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Music Therapy in the Treatment of Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT02146235
First received: May 21, 2014
Last updated: May 22, 2014
Last verified: May 2014
  Purpose
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

Condition Intervention
Pulmonary Diseases
Behavioral: Psycho-Music Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Music Therapy in the Treatment of Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Chronic Respiratory Questionnaire Self-Reported (CRQ-SR) [ Time Frame: 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.

  • Beck Depression Inventory 2nd edition-Fast Screen (BDI-FS) [ Time Frame: 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.

  • Perceived dyspnea Visual Analogue Scale (VAS) [ Time Frame: 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.


Enrollment: 68
Study Start Date: June 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group - Music Therapy
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.
Behavioral: Psycho-Music Therapy
No Intervention: Standard Pulmonary Rehabilitation

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


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02146235

Locations
United States, New York
Mount Sinai Beth Israel
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Johnson & Johnson
  More Information

Publications:
Goodridge D, Nicol JJ, Horvey KJ, Butcher S. Therapeutic Singing as an Adjunct for Pulmonary Rehabilitation Participants With COPD Outcomes of a Feasibility Study. Music and Medicine 2013; 5(3): 169-176.
Bouhuys A (1968) Pressure-flow events during wind instrument playing. Ann New York Acad Sci 155(1):264-275

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT02146235     History of Changes
Other Study ID Numbers: 081-08
Study First Received: May 21, 2014
Last Updated: May 22, 2014

Keywords provided by Beth Israel Medical Center:
Music Therapy
Pulmonary Disease
COPD
Music Visualization
Therapeutic Singing
Wind-playing
Lung Condition

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 25, 2017