and Exclusion Criteria 
Setting:   
Upon admission to Tower 4- an acute care, remotely monitored telemetry unit at 
UC Davis Medical Center in Sacramento, CA., if the patient is interested in 
participating in the study, the patient will first be evaluated on whether they meet 
 
2 Johnson, Rivard, Griffinm Kolste, Joswiak, Kinney, Dusek. The effectiveness of nurse-delivered 
aromatherapy in an acute care setting. Complementary Therapies in Medicine. 2016; 25:  164-
169. 
3 Cho M, Min E, Hur M. Effects of Aromatherapy on the Anxiety, Vital Signs and Sleep Quality of 
Percutaneous Coronary Intervention Patients in Intensive Care Units. Evid Based Complement 
Alternat Med. 2013; 2013: 381381. 
4 Moeini M, Khadibi M, Bekhradi R, Mahmoudian S, Nazan F. Effect of aromatherapy on the 
quality of sleep in ischemic heart disease patients hospitalized in intensive care units of heart 
hospitals of the Isfahan University of Medical Sciences. Iran J Nurs Midwifery Res. 2010 Autumn; 
15(4): 234-239. 
5 Elequil Aromatab Informational handout. https://www.beekley.com/   

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the inclusion criteria to participate in the study.  
Inclusion criteria: 
• Age 18 years or older 
• Admission to Tower 4 for an anticipated inpatient stay >24 hours 
• Alert and oriented 
• Capable of using a visual scale to self-report symptoms 
• Naïve to the use of aromatherapy for the use of decreasing pain, 
anxiety, and/or nausea to participate.   
• Not on a pediatric service 
The specific criteria for subject selection are patients admitted to Tower 4, an 
acute care/telemetry unit, who are conscious and able to communicate, that 
understands the purpose of the study and is competent and can give consent. The 
patient must not include any of the following: 
Exclusion criteria: 
• Cognitively impaired 
• Post-op from an otolaryngologic surgery 
• Known impaired olfactory function (limited or no sense of smell) 
• On any psychiatric holds (e.g., 5150’s) 
• Known allergies to essential oils.  
• Sensitive or allergic to plants (specifically to lavender plants, 
orange blossoms, sandalwood trees, or peppermint leaves) as 
essential oils are natural aromas derived from plants. 
• Active participant of another Research Protocol 
• Admitted as a “short stay” or on “observation” status. 
• Has known history of Atrial Fibrillation 
• Is a prisoner. 
• Known pregnancy, or 

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• Expected to be transferred out of Tower 4 and/or discharged from 
the hospital within 24 hours. 
5) Study Timelines 
Participants of the study will ideally wear the aromatherapy tab on their gown 
for at least 8 hours to assess its effectiveness.  After a minimum of 8 hours has 
elapsed, they will be given a follow up assessment tool to evaluate their 
symptoms and their experience in using aromatherapy. 
• 
Identification of eligibility 
• 
Consent 
• 
Assessment 1 (Hour 0) 
Awake - complete assessment tool. 
• 
Aromatherapy tab application 
• 
Assessment 2 (Hour 8) 
Sleeping - no assessment/document sleep 
Awake – complete end assessment tool. 
Satisfaction assessment 
 
If patient prefers, they can continue to utilize aromatherapy, otherwise tab is to be 
removed, and study is complete. 
 
• 
Assessment 3 (Hour 12-24) 
• 
Aromatherapy tab removal (after the maximum 24 hours worn) 
• 
Additional data collection as noted below (medication use) 
 
Individual subject participation will total up to 8 hours to a maximum of 
twenty-four hours. 
We anticipate that our goal enrollment of one hundred subjects will be 
accomplished within six months (from first subject enrolled to last subject). 
Our total estimate for study completion is twelve months.  
6) Study Endpoints 
Primary endpoint: Elequil aromatherapy tab use is effective on  
1. Patient-reported pain score 
2. Patient-reported anxiety score 
3. Patient-reported nausea score 
Secondary endpoints: Elequil aromatherapy tab use is effective in decreasing the 
following as measured by the corresponding scales: 

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1. 
Total anxiolytic medication use 
2. 
Total antiemetic medication use 
3. 
Total opioid medication use 
4. 
Observed and patient-reported sleep. 
5. 
Patient-reported patient satisfaction  
6. 
Patient-reported well-being 
7) Procedures Involved 
Methods:   
Staff education will be completed prior to the start of the study.  Staff will 
watch a short instructional video. https://vimeo.com/276457486. They will 
then practice how to open the Elequil tabs. Staff will be educated on how to 
introduce the study to eligible patients.  
Upon admission to Tower 4 - an acute care, remotely monitored telemetry unit 
at UC Davis Medical Center in Sacramento, CA., the bedside RN will 
introduce the study to the patient. If they are interested in participating, the 
patient will be evaluated by a member of the research team on whether they 
meet the inclusion criteria to participate in the study. If inclusion data is met, 
the research team member will fully introduce and explain the study to the 
patient. If the patient is interested in participating in the study, the research 
team member will consent the patient.  
After consent is obtained, a baseline assessment tool will be given to the 
subject for completion, asking them to rate their pain, anxiety and/or nausea 
using a Likert scale. 
Upon completion of these assessment tools, the subject will be asked to 
identify their highest priority among the symptoms ranked to which they will 
then be given the corresponding aromatherapy tab to treat that symptom.  
The research team member will then provide the tab that is identified to treat 
that symptom. 
• Lavendar: Promotes relaxation, comfort, and sleep. Assists with 
decreasing anxiety. 
• Lavendar-sandalwood: Promotes relaxation, comfort, and sleep. 
Assists with aches and restlessness.  
• Lavendar-peppermint:  Promotes relaxation during pain, calm 

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anxiousness, and soothe queasiness. 
• Orange-peppermint: Uplifts, energizes, and soothes queasiness/nausea. 
Subjects will have the option of choosing how much scent they receive by 
determining how much of the essential oil pad is exposed. MAX SCENT will 
be used for the full effect of the essential oil or MIN SCENT for a lighter 
effect of the essential oil. The aromatherapy tab will then be attached to the 
front of the patient gown in the proximity of the clavicle area. It should not be 
placed directly on skin. 
1. Recruitment of participants 
2. Consent of participants 
3. Baseline survey completion and assessment 
a. Demographic characteristics of subjects (age, gender) 
b. Baseline assessment scores 
i. Likert Scales 
4. Offer of aromatherapy tab to participant 
5. Application of aromatab to the patient’s gown or clothing in the proximity 
of the clavicular area 
6. Assessment/observation after 8 hours of application to a maximum of 24 
hours  
a. Anxiety 
b. Pain 
c. Nausea 
7. Removal of aromatherapy tab after a maximum of twenty-four hours 
8. Follow up survey completion after 8 hours. 
a. Follow up assessment scores. 
i. Likert Scales 
9. Additional data retrieval (from medical chart in the EMR) 
a. Anxiolytic medication use  

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b. Pain relieving medication use  
c. Antiemetic medication use  
d. Medication use for treating insomnia.  
e. Patient report of satisfaction on exit survey 
10. Data analysis  
The collected data will be analyzed by the study team in consultation with 
Susan Stewart, CTSC Statistician, and Lori Madden, Clinical Nurse Scientist. 
11. Reporting/dissemination  
The deidentified information and findings collected from this study will be 
reported/disseminated with stakeholders within the institution. Investigators 
also intend to disseminate findings on a broader scale (e.g., professional 
meeting presentation, publication). 
8) Data and/or Specimen Management and Confidentiality 
Individual’s responses/statements will not include any information that 
identifies the individual, but the responses/statements will be coded and linked 
to their identity on a separate document or in a separate database.  
All identifiable electronic data will be maintained on an encrypted device 
requiring a password for access. Passwords will not be shared and will be 
protected from access. 
I understand that if this study involves the use of the UC Davis Health 
Electronic Health Record (EMR/EPIC) which also contains the clinical data 
for Marshall Medical Center (MMC), that MMC patient data cannot be 
accessed for research purposes and that I must take the necessary steps to 
ensure that MMC data is not accessed, used, or disclosed for UC Davis Health 
research purposes. Identifiable information from medical records will be 
stored on a password protected, encrypted device. Investigators will follow 
applicable university policies (UC Davis Hospital Policy 1313, UCDHS P&P 
23002499, and UC Business and Finance Bulletin on Information Security 
(IS-3). 
All paper records will be stored in a locked room/file-cabinet with access 
limited to only individuals who have a right and need for access.  
9) Data and/or Specimen Banking 
Data will not be banked.  

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10) 
Withdrawal of Subjects 
Subjects may withdraw consent at any time, and they will be reassured that their 
clinical care will not be compromised if they were to withdraw. Subjects will be 
withdrawn from the study for the following reasons: 
• Subject changes their mind and decides to opt out of the study before utilizing 
aromatherapy. 
• Development of an allergic reaction (rash, indurations, increased discomfort, 
anaphylactic symptoms) to the use of aromatherapy 
o The aromatherapy tab will be removed and sequestered so as to not be 
used again. 
o Subject will be monitored with provider notification of patient’s 
allergic reaction. 
• Hospital discharged within 12 hours of admission. 
o Aromatherapy tab will be removed before discharge. 
o Subject will be asked to complete the survey, and the time of 
completion (since aromatherapy initiated) will be noted. 
• Transferred off the unit (to ICU or a different unit) 
o Aromatherapy tab will be removed before transfer. 
o Subject will be asked to complete the survey, and the time of 
completion (since aromatherapy initiated) will be noted. 
Subjects are free to withdraw from the study at any time upon request. Subject 
participation in the study may be stopped at any time at the discretion of the 
Investigator or Attending Physician. When a subject withdraws from the study, 
the reason(s) for withdrawal will be recorded by the Investigator.  
11) 
Risks to Subjects  
Even though the products that will be used are diluted and we will not be 
applying concentrated solutions directly to the skin, the following are 
identified risks related to aromatherapy use: 
• Allergic reaction to the use of aromatherapy, including the 
development of  
o Dermatitis 

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o Runny nose/nasal congestion (sinus issues) 
o Rash 
o Red or bumpy skin (indurations) 
o Increased discomfort 
o Anaphylactic symptoms 
The rates of allergic reactions for each essential oil that will be used for 
this study are as follows: 
Sandalwood:  0.9%, orange and peppermint:  0.6% 6 
Lavender:  2.2% 7 
The patient will notify the nurse immediately if any of these symptoms 
appear. 
12) 
Potential Benefits to Subjects 
Subjects may experience relief of or decrease in their symptoms of nausea, pain, 
anxiety, and/or insomnia with the use of aromatherapy. They may resultantly use 
less medications and have fewer associated undesirable side effects from those 
medications. 
The results of this study may contribute to our knowledge about aromatherapy as 
a non-pharmacologic intervention to relieve or minimize pain, anxiety, nausea, 
and/or insomnia. Future individuals who have such symptoms may benefit as a 
result. 
13) 
Sharing of Results with Subjects 
Results will be shared with subjects.  Any peer reviewed manuscripts that result 
from the study will be made available to the subjects on request. 
14) 
Prior Approvals 
The research team has already obtained approval from the Product Standards 
 
6. Frosch, P.J., Johansen, J.D., Menné, T., Pirker, C., Rastogi, S.C., Andersen, K.E., Bruze, M., 
Goossens, A., Lepoittevin, J.P. and White, I.R. (2002), Further important sensitizers in 
patients sensitive to fragrances. Contact Dermatitis, 47: 279-287. doi:10.1034/j.1600-
0536.2002.4704171.x 
7 Bingham, LJ, Tam, MM, Palmer, AM, Cahill, JL, Nixon, RL. Contact allergy and allergic 
contact dermatitis caused by lavender: A retrospective study from an Australian clinic. 
Contact Dermatitis. 2019; 81: 37– 42. https://doi.org/10.1111/cod.13247 

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Committee. The team has also communicated with and will continue to coordinate 
with the manufacturer of the aromatherapy tabs, Beekley Medical, regarding 
procurement. A letter of support noting the agreement from the manufacturer to 
supply 100 aromatherapy tabs at no cost is enclosed (Attachment A).  
15) 
Provisions to Protect the Privacy Interests of Subjects 
Steps will be taken to protect subjects’ privacy interests. Subjects will only 
interact with approved study personnel who have successfully completed human 
subjects training. This includes those involved in the study visits, consent, and in 
any study related procedures. We will do our best to make sure that the personal 
information in the subject’s medical record is kept private. However, no study can 
guarantee 100% protection of confidential information despite all our measures to 
protect each subject’s privacy. Subjects will be made aware of this during the 
consent process.  
16) 
Compensation for Research-Related Injury 
The research study does not involve more than Minimal Risk. If a subject 
is injured as a result of being in this study, the University of California 
will provide necessary medical treatment. Depending on the 
circumstances, the costs of the treatment may be covered by University or 
the study sponsor or may be billed to the subject’s insurance company just 
like any other medical costs. The University and the study sponsor do not 
normally provide any other form of compensation for injury. For more 
information about compensation, call the IRB administration at (916) 703-
9151 or email at IRBAdmin@ucdmc.ucdavis.edu.  
 
17) 
Economic Burden to Subjects 
No expenses will be billed to conduct the study, printing costs for study 
document and analysis are supported by the Center for Nursing Science. 
No study-related procedures or costs are billed to subjects.  
18) 
Drugs or Devices 
No drugs or devices will be used for this study. The aromatherapy tabs 
will be intended to supplement subjects’ medication plan. Per Elequil, the 
aromatherapy tabs are neither considered a drug or device. See letter from 
Elequil (Attachment B). 
19) Review Requirements 
There are no contractual obligations or other considerations that require IRB 
review of this research, or review at intervals other than those required by the 
Common Rule or FDA. 

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Assessment Tools 
Anxiety Likert Scale: This one-item scale consisted of five evenly spaced 
numbers each anchored to a level of anxiety (0 = not at all anxious, 2 = a little 
anxious, 3 = moderately anxious, 4 = very anxious, 5 = extremely anxious). 
The Numerical Rating Pain Scale measures pain experienced right now based 
on a 11-point Likert scale with choices of 0 = no pain, 5 = Moderate pain, 10 = 
Worst possible pain. We will be utilizing this 0-10 scale for pain because it is one 
of the most commonly used pain scales that is used at the bedside. 
Nausea Scale:  0-5 Nausea Scale 
 
Halpin, Angela MN, RN, CNS; Huckabay, Loucine M. PhD, RN, PNP, FAAN; Kozuki, Jessica L. MSN, 
RN, AOCNP, CNS, NP, OCN; Forsythe, Deborah RN, OCN.  Nursing2010: November 2010 - Volume 
40 - Issue 11 - p 18-20.  doi: 10.1097/01.NURSE.0000389030.33760.7a 
 
Attachment A 
 

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Attachment B