Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001031954
Ethics application status
Approved
Date submitted
14/08/2020
Date registered
12/10/2020
Date last updated
12/10/2020
Date data sharing statement initially provided
12/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of ambient and individual music listening during pulmonary and cardiac rehabilitation programs in Australia
Scientific title
An online survey of the use of ambient and individual music listening during pulmonary and cardiac rehabilitation programs in Australia
Secondary ID [1] 302041 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac rehabilitation
 318626 0
Pulmonary rehabilitation 318627 0
Condition category
Condition code
Public Health 316644 316644 0 0
Health service research
Physical Medicine / Rehabilitation 316645 316645 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This survey will ask questions about the use of ambient (background) music during pulmonary or cardiac rehabilitation exercise sessions, including the type of music selected, who makes the selection and the reasons for this selection. It will also ask questions as to whether participants in pulmonary or cardiac rehabilitation engage with their own music listening during exercise sessions. If so, questions will include the type of music selected and the reasons for this section. The survey will take approximately 5 minutes to complete. An online survey administered by Qualtrics will be used to collect this data. This survey has been specifically designed for this study. Pulmonary rehabilitation or cardiac rehabilitation programs in Australia who are registered with the Lung Foundation Australia pulmonary rehabilitation database or the Australian Cardiac Rehabilitation Association network respectively will be invited to participate by email, following endorsement and approval of this project by both organisations. Potential participants will be emailed an introduction to the study, following by a link to the explanation and consent form and the online survey. A separate survey will be sent to cardiac rehabilitation and pulmonary rehabilitation clinicians. Completion of the survey will be required once. The participants can complete the survey at any time, as they are coordinators or instructors of these program and questions are not specific to individual participants involvement or completion of a rehabilitation program. To maximise uptake, 1 reminder email will be sent to potential participants, one month after the initial invitation email. Data will be extracted from Qualtrics in a de-identified manner.
Intervention code [1] 318337 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324764 0
Use of ambient (background) music during exercise sessions in pulmonary or cardiac rehabilitation. This will assessed using a yes/no response and will be analysed via counts and percentages.
Timepoint [1] 324764 0
Single time point of survey completion
Primary outcome [2] 324765 0
Use of individual patient self-selected music listening during pulmonary or cardiac rehabilitation exercise sessions. This will assessed using a yes/no response and will be analysed via counts and percentages.
Timepoint [2] 324765 0
Single time point at survey completion
Secondary outcome [1] 385704 0
Genre(s) of ambient (background) music played during exercise sessions during pulmonary or cardiac rehabilitation. This will be analysed via counts and percentages for specific genres.
Timepoint [1] 385704 0
Single time point at survey completion
Secondary outcome [2] 385705 0
Factors influencing the selection of ambient (background) music genre played during exercise sessions for cardiac or pulmonary rehabilitation.This will be analysed via counts and percentages for specific reasons.
Timepoint [2] 385705 0
Single time point at survey completion
Secondary outcome [3] 385706 0
Genre(s) of individual patient self-selected music listening during exercise sessions during pulmonary or cardiac rehabilitation.This will be analysed via counts and percentages for specific genres.
Timepoint [3] 385706 0
Single time point at survey completion
Secondary outcome [4] 385707 0
Factors influencing the self-selected music listening genre used by individual participants during exercise sessions for cardiac or pulmonary rehabilitation.This will be analysed via counts and percentages for specific reasons.
Timepoint [4] 385707 0
Single time point at survey completion.

Eligibility
Key inclusion criteria
Key inclusion criteria are that participants are program coordinators or are involved in the delivery of pulmonary rehabilitation or cardiac rehabilitation programs in Australia and are registered with the Lung Foundation Australia's pulmonary rehabilitation database or with the Australian Cardiac Rehabilitation Association.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None for clinicians.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The absolute number and percentage of responses will be recorded for each question. Counts and proportion, means and standard deviations and median and interquartile ranges will be calculated as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2020
Actual
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
28/02/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306464 0
University
Name [1] 306464 0
Monash University
Country [1] 306464 0
Australia
Primary sponsor type
Individual
Name
Annemarie Lee
Address
Department of Physiotherapy
Monash University
McMahons Road
Frankston 3199, Victoria
Country
Australia
Secondary sponsor category [1] 306981 0
None
Name [1] 306981 0
Address [1] 306981 0
Country [1] 306981 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306669 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 306669 0
Faculty Research Office
Faculty of Medicine, Nursing and Health Sciences
35 Rainforest Walk (Level 5),
Monash University,
Wellington Road, Clayton
Victoria 3800.
Ethics committee country [1] 306669 0
Australia
Date submitted for ethics approval [1] 306669 0
24/08/2020
Approval date [1] 306669 0
04/09/2020
Ethics approval number [1] 306669 0
25734

Summary
Brief summary
Pulmonary and cardiac rehabilitation programs are part of standard care for people with chronic respiratory conditions and cardiac disease. As part of these programs, a mix of endurance and resistance exercise training is undertaken, with the benefits of improving exercise tolerance, reducing symptoms, improving quality of life and reducing the risk of future cardiac events. However, some individuals undertaking a pulmonary or cardiac rehabilitation program achieve minimal benefit. For some individuals in pulmonary rehabilitation, this has been attributed to symptoms of breathlessness or fatigue which may reduce the adherence to an exercise program. In cardiac rehabilitation, compliance may be dependent on the degree of pleasure experienced during the program as well as motivation and family support. In healthy people, listening to music during exercise can reduce the perception of fatigue or breathlessness and this has been linked to achievement in greater exercise intensity, due to the distraction of the music listening. To maximise the benefits of music listening, the tempo of the music and type of music are both important.
It is thought that music listening during cardiac and pulmonary rehabilitation programs may optimise the benefits of these exercise sessions, as it may desensitise individuals to their symptoms of breathlessness and fatigue and may enhance motivation for attending these programs.
Anecdotally, background music is often played during cardiac or pulmonary rehabilitation programs as part of clinical practice. However, the use of background music in these program, the actual choice of music and the reasons for these choices have not been examined. In addition, while individuals attending these programs may choose to listen to their own music choices, but the frequency to which this occurs, the interface used for self-selected music listening and the reasons for self-selected music choices have not been examined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104618 0
Dr Annemarie Lee
Address 104618 0
Department of Physiotherapy
Peninsula Campus
Monash University
McMahons Road
Frankston 3199
Victoria
Country 104618 0
Australia
Phone 104618 0
+61 3 99044121
Fax 104618 0
Email 104618 0
[email protected]
Contact person for public queries
Name 104619 0
Dr Annemarie Lee
Address 104619 0
Department of Physiotherapy
Peninsula Campus
Monash University
McMahons Road
Frankston 3199
Victoria
Country 104619 0
Australia
Phone 104619 0
+61 3 99044121
Fax 104619 0
Email 104619 0
[email protected]
Contact person for scientific queries
Name 104620 0
Dr Annemarie Lee
Address 104620 0
Department of Physiotherapy
Peninsula Campus
Monash University
McMahons Road
Frankston 3199
Victoria
Country 104620 0
Australia
Phone 104620 0
+61 3 99044121
Fax 104620 0
Email 104620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Frequency of use of ambient (background) music during exercise sessions in pulmonary or cardiac rehabilitation, common genres of music selected and reasons for these choices.
Frequency of use of individual patient self-selected music listening during exercise sessions in pulmonary or cardiac rehabilitation, common genres of music selected and reasons for these choices.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims of the approved proposal
How or where can data be obtained?
Data will be sored in Bridges, to which the Principal Investigator has access to at Monash University. Access to this data will be subject to approval by the Principal investigator ([email protected])


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.