Anxiety Clinical Trial
Official title:
The Use of the CalmiGo Handheld Device in the Management of Patients With Anxiety and Panic Attack Symptoms in the Emergency Department
NCT number | NCT03884712 |
Other study ID # | 19-0033 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 7, 2019 |
Est. completion date | January 1, 2025 |
Currently, there are limited options in the management of anxiety and panic attack symptoms in the Emergency Department (ED). The most common treatment method is the use of anti-anxiety and anti-depressant medications; however, these drugs have serious health risks which make them ineffective as a long-term treatment option. The CalmiGo handheld device, formerly known as "myReLeaf", provides an alternative early intervention option in treating patients presenting with anxiety and panic attack symptoms by using guided breathing, aromatherapy, and grounding techniques. The hypothesis of this study is that CalmiGo will provide a drug-free, early intervention, and long-term treatment option in the ED that will improve patients' anxiety and panic attack symptoms. Patients who present to the ED with anxiety or panic attack symptoms will be considered eligible for this study. These patients will be approached, and they will give informed consent to participate in the study. Patients will be enrolled in the study which consists of completing validated surveys asking about their anxiety and panic symptoms, using CalmiGo, and allowing investigators to access their medical records. These surveys will be completed before and after using CalmiGo in the ED to measure the presence and severity of anxiety and panic symptoms. The goal of this study is to analyze the effectiveness of using CalmiGo to improve anxiety and panic attack symptoms based on validated survey responses. Overall, this study seeks to identify CalmiGo as an effective and alternative early intervention treatment option for patients presenting to the ED with anxiety or panic attack symptoms.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | January 1, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients in the LHH Emergency Department (ED) - Presenting with anxiety and panic attack symptoms (confirmed by ED provider) - Able to provide informed consent - Must be aged 18 years or older Exclusion Criteria: - Pregnant patients - Patients less than 18 years of age - Prisoners - Cognitively impaired. - Asthma - Chief obstructive pulmonary disorder (COPD) - Bi-polar disorder - Psychosis or delusional disorders - History of substance abuse or dependence - History of being suicidal - Organic mental disorder - Severe unstable medical illness - Chronic respiratory disease - History of seizures. |
Country | Name | City | State |
---|---|---|---|
United States | Lenox Hill Hospital | Manhattan | New York |
Lead Sponsor | Collaborator |
---|---|
Yves Duroseau | Dendro Technologies, Inc |
United States,
Ebell MH. Diagnosis of anxiety disorders in primary care. Am Fam Physician. 2008 Aug 15;78(4):501-2. No abstract available. — View Citation
Fleet R, Foldes-Busque G, Gregoire J, Harel F, Laurin C, Burelle D, Lavoie K. A study of myocardial perfusion in patients with panic disorder and low risk coronary artery disease after 35% CO2 challenge. J Psychosom Res. 2014 Jan;76(1):41-5. doi: 10.1016/j.jpsychores.2013.08.003. Epub 2013 Aug 15. — View Citation
Locke AB, Kirst N, Shultz CG. Diagnosis and management of generalized anxiety disorder and panic disorder in adults. Am Fam Physician. 2015 May 1;91(9):617-24. — View Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in presentation and severity of anxiety and panic symptoms | Panic Symptom Scale (PSS) survey responses before using CalmiGo will be compared to the PSS survey responses after using CalmiGo. The PSS rates the severity of 13 panic symptoms on a scale of 0 to 4; a rating of 0 indicates that the symptom is not present and a rating of 4 indicates that the symptom is extremely severe. The sum of all the ratings for the 13 symptoms on the PSS (raw score) represents the overall severity of the patient's panic state. A lower raw score indicates a lesser severity of symptoms and a higher raw score indicates a higher severity of symptoms. If a patients raw score decreases after using CalmiGo, this would indicate an improvement in anxiety and panic attack symptoms and would indicate the effectiveness of using CalmiGo to treat anxiety and panic attack symptoms. | 1 year | |
Secondary | Change in presentation and severity of anxiety and panic attack symptoms between patients who use and patients who do not use medications to treat anxiety or panic attacks | In the Patient Demographic Survey, participants will be asked if they use any medications to treat their anxiety or panic attack symptoms. In addition, the participants' electronic medical records will be reviewed for any anti-anxiety or panic attack medications. This will establish two cohorts of participants: those who use anti-anxiety and panic attack medications and those who do not. Changes in PSS survey responses from before using CalmiGo to after using CalmiGo will be compared between these cohorts to assess the effectiveness of CalmiGo to treat anxiety and panic attack symptoms in conjunction with anti-anxiety and panic attack medications. If the overall raw score for patients who uses anti-anxiety and panic attack medications decreases after using CalmiGo more than for patients who do not use medications, this would indicate that CalmiGo and medications benefit patients in reducing their anxiety and panic attack symptoms more than using CalmiGo on its own. | 1 year |
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