Trial Review

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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] 287627 0
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 296440 0
Condition category
Condition code
Oral and Gastrointestinal 296705 296705 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 296750 296750 0 0
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withdrawn from the colon.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] 293029 0
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] 296317 0
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] 296317 0
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] 296318 0
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] 296318 0
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] 296319 0
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] 296319 0
from the time of entering the anus to the time the colonoscope is withdrawn from the colon.
Secondary outcome [1] 318144 0
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] 318144 0
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?
No
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] 4438 0
Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors
Funding source category [1] 292188 0
Self funded/Unfunded
Name [1] 292188 0
None
Country [1] 292188 0
Primary sponsor type
Individual
Name
Zaid Ardalan
Address
Austin hospital
145 studley road
Heidelberg
Melbourne 3084
VIC
Country
Australia
Secondary sponsor category [1] 290866 0
Individual
Name [1] 290866 0
Abhinav Vasudevan
Address [1] 290866 0
Austin hospital
145 studley road
Heidelberg
Melbourne 3084
VIC
Country [1] 290866 0
Australia
Other collaborator category [1] 278653 0
Individual
Name [1] 278653 0
Simon Hew
Address [1] 278653 0
Austin hospital
145 studley road
Heidelberg
Melbourne 3084
VIC
Country [1] 278653 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293661 0
Austin Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 293661 0
Ethics committee country [1] 293661 0
Australia
Date submitted for ethics approval [1] 293661 0
18/08/2015
Approval date [1] 293661 0
04/09/2015
Ethics approval number [1] 293661 0
LNR/15/Austin/372

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60866 0
Dr Zaid Ardalan
Address 60866 0
Austin
145 studely road
Heidelberg
Melbourne
Victoria
3084
Country 60866 0
Australia
Phone 60866 0
+61432275953
Fax 60866 0
Email 60866 0
[email protected]
Contact person for public queries
Name 60867 0
Zaid Ardalan
Address 60867 0
Austin hospital
145 studley road
Heidelberg
Melbourne
Victoria
3084
Country 60867 0
Australia
Phone 60867 0
+61432275953
Fax 60867 0
Email 60867 0
[email protected]
Contact person for scientific queries
Name 60868 0
Zaid Ardalan
Address 60868 0
Austin hospital
145 studley road
Heidelberg
Melbourne
Victoria
Country 60868 0
Australia
Phone 60868 0
+61432275953
Fax 60868 0
Email 60868 0
[email protected]

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

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