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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?
Scientific title
Music during flexible cystoscopy to reduce pain and anxiety – a patient blinded multi-centre randomised control trial
Secondary ID [1] 301132 0
Nil known
Universal Trial Number (UTN)
U1111-1250-9596
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bladder cancer 317244 0
Condition category
Condition code
Renal and Urogenital 315378 315378 0 0
Other renal and urogenital disorders
Cancer 315565 315565 0 0
Bladder
Surgery 315566 315566 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 317442 0
Treatment: Other
Comparator / control treatment
No music. The procedure is otherwise identical. This is standard care.
Control group
Active

Outcomes
Primary outcome [1] 323627 0
Pain on visual analogue scale
Timepoint [1] 323627 0
At interview immediately following procedure.
Primary outcome [2] 323628 0
Anxiety on STAI-S
Timepoint [2] 323628 0
At interview immediately following procedure.
Secondary outcome [1] 382428 0
Change in vital signs - HR (BPM) and BP (delta mmHg)
Timepoint [1] 382428 0
At interview immediately following procedure.

Eligibility
Key inclusion criteria
All patients undergoing flexible cystoscopy at the included hospitals.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Over 18, able to consent to participate in study.

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)
Central randomisation.
Patients were enrolled and after being chosen to have the next procedure were randomised by computerised random number generation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16579 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 16580 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 30142 0
2170 - Liverpool
Recruitment postcode(s) [2] 30143 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 305573 0
Government body
Name [1] 305573 0
South Western Sydney Local Health District
Address [1] 305573 0
52 Scrivener St, Warwick Farm NSW 2170
Country [1] 305573 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
52 Scrivener St, Warwick Farm NSW 2170
Country
Australia
Secondary sponsor category [1] 306245 0
None
Name [1] 306245 0
Address [1] 306245 0
Country [1] 306245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305876 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305876 0
Locked Bag 7103, Liverpool BC, NSW, 1871
Ethics committee country [1] 305876 0
Australia
Date submitted for ethics approval [1] 305876 0
15/06/2015
Approval date [1] 305876 0
26/08/2015
Ethics approval number [1] 305876 0
HREC/15/LPOOL/355

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101902 0
Dr Nicola Jeffery
Address 101902 0
Liverpool Hospital,
75 Elizabeth St,
Liverpool, NSW,
2170
Country 101902 0
Australia
Phone 101902 0
+61 02 8738 3000
Fax 101902 0
Email 101902 0
nikki.jeffery@gmail.com
Contact person for public queries
Name 101903 0
Dr George McClintock
Address 101903 0
Lifehouse Hospital,
119-143 Missenden Rd,
Camperdown NSW 2050
Country 101903 0
Australia
Phone 101903 0
+61 02 85140586
Fax 101903 0
Email 101903 0
geo.mcc@gmail.com
Contact person for scientific queries
Name 101904 0
Dr George McClintock
Address 101904 0
Lifehouse Hospital,
119-143 Missenden Rd,
Camperdown NSW 2050
Country 101904 0
Australia
Phone 101904 0
+61 02 85140586
Fax 101904 0
Email 101904 0
geo.mcc@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data collected during the trial, after de-identification;
When will data be available (start and end dates)?
Until 10 years post recruitment
Will be available until Dec 31 2025.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
No restrictions
How or where can data be obtained?
access subject to approvals by publishing researcher
George McClintock, geo.mcc@gmail.com
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7795 0
Study protocol
Citation [1] 7795 0
Link [1] 7795 0
Email [1] 7795 0
geo.mcc@gmail.com
Other [1] 7795 0
Attachment [1] 7795 0
Type [2] 7796 0
Ethical approval
Citation [2] 7796 0
Link [2] 7796 0
Email [2] 7796 0
geo.mcc@gmail.com
Other [2] 7796 0
Attachment [2] 7796 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
No statistical difference was found in pain, anxiety, or vital signs between the patients who underwent flexible cystoscopy with and without music.