Clinical trial NCT05231512: The Effects of a Music Therapy Respiratory Protocol on Post-Covid-19 Respiratory Symptoms
Official title: The Effects of a Music Therapy Respiratory Protocol on Post-Covid Respiratory Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Covid-19 Respiratory
Dyspnea
SARS-CoV 2
Keywords: Post-Covid-19
respiratory
pulmonary
music
therapy
music therapy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Since November 2019, the SARS-CoV-2 (COVID-19) virus has rapidly spread to countries across the globe. The COVID-19 pandemic is particularly destructive in the U.S., where, as of August 2020, total case numbers exceed 4 million. Recovering patients of COVID-19 report symptoms of fatigue, dyspnea (shortness of breath) and other pulmonary dysfunctions. A study conducted in Italy, where cases spiked to around 40,000 in March, showed that 87.4% of participants with post-acute COVID-19 experience at least one persistent symptom. Pulmonologists facing the pressing challenge of creating a respiratory rehabilitation program for recovering COVID-19 patients can benefit from integrating music therapy into their practice. Music therapy is the use of music, vocal or instrumental, to therapeutically address the holistic needs of a patient. Several studies have been conducted in the past investigating the neurological and physiological benefits of music therapy for patients engaging in breath regulation, and with pulmonary dysfunction such as COPD or asthma. At Mount Sinai Beth Israel, the Louis Armstrong Department of Music Therapy provides the Music for AIR (Advances in Respiration) programs to treat patients with lung disease, especially those with COPD. Music for AIR has successfully used wind instrument playing, singing, and music visualization to ease common symptoms of COPD including dyspnea and fatigue. As dyspnea and fatigue are also common persisting symptoms of patients recovering from COVID-19, Music for AIR interventions and its possible therapeutic benefits for recovering COVID-19 patients warrant a necessary investigation. Currently, there is no research looking specifically at music therapy as a modality of treatment for physical symptoms in post-COVID-19 patients. Thus, the aim of this study is to utilized previously validated interventions to measure efficacy in this unique population.COVID-19 affects multiple organs and systems. Current evidence shows that effects of the virus have surpassed the acute phase, manifesting in residual symptoms in neurological, physical, cognitive, pulmonary, and emotional areas. Music therapy is a clinical therapy that has demonstrated efficacy in improving function in these aforementioned areas. The purpose of this study is to examine clinical music therapy - specifically including wind playing, singing, and music visualizations - to study the effects on physical function and quality of life for adults experiencing shortness of breath who have been previously diagnosed with (or presumptive) COVID-19. This study aims to test a previously studied music therapy protocol on patients presenting with continued respiratory symptoms following confirmed or presumed COVID-19 diagnosis over an 8-week period within a virtual group setting. Secondary aims to be monitored are any changes in depression, anxiety, fatigue, sleep, quality of life, and resilience.

Eligibility criteria: 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

Primary outcomes:
measure: MRC dyspnea score
timeFrame: 12 weeks
Secondary outcomes:
measure: Self-reported Chronic Respiratory Questionnaire (CRQ-SR)
timeFrame: 12 weeks
measure: Visual Analog Scale (VAS)
timeFrame: 12 weeks
measure: Beck Depression Inventory - short form (BDI-SF)
timeFrame: 12 weeks
measure: General Anxiety Disorder 7-item questionnaire (GAD-7)
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: Coronavirus Anxiety Scale (CAS)
timeFrame: 12 weeks
measure: Fatigue Severity Scale
timeFrame: 12 weeks
measure: The Epworth Sleepiness Scale (ESS
timeFrame: 12 weeks
measure: EuroQoL 5 dimensions 5 levels (EQ-5D-5L)
timeFrame: 12 weeks
measure: Connor-davidson Resilience Scale (CD-RISC)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Louis Armstrong Dept. of Music & Medicine, Mount Sinai Union Square
state: New York
city: New York
country: United States
facility: NYC Health & Hospitals - Elmhurst
state: New York
Study officials:
affiliation: Director Louis Armstrong Center for Music & Medicine,
name: Joanne V Loewy, DA
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.