- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02201836
The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma
July 24, 2014 updated by: Beth Israel Medical Center
The onset of asthma is particularly frightening for children.
When the symptoms of asthma decrease, children and parents forget about the maintenance and control of breath and lung volume.
Because adherence is so poor, asthma is known as the emergency room illness.
The playing of a wind instrument is a unique way to provide a creative means for children and teens to understand both the impact of diaphramatic breathing and their ability to control it as well.
This study builds upon the evidence, though sparse, that suggest that the blowing of a wind instrument with clinical music therapy intervention strengthens the muscles of breathing and fortifies the incentive toward attending to the daily symptoms and general management of asthma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10003
- Beth Israel Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- between the ages of 7 and 18
- diagnosed with asthma
Exclusion Criteria:
- over 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
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Active Comparator: One time music therapy session
One time music therapy session which consists of music meditation, including as assessment/evaluation of confined body breathing function as expressed through drawing and coloring post music imagery session.
This is followed by an entrainment wind playing/breath expansion music therapy intervention.
At the end of the session, the subjects are given a donated wind instrument for play at home.
|
|
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Active Comparator: Weekly group music therapy intervention
The weekly group music therapy intervention consists of children and teens using guided visualization and expressing their fears and or fantasies related to breathing with one another.
This is followed by creative music improvisations with part-playing on flutes, slide whistles, recorders and melodicas.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life
Time Frame: 6 months
|
The Juniper Questionnaire is a stringent quality of life measure that provides interview for children and teens and their parents.
It is one of the few scales that requires these interviews to occur separately, so that children and parents do not feel compelled to answer what they think the other desires to hear.
We also used take home journals and a comprehensive medical assessment to learn of ER visits, missed school days, avoidance of medication, and allergens in the home, as well as socio-economic status - these factors are known in the literature to effect outcomes and exacerbations with this population.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increase volume capacity
Time Frame: 6 months
|
Spirometry enabled us to analyze the possible effects of wind playing on the child's breathing
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanne Loewy, DA, Beth Israel Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
July 24, 2014
First Submitted That Met QC Criteria
July 24, 2014
First Posted (Estimate)
July 28, 2014
Study Record Updates
Last Update Posted (Estimate)
July 28, 2014
Last Update Submitted That Met QC Criteria
July 24, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 142-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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