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Trial registered on ANZCTR

Registration number

ACTRN12615001109594

Ethics application status

Approved

Date submitted

7/10/2015

Date registered

21/10/2015

Date last updated

21/10/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Value of Audio Devices in the Endoscopy Room (VADER) study: a randomised
control trial

Scientific title

The value of different genres of music on the performance quality of colonoscopy

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1175-3086

Trial acronym

VADER

Linked study record

Health condition

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

Quality of colonoscopy

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

To evaluate the effect of Star Wars music (SW) compared to endoscopist-selected
popular music (PM) on quality outcomes in colonoscopy
Patients would be randomised using a coin toss by the endoscopist prior to colonoscopy to determine which music would be played; heads for Star Wars music (SW), tails for
endoscopist- selected popular music (PM), which includes music of all genres but that are part of the endoscopist's list with the exception of epic movie soundtracks. These would be stored on the same personal computer used in the endoscopy room with each endoscopist having his own popular music selection.

The music would be played through a personal computer in the endoscopy suite at a volume of between approximately 40 and 70 decibels and would be started just prior to commencement of the colonoscopy,after patient were sedated, and stopped upon finishing the procedure.

Patients Would be blinded to the music type being used.

There are Five endoscopists participating in the study, one consultant with more than ten years experience and four specialist registrars with one to two years experience.
All colonoscopies were performed under anaesthetist administered monitored sedation with intravenous propofol.
An independent member of the endoscopy team keeps timing of procedures
and endoscopists are blinded to the timing of the procedure. Timing of the procedure is commenced at time of entering the anus and continued until the scope is
withdrawn from the colon.

Intervention code [1]

Other interventions

Comparator / control treatment

The control group includs patients in whom the coin toss results in tails. The music that would be played is endoscopist-selected popular music (PM),which includes music of all genres but that are part of the endoscopist's list with the exception of epic movie soundtracks
As above the music would be played through a personal computer in the endoscopy suite at a volume of between approximately 40 and 70 decibels and would be started just prior to commencement of the colonoscopy,after patient were sedated, and stopped upon finishing the procedure.

These would be stored on the same personal computer used in the endoscopy room.

Everything else would be measured and carried out the same way as in the intervention group.

Patients Would blinded to the music type being used.

Control group

Active

Outcomes

Primary outcome [1]

Polyp detection rate(PDR).The PDR was defined as the
number of colonoscopies in which one or more polyps were removed, divided by the total number of colonoscopies performed.

The data would be collected by an independant memeber of the endoscopy team at the time of the colonoscopy and saved on an excel spreadsheet to be used to measure outcome.

Timepoint [1]

The data collected at the time of colonoscopy and stored on an excel spreadsheet would be analyzed at the end of study.

Primary outcome [2]

Adenoma dection rate (ADR) . The ADR was defined as the number of colonoscopies
in which one or more adenomas were removed, divided by the total number of
colonoscopies.

The data would be collected by an independant memeber of the endoscopy team at the time of the colonoscopy and saved on an excel spreadsheet to be used to measure

Timepoint [2]

The data collected at the time of colonoscopy and stored on an excel spreadsheet would be analyzed at the end of study..

Primary outcome [3]

Procedure time was assessed by an independant memeber of the endoscopy team using the endosopcy software ProVation (registered trademark) MD software(ProVation Medical, Minneapolis, USA), which allows recording the time of insertion , time of reaching caecum and time of withdrawl as part of quality measure and documentation. This was utilized in measuring our procedure time.

Timepoint [3]

from the time of entering the anus to the time the colonoscope is withdrawn from the colon.

Secondary outcome [1]

Adenoma per colonoscopy (APC) defined as the total number of adenomas detected divided by the number of colonoscopies.

The data would be collected by an independant memeber of the endoscopy team at the time of the colonosopcy and saved on an excel spreadsheet to be used to measure outcome.

Timepoint [1]

The data collected at the time of colonoscopy and stored on an excel spreadsheet would be analyzed at the end of study.

Eligibility

Key inclusion criteria

All patients undergoing colonoscopy for any indication are included.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Situations in which music can't be played in the endoscopy room.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using procedures like coin-tossing

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size a background polyp incidence of 26% with an assumed relative benefit of 2 from Star Wars music, a power of 0.8 and a confidence level of 0.95 we estimated a sample size of 104 patients (52 per group).

Data would be analysed using the statistical software GraphPad Prism Version 6 (California, USA). Non-parametric data comparisons between two groups use Mann-Whitney tests to determine differences in procedure time , PDR and ADR . A P-value = 0.05 was used as the statistical significance level.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

30/06/2015

Date of last participant enrolment

Anticipated

Actual

30/08/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

104

Accrual to date

Final

104

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

None

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Zaid Ardalan

Address

Austin hospital
145 studley road
Heidelberg
Melbourne 3084
VIC

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Abhinav Vasudevan

Address [1]

Austin hospital
145 studley road
Heidelberg
Melbourne 3084
VIC

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Simon Hew

Address [1]

Austin hospital
145 studley road
Heidelberg
Melbourne 3084
VIC

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee (HREC)

Ethics committee address [1]

145 studley road 
Heidelberg 
Melbourne 
3084
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/08/2015

Approval date [1]

04/09/2015

Ethics approval number [1]

LNR/15/Austin/372

Summary

Brief summary

The use of music in the operating theatre has been longstanding with reports of its potential therapeutic effects dating back to the 1940s. Music therapy prior to and during an operation have been shown to reduce anaesthetic requirement, patient anxiety, and improve overall satisfaction. There is also evidence that proceduralist-selected music improves surgical skill acquisition.
In gastrointestinal endoscopy, music has shown benefits for patients, however, there is
no data on the effects of music on improving the performance of endoscopists and whether a specific style of music would lead to optimal performance. This is particularly relevant in an era where high volumes of endoscopic procedures are performed in an often stressful clinical environment and procedural outcomes, such as adenoma detection rate (ADR) in colonoscopy, are reported as validated benchmarks of quality endoscopy.
The appropriate style of music to use and avoid in the operating theatre has been previously proposed, but there was an absence of music from epic movies on this list.
Thesoundtracks from these movies often contain uplifting musical tracks associated with glory,success, and large scale victory
We hypothesise that music from the epic movie Star Wars would be superior to endoscopist-selected popular music when measuring quality outcomes in colonoscopy.

Trial website

Trial related presentations / publications

Not published or presented yet.

Public notes

Given we are avid fans of the Star Wars movies (Lucasfilms,
San Francisco, USA) and with the imminent release of the latest instalment, Star Wars: The
Force Awakens, we felt it would be important and timely to evaluate the effect of music
from the Star Wars soundtrack in colonoscopy.
It follows, individuals from the ‘”baby boomer” generation, many of whom were fans of the original Star Wars trilogy, are approaching the appropriate age to undergo bowel cancer screening. It is therefore essential that strategies to enhance quality outcomes in colonoscopy are evaluated.
We did such a study where we radomized patients undergoing colonoscopies to either star wars music being played or music from other genre that the endoscopist had on their playlist , other than epic movie soundracks.Our aim was to get the data and present our results prior to the release of the new star wars movie " The force awakens". 
We initially began collecting data assuming that the study would not require ethics approval given that the use of music in the endoscopy suite is common practice and a  safe  intervention.  After discussion with our ethics department, it was determined that it would be best practice to obtain an ethics evaluation and approval for the study, but given that the data collected was standard measures of the quality of endoscopy that the unit would routinely record, the data collected was not void of inclusion in our study.

Contacts

Principal investigator

Name

Dr Zaid Ardalan

Address

Austin
145 studely road
Heidelberg
Melbourne
Victoria
3084

Country

Australia

Phone

+61432275953

Fax

zaid.ardalan@austin.org.au

Contact person for public queries

Name

Zaid Ardalan

Address

Austin hospital
145 studley road
Heidelberg
Melbourne
Victoria
3084

Country

Australia

Phone

+61432275953

Fax

zaid.ardalan@austin.org.au

Contact person for scientific queries

Name

Zaid Ardalan

Address

Austin hospital
145 studley road
Heidelberg
Melbourne
Victoria

Country

Australia

Phone

+61432275953

Fax

zaid.ardalan@austin.org.au

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.

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