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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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.

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
Both males and females
Can healthy volunteers participate?
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
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
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 1 / Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1736 0
Name [1] 1736 0
Australian College of Critical Care Nurses
Address [1] 1736 0
Australian College of Critical Care Nurses
P O Box 219
South Carlton
Country [1] 1736 0
Primary sponsor type
Griffith University
Nathan Qld 4111
Secondary sponsor category [1] 1530 0
Name [1] 1530 0
Gold Coast Hospital
Address [1] 1530 0
Southport Qld
Country [1] 1530 0
Secondary sponsor category [2] 1531 0
Name [2] 1531 0
Tweed Heads Hospital
Address [2] 1531 0
The Tweed Hospital
Powell Street, Tweed Heads, NSW, 2485
Country [2] 1531 0

Ethics approval
Ethics application status
Ethics committee name [1] 3211 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 3211 0
Nathan Qld 4111
Ethics committee country [1] 3211 0
Date submitted for ethics approval [1] 3211 0
Approval date [1] 3211 0
Ethics approval number [1] 3211 0
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
Date submitted for ethics approval [2] 3212 0
Approval date [2] 3212 0
Ethics approval number [2] 3212 0
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
Date submitted for ethics approval [3] 3213 0
Approval date [3] 3213 0
Ethics approval number [3] 3213 0

Brief summary
Studies demonstrate that critically ill patients experience anxiety, pain and discomfort as part of their hospital stay. Being subject to numerous procedures common in the intensive care unit such as turning, endotrachael suctioning and wound care impact adversely on patients' experiences. The discomfort associated with these procedures can result in a number of stress sequela for patients that can be detrimental to their health and well-being in terms of their discomfort and anxiety levels. The challenge for nurses working in intensive care settings is to find ways to reduce these stressful experiences. Researchers hypothesize that listening to music is one way of reducing activation of the hypothalamic-pituitary-adrenal (HPA)axis that induces release of various hormones particularly cortisol which reduces immune function and peripheral perfusion. Stress reduction can potentially reduce HPA axis activation and enhance immediate, short- and longer-term.patient outcomes, in a clinical setting. The theoretical basis of music as an intervention for anxiety lies in its ability to promote relaxation and improve mood through the autonomic nervous system, which controls the stress response. It is believed that the auditory stimulation of music enhances activation of a number of neurotransmitters thereby diverting feelings of anxiety, fear and pain resulting in a more positive perceptual experience.
Trial website
Trial related presentations / publications
Cooke, M., Chaboyer, W., Schluter, P., Foster, M., Harris, D. & Teakle, R. (2010). The Effect of Music on Discomfort Experienced by ICU Patients During Turning: A Randomised Cross-over Study. International Journal of Nursing Practice. 16, 125-131.
Public notes

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
Phone 27437 0
61 7 37355253
Fax 27437 0
Email 27437 0
Contact person for public queries
Name 10692 0
Prof Dr Marie Cooke
Address 10692 0
School of Nursing and Midwifery
Griffith University
Nathan Campus
Kessels Rd
Nathan, Brisbane QLD
Country 10692 0
Phone 10692 0
+61 7 38757985
Fax 10692 0
Email 10692 0
Contact person for scientific queries
Name 1620 0
Prof Dr Marie Cooke
Address 1620 0
School of Nursing and Midwifery
Griffith University
Nathan Campus
Kessels Rd
Nathan, Brisbane QLD
Country 1620 0
Phone 1620 0
+61 7 38757985
Fax 1620 0
Email 1620 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary