The Effects of a Music Therapy Respiratory Protocol on Post-Covid-19 Respiratory Symptoms

Dyspnea Clinical Trial

Official title:

The Effects of a Music Therapy Respiratory Protocol on Post-Covid Respiratory Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05231512
• Other study ID #: STUDY 20-02110
• Status: Completed
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: March 13, 2023

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• COVID-19
• Dyspnea
• SARS-CoV 2
• Signs and Symptoms, Respiratory

Intervention

Other:
• Respiratory Music Therapy Protocol
Participants will engage in eight (8) 45-minute virtual music therapy groups containing up to 6 participants over the course of 8 weeks. Within these groups, participants will be invited to use instruments provided including a Yamaha recorder and a Grover Trophy slide whistle. 45 minute virtual music therapy sessions facilitated by board-certified music therapy will consist of music-assisted relaxation through music visualization, followed by gentle pulmonary exercise via wind instrumental playing, and concluding with group singing.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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