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The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One time music therapy
Group music therapy
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • between the ages of 7 and 18
  • diagnosed with asthma

Exclusion Criteria:

  • over 18

Sites / Locations

  • Beth Israel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

One time music therapy session

Weekly group music therapy intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of Life
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.

Secondary Outcome Measures

Increase volume capacity
Spirometry enabled us to analyze the possible effects of wind playing on the child's breathing

Full Information

First Posted
July 24, 2014
Last Updated
July 24, 2014
Sponsor
Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02201836
Brief Title
The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma
Official Title
The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One time music therapy session
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Weekly group music therapy intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
One time music therapy
Intervention Type
Other
Intervention Name(s)
Group music therapy
Primary Outcome Measure Information:
Title
Quality of Life
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Increase volume capacity
Description
Spirometry enabled us to analyze the possible effects of wind playing on the child's breathing
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: between the ages of 7 and 18 diagnosed with asthma Exclusion Criteria: over 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Loewy, DA
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma

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