The Effects of a Music Therapy Respiratory Protocol on Post-Covid-19 Respiratory Symptoms
Primary Purpose
Post Covid-19 Respiratory, Dyspnea, SARS-CoV 2
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respiratory Music Therapy Protocol
Sponsored by
About this trial
This is an interventional supportive care trial for Post Covid-19 Respiratory focused on measuring Post-Covid-19, respiratory, pulmonary, music, therapy, music therapy
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
Sites / Locations
- Louis Armstrong Dept. of Music & Medicine, Mount Sinai Beth Israel
- NYC Health & Hospitals - Elmhurst
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Individuals living with post-Covid-19 respiratory symptoms
Arm Description
Live virtual music therapy interventions for people experiencing difficulties breathing after having had COVID-19 (diagnosed or presumed).
Outcomes
Primary Outcome Measures
MRC dyspnea score
MRC Dyspnea Score -Total scale from 1-5, with higher score indicating more perceived breathlessness.
Secondary Outcome Measures
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.
Visual Analog Scale (VAS)
VAS full range from 0-10, with higher score indicating more fatigue
Beck Depression Inventory - short form (BDI-SF)
13 items, full range from 0-39, with higher score indicating more severe symptoms of depression.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05231512
First Posted
February 7, 2022
Last Updated
March 19, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05231512
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Covid-19 Respiratory, Dyspnea, SARS-CoV 2
Keywords
Post-Covid-19, respiratory, pulmonary, music, therapy, music therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individuals living with post-Covid-19 respiratory symptoms
Arm Type
Experimental
Arm Description
Live virtual music therapy interventions for people experiencing difficulties breathing after having had COVID-19 (diagnosed or presumed).
Intervention Type
Other
Intervention Name(s)
Respiratory Music Therapy Protocol
Other Intervention Name(s)
Music therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRC dyspnea score
Description
MRC Dyspnea Score -Total scale from 1-5, with higher score indicating more perceived breathlessness.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Self-reported Chronic Respiratory Questionnaire (CRQ-SR)
Description
20 item questionnaire, each item score from 1 to 7. Total range from 20-140, with higher score indicating better health outcomes.
Time Frame
12 weeks
Title
Visual Analog Scale (VAS)
Description
VAS full range from 0-10, with higher score indicating more fatigue
Time Frame
12 weeks
Title
Beck Depression Inventory - short form (BDI-SF)
Description
13 items, full range from 0-39, with higher score indicating more severe symptoms of depression.
Time Frame
12 weeks
Title
General Anxiety Disorder 7-item questionnaire (GAD-7)
Description
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.
Time Frame
12 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
12 weeks
Title
Coronavirus Anxiety Scale (CAS)
Description
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.
Time Frame
12 weeks
Title
Fatigue Severity Scale
Description
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.
Time Frame
12 weeks
Title
The Epworth Sleepiness Scale (ESS
Description
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.
Time Frame
12 weeks
Title
EuroQoL 5 dimensions 5 levels (EQ-5D-5L)
Description
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.
Time Frame
12 weeks
Title
Connor-davidson Resilience Scale (CD-RISC)
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne V Loewy, DA
Organizational Affiliation
Director Louis Armstrong Center for Music & Medicine,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Armstrong Dept. of Music & Medicine, Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NYC Health & Hospitals - Elmhurst
City
New York
State/Province
New York
ZIP/Postal Code
11373
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data is specific to this study only
Citations:
PubMed Identifier
31906748
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.
Results Reference
background
PubMed Identifier
26522499
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.
Results Reference
background
Learn more about this trial
The Effects of a Music Therapy Respiratory Protocol on Post-Covid-19 Respiratory Symptoms
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