Using Aromatherapy for Comfort, Ease, and Stress for Adults Being Treated for Substance Use Disorder in North Central Appalachia: A Randomized Controlled Trial
Phase: NA
Conditions: Substance Use Disorders
Sponsor: West Virginia University

 
 
 
 
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Using Aromatherapy for Comfort, Ease, and Stress for Adults Being 
Treated for Substance Use Disorder in North Central Appalachia: A 
Randomized Controlled Trial 
NCT05660434 
December 27, 2023 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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INVESTIGATOR INITIATED PROTOCOL
AROMATHERAPY & SUD
MARIAN.REVEN@HSC.WVU.EDU
WEST VIRGINIA UNIVERSITY
AROMATHERAPY & SUD STUDY PROTOCOL

 
 
 
 
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Table of Contents 
Study Protocol ....................................................................................................................... 9 
Common Terms List ............................................................................................................... 9 
Study Team ......................................................................................................................... 11 
Research Summary ...................................................................................................................... 11 
Updates to Study Protocol ................................................................................................... 11 
Update: IRB amendment 09262022 (Appendix G) ......................................................................... 11 
Update: IRB Amendment 08312022 (Appendix H) ......................................................................... 11 
Update: From QIP Audit 10252022 (Appendix I) ............................................................................ 11 
Study Population ................................................................................................................................................ 12 
Study Design ................................................................................................................................ 12 
Study Duration (7 days) ................................................................................................................ 13 
Study Time Involved for Participants ............................................................................................ 13 
Time involved in completing prescreening, informational session, & pre-surveys ........................................... 13 
Time involved in study activities from day 1 to day 7 and completing post-surveys ......................................... 14 
Background & Significance .................................................................................................. 15 
Prevalence Information...................................................................................................................................... 15 
Significance to Nursing ....................................................................................................................................... 16 
Background ........................................................................................................................................................ 16 
Objectives ........................................................................................................................... 17 
Purpose: ............................................................................................................................................................. 17 

 
 
 
 
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Primary Objectives & Aims: ................................................................................................................................ 17 
Study Design & Methodology .............................................................................................. 17 
Risk ............................................................................................................................................. 17 
Benefits ....................................................................................................................................... 18 
Statistical Analysis Plan ....................................................................................................... 18 
Sample Size.................................................................................................................................. 18 
Data Safety Monitoring ................................................................................................................ 19 
Safety Monitoring & Unanticipated Event Reporting ..................................................................... 19 
Study Duration & Timeline ................................................................................................... 20 
Informed Consent Process .................................................................................................... 20 
Informed Consent Process ............................................................................................................ 21 
Confidentiality & Privacy .............................................................................................................. 21 
Other Considerations ........................................................................................................... 21 
Supplies Available for Enrolling Participants (Kept in Locked Office): .................................... 22 
*Surveys Used in this Study (See Appendix A) ............................................................................... 22 
**Aroma Inhalers Used in this Study (See Appendix B) .................................................................. 22 
Contents of Study Packets ............................................................................................................ 22 
Prior to opening a Study Packet .................................................................................................... 23 
a. 
Inclusion criteria ....................................................................................................................................... 23 
b. 
Exclusion criteria ....................................................................................................................................... 23 

 
 
 
 
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3. 
IF PARTICIPANT IS INELIGIBLE, .................................................................................................................. 23 
4. 
IF PARTICIPANT IS ELIGIBLE ...................................................................................................................... 23 
Study Packet is Opened ................................................................................................................ 23 
7. 
Consent form ............................................................................................................................................ 24 
8. 
Pre-surveys for Comfort, Ease, and Stress................................................................................................ 24 
Use of the Aethereo®Stick is reviewed (Appendix B for details about inhaler): .............................. 24 
9. 
As needed use .......................................................................................................................................... 24 
10. 
Use other than instructed .................................................................................................................... 24 
11. 
How Participant begins intervention ................................................................................................... 24 
Documents to Leave in Participant Packet: .......................................................................... 26 
INTERVENTION: ........................................................................................................................... 26 
CONTROL: .................................................................................................................................... 26 
How Participants are Returning Study Materials: ................................................................. 27 
Timing Of Gift Card ............................................................................................................................................. 27 
Frequently Asked Questions: ................................................................................................ 28 
What if a Participant Loses Their Aroma Inhaler? .......................................................................... 28 
What if a Participant has a Reaction?............................................................................................ 28 
What if a Participant Wants to Withdraw from the Study? ............................................................ 28 
References........................................................................................................................... 29 
Appendix A .......................................................................................................................... 34 
PRESCREEN SURVEY ..................................................................................................................... 34 

 
 
 
 
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COMFORT SURVEY ....................................................................................................................... 37 
EASE MEASURE ............................................................................................................................ 38 
STRESS SURVEY ............................................................................................................................ 39 
POST SURVEY ............................................................................................................................... 40 
Appendix B .......................................................................................................................... 42 
SAFETY DATA SHEET ..................................................................................................................... 42 
MANUFACTURER SAFETY DATA SHEET .......................................................................................... 43 
GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) ........................................................... 44 
FDA TRIAL REGISTRATION BERGAMOT.......................................................................................... 45 
AETHEREOSTICK INFORMTION SHEET ........................................................................................... 46 
PRODUCT EXPIRY INFORMATION ................................................................................................. 48 
Appendix C .......................................................................................................................... 49 
Cover Letter (Formatted per IRB) .................................................................................................. 49 
Appendix D .................................................................................................................................. 50 
Logbooks for Intervention & Control Groups ................................................................................. 50 
Appendix E .......................................................................................................................... 69 
Reminder Paper ........................................................................................................................... 69 
Appendix F .......................................................................................................................... 71 
Why is this research being done and what is involved? ................................................................. 71 
Do I have to participate and what are the risks involved? .............................................................. 71 

 
 
 
 
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Who can I talk to if I have questions or concerns? ......................................................................... 72 
Informed Consent for Research | Minimal Risk ....................................................................... 0 
Introduction ..................................................................................................................................0 
Purpose .........................................................................................................................................0 
Description of Procedures ..............................................................................................................0 
Risks and Discomforts ....................................................................................................................1 
Alternatives ...................................................................................................................................2 
Benefits .........................................................................................................................................2 
Financial Considerations ................................................................................................................2 
Confidentiality ...............................................................................................................................3 
HIPAA Authorization ......................................................................................................................3 
Persons/Organizations Receiving the Information ............................................................................................ 4 
Voluntary Participation ..................................................................................................................5 
Contact Persons .............................................................................................................................5 
Signatures and Authorization .........................................................................................................6 
Participant Signature ............................................................................................................................................ 6 
Consenting Individual Signature .......................................................................................................................... 6 
Appendix G (IRB Update allowing Stages one, two, three, and peer recovery recruitment) ..... 8 
Appendix H (IRB approval to recruit online complete consent online) ................................... 10 
Appendix I (QIP Audit letter from IRB) .................................................................................. 12 

 
 
 
 
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Study Protocol 
Title: Using aromatherapy for comfort, ease, and stress for adults being treated for substance 
use disorder in north central Appalachia: A randomized controlled trial 
 
INSTITUTIONAL REVIEW BOARD APPROVAL NUMBER: __ 2204562633___ 
CHESTNUT RIDGE APPROVAL FORM: _on file 7/29/2022__ 
 
CLINICAL TRIAL NUMBER: __NCT05660434__ 
 
Common Terms List 
Enroller – person who works with potential study participants to complete prescreening and 
explain study. This will be Investigator Marian Reven or designee. 
 
Participant – one who is willing and able to voluntarily participate in this study. 
 
Aroma Inhaler – A small tube-shaped device about the size of a lipstick container. It contains a 
pure cotton wick. This wick is impregnated with pure essential oil. This is done at the 
manufacturer site. An Aethereo®Stick is used for this study. See appendix B for more 
information. 
 
Aromatherapy – the use of aromas usually in the form of essential oils to impact a person’s 
feelings of health and wellbeing.  
 
Bergamot essential oil – is a citrus essential oil extracted from the rind of the fruit Bergamot 
(Citrus bergamia). The aroma is described as sharp, fruity, powdery, and refreshing. Research 
shows that chemical constituents found in Bergamot (linalool and linalyl acetate) may impact 
nerve receptors to bring about anxiolytic effects. 
 
Randomized Controlled Trial (RCT) – a type of study where participants are randomly assigned 
to either an intervention or a control group. In this way, the risk of bias is decreased. Packets 
are distributed in an exact order and the Enroller does not pick which participants go into 
groups. 
 
Random Number Table (RNT) – used to minimize risk of bias in studies. A table of numbers 
generated in an unpredictable, haphazard sequence.  
 
Master Log Sheet (MLS) – Securely maintained Excel spreadsheet used to track assignment of 
participants to intervention or control groups. Also used to track those who are ineligible as 
determined by prescreening survey. 

 
 
 
 
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Study Team 
Principle-Investigator (PI): Marian “Marnie” Reven, marian.reven@hsc.wvu.edu or 304-479-
4825 
 
Co-Investigator (CoI): Amanda Newhouse, atorbich@hsc.wvu.edu or 304-581-1965 
 
Assistant Professor, West Virginia University 
 
Research Summary 
Updates to Study Protocol 
Update: IRB amendment 09262022 (Appendix G) 
To allow Stages one, two, and three and peer recovery persons to participate. 
Update: IRB Amendment 08312022 (Appendix H) 
To recruit and consent participants online 
Update: From QIP Audit 10252022 (Appendix I) 
Annual Review with approval received 7/29/2023 
8/23/2023 Per email communication with co-I Amanda Newhouse, BMed no longer using site 
approval forms. I have approval to proceed with recruitment when IRB approval is obtained. 
 
Update to consent process 8/2023 (completed) 
Communication with participants, begin using RedCap WVU for all surveys and emails. WVU 
phone and computer for all communication. 
 
10/23/2023 Update: Will no longer include copy of consent in study packets mailed to 
participants. This will save on mailing costs. Participants can download and print or save to their 
devices. Approved 11/7/2023 
 
11/21/23 Submitted amendment re: addition of Abigail Farris and Ella Jane Dailey CITI training 
certificates to the protocol 
 
12/27/23 Amendment to add a population from Health Right, approved 2/5/2024 
 

 
 
 
 
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Study Population 
Adults (>18 years) who are currently receiving treatment for SUD in the outpatient treatment 
program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.).  
 
Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 
treatment, and who desire to pursue continuous recovery phases (per facility protocol). All 
participants must be alert and oriented, provide written consent, and be able to read and write 
English.  
 
Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to 
participate), have a medical history of asthma or other serious respiratory disease, and known 
allergy to citrus. There are no exclusion criteria for gender, race, and/or ethnicity. 
 
Anyone who meets inclusion criteria in the sample population is invited to participate. I am 
advertising throughout entire population of the study. 
 
Study Design 
The purpose of this study is to see if Bergamot, an aroma therapy essential oil, has any effect on 
comfort, ease, and stress. Participants will be asked to use a bergamot aroma inhaler, which is a 
small tube about the size of a lipstick container, at least three times a day for one week. 
Comfort, ease, and stress will be measured with self-report survey at the beginning and at the 
end of the week. In addition, participants will be asked to complete a daily logbook to record 
use of the inhaler. The study lasts for one week (7 days). The aims of this study are to explore 
the effects of Bergamot essential oil on comfort, ease, and stress in adults in a SUD treatment 
program, and to evaluate the feasibility of this type of aroma therapy intervention. 
 

 
 
 
 
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Study Duration (7 days) 
 
Study Time Involved for Participants 
Time involved in completing prescreening, informational session, & pre-surveys 
 
Step 
What is 
happening 
Who does what 
Approximately 
how much time to 
expect 
1 
Prescreening 
6 question 
survey 
Administered by 
Enroller 
2-3 minutes 
2 
Open packet & review 
contents 
Complete CONSENT 
Looking at 
contents of 
packets  
Enroller reviews 
consent & 
participant will 
either sign or 
decline 
5-10 minutes 
2a 
Trying out aroma 
inhaler & giving 
directions for use 
Participant 
opening their 
own aroma 
inhaler 
Participant opens 
aroma inhaler. 
Enroller 
demonstrates 
correct use using 
their own inhaler 
1-2 minutes 
2b 
Personalizing packet for 
each participant 
Adding dates 
and organizing 
packet, going 
Enroller adds 
dates with 
participant 
2-4 minutes 

 
 
 
 
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over logbook 
together 
involvement. 
Enroller explains 
follow up texts or 
emails that 
participant will 
begin receiving 
the next day. 
3 
Complete 3 pre-surveys 
69 questions (28 
GCQ, 20 Ease, 21 
DASS) 
Participant does 
this and then they 
are excused 
5-6 minutes 
 
 
 
TOTAL 
15-25 minutes  
More time can be taken to complete these steps and participants may request to meet with 
the Enroller again if they still have questions. 
 
Time involved in study activities from day 1 to day 7 and completing post-surveys 
 
Step 
What is 
happening 
Who does what 
& extra details 
Approximately 
how much time 
to expect 
1 
Using aroma inhaler 3 
x day x 7 days 
Participant 
inhales aroma 
from inhaler for 
approximately 1 
minute on 3 
separate 
occasions 
during each day 
of the study 
Participant is 
responsible. 
Reminders are 
sent via text or 
email during the 
first 3 days of 
the study. This 
reminder 
should not add 
any extra time 
to the study 
21 minutes 
2 
Intervention 
Filling out daily 
logbook x 7 days 
Participant puts 
an X or check 
mark next to 
the 3 spaces to 
document use 
of aroma 
inhaler. Also, at 
the end of the 
participant’s 
day, Comfort is 
rated on a 0-10 
VAS.  
Participant is 
responsible. A 
place for 
comments is 
available and 
participants 
may take their 
time to add 
comments 
about the day 
(this is 
discretionary) 
7-10 minutes 

 
 
 
 
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2 Control 
Filling out daily 
logbook x 7 days 
At the end of 
the 
participant’s 
day, Comfort is 
rated on a 0-10 
VAS. 
Participant is 
responsible. A 
place for 
comments is 
available and 
participants 
may take their 
time to add 
comments 
about the day 
(this is 
discretionary) 
Same as 
Intervention 
group 
3 
Completing post 
surveys/ logbook 
Participant is 
completing the 
logbook for 7 
days. Then is 
opening 
prepaid postage 
envelope and 
completing post 
surveys 
Participant is 
completing 
these that 
include the 
GCQ, Ease, 
DASS, and post 
aromatic 
survey. They are 
then sealing the 
envelop and 
mailing back to 
WVU CRC 
(preaddressed) 
5-6 
 
 
 
TOTALS 
34-37 minutes 
 
Background & Significance 
Prevalence Information  
 
During 2017–2019, the annual average prevalence of past-year substance use disorder 
in West Virginia was 13.4% (or 24,000), similar to both the regional average 
(15.1%) and the national average (14.7%) (SAMHSA, 2020). The population is ages 18-25.  
Overdose and opioid related mortality rates, comparing Appalachian and non-Appalachian 
portions of states, ages 15 to 64 in 2015, 59.7% of diseases of despair were related to overdose 
of opioids. WV has no non-Appalachian portions of the state (Meit et al., 2017). 
Nationally, 1.6 million people had an opioid use disorder in the past year ((2019 National Survey 
on Drug Use and Health, 2020). 
.  

 
 
 
 
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Significance to Nursing 
This grant proposal is based on holistic nursing research principles (Helming et al., 2022), 
including work with a marginalized population of those in recovery for substance use disorder 
(SUD) in north central Appalachia. This study also aligns with National Institutes of Health (NIH) 
National Center for Complementary and Integrative Health (NCCIH) standards to advance the 
evidence base for integrative complementary therapies such as aromatherapy through a whole 
person health approach (NCCIH, 2021). The positive impact of this aromatherapy intervention is 
to increase comfort and ease, while reducing stress. 
 
Background 
  
West Virginia is at the epicenter of the opioid addiction crisis with hardly a family left 
untouched by the devastating consequences (Governor’s Council on Substance Abuse 
Prevention and Treatment, 2020; Saloner et al., 2019). Compared to the rest of the United 
States, West Virginians are disproportionately affected by deaths due to “diseases of despair”, 
such as drug overdose (Merino et al., 2019; SAMHSA, 2018). Those who make it into recovery 
programs are often plagued by anxiety and depression (Cicero & Ellis, 2017; Johannessen et al., 
2019; Yang et al., 2020) with the most common concurrent mental health issues being 
depressive disorder, stress, and anxiety (Hutton et al., 2017; Roos et al., 2020). Relapse 
prevention is key (SAMHSA, 2018). It is recommended that aromatherapy (such as using an 
aroma stick with bergamot essential oil) has the potential to support those in recovery (Wesa, 
2004). 
 
Substance use disorder is characterized by a cluster of physiological, behavioral, and cognitive 
symptoms occurring when recurrent use of alcohol and/or drugs causes significant impairment, 
disability, and failure to meet major responsibilities (SAMHSA, 2018; World Health Organization 
[WHO], 1992). Those in treatment have identified that increasing the level of comfort during 
substance use recovery is vital (Yang et al., 2020). Integrating aromatherapy could help improve 
perception of comfort and ease and reduce stress which could support healthy choices and 
encourage recovery program progression. 
 
Aromatherapy has long been used as a non-pharmacologic treatment alongside medical 
treatments for various health conditions (Armstrong et al., 2019; Buckle, 2015; Coelho et al., 
2017; Herz, 2009; Lizarraga‐Valderrama, 2021; Perry & Perry, 2006). Specifically, bergamot 
(Citrus bergamia) essential oil (natural plant based oil) has been reported as one of the most 
commonly used essential oils because of its effectiveness, low price point, and safety when 
used via inhalation (Chang & Shen, 2011; Han et al., 2017; Navarra et al., 2015). Bergamot 
essential oil has the ability to bind to GABAergic receptors and influence the hypothalamic-
pituitary-adrenal axis (HPA) providing possible explanation for it anxiolytic properties (Morrone 
et al., 2007; Saiyudthong & Marsden, 2011). Over the decades, bergamot essential oil has been 
successfully among persons with mood alterations including anxiety, depression, and stress 
(Lizarraga‐Valderrama, 2021; Mannucci et al., 2017; Perry & Perry, 2006; Scuteri et al., 2017).  

 
 
 
 
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Objectives 
Purpose:  
The purpose of the study is to examine the effect of an aromatic intervention using bergamot 
essential oil on comfort, ease, and stress in adults in a SUD recovery program. 
 
Primary Objectives & Aims: 
The innovation of this study is to use bergamot essential oil to improve perception of comfort 
and ease and reduce stress among the marginalized population in a SUD recovery program in 
rural Appalachia. 
 
Specific Aim #1: Pilot test bergamot essential oil intervention with adults in a substance use 
disorder recovery program.  
Hypothesis 1a: Participants in the intervention group will report higher scores on comfort and 
ease than those in the control group. 
Hypothesis 1b: Participants in the intervention group will report lower scores in stress than 
those in the control group. 
 
Specific Aim #2: Evaluate the feasibility and acceptability of an aromatherapy intervention by 
examining recruitment, enrollment and retention rates, intervention fidelity, and cost analysis. 
 
Study Design & Methodology 
The study uses a parallel-randomized control group comparison design. Data will be collected 
from participants daily and post intervention.  
For Aim #1, descriptive and bivariate analysis will be conducted. Statistical assumptions will be 
tested. Sample demographics will be reported.  
For Aim #2, descriptive statistics will be used as well as participant recruitment, enrollment, and 
retention rates. Reasons for non-participation and attrition will be recorded. Percentage of 
intervention consistency will be calculated, and cost of the intervention will be determined. 
 
Risk 
This study is only minimal risk because it involves aroma of a citrus essential oil named 
Bergamot. This essential oil is impregnated on a pure cotton wick within a manufacturer-sealed 
aroma inhaler. Participants are instructed and will demonstrate back to the researcher that 
they will use the inhaler in the prescribed fashion. Participants encounter odors and aromas 
during daily life and the anticipated magnitude of harm or discomfort anticipated in the 

 
 
 
 
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research is not greater in and of itself than those ordinarily encountered in daily life or during 
the performance of routine physical or psychological examinations or tests. 
 
Potential risks or discomforts include a dislike of the scent or possibly a headache because of 
inhaling the essential oil aroma from the aroma inhaler. If headache or feeling of dislike 
continues the participant is asked to discontinue use of the aroma inhaler and contact me, 
Marian Reven, at marian.reven@hsc.wvu.edu for further instructions.  
 
This study does include surveys that ask questions about feelings of comfort, ease, and stress. 
This may cause distress to some participants. Should a participant experience or express any 
psychological distress or disclose information that indicates a need for urgent psychological or 
clinical care, the researcher will connect the participant with their provider. 
 
Benefits  
The participant may or may not directly benefit from participating in this research.  The 
knowledge gained from this study may eventually benefit others. 
Statistical Analysis Plan 
Data analysis For Aim 1, Descriptive (frequencies, means, ranges, standard deviations) and 
bivariate analysis will be conducted on the demographics, GCQ, Ease measure, and DASS scales. 
Statistical assumptions (i.e., normal distribution and homogeneity of variances etc.) will be 
tested. Sample demographics of patients will be reported. Fisher's exact test will be used for 
categorical variables; Repeated measures ANOVA and paired t-test will be used for continuous 
variables. Pearson's and Spearman's correlation analyses will be used to explore relationships 
among variables (Pallant, 2020). The statistical significance is set at a 5% (alpha = 5%). All 
analyses will be completed using Statistical Package for the Social Sciences (IBM SPSS).  
 
For Aim 2, Descriptive statistics will be used to analyze Aim 2a. Participant recruitment, 
enrollment, and retention rates will be tabulated and reported. Reasons for non-participation 
and attrition will be recorded and will be used to develop strategies to address this. For Aim 2b, 
adherence to the intervention protocol will be calculated from responses in the logbooks. For 
Aim 2c, to determine the cost of the intervention implementation, all charges related to 
implementation are calculated. This includes costs of personnel time for administering each 
session, the materials, and incentives. 
 
Sample Size 
Sample size was calculated using G*Power v.3.1.9.7 on repeated measure ANOVA given α=0.05, 
moderate effect size (0.25), power of 80%, two groups with 2 measurements, correlation 
among repeated measures (0.50), a total sample size of 98 will be required. A total sample size 
of n=49 for intervention group and n=49 for control group is sought.  

 
 
 
 
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Data Safety Monitoring 
Data safety will be maintained throughout the study. All information about participants will be 
stored in a locked cabinet inside a locked office. All electronic data will be stored on a password 
encrypted computer.  
 
Safety Monitoring & Unanticipated Event Reporting 
This study involves use of an aroma inhaler. This study is only minimal risk because it involves 
aroma of a citrus essential oil named Bergamot. This essential oil is impregnated on a pure 
cotton wick within a manufacturer-sealed aroma inhaler. Participants are instructed and will 
demonstrate back to the researcher that they will use the inhaler in the prescribed fashion.  
 
Participants encounter odors and aromas during daily life and the anticipated magnitude of 
harm or discomfort anticipated in the research is not greater in and of itself than those 
ordinarily encountered in daily life or during the performance of routine physical or 
psychological examinations or tests. 
 
Participants will have an informational session with a Registered Aromatherapist, Marian 
Reven, who will demonstrate use and care of the aroma inhaler.  
The following reminder is provided in writing for participants. 
 
*(When not in use, recap to close & store in a cool, dry place away from children and pets) It is 
OKAY to keep your closed inhaler in your pocket or purse and at room temperature  
Do not tamper with the packaging. Keep out of reach of children and animals. If you develop 
any adverse reactions such as a headache, stop, recap inhaler, and retry a little later. If 
unpleasant effects, such as headache continue, discontinue use and contact Marian Reven, Co-
Investigator at marian.reven@hsc.wvu.edu  
 
Every effort has been made to ensure the safety of all Participants and those at the study site. 
1. Aroma inhalers are factory sealed 
2. Tamper resistant packaging is used 
3. Safety data sheets are available online and on site 
4. Inhalation of essential oils such as Bergamot is considered low risk 
5. Specific instructions are provided 
6. A Registered Aromatherapist created and manages this study 
 
Participants will be instructed to seek medical care if needed and are able to withdraw from the 
study at any time without any repercussions. Participants are already in the care of medical 
staff.  

 
 
 
 
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Study Duration & Timeline 
Task 
March to 
June 2022  
May to 
June 2022 
August to 
December 
2022 
January to 
March 2023 
April to May 
2023 
Create grant documents 
X 
 
 
 
 
Finalize & refine grant 
application and submit 
X  
 
 
 
 
Submit proposal to WVU 
IRB, make revisions as 
needed 
 
X  
 
 
 
Complete BMED 
research & recruitment 
form 
 
 
X 
 
 
Enrollment & run study 
 
 
X 
 
 
Complete enrollment & 
run data 
 
 
 
X 
 
Dissertation defense & 
graduate 
 
 
 
 
X 
 
Informed Consent Process 
Participation in this study is contingent upon informed and ongoing consent by each adult 
participant. They are free to withdraw from the study at any time without any repercussion.  
The following pieces of data will be collected including: 
 
Will collect the following listed data 
Name 
Email address 
Telephone number 
 
Plus, the following 
Data will be collected from the chart and from survey (self-report) 
1. Identifier variables of Comfort, Ease, and Stress 
2. Stage of treatment in the SUD treatment program (Chart) 
3. Presence of anxiety and/or depression (Chart) 
4. Presence of severe mental illness Dx (Chart) 
5. Allergies to citrus fruits such as grapefruit, lemon, orange, or bergamot (Chart and self 
report) 

 
 
 
 
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6. Previous experience with any integrative or complementary therapies such as yoga, massage, 
acupuncture, aromatherapy with essential oils, herbal preparations, meditation, mindfulness 
practices (Self-report) 
7. Pregnant and/or nursing (Self-report) 
8. Severe breathing problems such as asthma, chronic bronchitis, or COPD (Chart and self-
report) 
9. Report of sense of smell (self-report) 
10. Dx of a problem with sense of smell (Chart and self-report) 
11. Current illness with cold, flu, or covid (Self-report) 
 
Informed Consent Process 
See Appendix F 
Confidentiality & Privacy 
Subjects in this research study will not be anonymous but all study participant data and 
information will be de-identified. Upon enrollment, participants will be given a unique identifier 
by which all study materials will be identified. A master spreadsheet will be maintained to 
identify each participant by name with their unique identifier. All study data will be kept 
securely in a locked office. 
 
Data will be kept for a minimum of 3 years. Electronic data will be destroyed using appropriate 
data deletion methods to ensure data cannot be recovered. Paper documents will be destroyed 
by shredding and other methods as specified by WVU procedures.  
 
No Federal Certificate of Confidentiality is used for this study. 
Other Considerations 
There are no conflicts of interest to report for the PI, Dr. Roger Carpenter, or Co-I’s, Marian 
Reven, and Amanda Newhouse 
. 
The results of this work could be published or presented without any participant identifiers. 
 
Other research purposes include reviewing the safety and feasibility of the aromatic 
intervention and developing a better understanding of disease, improving the design of future 
clinical trials. 

 
 
 
 
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Supplies Available for Enrolling Participants (Kept in Locked Office): 
1. Supply of prescreening surveys 
2. Master Log Sheet (MLS) for recording Participant name and number 
3. Master Random Number Table (RNT) for randomization 
4. Tote with Study Packets (including surveys*) 
5. Extra forms 
6. Aroma inhalers** 
 
*Surveys Used in this Study (See Appendix A) 
Surveys in this study include: 
1. Prescreening survey for the aromatic elements of the study 
2. Generalized Comfort Questionnaire (GCQ) 
3. Ease Measure 
4. Depression, Anxiety, and Stress Scale (DASS) 
5. Post survey for aromatic elements of the study 
 
**Aroma Inhalers Used in this Study (See Appendix B) 
1. Company supplying: Plant Extracts International https://plantextractsinc.com/  
2. Bergamot essential oil is used 
3. No direct contact with essential oil is anticipated 
4. No ambient odor should be present as inhalers are factory sealed and enclosed in 
tamper resistant packaging 
 
Contents of Study Packets 
1. Aroma inhaler 
2. Aethereo®Stick Information Sheet 
3. Cover letter (Appendix C) 
4. Consent forms (2 copies) 
5. Pre surveys (Comfort, Ease, and Stress) 
6. Logbooks for Intervention or Control Groups (Appendix D) 
7. Reminder paper (Appendix E) 
8. 6 x 9 Postage paid return envelope 
a. Post surveys (Comfort, Ease, Stress, Post Aroma) 
 
 

 
 
 
 
P a g e  23  
Prior to opening a Study Packet 
1. In a private location, Enroller will determine eligibility for this study. 
a. Inclusion criteria are as follows: 
i. Older than 18 years of age 
ii. Currently enrolled in treatment 
iii. Have completed intensive phase 1 and wish to continue with treatment 
iv. Alert & oriented 
v. Able to provide written consent 
vi. Able to read & write English 
b. Exclusion criteria are as follows: 
i. Diagnosed with severe mental illness 
ii. Medical history of asthma 
iii. Other serious respiratory disease 
iv. Known allergy to citrus 
2. In a private location, Enroller will prescreen using created survey tool (appendix A) 
a. Use the prescreening survey provided 
b. Read prescreening survey to participants and record answers 
c. If not contraindicated by prescreening questions, allow participant to smell the 
aroma inhaler (3 inches from nose) 
i. Record all reactions, “liked the smell”, “sneezed”, “said ‘yuck’” on the 
presurvey. Record “no negative reactions” as applicable (This is a vital 
component of aromatic research) 
3. IF PARTICIPANT IS INELIGIBLE, thank them for their time, note on MLS that they were 
screened and why they were ineligible. Use the special section at the end of the MLS to 
make this notation. Do not use an Id # space. Write “ineligible” and the date across the 
top of the survey.  
4. IF PARTICIPANT IS ELIGIBLE, file prescreening form in predetermined place and obtain a 
study packet in the order they are arranged (001-098)  
a. Enter date and name of participant on the Random Number Table (RNT) sheet  
5. Record Unique Identifier packet number on Master Log Sheet (MLS) 
a. Use MLS to track Participants 
b. This Unique Identifier number is already on every document in each packet 
 
Study Packet is Opened 
6. The study packet is opened in the presence of the study participant and contents of the 
folder are reviewed Contents of Study Packets: 
a. Left pocket:  
i. Aroma inhaler 
ii. Welcome letter 
iii. Consent form x 2 
iv. Pre-Surveys (Comfort, Ease, and Stress) 

 
 
 
 
P a g e  24  
b. Right pocket: 
i. Logbook 
ii. Reminder paper (To post as a reminder) ADD DATES 
iii. Closed postage paid envelope 
 
7. Consent form is reviewed and signed 
8. Pre-surveys for Comfort, Ease, and Stress are completed 
Use of the Aethereo®Stick is reviewed (Appendix B for details about inhaler): 
a. Enroller will either open or have participant open the sealed package for the 
Aethereo®Stick (aroma inhaler) open the outer sealed package  
b. Save the package for storage  
c. Pick up the inhaler and twist to the right to remove the cap  
d. There is no need to shake the inhaler  
e. Breath out gently  
f. While holding the inhaler about 3 inches (7.62 cm) from the nose  
g. Inhale through the nose using 3 sniffs as directed 
h. Hold breath for about 3 seconds  
i. Exhale for 3 seconds  
j. Repeat 3 times and then recap and store the inhaler in a safe place away from 
high heat and direct sunlight, children, and pets. 
k. NOTE: The Enroller will record all reactions to participant exposure to the aroma 
inhaler. Verbatim recording of any negative or positive response is vital. This is 
recorded on the Prescreening survey at the bottom of the form. Any negative or 
adverse reaction must be recorded. If no negative reaction, then the Enroller 
must write, “No negative reaction” 
9. As needed use:  
a. The inhaler may be used more than 3 x daily 
b. Participants may use as needed and are asked to record all uses and reasons for 
uses in the provided logbook 
10. Use other than instructed: 
a. If the participant uses the inhaler in some other fashion than instructed, they are 
asked to record this information as well (i.e. inhales x 10, inserts into nostril 
[which is considered safe], uses a different count to exhale etc.) 
11. How Participant begins intervention: 
a. The participant begins the 7-day intervention at the beginning of their next full 
day of life (This allows for those who work nights etc.)  
i. ADD DATES: Participants (preferrable to have participants do this and not 
the Enroller) will add dates to pages of the logbook (e.g., If they received 
their packet and instructions on October 11, then they should begin their 
study on the NEXT FULL DAY, October 12, and their study would be 

 
 
 
 
P a g e  25  
complete on October 18. Dates on pages should reflect the 7-days of the 
study, 10/12, 10/13 and so forth to 10/18) 
b. Three times daily means spaced out in 3 times, which could mean morning, 
afternoon, and evening, or anything else that is separated by approximately 4-6 
hours (while awake) 
c. On day 1, 2, & 3 a text or email messages will be provided to participants to 
remind them to complete their diary indicating if they used the inhaler and mark 
how they are feeling on the VAS. They will be instructed to contact the 
researcher with any questions.  
d. Days 4, 5, 6, & 7, participants will not receive reminders.  
i. A reminder will be sent on day 7.  
ii. After day 7, all participants will open their final survey packet included in 
the folder.  
iii. They will be instructed to complete the survey packet and return it and 
the logbook using the prepaid postage envelope. 
 
 

 
 
 
 
P a g e  26  
Documents to Leave in Participant Packet: 
INTERVENTION: 
iv. Those randomized to the Intervention group 
1. Left pocket (in this order) 
a. Aroma inhaler 
b. Aethereo®Stick information sheet 
c. Welcome letter 
d. Copy of consent 
2. Right pocket (in this order) 
a. Logbook (with dates written in) 
b. Reminder paper 
c. Postage paid envelope (with date and instructions for 
return on note attached to front of the envelop) 
CONTROL: 
v. Those randomized to the Control group (The AROMA INHALER from 
Control group packets is labeled with participants ID# and kept in a 
secure location until they complete the study. It will have been opened 
and demonstrated with the participant during study introduction) 
1. Left pocket (in this order) 
a. Welcome letter 
b. Copy of consent 
2. Right pocket (in this order) 
a. Logbook (with dates written in) 
b. Reminder paper 
3. Postage paid envelope (with date and instructions for return on 
note attached to front of the envelope) 
 
 

 
 
 
 
P a g e  27  
How Participants are Returning Study Materials: 
Postage paid envelop is marked “Complete the Logbook and the surveys and return them ALL 
on _______.” Add date they will complete the 7-day study  
e. (e.g., If they received their packet and instructions on October 11, then they 
should begin their study on the NEXT FULL DAY, October 12, and their study 
would be complete on October 19. October 19 is the date entered on the note 
attached to this envelope) 
 
Timing Of Gift Card 
Once the final survey is received, the $20 gift card will be issued to the intervention group and 
the $20 gift card and inhaler to the control group.  
 
 

 
 
 
 
P a g e  28  
Frequently Asked Questions: 
What if a Participant Loses Their Aroma Inhaler? 
Participants are instructed to contact Marian Reven at marian.reven@hsc.wvu.edu  if they lose 
their inhaler and arrange for a replacement.  
• The study will continue during the time they are without an inhaler and resume when 
they have one.  
• The researcher will note this occurrence, but data analysis will occur as if the days were 
consecutive. 
 
What if a Participant has a Reaction? 
Participants are instructed to contact Marian Reven at marian.reven@hsc.wvu.edu if they 
experience adverse reactions such as a headache. 
• They are asked to stop using the inhaler, recap it, and retry the inhaler as directed a 
little later.  
• If unpleasant effects, such as headache continue, discontinue use, and contact Marian 
Reven, Investigator at marian.reven@hsc.wvu.edu  
• If participant feels any severe reaction like difficulty breathing, they are asked to seek 
medical care 
 
What if a Participant Wants to Withdraw from the Study? 
Participants are instructed to contact Marian Reven at marian.reven@hsc.wvu.edu if they wish 
to withdraw from the study. 
• They are free to withdraw from the study at any time without penalty 
• They can keep the aroma inhaler and all study materials 
• They are asked to return the logbook if they completed it 
• They will not receive the $20 gift card 
 
 
 

 
 
 
 
P a g e  29  
References 
Armstrong, M., Flemming, K., Kupeli, N., Stone, P., Wilkinson, S., & Candy, B. (2019). 
Aromatherapy, massage and reflexology: A systematic review and thematic synthesis of 
the perspectives from people with palliative care needs. Palliative Medicine, 33(7), 757–
769. https://doi.org/10.1177/0269216319846440 
Buckle, J. (2015). Clinical aromatherapy: Essential oils in healthcare (3rd ed.). Elsevier. 
Chang, K. M., & Shen, C. W. (2011). Aromatherapy benefits autonomic nervous system 
regulation for elementary school faculty in Taiwan. Evidence-Based Complementary and 
Alternative Medicine, 2011, 1–7. https://doi.org/10.1155/2011/946537 
Cicero, T. J., & Ellis, M. S. (2017). The prescription opioid epidemic: A review of qualitative 
studies on the progression from initial use to abuse. Dialogues in Clinical Neuroscience, 
19(3), 259–269. 
Coelho, A., Parola, V., Cardoso, D., Bravo, M. E., & Apóstolo, J. (2017). Use of non-
pharmacological interventions for comforting patients in palliative care: A scoping 
review. JBI Evidence Synthesis, 15(7), 1867–1904. https://doi.org/10.11124/JBISRIR-
2016-003204 
Governor’s Council on Substance Abuse Prevention and Treatment. (2020). West Virginia 2020-
2022 substance use response plan. West Virginia Department of Health & Human 
Resources Office of Drug Control Policy. https://dhhr.wv.gov/office-of-drug-control-
policy/news/Documents/FINAL%20-
%20West%20Virginia%202020_2022%20Council%20Substance%20Use%20Plan_Janu
ary%2020,%202020%20(as%20filed).pdf 

 
 
 
 
P a g e  30  
Han, X., Gibson, J., Eggett, D. L., & Parker, T. L. (2017). Bergamot (Citrus bergamia) essential 
oil inhalation improves positive feelings in the waiting room of a mental health treatment 
center: A pilot study. Phytotherapy Research, 31(5), 812–816. 
https://doi.org/10.1002/ptr.5806 
Helming, M. A. B., Avino, K., Shields, D., Rosa, W., & Dossey, B. M. (Eds.). (2022). Dossey & 
Keegan’s holistic nursing: A handbook for practice (8th ed.). Jones & Bartlett Learning. 
Herz, R. S. (2009). Aromatherapy facts and fictions: A scientific analysis of olfactory effects on 
mood, physiology and behavior. International Journal of Neuroscience, 119(2), 263–290. 
https://doi.org/10.1080/00207450802333953 
Hutton, H., Lesko, C. R., Chander, G., Lau, B., Wand, G. S., & McCaul, M. E. (2017). 
Differential effects of perceived stress on alcohol consumption in moderate versus heavy 
drinking HIV-infected women. Drug and Alcohol Dependence, 178, 380–385. 
https://doi.org/10.1016/j.drugalcdep.2017.05.021 
Johannessen, D. A., Nordfjærn, T., & Geirdal, A. Ø. (2019). Change in psychosocial factors 
connected to coping after inpatient treatment for substance use disorder: A systematic 
review. Substance Abuse Treatment, Prevention, and Policy, 14(1), 16. 
https://doi.org/10.1186/s13011-019-0210-9 
Kalayasiri, R., Maneesang, W., & Maes, M. (2018). A novel approach of substitution therapy 
with inhalation of essential oil for the reduction of inhalant craving: A double-blinded 
randomized controlled trial. Psychiatry Research, 261, 61–67. 
https://doi.org/10.1016/j.psychres.2017.12.015 
Lizarraga‐Valderrama, L. R. (2021). Effects of essential oils on central nervous system: Focus on 
mental health. Phytotherapy Research, 35(2), 657–679. https://doi.org/10.1002/ptr.6854 

 
 
 
 
P a g e  31  
Mannucci, C., Navarra, M., Calapai, F., Squeri, R., Gangemi, S., & Calapai, G. (2017). Clinical 
pharmacology of citrus bergamia: A systematic review: Systematic review of citrus 
bergamia clinical studies. Phytotherapy Research, 31(1), 27–39. 
https://doi.org/10.1002/ptr.5734 
Meit, M., Heffernan, M., Tanenbaum, E., & Hoffman, T. (2017). Appalachia diseases of despair 
(p. 23) [Policy Analysis and Research]. Appalachian Regional Commission. 
https://www.arc.gov/wp-
content/uploads/2020/06/AppalachianDiseasesofDespairAugust2017.pdf 
Merino, R., Bowden, N., Katamneni, S., & Coustasse, A. (2019). The opioid epidemic in West 
Virginia. The Health Care Manager, 38(2), 187–195. 
https://doi.org/10.1097/HCM.0000000000000256 
Morrone, L. A., Rombolà, L., Pelle, C., Corasaniti, M. T., Zappettini, S., Paudice, P., Bonanno, 
G., & Bagetta, G. (2007). The essential oil of bergamot enhances the levels of amino acid 
neurotransmitters in the hippocampus of rat: Implication of monoterpene hydrocarbons. 
Pharmacological Research, 55(4), 255–262. https://doi.org/10.1016/j.phrs.2006.11.010 
Navarra, M., Mannucci, C., Delbò, M., & Calapai, G. (2015). Citrus bergamia essential oil: From 
basic research to clinical application. Frontiers in Pharmacology, 6. 
https://doi.org/10.3389/fphar.2015.00036 
NCCIH. (2021). NCCIH strategic plan fiscal year 2021–2025. 
https://www.nccih.nih.gov/about/nccih-strategic-plan-2021-2025 
Pallant, J. (2020). SPSS survival manual: A step by step guide to data analysis using IBM SPSS. 
https://www.taylorfrancis.com/books/9781003117407 

 
 
 
 
P a g e  32  
Perry, N., & Perry, E. (2006). Aromatherapy in the management of psychiatric disorders. CNS 
Drugs, 20(4), 257–280. https://doi.org/10.2165/00023210-200620040-00001 
Redstone, L. (2015). Mindfulness meditation and aromatherapy to reduce stress and anxiety. 
Archives of Psychiatric Nursing, 29(3), 192–193. 
https://doi.org/10.1016/j.apnu.2015.03.001 
Roos, C. R., Kiluk, B. D., McHugh, R. K., & Carroll, K. M. (2020). Evaluating a longitudinal 
mediation model of perceived stress, depressive symptoms, and substance use treatment 
outcomes. Psychology of Addictive Behaviors, 34(6), 660–668. 
https://doi.org/10.1037/adb0000581 
Saiyudthong, S., & Marsden, C. A. (2011). Acute effects of bergamot oil on anxiety-related 
behaviour and corticosterone level in rats. Phytotherapy Research, 25(6), 858–862. 
https://doi.org/10.1002/ptr.3325 
Saloner, B., Landis, R., Stein, B., & Barry, C. L. (2019). The Affordable Care Act in the heart of 
the opioid crisis: Evidence from West Virginia. Health Affairs (Project Hope), 38(4), 
633–642. https://doi.org/10.1377/hlthaff.2018.05049 
SAMHSA. (2018). SAMHSA releases national survey on drug use and health. Capitol 
Connector. https://www.thenationalcouncil.org/capitol-connector/2018/09/samhsa-
releases-national-survey-on-drug-use-and-health/ 
SAMHSA. (2020). Behavioral health barometer: West Virginia, volume 6. Indicators as 
measured through the 2019 national survey on drug use and health and the national 
survey of substance abuse treatment services (p. 45) [HHS Publication No. SMA–20–
Baro–19–WV]. https://store.samhsa.gov/ 

 
 
 
 
P a g e  33  
Scuteri, D., Morrone, L. A., Rombolà, L., Avato, P. R., Bilia, A. R., Corasaniti, M. T., Sakurada, 
S., Sakurada, T., & Bagetta, G. (2017). Aromatherapy and aromatic plants for the 
treatment of behavioural and psychological symptoms of dementia in patients with 
Alzheimer’s disease: Clinical evidence and possible mechanisms. Evidence-Based 
Complementary and Alternative Medicine, 2017, 1–9. 
https://doi.org/10.1155/2017/9416305 
Wesa, K. M. (2004). Recommendations and guidelines regarding the preferred research 
protocol for investigating the impact of an optimal healing environment on patients with 
substance abuse. 10(S1), S-193-S-199. 
World Health Organization (Ed.). (1992). The ICD-10 classification of mental and behavioural 
disorders: Clinical descriptions and diagnostic guidelines. World Health Organization. 
Yang, Y., Perkins, D. R., & Stearns, A. E. (2020). “I started to feel better now”: Qualitative 
findings from client narratives on early recovery in inpatient substance use treatment. 
International Journal of Mental Health & Addiction, 18(4), 1048–1066. 
https://doi.org/10.1007/s11469-019-00107-z 
  
 

 
 
 
 
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Appendix A 
PRESCREEN SURVEY 
To be completed by the Enroller:  
1. Please answer the following questions about aversion (dislike) or allergy.  
a. Do you have a strong aversion to smells of citrus and/or citrus fruit(s) themselves 
(such as grapefruit, orange, lemon, or bergamot). Yes/No (If no, please go to the 
next question) 
i. Do you have any allergies to citrus? Yes/No (If no, answer next question) 
ii. This study uses the pure essential oil of Bergamot. Have you ever smelled 
this fruit or essential oil? Yes/No 
iii. If yes, you have smelled Bergamot fruit or essential oil, do you dislike the 
smell? Yes/No 
iv. If yes, you dislike the smell of Bergamot essential oil, you are excused 
from participation in this study.  
 
If yes, you have a strong dislike or allergy to Bergamot fruit or essential oil, you are not 
eligible to participate in this study. 
 
If no strong aversion or allergy to Bergamot, proceed with the following questions. 
 
2. Do you or have you ever been told by a doctor that you have any of the following 
medical or health conditions? Yes/No (If No, go to question 3) 
a. ___ Severe breathing problems such as asthma, chronic bronchitis, or a chronic 
obstructive pulmonary disease (COPD) 
b. ___ Pregnant or the possibility of becoming pregnant and/or breastfeeding 
c. ___ Allergies to citrus fruits such as grapefruit, lemon, orange, or bergamot 
 
If yes to any responses to question 2, you are not eligible to participate in this study. 
3. Have you ever tried any integrative or complementary therapies (examples include; 
massage, yoga, acupuncture, aromatherapy with essential oils, herbs, meditation, 
mindfulness practices etc.) Yes/No (If Yes, please answer the following. If No, go to 
question 5) 
a. If yes, list which ones? ______________________________ 
b. If yes, what was your main reason for using complementary therapies? Choose 
all that apply 
i. ___Pain  
ii. ___Anxiety 
iii. ___Relaxation  
iv. ___Stress relief 

 
 
 
 
P a g e  35  
v. ___Other, please write in ______________ 
c. If there is a specific therapy used for a specific symptom, please write the 
therapy beside the symptom listed above. 
d. On a scale of 0 to 10 with 0 being not at all effective and 10 being very effective, 
how effective was the therapy noted above for relief of the symptom? (Example: 
Pain, massage, 7/10) 
 
4. Was one of the complementary therapies you have tried aromatherapy or essential oils? 
Yes/No (If Yes, please answer the following. If No, go to question 5) 
a. No, I have not used aromatherapy or essential oils. (Proceed to question 5) 
b. Yes, I have used essential oils and have tried (please list the essential oils you 
have tried) ______________ 
c. Of those essential oils you have tried, which one or ones would you consider to 
be your favorite(s) _______________ 
d. Of those essential oils you have tried, which one or ones would you consider to 
be your least favorite(s) ______________ 
e. Have you ever tried Bergamot essential oil? Yes/ No 
i. If yes, why did you try it? _____________ 
If yes, what, if any effect, did you think it had? _____________ 
 
5. Do you have difficulty smelling or recognizing odors? Yes/No  
a. If yes, do you think your problems with smelling are because of allergies or stuffy 
nose and congested sinuses? Yes/No 
i. Are you currently feeling sick with a cold, the flu, or with COVID? Yes/No 
b. If yes, you have problems with your sense of smell, have you ever been told by a 
doctor that you have a problem with your sense of smell? Yes/No 
i. If yes, have you ever been diagnosed or told by a doctor that you have 
anosmia, which is a total loss of the sense of smell? Yes/No 
1. Was this loss of smell related to COVID or some other illness? 
Yes/No 
If yes, approximately when did the loss of smell begin ____ 
END OF SURVEY  
 
Participant is not eligible to participate in this study 
If they answered “Yes” to either or both of the following questions:  
Question 1. "I am allergic to or have a strong aversion to smells of citrus and/or citrus fruit(s) 
themselves (such as grapefruit, orange, lemon, bergamot)” 
Question 2. “Do you or have you ever been told by a doctor that you have any of the following 
medical or health conditions”, and/or 
 
ENROLLER: Record all reactions to the smell of Bergamot during prescreening. If no negative 
reaction, write “No negative reaction” ___________________________ 
 

 
 
 
 
P a g e  36  
Once complete, either excuse participant if they are not eligible or proceed by obtaining a 
packet and opening study materials. 
 
 
 

 
 
 
 
P a g e  37  
COMFORT SURVEY 
Thank you VERY MUCH for helping us understand your comfort. Below are statements that relate to 
your comfort right now. Six numbers are provided for each question; please circle the number you think 
most closely matches your feeling. Your responses should describe your comfort right now. 
Right now… 
Strongly Disagree 
 
 
Strongly Agree 
1. 
My body is relaxed right now 
1 
2 
3 
4 
5 
6 
2. 
I feel useful because I am working 
hard 
1 
2 
3 
4 
5 
6 
3. 
There are those I can depend on when 
I need help 
1 
2 
3 
4 
5 
6 
4. 
My condition gets me down 
1 
2 
3 
4 
5 
6 
M5. 
I feel confident 
1 
2 
3 
4 
5 
6 
6. 
I feel dependent on others 
1 
2 
3 
4 
5 
6 
7. 
I feel my life is worthwhile right now 
1 
2 
3 
4 
5 
6 
8. 
I am inspired by knowing that I am 
loved 
1 
2 
3 
4 
5 
6 
9. 
No one understands me 
1 
2 
3 
4 
5 
6 
10. 
My pain is difficult to endure 
1 
2 
3 
4 
5 
6 
11. 
I am inspired to do my best 
1 
2 
3 
4 
5 
6 
12. 
I am unhappy when I am alone 
1 
2 
3 
4 
5 
6 
13. 
My faith helps me not to be afraid 
1 
2 
3 
4 
5 
6 
14. 
I do not feel healthy right now 
1 
2 
3 
4 
5 
6 
15. 
I am afraid of what is next 
1 
2 
3 
4 
5 
6 
16. 
I am being treated fairly 
1 
2 
3 
4 
5 
6 
17. 
I have experienced changes which 
make me feel uneasy 
1 
2 
3 
4 
5 
6 
18. 
I am very tired 
1 
2 
3 
4 
5 
6 
19. 
I can rise above my pain 
1 
2 
3 
4 
5 
6 
20. 
The mood around here uplifts me 
1 
2 
3 
4 
5 
6 
21. 
I am content 
1 
2 
3 
4 
5 
6 

 
 
 
 
P a g e  38  
22. 
My beliefs give me peace of mind 
1 
2 
3 
4 
5 
6 
23. 
I feel out of control 
1 
2 
3 
4 
5 
6 
24. 
I feel safe 
1 
2 
3 
4 
5 
6 
25. 
I feel peaceful 
1 
2 
3 
4 
5 
6 
26. 
I am depressed 
1 
2 
3 
4 
5 
6 
27. 
I have found meaning in my life 
1 
2 
3 
4 
5 
6 
28. 
I need to feel good again 
1 
2 
3 
4 
5 
6 
 
EASE MEASURE 
Ease Measure: Please circle the number (never; sometimes; frequently; always) to indicate your degree 
of agreement with each statement as a descriptor of what is generally happening in your everyday life. 
 
 
 
 
 
 
 
 
Never 
Sometimes 
Frequently 
Always 
1. I can let go of my daily stress. 
 
1 
2 
3 
4 
2. I am comfortable in knowing what to 
do when in a difficult situation. 
1 
2 
3 
4 
3. I feel comfort when I share my 
everyday experiences. 
1 
2 
3 
4 
4. I am at peace with myself. 
 
1 
2 
3 
4 
5. I can handle situations in a calm 
manner. 
 
1 
2 
3 
4 
6. I struggle to get though my day. 
 
1 
2 
3 
4 
7. I can go to a place of tranquility when 
needed. 
1 
2 
3 
4 
8. I accept things I cannot change. 
 
1 
2 
3 
4 
9. I take time to rest during my busy day. 
 
1 
2 
3 
4 
10. I feel safe. 
 
1 
2 
3 
4 
11. I am content with my life. 
 
1 
2 
3 
4 
12. I experience moments of joy. 
1 
2 
3 
4 

 
 
 
 
P a g e  39  
 
13. I take time for soothing activities. 
 
1 
2 
3 
4 
14. I am uncomfortable in everyday 
situations. 
1 
2 
3 
4 
15. I have sadness during my day. 
 
1 
2 
3 
4 
16. I am nervous during everyday 
circumstances. 
1 
2 
3 
4 
17. I worry about what is happening in my 
life. 
1 
2 
3 
4 
18. I experience my day going smoothly. 
 
1 
2 
3 
4 
19. I can let go of restrictive 
circumstances. 
 
1 
2 
3 
4 
20. I have energy to face whatever comes 
my way. 
1 
2 
3 
4 
 
STRESS SURVEY 
Please read each statement and circle a number 0, 1, 2, or 3, which indicates how much this statement 
applied to you over the past week. There are no right or wrong answers. Do not spend too much time on 
any statement. 
 
The rating scale is as follows: 
0 
Did not apply to me at all 
1 
Applied to me to some degree, so some of the time 
2 
Applied to me to a considerable degree or a good part of the time 
3 
Applied to me very much or most of the time 
1. I find it hard to wind down 
 
0 
1 
2 
3 
2. I was aware of my dry mouth 
 
0 
1 
2 
3 
3. I couldn’t seem to experience any positive feelings at all 
 
0 
1 
2 
3 
4. I experienced breathing difficulty (e.g. excessively rapid breathing, 
breathlessness in the absence of physical exertion) 
0 
1 
2 
3 
5. I found it difficult to work up the initiative to do things 
 
0 
1 
2 
3 
6. I tend to over-react to situations 
 
0 
1 
2 
3 
7. I experienced trembling (e.g. in the hands) 
 
0 
1 
2 
3 

 
 
 
 
P a g e  40  
8. I felt that I was using a lot of nervous energy 
 
0 
1 
2 
3 
9. I was worried about situations where I might panic and make a fool 
of myself 
0 
1 
2 
3 
10. I felt that I had nothing to look forward to 
 
0 
1 
2 
3 
11. I found myself getting agitated 
 
0 
1 
2 
3 
12. I found it difficult to relax 
 
0 
1 
2 
3 
13. I felt down-hearted and blue 
 
0 
1 
2 
3 
14. I was intolerant of anything that kept me from getting on with what 
I was doing 
0 
1 
2 
3 
15. I felt I was close to panic 
 
0 
1 
2 
3 
16. I was unable to become enthusiastic about anything 
 
0 
1 
2 
3 
17. I felt I wasn’t worth much as a person 
 
0 
1 
2 
3 
18. I felt that I was rather touchy 
 
0 
1 
2 
3 
19. I was aware of the action of my heart in the absence of physical 
exertion (e.g. sense of heart rate increase, heart missing a beat) 
0 
1 
2 
3 
20. I felt scared without any good reason 
 
0 
1 
2 
3 
21. I felt that life was meaningless 
0 
1 
2 
3 
 
POST SURVEY 
 
Please answer the following regarding the intensity or strength of the aroma inhaler. 
 
1. On a scale of 1 to 10 rate overall how enjoyable the aroma of the inhaler was (0 being 
not enjoyable at all and 10 being very enjoyable) 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
2. On a scale of 1 to 10 rate the usual strength smell of the aroma inhaler (0 being no 
strength and very weak to 10 the strongest it could be) 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
3. How likely are you to continue to use this aroma inhaler (1 being not at all likely and 10 
being very likely)? 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

 
 
 
 
P a g e  41  
 
4. Any other thoughts you wish to share about this experience? 
 
 
Thank you for taking the time to complete this study, please return this and all other surveys 
and the logbook in the prepaid envelope. Once this is received, a gift card will be sent. 
If you have any further questions, please contact Marian Reven at marian.reven@hsc.wvu.edu 
 
 

 
 
 
 
P a g e  42  
Appendix B 
SAFETY DATA SHEET 
 
 

 
 
 
 
P a g e  43  
MANUFACTURER SAFETY DATA SHEET 
 
 
 

 
 
 
 
P a g e  44  
Safety Data Sheet and GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) 
 

 
 
 
 
P a g e  45  
FDA TRIAL REGISTRATION BERGAMOT 
 

 
 
 
 
P a g e  46  
 
AETHEREOSTICK INFORMTION SHEET 

 
 
 
 
P a g e  47  
 

 
 
 
 
P a g e  48  
PRODUCT EXPIRY INFORMATION 
 

 
 
 
 
P a g e  49  
Appendix C 
Cover Letter (Formatted per IRB) 
 
Dear Participant, 
 
This letter is to inform you about the research project Using aromatherapy for comfort, ease, 
and stress for adults being treated for substance use disorder in north central Appalachia: A 
randomized controlled trial. This project is being conducted by Marian Reven, MSN, RN in the 
Adult Health Department at the WVU School of Nursing. This study is done to fulfill the 
requirements of earning my PhD in nursing philosophy at WVU. 
 
For this study, you will either be asked to answer survey questions, use an aroma inhaler, and 
fill out a daily logbook or asked to answer surveys, and fill out a daily logbook. The study has 
one group that uses the aroma inhaler and one group that does not, and this is randomly 
assigned. The study lasts for 7-days. The survey questions focus on comfort, ease, and stress.  
 
The day you receive your materials, you will complete the consent form and take the surveys. 
At the beginning of the following day, you will begin to use the aroma inhaler or continue with 
treatment as usual. Each day during the 7 days, you will use the logbook to track your progress. 
With your consent, I will send a reminder text message to your cell phone for the first 3 days of 
the study and at the end. You will receive a $20 gift card and an aroma inhaler valued at $7 for 
completion of this study.  
 
Your participation in this project will be kept as confidential as legally possible. All data will be 
reported in the aggregate (all together). Your participation is entirely voluntary. You may skip 
any question that you do not wish to answer, and you may stop participating at any time. The 
West Virginia University Institutional Review Board's approval of this project is on file with the 
WVU Office of Human Research Protections.  
 
If you have any questions about this research project, please feel free to contact me at 
marian.reven@hsc.wvu.edu. Additionally, you can contact the WVU Office of Human Research 
Protections at 304-293-7073. Thank you for your participation.  
 
Sincerely, 
 
 
Marian Reven, MSN, RN 
 
 
For more information, please see the informed consent.

 
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Appendix D 
Logbooks for Intervention & Control Groups 
 
ID#___________ 
 
 
 
 
 
 
 
 
 
 
 
 
AROMA INHALER STUDY 
 
LOGBOOK 
 
INTERVENTION GROUP 
 
 

 
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Directions for using your aroma inhaler and this logbook: 
Follow these steps to use your aroma inhaler: 
 
1. Hold the aroma inhaler by the base  
2. Twist off the cap. The inner part of the aroma inhaler with the essential oil-soaked 
cotton wick is part of a closed system and is not intended to be opened. All you need to 
do is twist off the cap 
3. Hold the aroma inhaler within 3 inches of your nose  
4. Breath in gently through your nose for 3 seconds  
5. Hold your beath for about three seconds and then exhale gently through your mouth 
6. Repeat this 3 times* and then replace the cap and store your aroma inhaler in a cool, 
dry place away from children or pets. (You may repeat this breathing cycle more than 3 
times each day, please remember to make a note of this in the comments section about 
when and why you did) 
7. Use at least 3 times a day, and if you want to, use it more, but this should be recorded 
on the daily logbook page 
 
Follow these steps to use your Logbook: 
Use your logbook to track how you are using your aroma inhaler and how you are feeling 
 
1. Use a new page of the logbook for each of the seven days of the study 
2. If you forget or purposely do not do the aroma inhaler, please make a note with a brief 
reason why 
3. Do not stop the study because you miss a step of using the inhaler or recording in the 
logbook  
4. Keep your logbook in a secure place as we will collect it at the end of the study  
5. Do not write important or private information that does not have to do with using your 
aroma inhaler in this logbook  
6. Do not write your name on the logbook  
7. All information provided in the logbook will be kept confidential 
8. Return within 3 days of completion 
 
 
*NOTE: If you develop any uncomfortable symptoms such as a headache, stop using the aroma 
inhaler, recap, and retry a little later. If unpleasant symptoms continue the next time, 
discontinue use and contact Marian Reven, the Principal Investigator (PI), at 
marian.reven@hsc.wvu.edu.  
 
 
 
 
 

 
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Day 1 
 
Please indicate each time you use your inhaler today (approximate time of day) 
 
____ I used my aroma inhaler as directed for the first time today 
____ I used my aroma inhaler as directed for the second time today 
____ I used my aroma inhaler as directed for the third time today 
 
Any additional comments: 
If you used your aroma inhaler any extra times, please indicate when and brief reason why 
(example: 2:30p, feeling stressed, and it seemed to help) 
 
 
 
 
 
 
One time at the end of each day, after using the inhaler throughout your day, place an X on the 
line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 2 
 
Please place a check mark or X on the line each time you use your inhaler today 
 
____ I used my aroma inhaler as directed for the first time today 
____ I used my aroma inhaler as directed for the second time today 
____ I used my aroma inhaler as directed for the third time today 
 
Comments: (example: I used my aroma inhaler an extra time today because…) 
 
 
 
 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 3 
 
Please place a check mark or X on the line each time you use your inhaler today 
 
____ I used my aroma inhaler as directed for the first time today 
____ I used my aroma inhaler as directed for the second time today 
____ I used my aroma inhaler as directed for the third time today 
 
Comments: (example: I used my aroma inhaler an extra time today because…) 
 
 
 
 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 4 
 
Please place a check mark or X on the line each time you use your inhaler today 
 
____ I used my aroma inhaler as directed for the first time today 
____ I used my aroma inhaler as directed for the second time today 
____ I used my aroma inhaler as directed for the third time today 
 
Comments: (example: I used my aroma inhaler an extra time today because…) 
 
 
 
 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 5 
 
Please place a check mark or X on the line each time you use your inhaler today 
 
____ I used my aroma inhaler as directed for the first time today 
____ I used my aroma inhaler as directed for the second time today 
____ I used my aroma inhaler as directed for the third time today 
 
Comments: (example: I used my aroma inhaler an extra time today because…) 
 
 
 
 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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86 
Day 6 
 
Please place a check mark or X on the line each time you use your inhaler today 
 
____ I used my aroma inhaler as directed for the first time today 
____ I used my aroma inhaler as directed for the second time today 
____ I used my aroma inhaler as directed for the third time today 
 
Comments: (example: I used my aroma inhaler an extra time today because…) 
 
 
 
 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 7 
 
Please place a check mark or X on the line each time you use your inhaler today 
 
____ I used my aroma inhaler as directed for the first time today 
____ I used my aroma inhaler as directed for the second time today 
____ I used my aroma inhaler as directed for the third time today 
 
Comments: (example: I used my aroma inhaler an extra time today because…) 
 
 
 
 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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• Thank you for completing your seven-day aroma inhaler study! 
• Please place your survey and logbook in the envelope provided and seal it 
• Return this envelope to the Chestnut Ridge Center within 3 days of completion 
• Receive a $20 gift card  
• Keep the aroma inhaler and all other study materials as our way of saying thank you! 
 
 

 
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ID#___________ 
 
 
 
 
 
 
 
 
 
 
 
 
AROMA INHALER STUDY 
 
LOGBOOK 
 
CONTROL GROUP 
 
 

 
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Follow these steps to use your Logbook: 
Use your logbook to track your comfort on each of the seven days of the study 
 
 
Day 1 
 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 2 
 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 3 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 4 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 5 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 6 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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Day 7 
 
One time each day place an X on the line under “I feel as comfortable as possible today” 
 
I feel as comfortable as possible today 
 
 
Strongly disagree 
 
Strongly agree 
 
 
 
Comments:  
 
 
 
If you have any questions or comments, contact Marian Reven at marian.reven@hsc.wvu.edu. 
Thank you  
 

 
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• Thank you for completing your logbook for the seven-day aroma inhaler study! 
• Please place your survey and logbook in the envelope provided and seal it 
• Return this envelope to the Chestnut Ridge Center within 3 days of completion 
• Receive a $20 gift card  
• You will receive the aroma inhaler and all other study materials as our way of saying 
thank you! 
 
 

 
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Appendix E 
Reminder Paper 
SEVEN DAY AROMA INHALER STUDY   
(Please post this in a place where you will see it each day as a reminder to use your aroma 
inhaler and logbook) Thank you for your participation  
How to use & store your aroma inhaler* 
DIRECTIONS: To use 3 times daily and as desired: 
1. Uncap Inhaler 
 
Hold within 3 inches of the nose 
2. Gently breath in through your nose and hold for 3 seconds, gently exhale through your 
mouth 
 
Repeat 3 times each day and as desired (Use the comments section of the logbook to 
 
record extra use and thoughts about using your aroma inhaler) 
3. Recap Inhaler & Record all uses & reactions to the inhaler in the Logbook** 
4. Keep your aroma inhaler and logbook in a safe place. The aroma inhaler is yours to keep.  
 
**The logbook is returned at the end of this study 
*(When not in use, recap to close & store in a cool, dry place away from children and pets) It is 
OKAY to keep your closed inhaler in your pocket or purse and at room temperature  
Do not tamper with the packaging. Keep out of reach of children and animals. If you develop 
any adverse reactions such as a headache, stop, recap inhaler, and retry a little later. If 

 
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unpleasant effects, such as headache continue, discontinue use and contact Marian Reven, 
Investigator at marian.reven@hsc.wvu.edu  
Thank you! 
 
 

 
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Appendix F 
Key Information for: 
Using aromatherapy for comfort, ease, and stress for adults being treated for substance use 
disorder in north central Appalachia: A randomized controlled trial 
 
You are being asked to participate in the research described below.  This page provides key 
information that may help you to make this decision; more detailed information can be found 
after this section.   
Why is this research being done and what is involved? 
• The purpose of this study is to see if using an essential oil called Bergamot will have any 
effect on your comfort, ease, and stress 
• You will be asked to use an aroma inhaler, which is a small container about the size of a 
lipstick container, that contains a small amount of pure essential oil, three times a day for 
one week. Surveys are completed at the beginning and at the end of the week. A daily 
logbook with a short checklist is also used. 
• The study lasts for one week (7 days) 
Do I have to participate and what are the risks involved?  
Participation in this research study is completely voluntary and you are free to withdraw from the 
research at any time.  If you do not wish to participate, please discuss alternatives with the 
researcher or refer to the “Alternatives” section in the consent form.  You may or may not 
directly benefit from participating in this research. 
Risks from participation in this study include having an adverse reaction to the essential oil of 
Bergamot that is contained in the aroma inhaler. Additionally, time spent completing surveys and 
a daily logbook may seem like it adds additional stress to the participant.  

 
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Who can I talk to if I have questions or concerns? 
If you have any questions or concerns about this research or would want to withdrawal from the 
study, you can contact Marian Reven at marian.reven@hsc.wvu.edu from the School of Nursing 
at West Virginia University. 
 
For more information, please see the Informed Consent Form. 
 
 

 
 
 
Page 31 
 
Informed Consent for Research | Minimal Risk  
 
Principal Investigator (PI) | 
Dr. Roger Carpenter (Marian Reven Dissertation work) 
Department | 
School of Nursing 
Sponsor or Funding Source | 
TBD 
WVU IRB Protocol # | 
Pending 
Study Title | 
Using aromatherapy for comfort, ease, and stress for adults 
being treated for substance use disorder in north central Appalachia: A randomized controlled 
trial  
 
Introduction 
You have been asked to participate in this research study, which has been explained to you by an 
authorized member of the research team.  This research is being conducted to fulfill the requirements 
for a [PhD] in [Philosophy of Nursing] from the Department of Nursing at West Virginia University.  
This research is being conducted under the supervision of Dr. Roger Carpenter. 
Purpose 
The purpose of this study is to see if using an essential oil called Bergamot will have any effect on 
your comfort, ease, and stress.  WVU expects to enroll approximately 98 subjects.    
Description of Procedures 
1. First, you will be pre-screened using a survey that includes questions about integrative or 
complementary therapies (massage, yoga, acupuncture, aromatherapy with essential oils, herbs, 
meditation, mindfulness practices). This survey also asks questions about allergies and sense of 
smell because this study involves smelling aroma in the form of an essential oil called Bergamot.  
2. If a severe allergy or medical condition does not allow you to participate, the prescreening form 
will be destroyed, and you will be excused from further participation.  

PROTOCOL MANUAL: AROMATHERAPY & SUD 
 
 
 
 
 
1
3. If you qualify to be in the study, you will sign a consent form, and then receive a study packet.   
4. You will be randomly assigned to one of two groups. One groups will receive an aroma inhaler 
to use 3 x day for 7 days and complete a daily logbook. The other group will receive only the 
daily logbook. But those who do not get their aroma inhaler at the beginning of the study will 
receive it at the end of the study. 
5. Both groups will do surveys before the study, the logbook every day, and surveys after the study.  
6. The surveys include questions about overall comfort, ease, and stress.  
7. Once consent and pre-surveys are complete, you will be shown how to use the aroma inhaler 
correctly.  
8. The study lasts for 7 days and begins on the day after you sign the consents and receive your 
packet. (So, if you sign up on a Tuesday, you will start the study on Wednesday).  
9. At the end of 7 days, you are asked to place your completed logbook and post surveys in a 
postage paid envelope and return them to the Chestnut Ridge Center within 3 days. 
10. Once the post survey is received, you will receive a gift card and if you had not received the 
aroma inhaler, you will receive that aroma inhaler as our way of saying thank you.  
11. Health related medical history data and demographic information from your medical record will 
be collected including stage of treatment in the SUD treatment program, Presence of medical 
diagnoses of anxiety and/or depression, and presence of severe mental illness.   
12. Your permission to use your cell phone number to contact you via text message for reminders on 
days 1 through 3 and at the end of the study is requested (Optional). 
Risks and Discomforts 
Potential risks or discomforts include a dislike of the scent or possibly a headache because of 
inhaling the essential oil fragrance from the aroma inhaler. If headache or feeling of dislike 
continues the participant is asked to discontinue use of the aroma inhaler and contact me, Marian 
Reven, at marian.reven@hsc.wvu.edu for further instructions. Logbooks will still be collected, and a 
post survey provided. Those who complete the study, even if they must discontinue use of the aroma 
inhaler before the end will receive the gift card if study materials and surveys are returned and 
complete.  
This study does include surveys that ask questions about feelings of comfort, ease, and stress. This 
may cause distress to some participants. Should a participant experience or express any 
psychological distress or disclose information that indicates a need for urgent psychological or 
clinical care, the researcher will connect the participant with their provider. 

PROTOCOL MANUAL: AROMATHERAPY & SUD 
 
 
 
 
 
2
While not anticipated, this research may involve side effects that are unforeseeable, uncommon, or 
previously unknown. 
In addition, there is always the risk of uncommon or previously unknown side effect(s) or event.   
Alternatives   
You do not have to participate in this study.   
Benefits 
You may or may not directly benefit from participating in this research.  The knowledge gained from 
this study may eventually benefit others. 
Financial Considerations 
 
You will be compensated with a $20 gift card for completing this study.   
You will keep your aroma inhaler valued at $7.00 
If you do not complete the study, you will not be compensated. 
For information regarding the method of payment, contact Marian Reven at 
marian.reven@hsc.wvu.edu . 
Your information may be provided to the appropriate parties for billing and/or payment purposes.  
Please be advised that any compensation received for participation in a research study, including a 
gift card, is considered taxable income and must be reported to the Internal Revenue Service (IRS). 
Your data, health information, and research results, or any and all other information related to this 
research study used in this research study may contribute to a new discovery or treatment.  In some 
instances, your data, your health information, your research results, these discoveries or treatments, 
or any other information related to this research study, even if identifiers are removed, may be of 

PROTOCOL MANUAL: AROMATHERAPY & SUD 
 
 
 
 
 
3
commercial value and may be sold, patented, or licensed by the investigators and West Virginia 
University for use in other research or the development of new products.  You will not retain any 
property rights nor will you share in any money or commercial profit that the investigators, West 
Virginia University, or their agents may realize.   
Confidentiality 
Any information about you that is obtained as a result of your participation in this research will be 
kept as confidential as legally possible.  Your research records and test results, just like hospital 
records, may be subpoenaed by court order or may be inspected by the study sponsor or federal 
regulatory authorities, including the Food and Drug Administration (FDA), without your additional 
consent. 
In addition, there are certain instances where the researcher is legally required to give information to 
the appropriate authorities.  These would include mandatory reporting of infectious diseases, 
mandatory reporting of information about behavior that is imminently dangerous to you or to others, 
such as suicide, child abuse, etc. 
In any publications that result from this research, neither your name nor any information from which 
you might be identified will be published without your consent. 
HIPAA Authorization  
We know that information about your health is private. We are dedicated to protecting the privacy of 
that information. Because of this promise, we must get your written authorization (permission) 
before we may use or disclose your protected health information or share it with others. 

PROTOCOL MANUAL: AROMATHERAPY & SUD 
 
 
 
 
 
4
You can decide to sign or not to sign this authorization section. However, if you choose not to sign 
this authorization, you will not be able to take part in the research study. Whatever choice you make 
about this research study will not have an effect on your access to medical care. 
Persons/Organizations Providing the Information 
Patient data and data from the WVU Chestnut Ridge/West Virginia University Hospitals/ WVU 
Medicine/ WVU will be collected. 
Persons/Organizations Receiving the Information 
• This study will be conducted at the West Virginia University Chestnut Ridge Center 
(WVUCRC), outpatient substance use disorder treatment and recovery program in north 
central Appalachia located at 930 Chestnut Ridge Rd., Morgantown, West Virginia, 26505.   
• Health care providers who provide services to you as part of this research study. 
• (Sponsor name, if applicable) and the people and companies that they use to oversee, 
manage, or conduct the research. 
• The members and staff of any institutional review board that oversees this research study. 
• The West Virginia University Office of Human Research Protection and the West Virginia 
University Office of Sponsored Programs. 
• If applicable, West Virginia University School of Nursing 
 
The Following Information Will Be Used  
Information from your existing medical records, and new information about you that is created or 
collected during this study, such as: demographic data and diagnosis data as it relates to your 
treatment for substance use disorder only.  
The Information is Being Disclosed for the Following Reasons 
• Publication of study results (without identifying you) 
• Other research purposes include reviewing the safety and feasibility of the aromatic 
intervention and developing a better understanding of disease; improving the design of future 
clinical trials. 

PROTOCOL MANUAL: AROMATHERAPY & SUD 
 
 
 
 
 
5
You may Cancel this Authorization at Any Time by Writing to the Principal Investigator 
Dr. Roger Carpenter, West Virginia University, 64 Medical Center Drive, Morgantown, WV 26506-
9600.   
Voluntary Participation 
Participation in this study is voluntary.  You are free to withdraw your consent to participate in this 
study at any time.  To withdraw from the study, contact Dr. Roger Carpenter at 
rcarpenter@hsc.wvu.edu or Marian Reven at marian.reven@hsc.wvu.edu.  
Refusal to participate or withdraw will not affect your future care or status at West Virginia 
University.  
In the event new information becomes available that may affect your willingness to participate in 
this study, this information will be given to you so that you can make an informed decision about 
whether or not to continue your participation.   
Contact Persons 
If you have any questions, concerns, or complaints about this research, you can contact Dr. Roger 
Carpenter (PI) at West Virginia University School of Nursing, rcarpenter@hsc.wvu.edu or  Marian 
Reven (Co-I) West Virginia University School of Nursing, marian.reven@hsc.wvu.edu.  
If you are hurt from being in this research, you should contact Dr. Roger Carpenter at 304-293-1410 
Monday through Friday 9am to 5pm.   If injury occurs outside of business hours and is related to 
your participation in this research, please contact Marian Reven (Co-I) at 304-479-4825.  

PROTOCOL MANUAL: AROMATHERAPY & SUD 
 
 
 
 
 
6
For information regarding your rights as a participant in research or to talk about the research, 
contact the WVU Office of Human Research Protection (OHRP) at (304) 293-7073 or by email at 
IRB@mail.wvu.edu.   
 
Signatures and Authorization  
You have been given the opportunity to ask questions about the research (if applicable) and your 
authorization of HIPAA, and you have received answers concerning areas you did not understand.  
Upon signing this form, you will receive a copy. 
 
Would you like us to contact you in the future for other studies?  Yes _________    No  ___________ 
If you agree to future contact, please fill in the information below. If you do not want future contact, your 
participation in this study will not be impacted.  
Address:__________________________________________________________________________________
________ 
Email:  ____________________________________________________ 
 
Participant Signature 
I willingly consent to participate in this research. 
 
Signature of Subject or Subject’s Legal Representative 
 
 
Printed Name 
 
Date 
 
Consenting Individual Signature 
The participant has had the opportunity to have questions addressed.  The participant willingly 
agrees to be in the study. 

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Signature of Person Obtaining Informed Consent 
 
 
Printed Name 
 
Date 
 
 
The participant has provided permission to use their cell phone to send text messages 
Phone number_______________________________ 
 
 

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Appendix G (IRB Update allowing Stages one, two, three, and peer 
recovery recruitment) 

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Appendix H (IRB approval to recruit online complete consent online) 

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Appendix I (QIP Audit letter from IRB) 

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