NCT05231512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

February 7, 2022

Last Update Submit

February 13, 2024

Conditions

Post Covid-19 RespiratoryDyspneaSARS-CoV 2

Keywords

Post-Covid-19respiratorypulmonarymusictherapymusic therapy

Outcome Measures

Primary Outcomes (1)

  • MRC dyspnea score

    MRC Dyspnea Score -Total scale from 1-5, with higher score indicating more perceived breathlessness.

    12 weeks

Secondary Outcomes (10)

  • Self-reported Chronic Respiratory Questionnaire (CRQ-SR)

    12 weeks

  • Visual Analog Scale (VAS)

    12 weeks

  • Beck Depression Inventory - short form (BDI-SF)

    12 weeks

  • General Anxiety Disorder 7-item questionnaire (GAD-7)

    12 weeks

  • Hospital Anxiety and Depression Scale (HADS)

    12 weeks

  • +5 more secondary outcomes

Study Arms (1)

Individuals living with post-Covid-19 respiratory symptoms

EXPERIMENTAL

Live virtual music therapy interventions for people experiencing difficulties breathing after having had COVID-19 (diagnosed or presumed).

Other: Respiratory Music Therapy Protocol

Interventions

Respiratory Music Therapy ProtocolOTHER

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.

Also known as: Music therapy
Individuals living with post-Covid-19 respiratory symptoms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older

You may not qualify if:

  • Under 18 years
  • MRC Dyspnea Score of grade 1 or 2
  • Presence of respiratory issues without confirmed or presumptive COVID-19 diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Louis Armstrong Dept. of Music & Medicine, Mount Sinai Union Square

New York, New York, 10003, United States

Location

NYC Health & Hospitals - Elmhurst

New York, New York, 11373, United States

Location

Related Publications (2)

  • 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.

    PMID: 31906748BACKGROUND

  • 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.

    PMID: 26522499BACKGROUND

MeSH Terms

Conditions

Dyspnea

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joanne V Loewy, DA

    Director Louis Armstrong Center for Music & Medicine,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor, Director Louis Armstrong Dept. of Music & Medicine

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 9, 2022

Study Start

January 13, 2022

Primary Completion

March 13, 2023

Study Completion

March 13, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

The data is specific to this study only

Locations

US(2)