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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12620000608965
Ethics application status
Approved
Date submitted
2/05/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Date results information initially provided
25/05/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Does music during flexible cystoscopy reduce pain and anxiety?
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Scientific title
Music during flexible cystoscopy to reduce pain and anxiety – a patient blinded multi-centre randomised control trial
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Secondary ID [1]
301132
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Nil known
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Universal Trial Number (UTN)
U1111-1250-9596
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
bladder cancer
317244
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Condition category
Condition code
Renal and Urogenital
315378
315378
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0
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Other renal and urogenital disorders
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Cancer
315565
315565
0
0
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Bladder
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Surgery
315566
315566
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention: Presence of music
During flexible cystoscopy, music played to patients to determine if this deceases their pain and anxiety. Patients do not get to choose the music. It will be delivered via a speaker in the procedure room, which will be otherwise identical.
The intervention will be delivered a single time, for the length of time that the patient is in the procedure room.
Music was slow tempo piano music from the Album “Easy Listening: Music for Quiet Moments” (SPG Records 2003) via a speaker within the procedure room. Volume was less than that of normal conversation, but easily audible.
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Intervention code [1]
317442
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Treatment: Other
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Comparator / control treatment
No music. The procedure is otherwise identical. This is standard care.
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain on visual analogue scale
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Assessment method [1]
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0
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Timepoint [1]
323627
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At interview immediately following procedure.
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Primary outcome [2]
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Anxiety on STAI-S
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Assessment method [2]
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Timepoint [2]
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At interview immediately following procedure.
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Secondary outcome [1]
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Change in vital signs - HR (BPM) and BP (delta mmHg)
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Assessment method [1]
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Timepoint [1]
382428
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At interview immediately following procedure.
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Eligibility
Key inclusion criteria
All patients undergoing flexible cystoscopy at the included hospitals.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Over 18, able to consent to participate in study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation.
Patients were enrolled and after being chosen to have the next procedure were randomised by computerised random number generation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised random number generator.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The study was powered to detect a minimally clinically significant difference of 1 point on a ten point VAS pain scale, and 5 points on the STAI-S. A sample size of n = 72 (n = 36 in each group) (P < 0.05, power 0.80) was required based on previous studies of pain in flexible cystoscopy.
The two groups compared using the independent t-test and chi-square tests. Statistical significance was defined as P < 0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
25/09/2015
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Date of last participant enrolment
Anticipated
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Actual
17/12/2015
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Date of last data collection
Anticipated
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Actual
17/12/2015
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Sample size
Target
72
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Accrual to date
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Final
109
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
16580
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Campbelltown Hospital - Campbelltown
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Recruitment postcode(s) [1]
30142
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2170 - Liverpool
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Recruitment postcode(s) [2]
30143
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2560 - Campbelltown
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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South Western Sydney Local Health District
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Address [1]
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52 Scrivener St, Warwick Farm NSW 2170
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Country [1]
305573
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Australia
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Primary sponsor type
Government body
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Name
South Western Sydney Local Health District
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Address
52 Scrivener St, Warwick Farm NSW 2170
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
306245
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Country [1]
306245
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305876
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South Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
305876
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Locked Bag 7103, Liverpool BC, NSW, 1871
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Ethics committee country [1]
305876
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Australia
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Date submitted for ethics approval [1]
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15/06/2015
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Approval date [1]
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26/08/2015
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Ethics approval number [1]
305876
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HREC/15/LPOOL/355
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Summary
Brief summary
Purpose : Flexible cystoscopy is a common urological procedure, however it is often painful and this pain can lead to loss of patients to follow up. Music has been studied as an adjunct to pain management in multiple fields including urology. Previous research has been performed unblinded, we believe this may be a contributor to previous positive findings of the effect of music on pain.
Methods: We performed a patient blinded randomised control trial of music during flexible cystoscopy comparing the pain, measured by visual analogue scale (VAS), anxiety (measured by the state trait anxiety inventory (STAI)) and vital signs of 109 patients across two public hospitals in NSW, Australia. Patients were blinded to the purpose of the study until after results had been collected.
Results: No statistically significant differences were detected between the Non-Music and Music groups in VAS pain score (2.04±1.94 vs 2.10±1.90, P=0.86), change in STAI anxiety score (4.87±9.87 vs 6.8±11.07, P=0.33) or post procedural vital signs (HR 74±14 vs 72±13, P=0.66, SBP 144±20 vs 141±19, P=0.47) between the two groups.
Conclusion: Music does not appear to decrease perceived pain or anxiety when used during flexible cystoscopy. These findings may differ from the literature due to a number of factors including patient blinding, ethnic makeup of the study population or no of choice of music.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Nicola Jeffery
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Address
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Liverpool Hospital,
75 Elizabeth St,
Liverpool, NSW,
2170
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Country
101902
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Australia
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Phone
101902
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+61 02 8738 3000
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Fax
101902
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Email
101902
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[email protected]
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Contact person for public queries
Name
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Dr George McClintock
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Address
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Lifehouse Hospital,
119-143 Missenden Rd,
Camperdown NSW 2050
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Country
101903
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Australia
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Phone
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+61 02 85140586
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Fax
101903
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr George McClintock
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Address
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Lifehouse Hospital,
119-143 Missenden Rd,
Camperdown NSW 2050
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Country
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Australia
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Phone
101904
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+61 02 85140586
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Fax
101904
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Email
101904
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
individual participant data collected during the trial, after de-identification;
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When will data be available (start and end dates)?
Until 10 years post recruitment
Will be available until Dec 31 2025.
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Available to whom?
Only researchers who provide a methodologically sound proposal
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Available for what types of analyses?
No restrictions
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How or where can data be obtained?
access subject to approvals by publishing researcher
George McClintock,
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7795
Study protocol
[email protected]
7796
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Music during flexible cystoscopy for pain and anxiety - a patient-blinded randomised control trial.
2021
https://dx.doi.org/10.1111/bju.15527
N.B. These documents automatically identified may not have been verified by the study sponsor.
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