Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000471280
Ethics application status
Approved
Date submitted
20/05/2009
Date registered
16/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Let's Sing Out!: The effects of singing on quality of life and lung function of children and adolescents with cystic fibrosis
Scientific title
The effects of singing on quality of life and lung function of children and adolescents with cystic fibrosis
Secondary ID [1] 253472 0
Music and health
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis 4821 0
Condition category
Condition code
Human Genetics and Inherited Disorders 237163 237163 0 0
Cystic fibrosis
Respiratory 237257 237257 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised into two groups (treatment vs control) and the treatment group receives eight half-hour individual singing sessions held over a period of 2 weeks during their hospital admission, with a singing teacher.
Intervention code [1] 4597 0
Treatment: Other
Intervention code [2] 236692 0
Other interventions
Comparator / control treatment
Participants in the control group can choose any activity they like to do for eight half-hour individual sessions with a research assistant over a period of 2 weeks during their hospital admission.
Control group
Active

Outcomes
Primary outcome [1] 237982 0
Cystic Fibrosis Questionnaire-Revised (CFQ-R), to assess the effects of the singing program on their perceived quality of life (QoL)
Timepoint [1] 237982 0
pre, post treatment, and at follow-up 4 weeks after completion of singing/control program.
Primary outcome [2] 237983 0
Maximal Inspiratory Pressures using SensorMedics V6200 Autobox (Legacy) total body plethysomograph or P.K. Morgan Pmax pressure manometer (Please note that two Cystic Fibrosis (CF) clinic where the recruitment takes places use different test methods.)
Timepoint [2] 237983 0
pre, post treatment program, and at follow-up 4 weeks after completion of singing/control program.
Secondary outcome [1] 242106 0
Forced Expiratory Volume in one Second (FEV1) using spirometry
Timepoint [1] 242106 0
pre, post treatment program, and at follow-up 4 weeks after completion of singing/control program.
Secondary outcome [2] 242107 0
Participants' singing is assessed using two simple singing tasks (sing a note for as long as possible, and singing "happy birthday song"). Participants' singing is recorded using a Zoom Handy Recorder (H4), Sound Pressure Level Meter (Rion NL-06) and a calibrator (B&K 4231).
Timepoint [2] 242107 0
pre, post treatment program, and at follow-up 4 weeks after completion of singing program.

Eligibility
Key inclusion criteria
Young people with cystic fibrosis (CF), during exacerbation as inpatients
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
lung function measured on spirometry below 20 % of predicted value

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1711 0
4006
Recruitment postcode(s) [2] 1712 0
4101

Funding & Sponsors
Funding source category [1] 4983 0
Self funded/Unfunded
Name [1] 4983 0
Jung Yoon Irons
Country [1] 4983 0
Australia
Primary sponsor type
Individual
Name
Jung Yoon Irons
Address
Sydney Conservatorium of Music, University of Sydney, Cnr Bridge & Macquarie Streets, Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 4505 0
Individual
Name [1] 4505 0
Professor Dianna Kenny
Address [1] 4505 0
Department of Performance Studies, School of Letters, Arts and Media, Faculty of Arts
Cleveland St, Chippendale
The University of Sydney
AUSTRALIA 2006
Country [1] 4505 0
Australia
Other collaborator category [1] 672 0
Individual
Name [1] 672 0
Professor Dr Anne B. Chang
Address [1] 672 0
Queensland Children's Medical Research Institute
The University of Queensland
Brisbane, Queensland
Country [1] 672 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7085 0
Human Research Ethics Committee
Queensland Children's Health Services (RCH)
Ethics committee address [1] 7085 0
Ethics committee country [1] 7085 0
Australia
Date submitted for ethics approval [1] 7085 0
01/10/2007
Approval date [1] 7085 0
01/11/2007
Ethics approval number [1] 7085 0
EC00175
Ethics committee name [2] 7086 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [2] 7086 0
Ethics committee country [2] 7086 0
Australia
Date submitted for ethics approval [2] 7086 0
Approval date [2] 7086 0
Ethics approval number [2] 7086 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29623 0
Address 29623 0
Country 29623 0
Phone 29623 0
Fax 29623 0
Email 29623 0
Contact person for public queries
Name 12870 0
Jung Yoon Irons
Address 12870 0
31 raintree street, Mansfield, Queensland 4122
Country 12870 0
Australia
Phone 12870 0
+61 431246825
Fax 12870 0
Email 12870 0
[email protected]
Contact person for scientific queries
Name 3798 0
Jung Yoon Irons
Address 3798 0
31 raintree street, Mansfield, Queensland 4122
Country 3798 0
Australia
Phone 3798 0
+61 431246825
Fax 3798 0
Email 3798 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.