Dyspnea Clinical Trial
Official title:
The Effects of a Music Therapy Respiratory Protocol on Post-Covid Respiratory Symptoms
Verified date | February 2024 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The effects of a tested and published music therapy respiratory protocol shown to be efficacious with pediatric asthma and adult COPD is being studied with individuals living with post-Covid-19 respiratory symptoms. An interventional, single arm study is being conducted with individuals meeting eligibility criteria detailed below. Primary outcome is a change in the MRC Dyspnea score, with secondary aims focusing on improved quality of life, including reduced fatigue and depression and improved sleep and resilience.
Status | Completed |
Enrollment | 33 |
Est. completion date | March 13, 2023 |
Est. primary completion date | March 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participation in Mount Sinai Post-COVID Treatment Center care - Confirmed or presumptive COVID-19 history based on symptoms - Experiencing residual pulmonary issues (shortness of breath, fatigue) - MRC Dyspnea score of grade 3, 4, or 5 - 18 years or older Exclusion Criteria: - Under 18 years - MRC Dyspnea Score of grade 1 or 2 - Presence of respiratory issues without confirmed or presumptive COVID-19 diagnosis |
Country | Name | City | State |
---|---|---|---|
United States | Louis Armstrong Dept. of Music & Medicine, Mount Sinai Union Square | New York | New York |
United States | NYC Health & Hospitals - Elmhurst | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19. — View Citation
Loewy J, Goldsmith C, Deshpande S, Sun A, Harris J, van Es C, Zvi ZB, Dahmer S. Music therapy in pediatric asthma improves pulmonary function while reducing hospitalizations. J Asthma. 2021 May;58(5):674-682. doi: 10.1080/02770903.2020.1712725. Epub 2020 Jan 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRC dyspnea score | MRC Dyspnea Score -Total scale from 1-5, with higher score indicating more perceived breathlessness. | 12 weeks | |
Secondary | Self-reported Chronic Respiratory Questionnaire (CRQ-SR) | 20 item questionnaire, each item score from 1 to 7. Total range from 20-140, with higher score indicating better health outcomes. | 12 weeks | |
Secondary | Visual Analog Scale (VAS) | VAS full range from 0-10, with higher score indicating more fatigue | 12 weeks | |
Secondary | Beck Depression Inventory - short form (BDI-SF) | 13 items, full range from 0-39, with higher score indicating more severe symptoms of depression. | 12 weeks | |
Secondary | General Anxiety Disorder 7-item questionnaire (GAD-7) | The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). Full scale from 0-21, with higher score indicating more symptoms. | 12 weeks | |
Secondary | Hospital Anxiety and Depression Scale (HADS) | Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, scores for each subscale from 0 (normal) to 21 (severe symptoms) with full range from 0 to 42. Higher score indicating more distress. | 12 weeks | |
Secondary | Coronavirus Anxiety Scale (CAS) | 5-item scale, each item scored 0 (not at all) to 4 (nearly every day over the last 2 weeks). Full scale from 0-20, with higher score indicating poorer health outcomes. | 12 weeks | |
Secondary | Fatigue Severity Scale | 9 item scale, each item scored from 1 (strongly disagree) to 7 (strongly agree). Total scale from 9-63, with higher score indicating greater fatigue. | 12 weeks | |
Secondary | The Epworth Sleepiness Scale (ESS | An 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities. Each item is scored from 0, no chance of dozing, to 3, high chance of dozing. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness. | 12 weeks | |
Secondary | EuroQoL 5 dimensions 5 levels (EQ-5D-5L) | The EQ-5D is a generic instrument for describing and valuing health. The new version includes the 5 levels of severity in each of the existing five EQ-5D dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and now called the EQ-5D-5L. Full scale from 5 to 25, with higher score indicating poorer health outcomes. | 12 weeks | |
Secondary | Connor-davidson Resilience Scale (CD-RISC) | Self-report 25-item scale, each item score from 0 (not true at all) to 4 (true nearly all the time). Full scale from 0-100, with higher score indicating better health outcomes. | 12 weeks |
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