Aromatherapy Randomization of Pain Management in Adults

A. SPECIFIC AIMS This study aims to research the use of aromatherapy for pain control in the
emergency department, specifically, acute back pain. Aromatherapy, particularly Rose
Essential Oil (Rosa damascena) has been studied in recent literature and shown to be
effective versus placebos for the control of acute pain with lasting effects during burn
dressing changes and post-operative pain management. These studies have been small and
specific to discrete clinical conditions. Their evidence supports the use of aromatherapy for
acute pain control with additional patient satisfaction benefit, but they are not yet
externally validated to more common conditions facing emergency medicine physicians. The
investigators chose to study acute isolated back pain and sciatica presenting to the
emergency department and the use of Rosa damascena essential oil versus a control of Almond
Oil for the treatment of isolated back pain and sciatica. The authors will investigate the
use of aromatherapy in pain management by measuring and comparing pre- and post-treatment
pain levels using a 100 mm visual analog scale (VAS) for pain. A significant reduction in
pain by 13 mm on the VAS has been previously demonstrated as the minimal clinically important
difference for treatment of pain. The primary endpoint will be the evaluation of significant
change in VAS score greater than 13 mm between both groups immediately following a 30 minute
blinded aromatherapy treatment and again 30 minutes later. The secondary endpoints include
patient satisfaction, need to rescue medication (its type and dose), and subjective changes
in pain.

B. Background and Significance Aromatherapy has been hypothesized to be an effective
management strategy for acute pain control. Its use has been recently demonstrated in Iran,
using Rosa damascena (Damask Rose) essential oil. Rosa damascena is believed to possess
anti-anxiolytic, sedative, anticonvulsive, and analgesic effect on the central nervous system
(CNS) when delivered through the olfactory system (Mohebitabar et al. 2016). This theory is
believed to be in part due to the lateral gate theory of pain control and a stimulant's
ability to inhibit transmission of stimuli through pain fibers. However, while any olfactory
stimulant might be hypothesized to do just that, only Rosa damascena has been shown to
produce significant reduction in pain on the VAS as well as patient satisfaction when
compared to scented placebos like Almond Oil. Rosa damascena has been shown to improve pain
control during dressing changes of second- and third-degree burns (Bikmoradi et al 2016). It
has also been shown effective and equal to NSAID treatment of immediate post-operative pain
in children (Marofi et al. 2015). It may be an affordable and easy-to-use modality for pain
control in the emergency department. Its prior studies are small in sample size and carry
little external validity that could be applied to an American Emergency Department
population. The authors aim to assess whether aromatherapy using Rosa Damascena is
reproducible in the emergency department for control of isolated and acute back pain, two
common painful conditions seen with poor evidence for proper pain control. Validity of Rosa
damascena aromatherapy in acute back pain and sciatica may open new doors of pain control to
be researched in the emergency department and will further characterize the use of
aromatherapy in modern medicine.

C. Preliminary Studies The known external studies of Rosa damascena have been cited above and
will be presented in the references section. The authors have not yet studied aromatherapy in
the emergency department and will be completing this study fresh, based on methodology used
in external aromatherapy and back pain treatment studies. The Minimal Clinically Important
Difference (MCID) of 13 mm on the VAS has been studied repeatedly and validated as the
minimal VAS change needed for a patient to express significantly subjective improvements in
pain (Gallagher, Leibman, and Bijur 2001)(Jensen and Chen 2003). Successful pain treatment
has been shown by using 3-5 drops of 40% Rosa damascena oil on a cotton ball or gauze pad
20-30 cm from a patients face for 30 minutes (Bikmoradi et al. 2016). Additionally, uses of
rescue medications and patient satisfaction have been commonly used as secondary measures in
both aromatherapy and landmark back pain treatment studies. Patient demographics include age,
gender, comorbidities, prior treatment, BMI, education, marital status, and pain identifiers
have been repeatedly used to assess patient demographic distribution in many benchmark
Emergency Medicine acute pain management studies (Chang et al 2015.)(Friedman et al. 2015).

D. Research Design and Methods

Rationale and Overview Isolated acute back pain (less than 2 weeks duration) and sciatica are
common complaints to the emergency department requiring acute pain management with often
chronic follow-up. Their abundance in the ED as well as poorly defined treatment
recommendations make them an excellent candidate to study the use of aromatherapy in the
emergency department. The authors will replicate the Rosa damascena trials referenced above
in similar protocols, patients will be recruited if they fit the attached inclusion criteria
and do not meet exclusion criteria. Patients will be treated with either Almond Oil extract
or Rosa damascena extract, and both the investigator and patient will be blinded to the
control arm. A VAS pain scale will be recorded before treatment, after 30 minutes of
treatment, and after a following 2nd 30 minutes. Patients will additionally be asked about
their satisfaction and subjective changes in pain, they will be blinded to their prior VAS
line placements for proper evaluation of objective pain level changes. Demographics thought
to contribute to the sensation of pain, expression of pain, and response to pain treatment
will additionally be collected without entangling Private Health Information (PHI). Finally,
the use of rescue medication such as NSAIDs or Narcotics at the treating physician's
discretion will be recorded as an indicator of treatment failure and complication. Pain will
be qualified in its type, locations, duration, immediate episodes prior to presentation, and
prior remote episodes in the patient's lifetime health history. Pain will also be quantified
by attempted at-home treatments prior to presentation.

Research Site The entirety of this prospective clinical trial will be conducted at the Stony
Brook Hospital Emergency Department, an ED with over 110,000 annual visits.

Study Sample Patients will be recruited into this study by an investigator in the Stony Brook
Emergency Department. A sample size was calculated to be 30 patients for each treatment arm
based on a power of 0.80, desired p value below 0.05, and 95% confidence intervals with the
anticipated possibility of patient loss or desire to withdraw during treatment. Patients will
be approached for recruitment after an attending or resident physician has seen them and does
not anticipate immediate need for narcotic pain medication, immediate imaging, or immediate
threats to life or limb. Patients will be included by the attached inclusion and exclusion
criteria. Double-blinding will be ensured by block randomization of each treatment arm,
performed outside of the emergency department. In the Emergency Department Research Offices,
the two treatment arms will be allocated into identical, individual vessels with only a
codified label applied to each. Using block randomization, 30 treatments will be distributed
to each arm in secret by a clinical research assistant or investigator. Each treatment will
be codified individually and recorded in secrecy and kept from the investigators.
Randomization will then arrange the total 60 treatments in longitudinal order for sequential
random treatments to be selected as each patient is recruited.

Screening Patients will be approached in private and the name, title, and role of the
investigator explained after asking permission to speak with the patient. The patient will be
told that the investigators are conducting a clinical research trial for the treatment of
acute back pain and sciatica. Aromatherapy will be explained as the treatment of interest and
a modality that has been tested and proven effective in other types of pain. The use of
Almond products and Rose products will be briefly discussed with the patients. Patient's will
be asked about any allergies and then asked specifically about allergies to Almonds, Roses,
perfume, and ibuprofen. Patients will be informed that speaking with the investigator is
entirely optional, as is participating in the study, as there may be no direct benefit to
them despite disclosure of their private information to the investigator. An Inclusion and
Exclusion form will be reviewed with the patient and their chart, noting their sequential
patient number in this study as the only de-identified patient ID. No PMI will be collected;
no medical record numbers (MRN), address, phone number, emails, name, SSN, DOB, chief
complaint, past medical history (PMH), past surgical history (PSH) , or medications will be
recorded. The risks and benefits will be explained to the patient including risk of allergy,
risk of no change in pain, benefit of pain improvement, and benefit of contribution to
medical research. The consent form will be reviewed in full and any questions answered. Those
patients interested in participating and able to grant consent will do so.

Procedures Rosa damascena 40% and Almond Oil 40% kept outside of the ED will be prepared each
day and dispersed into identical vessels with randomized identification numbers. The coded
numbers and their respective modality will be recorded by an investigator not involved in
delivery and kept secured. Patients will be assigned into random treatment arms by block
randomization and their coded treatment recorded on the patient data sheet. Patients will be
given 4 drops of either modality (40%) on a cotton ball kept between 20 and 30 cm from their
face for 30 minutes.

With regards to study blinding, the treatments will be randomly assigned and the patients
will not be told which treatment they are receiving. The patients will be aware that the
study involves Rose and Almond scents and will likely be able to identify the scent used in
their treatment. However, at the end of the study procedures, an independent observer will
assess the patient's pain after the aromatherapy has been removed from the room, and will not
be aware of which patients received which treatment.

E. Statistics VAS differences immediately after treatment and 30-minutes following will be
aggregated from their respective 100 mm VAS for pain and the change calculated for each
patient. One-tailed paired t-Tests will be then conducted on the means after standard
deviation is calculated and compared between treatment and control groups. A chi-squared test
will then be applied between both groups for analysis of significant differences in patient
satisfaction and subjective reports of pre- and post-treatment pain. The use of rescue
medications by type and dosage will be measured as a percentage of each group and compared
via t-Test between both groups.

Inclusion Criteria:

- Age 18 or above

- Seen and attending or resident physician

- Isolated back pain or sciatica

- Pain lasting less than 2 weeks

- Pain between lower scapular borders and gluteal folds

- Patient maintains capacity and is interested in participating

Exclusion Criteria:

- Pregnant patient, minor, or inmate patient

- Patient lacks decision making capacity

- Patient is delirious, demented, altered, intoxicated, or agitated

- Patient allergic to Ibuprofen or NSAIDs

- Patient unable to demonstrate understanding of experiment by teach-back method

- Patient below age of 18

- Physician, clinician, or investigator concern for underlying etiology other than
isolated back pain or sciatica

- Patient already received narcotics or requires immediate standard pain control

- Patient demonstrated neurologic deficit or radicular symptoms

- Patient does not wish to be studied

- Patient endorses allergy to almond, roses, or perfumes

- Patients with pain lasting greater than 2 weeks