Clinical trial NCT02146235: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Diseases
Keywords: Music Therapy
Pulmonary Disease
COPD
Music Visualization
Therapeutic Singing
Wind-playing
Lung Condition
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2014-05-23
Enrollment: 68
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Chronic Respiratory Questionnaire Self-Reported (CRQ-SR)
timeFrame: up to six weeks
measure: Beck Depression Inventory 2nd edition-Fast Screen (BDI-FS)
timeFrame: up to six weeks
measure: Perceived dyspnea Visual Analogue Scale (VAS)
timeFrame: Treatment group only. It is administrated prior and post every music therapy session. (6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
Study officials:
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