跳至主要内容
临床试验/NCT05231512
NCT05231512已完成不适用

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

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2022年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
MRC dyspnea score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

MRC dyspnea score

时间窗: 12 weeks

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

次要结局

  • Visual Analog Scale (VAS)(12 weeks)
  • Connor-davidson Resilience Scale (CD-RISC)(12 weeks)
  • The Epworth Sleepiness Scale (ESS(12 weeks)
  • Self-reported Chronic Respiratory Questionnaire (CRQ-SR)(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)
  • Coronavirus Anxiety Scale (CAS)(12 weeks)
  • Fatigue Severity Scale(12 weeks)
  • EuroQoL 5 dimensions 5 levels (EQ-5D-5L)(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne Loewy

Associate Clinical Professor, Director Louis Armstrong Dept. of Music & Medicine

Icahn School of Medicine at Mount Sinai

研究点 (2)

Loading locations...

相似试验