NCT02201836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

6 years

First QC Date

July 24, 2014

Last Update Submit

July 24, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Increase volume capacity

    6 months

Study Arms (3)

One time music therapy session

ACTIVE COMPARATOR

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.

Other: One time music therapy

Weekly group music therapy intervention

ACTIVE COMPARATOR

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.

Other: Group music therapy

Control

NO INTERVENTION

Interventions

One time music therapy session
Weekly group music therapy intervention

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • over 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Joanne Loewy, DA

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 28, 2014

Study Start

January 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations