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Recruitment rate was lower than anticipated, preventing the study from achieving target sample size.
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| Name | Class |
|---|---|
| University of Arizona | OTHER |
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This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with cardiac arrhythmias.
Patients with cardiac arrhythmias develop increased rates of anxiety and depression. Atrial arrhythmias, such as paroxysmal atrial fibrillation (AF), and ventricular arrhythmias, such as those with implantable cardioverter defibrillators (ICD) are particularly at risk. While ICDs can be life saving, many patients (including those without prior psychiatric illness) develop elevated rates of anxiety and depression, particularly after receiving discharges (shocks) from the device. Treatments involving modulation of the breath have been shown to improve both psychological and cardiac outcomes in patients with AF. Since breathing modulation alters sympathetic balance, this may be a mechanism of the therapeutic effect. This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with atrial and ventricular cardiac arrhythmias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathing exercise | Experimental | Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing exercise | Behavioral | Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac anxiety | Assessed via the Cardiac Anxiety Questionnaire | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | Measured by the WHO Disability Assessment Scale (WHODAS) | 1 month |
| Wellbeing | NIH Patient Reported Outcome Measurement Information System (PROMIS) |
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Inclusion Criteria:
Exclusion Criteria:
No telephone access
Active suicidal ideation with intent or plan
Active drug or alcohol dependence, or active binge drinking within the last month
Cardiovascular instability, as evidenced any of the following:
Pacemakers or combined pacemaker/ICDs will be excluded
Presence of unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disease; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
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| Name | Affiliation | Role |
|---|---|---|
| Sahib Khalsa, MD, PhD | Laureate Institute for Brain Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laureate Institute for Brain Research | Tulsa | Oklahoma | 74136 | United States |
Not IPD, just de-identified data.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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| 1 month |
| ICD anxiety | Florida Shock Anxiety Scale | 1 month |
| Arrhythmia burden | Presence of atrial fibrillation or ICD shocks | 1 month |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D026741 |
| Physical Therapy Modalities |