AsthmaNCT02201836
The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma
A study testing One time music therapy and Group music therapy in people with Asthma, run by Beth Israel Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- One time music therapy and Group music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- between the ages of 7 and 18
- diagnosed with asthma
Who cannot join
- over 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
New York, New York, 10003
About this study
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.
- Conditions
- Asthma
- Being tested
- One time music therapy, Group music therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One time music therapyOther
Group music therapyOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Group music therapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Increase volume capacity
Spirometry enabled us to analyze the possible effects of wind playing on the child's breathing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJan 2006
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Loewy, DA, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201836
- Sponsor's protocol ID
- 142-04
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma
- ClinicalTrials.gov ID
- NCT02201836
- Acronym / sponsor ID
- 142-04
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One time music therapy session | Active comparator | Other: One time music therapyOne 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. |
| Weekly group music therapy intervention | Active comparator | Other: Group music therapyThe 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- between the ages of 7 and 18
- diagnosed with asthma
Key exclusion criteria (1 listed)
- over 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One time music therapy | Other | One time music therapy session |
| Group music therapy | Other | Weekly group music therapy intervention |
Primary outcome
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.
1 secondary outcome
Increase volume capacity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Loewy, DA principal investigator
Beth Israel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One time music therapy and Group music therapy in people with Asthma, run by Beth Israel Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.