Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001325594
Ethics application status
Approved
Date submitted
1/12/2015
Date registered
3/12/2015
Date last updated
19/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Music During Pleural Procedures
Scientific title
Effect of Music During Pleural Procedures: A Randomised Controlled Study of Anxiety, Perceived Pain and Satisfaction
Secondary ID [1] 288048 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pleural Effusions 296912 0
Condition category
Condition code
Respiratory 297148 297148 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Easy listening and relaxation ambient music, selected by investigator will be started 10 minutes before commencement of the pleural procedure and stopped after the procedure is over. The music will be delivered by a music compact disc (CD) player located in the patients' room.
Intervention code [1] 293370 0
Treatment: Other
Comparator / control treatment
Pleural procedures will be performed without music therapy
Control group
Active

Outcomes
Primary outcome [1] 296764 0
Anxiety: Procedure-related anxiety will be measured using the State-Trait Anxiety Inventory (STAI) scale. Instructions pertaining to this self-administered questionnaire will be provided to each patient by a nurse practitioner specially trained in questionnaire administration.
Timepoint [1] 296764 0
Immediately after pleural procedure
Secondary outcome [1] 319290 0
Procedure related pain
At the end of the pleural procedure, patients will be asked to rate their overall feelings of pain using a 10 point Visual Analogue Scale (VAS).
Timepoint [1] 319290 0
Immediately after procedure
Secondary outcome [2] 319291 0
Satisfaction with procedure

At the end of the pleural procedure, patients will be asked to rate their overall feelings of satisfaction of the procedure using a 10 point Visual Analogue Scale (VAS).
Timepoint [2] 319291 0
Immediately after procedure

Eligibility
Key inclusion criteria
Consecutive patients who are required to undergo a pleural procedure such as pleural aspiration (diagnostic/therapeutic) or intercostal tube insertion will be asked to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Below 18 years old
2. Unable to give consent
3. Significantly hearing impaired
4. Impaired mental status
5. Unable to speak and understand English
6. Pleural procedure is being performed as a medical emergency
7. Procedure is performed on the weekend or outside of usual working hours (8am-5pm).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2016
Actual
2/05/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
11/07/2017
Date of last data collection
Anticipated
Actual
11/10/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4811 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 12316 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 292487 0
Self funded/Unfunded
Name [1] 292487 0
NIL
Country [1] 292487 0
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Blvd
Southport
QLD 4215
Country
Australia
Secondary sponsor category [1] 291198 0
None
Name [1] 291198 0
NIL
Address [1] 291198 0
NIL
Country [1] 291198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293953 0
Gold Coast Hospitals and Health Service
Ethics committee address [1] 293953 0
Research Directorate
Level 2
Pathology and Education Building
1 Hospital Blvd
Southport
QLD 4215
Ethics committee country [1] 293953 0
Australia
Date submitted for ethics approval [1] 293953 0
04/12/2015
Approval date [1] 293953 0
09/03/2016
Ethics approval number [1] 293953 0
HREC16/QGC/1

Summary
Brief summary
Pleural procedures are performed both for diagnostic and therapeutic purposes. Similar to other endoscopy procedures, it is known that patients undergoing pleural procedures can experience considerable pain and anxiety. The use of sedative and analgesic medications can somewhat alleviate these symptoms. However these medications can be expensive and can result in side effects such as respiratory depression. On the contrary, music is an inexpensive and non-pharmacological intervention that has been shown to reduce pain and anxiety in patients undergoing endoscopy and surgical procedures. However, to date, there have not been any studies that have evaluated the effects of music therapy in patients undergoing pleural procedures. Our study aims to fill an important gap in knowledge. If our proposed study demonstrates that music indeed reduces anxiety and pain levels in patients undergoing pleural procedures, it will reduce the patient morbidity and lead to a more comfortable hospital experience. This may also result in reduce need for sedative and analgesic medications for our patients, resulting in cost savings and risk reduction for our health service.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61914 0
Dr Bajee Krishna Sriram
Address 61914 0
Department of Respiratory Medicine
Gold Coast University Hospital
1 Hospital Blvd
Southport
QLD 4215
Country 61914 0
Australia
Phone 61914 0
+61756870250
Fax 61914 0
Email 61914 0
[email protected]
Contact person for public queries
Name 61915 0
Dr Bajee Krishna Sriram
Address 61915 0
Department of Respiratory Medicine
Gold Coast University Hospital
1 Hospital Blvd
Southport
QLD 4215
Country 61915 0
Australia
Phone 61915 0
+61756870250
Fax 61915 0
Email 61915 0
[email protected]
Contact person for scientific queries
Name 61916 0
Dr Bajee Krishna Sriram
Address 61916 0
Department of Respiratory Medicine
Gold Coast University Hospital
1 Hospital Blvd
Southport
QLD 4215
Country 61916 0
Australia
Phone 61916 0
+61756870250
Fax 61916 0
Email 61916 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

Documents added manually
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Documents added automatically
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