ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

8/12/2024

Date data sharing statement initially provided

12/10/2020

Date results provided

8/12/2024

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiac rehabilitation

Pulmonary rehabilitation

Condition category

Condition code

Public Health

Health service research

Physical Medicine / Rehabilitation

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Single time point of survey completion

Primary outcome [2]

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]

Single time point at survey completion

Secondary outcome [1]

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]

Single time point at survey completion

Secondary outcome [2]

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]

Single time point at survey completion

Secondary outcome [3]

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]

Single time point at survey completion

Secondary outcome [4]

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]

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

Completed

Date of first participant enrolment

Anticipated

26/10/2020

Actual

26/10/2020

Date of last participant enrolment

Anticipated

31/01/2021

Actual

23/02/2021

Date of last data collection

Anticipated

28/02/2021

Actual

23/02/2021

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]

University

Name [1]

Monash University

Address [1]

McMahons Road
Frankston 3199 Victoria, Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

24/08/2020

Approval date [1]

04/09/2020

Ethics approval number [1]

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

Dr Annemarie Lee

Address

Department of Physiotherapy
Peninsula Campus
Monash University
McMahons Road
Frankston 3199
Victoria

Country

Australia

Phone

+61 3 99044121

Fax

Annemarie.Lee@monash.edu

Contact person for public queries

Name

Annemarie Lee

Address

Department of Physiotherapy
Peninsula Campus
Monash University
McMahons Road
Frankston 3199
Victoria

Country

Australia

Phone

+61 3 99044121

Fax

Annemarie.Lee@monash.edu

Contact person for scientific queries

Name

Annemarie Lee

Address

Department of Physiotherapy
Peninsula Campus
Monash University
McMahons Road
Frankston 3199
Victoria

Country

Australia

Phone

+61 3 99044121

Fax

Annemarie.Lee@monash.edu

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 (Annemarie.Lee@monash.edu)

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.

Trial Review

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