Generalized Anxiety-the display of excessive anxiety or worry for months-is associated
with several anxiety-related symptoms including restlessness, feeling wound-up or on
edge, being easily fatigued, difficulty concentrating, having the mind go blank,
irritability, muscle tension, difficulty controlling worry, and sleep abnormalities [The
National Institute]. Panic attacks-sudden periods of intense fear-include symptoms of
palpitations, pounding heart, accelerated heart rate, sweating, trembling, shaking,
sensations of shortness of breath, smothering, choking, and feelings of impending doom.
Panic attacks are symptoms of Panic Disorder-an anxiety disorder with reoccurring and
unforeseen episodes of panic attacks [The National Institute].
Typically, treatment consists of a combination of psychotherapy, Cognitive Behavioral
Therapy (CBT), support groups, stress-management techniques, and anti-anxiety and/or
anti-depressant medications. The caveat with these treatment options is that only
anti-anxiety or anti-depressant medications are available as an early intervention
option, especially in the ED. The use of anti-anxiety and anti-depressant medications in
the treatment of Generalized Anxiety, panic attacks, and Panic Disorder in the ED
provides challenges on multiple levels. For instance, some anti-depressants now carry a
"black box warning" from the U.S. Food and Drug Administration making these drugs high
risk with potentially serious health consequences. Therefore, the limited treatments
options for the symptoms of Generalized Anxiety, panic attacks, and Panic Disorder in the
ED raises the need for alternative, early intervention treatments.
This research study aims to use the CalmiGo handheld device in the ED to aide in the
short term and long term care of patients presenting with anxiety and panic attack
symptoms. The standard of care for treating anxiety and panic attack symptoms in the ED
consists of CBT, anti-anxiety medications such as benzodiazepines, and referring patients
for a psychiatry consult, if appropriate. Compared to current treatment options in the
ED, CalmiGo is a relatively less expensive, longer acting, drug-free device that
addresses many distress related symptoms of anxiety through a combination of exhalation
prolongation, aromatherapy, and grounding techniques [CalmiGo]. This study does not aim
to eliminate the need for medication or other combination therapies; however, CalmiGo can
provide an alternative treatment option that can alleviate clinical presentations of
anxiety and panic symptoms and can be used as an early intervention treatment option.
This study will be conducted through the administration of validated surveys, teaching
the participating subject how to use the CalmiGo device, and letting patients use the
CalmiGo device on their own.
Two screening tools that have been clinically shown to be effective forms of assessing
Generalized Anxiety, panic attacks, and Panic Disorder will be used to assess patients'
anxiety and panic attack symptoms: the Generalized Anxiety Disorder subscale (GAD-7) and
the Panic Symptom Scale (PSS). The GAD-7 uses a 7-item anxiety scale as a quick and easy
tool to identify patients with anxiety and to monitor treatment response [Spitzer],
[Ebell]. Whereas the GAD-7 is self-reporting, the PSS is an interview-based scale to
determine the severity of 13 different panic symptoms as outlined by the DSM-IV [Locke],
[Fleet]. The two of these screening tools are able to provide a thorough evaluation of
patient's anxiety and panic attack symptoms.
Two other surveys will be conducted in order to gain demographic information including
past medical history (Patient Demographic Survey) and a survey asking about the patient's
experience with the CalmiGo device (CalmiGo questionnaire). These surveys have been
designed by the study team.
To identify potentially eligible patients, investigators will screen the arrival board in
the ED for specific chief complaints including anxiety, panic, non-cardiac chest pain
(NCCP), unexplained chest pain (UCP), shortness of breath (SOB), and/or palpitations.
Investigators will open the patient's electronic medical record to determine if patients
are presenting to the ED with anxiety or panic attack symptoms, and investigators will
ensure that the patient doesn't meet any exclusion criteria. Investigators will confirm
with the patient's provider that the patient is experiencing anxiety and panic attack
symptoms before approaching the patient about this study.
Investigators will approach the patient and obtain informed consent before enrolling the
patient into the study.
First, the investigator will have the patient complete the GAD-7 and PSS surveys.
Following these surveys, the investigator will begin the CalmiGo device demonstration.
The investigator will explain how the device works, what comes in the CalmiGo package,
and will show the patient how to use CalmiGo by turning the device on and explaining the
different commands of the device.
Then, the patient will use CalmiGo once for 3 minutes with the investigator is in the
room to make sure that the patient understands how to use the device. The investigator
will leave the patient for 20 minutes to let them use the CalmiGo device on their own. In
these 20 minutes, the patient will be instructed to use CalmiGo for at least 2 additional
times for 3 minutes each time. Once the investigator returns, the investigator will
interview the patient with the PSS interviewed survey, the Patient Demographic Survey,
and the CalmiGo questionnaire.
The investigator will input the data from the surveys completed during enrollment into
REDCap, a HIPAA compliant database. The completed paper version of the surveys will be
stored in a binder in a labeled locked cabinet at Lenox Hill Hospital.
Subjects will leave with a CalmiGo device along with user guides, a copy of their consent
form and an additional aromatherapy element from the CalmiGo device.
Lastly, investigators will complete the Data Abstraction sheet after patients have been
enrolled in the ED, completed all surveys and used the CalmiGo handheld device. Patients'
medical charts will be accessed and reviewed to document the metrics on the Data
Abstraction sheet, which will be completed on REDCap; there will be no paper
documentation of the sheet. Abstracted information will include the patients' treatment
in the ED, ED diagnosis, and ED disposition.