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Trial record 57 of 73 for:    aromatherapy

Using CalmiGo to Manage Anxiety and Panic Attack Symptoms in the Emergency Department

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ClinicalTrials.gov Identifier: NCT03884712
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
Dendro Technologies, Inc
Information provided by (Responsible Party):
Yves Duroseau, Northwell Health

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anxiety Panic Attacks Device: CalmiGo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of the CalmiGo Handheld Device in the Management of Patients With Anxiety and Panic Attack Symptoms in the Emergency Department
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: CalmiGo Recipients
This arm will receive a CalmiGo handheld device during their participation in the study. Participants will first complete validated surveys assessing their anxiety and panic attack symptoms. Investigators will then demonstrate how to use the CalmiGo handheld device. Participants will use the device with the investigator and then participants will use the device on their own for at least 2 times. After using CalmiGo, participants will complete validated surveys reassessing their anxiety and panic attack symptoms, asking about their past medical history, and inquiring about their experience using CalmiGo.
Device: CalmiGo
The CalmiGo handheld device is a device of similar size to an inhaler that uses guided breathing, aromatherapy and grounding techniques to regulate breathing to bring users a sense of calm and relaxation. The CalmiGo handheld device is being tested in this study to alleviate participants' anxiety and panic attack symptoms.
Other Name: myReLeaf




Primary Outcome Measures :
  1. Change in presentation and severity of anxiety and panic symptoms [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Additional Information:
Publications:
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Responsible Party: Yves Duroseau, Chairman of Emergency Medicine, Lenox Hill Hospital, Northwell Health
ClinicalTrials.gov Identifier: NCT03884712     History of Changes
Other Study ID Numbers: 19-0033
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yves Duroseau, Northwell Health:
anxiety symptoms
panic attack symptoms
emergency department
CalmiGo

Additional relevant MeSH terms:
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Anxiety Disorders
Emergencies
Panic Disorder
Mental Disorders
Disease Attributes
Pathologic Processes