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Trial registered on ANZCTR


Registration number
ACTRN12606000517572
Ethics application status
Approved
Date submitted
13/12/2006
Date registered
14/12/2006
Date last updated
27/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Music on Discomfort Experienced by ICU Patients During Turning: A Randomised Cross-Over Study
Scientific title
A Randomised Cross-Over Study to Reduce Discomfort and Anxiety Experienced by Intensive Care Patients During the Turning Procedure.
Secondary ID [1] 288023 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Discomfort and anxiety of Intensive Care Unit (ICU) patients during the turning procedure 1494 0
Condition category
Condition code
Mental Health 1591 1591 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is listening to music of the participant's choice for 15 minutes before and during the turning procedure which takes approximately 3 minutes. Participants will be asked for their choice of music pre-operatively and will listen to this choice post-operatively. This study will use a single blind randomised cross-over design. Participants will be randomly assisgned to an intervention (music) or control group to begin the study. Participants' discomfort and anxiety will be measured 15 minutes prior to and immediatley after the turning procedure. After completion of the first arm of the study, participants will then 'cross over' into the opposite arm and the protocol repeated. Based on previous research we anticipate each arm to take approximately 20 minutes with a 2 hour wash-out period between arms. Thus participants will complete the whole protocol in about 2 hours and 40 minutes.
Intervention code [1] 1503 0
Other interventions
Comparator / control treatment
The control arm is that participants will wear a portabe CD and earphones but there will be no music being played.
Control group
Active

Outcomes
Primary outcome [1] 2195 0
The primary outcome is patient discomfort measured using a numeric rating scale (NRS) from 0= No Discomfort to 10 = Worst Possible Discomfort.
Timepoint [1] 2195 0
15 minutes prior to and immediately after the turning procedure.
Secondary outcome [1] 3825 0
Patient anxiety The Faces Anxiety Scale (FAS) is easy to administer and has minimal participant burden.
Timepoint [1] 3825 0
Will be administered 15 minutes prior to and immediatley after the turning procedure.

Eligibility
Key inclusion criteria
Patients who are scheduled for surgery and have a planned post-operative stay in ICU (ventilated and non ventilated). Patients who have an expected ICU length of stay greater than 8 hours. Patients able to respond to pre and post- turning discomfort and anxiety questions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are scheduled for neurosurgery. Patients who do not like music. Patients who are hearing impaired. Patients who have difficulty wearing earphones.

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)
Randomisation will be blocked to ensure that we have equal numbers of participants receiving the intervention in the first period as we do controls. Under the guidance of the biostatistician, a research assistant not associated with data collection will conduct the randomization process using a computer generated program and prepare sequentially numbered sealed opaque envelopes that will outline the different ordering of treatments for each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer generated program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The control will allow the nurse (assessor) collecting outcome data to be blinded to group allocation, thus limiting the potential for detection bias
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
25/01/2007
Date of last participant enrolment
Anticipated
Actual
2/04/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1736 0
Charities/Societies/Foundations
Name [1] 1736 0
Australian College of Critical Care Nurses
Country [1] 1736 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Qld 4111
Country
Australia
Secondary sponsor category [1] 1530 0
Hospital
Name [1] 1530 0
Gold Coast Hospital
Address [1] 1530 0
Southport Qld
Country [1] 1530 0
Australia
Secondary sponsor category [2] 1531 0
Hospital
Name [2] 1531 0
Tweed Heads Hospital
Address [2] 1531 0
The Tweed Hospital
Powell Street, Tweed Heads, NSW, 2485
Country [2] 1531 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3211 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 3211 0
Ethics committee country [1] 3211 0
Australia
Date submitted for ethics approval [1] 3211 0
Approval date [1] 3211 0
Ethics approval number [1] 3211 0
NRS/36/06/HREC
Ethics committee name [2] 3212 0
Human Research Ethics Committee, Gold Coast Health Service District
Ethics committee address [2] 3212 0
Ethics committee country [2] 3212 0
Australia
Date submitted for ethics approval [2] 3212 0
Approval date [2] 3212 0
26/07/2006
Ethics approval number [2] 3212 0
200656
Ethics committee name [3] 3213 0
Human Research Ethics Committee, North Coast Area Health Service
Ethics committee address [3] 3213 0
Ethics committee country [3] 3213 0
Australia
Date submitted for ethics approval [3] 3213 0
Approval date [3] 3213 0
26/10/2006
Ethics approval number [3] 3213 0
357

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

Contacts
Principal investigator
Name 27437 0
Prof Prof Marie Cooke
Address 27437 0
School of Nursing and Midwifery
Griffith University
170 Kessels Road
Nathan Q 4111
Country 27437 0
Australia
Phone 27437 0
61 7 37355253
Fax 27437 0
Email 27437 0
m.cooke@griffith.edu.au
Contact person for public queries
Name 10692 0
Dr Marie Cooke
Address 10692 0
School of Nursing and Midwifery
Griffith University
Nathan Campus
Kessels Rd
Nathan, Brisbane QLD
Country 10692 0
Australia
Phone 10692 0
+61 7 38757985
Fax 10692 0
Email 10692 0
m.cooke@griffith.edu.au
Contact person for scientific queries
Name 1620 0
Dr Marie Cooke
Address 1620 0
School of Nursing and Midwifery
Griffith University
Nathan Campus
Kessels Rd
Nathan, Brisbane QLD
Country 1620 0
Australia
Phone 1620 0
+61 7 38757985
Fax 1620 0
Email 1620 0
m.cooke@griffith.edu.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.