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Music Therapy in the Treatment of Chronic Obstructive Pulmonary Disease

Primary Purpose

Pulmonary Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psycho-Music Therapy
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Diseases focused on measuring Music Therapy, Pulmonary Disease, COPD, Music Visualization, Therapeutic Singing, Wind-playing, Lung Condition

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Sites / Locations

  • Mount Sinai Beth Israel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group - Music Therapy

Standard Pulmonary Rehabilitation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Chronic Respiratory Questionnaire Self-Reported (CRQ-SR)
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.
Beck Depression Inventory 2nd edition-Fast Screen (BDI-FS)
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.
Perceived dyspnea Visual Analogue Scale (VAS)
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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2014
Last Updated
May 22, 2014
Sponsor
Beth Israel Medical Center
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT02146235
Brief Title
Music Therapy in the Treatment of Chronic Obstructive Pulmonary Disease
Official Title
The Effects of Music Therapy in the Treatment of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center
Collaborators
Johnson & Johnson

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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: Depressive symptoms were evaluated using the Beck Depression Inventory 2nd edition-Fast Screen (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. Disease-specific quality of life as measured by the Chronic Respiratory Questionnaire Self-Reported (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. We measured CRQ-SR domain scores at the time of enrolment in the study and again at completion, immediately following the final session after six weeks). Visual Analogue Scale (VAS) scale. This measures perceived dyspnea or breathlessness in participants during the music therapy sessions. The VAS is widely used in the measurement of breathlessness as well as other symptoms, e.g. pain, anxiety (annotate to appendix) 4-Statistical analysis Each of the dependent measures of primary outcomes (Depression, Dyspnea, and Health-Related Quality of Life) was analyzed using a generalized linear mixed model (SAS Proc GLIMMIX, SAS 9.3) involving a single between subjects factor (Treatment vs. Control) and a single within subjects factor (Period - enrollment vs. follow up 6 weeks later) Test of Treatment Group differences at Enrollment and at 6 weeks were made using planned contrast on the Least-Square means.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Diseases
Keywords
Music Therapy, Pulmonary Disease, COPD, Music Visualization, Therapeutic Singing, Wind-playing, Lung Condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group - Music Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Pulmonary Rehabilitation
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Psycho-Music Therapy
Primary Outcome Measure Information:
Title
Chronic Respiratory Questionnaire Self-Reported (CRQ-SR)
Description
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.
Time Frame
up to six weeks
Title
Beck Depression Inventory 2nd edition-Fast Screen (BDI-FS)
Description
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.
Time Frame
up to six weeks
Title
Perceived dyspnea Visual Analogue Scale (VAS)
Description
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.
Time Frame
Treatment group only. It is administrated prior and post every music therapy session. (6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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
Facility Information:
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

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Music Therapy in the Treatment of Chronic Obstructive Pulmonary Disease

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