跳至主要内容
临床试验/NCT02146235
NCT02146235已完成不适用

The Effects of Music Therapy in the Treatment of Chronic Obstructive Pulmonary Disease

Beth Israel Medical Center1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2008年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Chronic Respiratory Questionnaire Self-Reported (CRQ-SR)

研究概览

简要总结

The investigators combine traditional medical care with an integrative modality - Music Therapy specifically including wind playing, singing, and music visualizations- to study the effects on physical function and quality of life for adults with COPD. The primary goals are to increase respiratory function and reduce respiratory symptoms and hospitalizations in order to improve breathing, functional capacity for activities of daily living, psychological well-being and quality of life in adult age 45 and above who are diagnosed with COPD

详细描述

This study examines the effect of a multimodal psycho-music therapy intervention on respiratory symptoms (dyspnea), depression, and quality of life of patients with pulmonary disease during Pumonary Rehabilitation, in the combined effort of two departments of Mount Sinai Beth Israel: The Alice Lawrence Center for Health and Rehabilitation and The Louis Armstrong Center for Music and Medicine

1. Desing The study cohort included patient with at least moderate COPD according to the GOLD classification as well as other chronic disabling respiratory diseases. Inclusion criteria were defined as being enrolled in a Pulmonary Rehabilitation (PR) program as well as the ability to attend music therapy sessions at least once a week for 5 of 6 weekly sessions. The patients were required to be medically stable simultaneously allowing them to participate in the pulmonary rehabilitation program. Standard, routine pulmonary rehabilitative medical care was used as the control to music therapy plus PR and patient selection was provided by a computer generated randomization protocol. The intervention included live music listening with visualization, wind playing and singing undertaken to study their effects on perceived dyspnea, depression and quality of life. Patients were allowed to choose between easy to play wind instruments i.e recorder, slide whistle, harmonica, etc. and instructed on their use. Ninety- eight subjects were evaluated as potential candidates for the study. Thirty of them were excluded because they would not commit to participate in the required number of music therapy sessions either due to the anticipated time commitment or personal/medical concerns. The 68 patients who agreed to participate in the investigation (Age Mean: 70.1), were randomize and 38 were allocated to the treatment group and 30 to the control group. These 68 patients who were newly enrolled in the Alice Lawrence Center had voluntarily sought to participate active PR through advertising and flyers posted in the community and throughout the hospital and affiliated office practices. The weekly music therapy sessions lasted 45 min, for a period of 6 weeks, in groups of 6 participants or less.

2- Method At the beginning and end of each session the patients were asked to score the intensity of current breathlessness by drawing a circle on different pictures of lungs that represented extent of dyspnea (VAS) These recorded measures would be collected at the end of each session, in order to evaluate the subjective effect of the treatment on the patients perception of dyspnea. CRQ and BDI were also administered at the beginning of the PR program and subsequently at 6 weeks, the end of the PR program. In the music therapy group, every session included music visualizations, wind instrument playing, and singing, providing direct methods of working with the breath control and offering active music-making experiences to support optimal breathing, foster self-expression, and increase opportunities for coping with the challenges of chronic respiratory disease.

3-Outcome measures

Primary outcomes were depressive symptoms, disease-specific quality of life factors, and patients' perceived dyspnea:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Patient with at least moderate COPD according to the GOLD classification as well as other chronic disabling respiratory diseases. Inclusion criteria were defined as being enrolled in a Pulmonary Rehabilitation (PR) program as well as the ability to attend music therapy sessions at least once a week for 5 of 6 weekly sessions.
  • •The patients were required to be medically stable simultaneously allowing them to participate in the pulmonary rehabilitation program

排除标准

  • 未提供

研究组 & 干预措施

Treatment Group - Music Therapy

Experimental

The experimental group participates in once weekly group music therapy session for 6 weeks using playing of simple wind instruments, singing, and music visualization. The Music therapy session lasts 45 min. and encourages patients to use breathing techniques to achieve a relaxation response. Extructured techniques involving singing, music improvisation supports breath pattens and provides supporting coping styles. The use of wind instruments involves a focus of breathing efficiently and elongating the exhalation to prolong musical tones and transferring breath control. Music Visualization involving deep breathing techniques provides optimal mind-body connection, influences breathing rhythms through more indirect means while reducing stress, accessing altered states and encourages healing imagery.

干预措施: Psycho-Music Therapy (Behavioral)

Standard Pulmonary Rehabilitation

No Intervention

Pulmonary rehabilitation is a program to people with chronic lung diseases like COPD, emphysema, and chronic bronchitis lead full, satisfying lives and restore them to their highest functional capacity. Pulmonary rehab is aimed to improve quality of life by:

Decreasing respiratory symptoms and complications Encouraging self-management and control over daily functioning Improving physical conditioning and exercise performance Improving emotional well-being Reducing hospitalizations

Pulmonary rehab programs include:

Medical management Exercise Breathing retraining Education Emotional support Nutrition counseling

结局指标

主要结局

Chronic Respiratory Questionnaire Self-Reported (CRQ-SR)

时间窗: up to six weeks

CRQ-SR is divided into four dimensions of dyspnea, fatigue, emotional function and mastery, with a 7-point Likert scale response for each question. Dyspnea relates to a patient's symptoms of shortness of breath and difficulty breathing. Mastery relates to a patient's sense of having control over his or her disease and symptoms. Emotion relates to a patient's general mood. Fatigue relates to a patient's energy level. Patients generally report that they feel better with an average improvement of 0.5 per dimension. Changes between 0.75 and 1.25 represent important changes of moderate magnitude, and changes greater than 1.5 represent important changes of large magnitude.

Perceived dyspnea Visual Analogue Scale (VAS)

时间窗: Treatment group only. It is administrated prior and post every music therapy session. (6 weeks)

A visual analogue scale, consisted in a succession of lung draws representing the breathlessness process with a numerical rating scale. This unidimensional instrument is commonly used in the measurement of dyspnea.

Beck Depression Inventory 2nd edition-Fast Screen (BDI-FS)

时间窗: up to six weeks

BDI-FS), a 7-item subscale of the BDI-II. The BDI-FS measures signs and symptoms such as sadness, pessimism, past failure, anhedonia, self-dislike, self-criticalness, and suicidal thoughts or ideation. (P5:22). Each question on the BDI is answered on a scale of 0-3 (zero being little or none, and 3 representing a high level of the characteristic in question). Therefore the scale for the sum of the 7 questions goes from 0-21. The suggested scoring is 0-3 = minimal symptoms of depression, 4-6 = mild symptoms of depression, 7-9 = moderate symptoms of depression, and 10-21 = severe symptoms of depression.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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