Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000444381
Ethics application status
Not yet submitted
Date submitted
28/03/2008
Date registered
5/09/2008
Date last updated
5/09/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of sound compositions on anxiety and satisfaction of emergency department patients
Scientific title
The effect of sound compositions and binaural beat audio on the anxiety and satisfaction of moderate acuity emergency department patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 2957 0
Condition category
Condition code
Mental Health 3113 3113 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sound works and binaural beat audio of a half hour duration will be assessed for their ability to affect anxiety in emergency department patients. Soundworks include musical and non-musical sound compositions. These may take the form of sounds derived from nature or urban environments and electro-acoustic instruments. Binaural beats or binaural tones are auditory processing artifacts, or apparent sounds. They are perceived in the brain independent of physical stimuli. Two sounds that are similar but slightly different in frequency will beat to produce two new frequencies, the sum and the difference of the original two sounds. These interventions will be applied to participants as electronic files audible through headphones. The interventions are given to participants after they have received medical assessment. This will occur at a point in time after initial assessment by the triage nurse (up to four hours in some cases). All patients will be located in a emergency cubicle.
Intervention code [1] 2709 0
Treatment: Other
Comparator / control treatment
1) CONTROL GROUP 1: Live ambient sound of the test environment of half an hour duration. Ambient sound will be audible without headphones.
2) CONTROL GROUP 2: Simulated ambient sound of the emergency department of half an hour duration and delivered through headphones. This will be delivered to participants after medical assessment is complete; this timepoint is identical to that for experimental interventions.
Control group
Active

Outcomes
Primary outcome [1] 4003 0
state anxiety measured using the State Trait Anxiety Inventory
Timepoint [1] 4003 0
Pretest (baseline) and immediately after exposure.
Secondary outcome [1] 6741 0
Patient satisfaction assessed using the Davis Consumer Emergency Care Satisfaction Scale
Timepoint [1] 6741 0
Pretest (baseline) and immediately after exposure.

Eligibility
Key inclusion criteria
Emergency Department Patients that are classified as Triage category Three using the Australasian triage scale.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that do not speak English, and that cannot consent including those highly dependent on medical care and those that care cognitively impaired.

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)
Patients will be consented by a clinician. Baseline measurements will then be recorded after which a sealed envelope containing the group to which the participant will be allocated will be opened. This allocation will be codified so that the researcher and participant are blinded to the group allocation until allocation is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated block randomisation sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3480 0
Government body
Name [1] 3480 0
Australian Research Council
Country [1] 3480 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital Melbourne
Address
41 Victoria Pde
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 2893 0
None
Name [1] 2893 0
Address [1] 2893 0
Country [1] 2893 0
Other collaborator category [1] 312 0
University
Name [1] 312 0
Royal Melbourne Institute of Technology
Address [1] 312 0
RMIT University
GPO Box 2476V
Melbourne VIC 3001
Australia
Country [1] 312 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5510 0
St. Vincent's Hospital Melbourne
Ethics committee address [1] 5510 0
41 Victoria Pde
Fitzroy VIC 3065
Ethics committee country [1] 5510 0
Australia
Date submitted for ethics approval [1] 5510 0
12/06/2008
Approval date [1] 5510 0
Ethics approval number [1] 5510 0

Summary
Brief summary
This three-phase interdisciplinary and collaborative project funded by the Australian Research Council. It draws together researchers from the fields of music composition and performance, sound art, emergency medicine and clinical psychology to determine the effect of sound and music on the anxiety of patients located in the Emergency department at St Vincent’s Hospital - Melbourne.

Phase one of the project will involve the development of sample soundtracks and musical compositions by a PhD Candidate from the School of Art, RMIT. A total of 20 soundtracks of 60 seconds duration will be created; 10 that are electronic/acoustic and 10 that are environmentally based (e.g., rain sounds).

In Phase two, 250 ED patients that consent to participate will be provided with the specially created soundwork samples to listen to using headphones. Patient impressions of and responses to the specially created soundtracks will be evaluated through a purpose designed questionnaire. This information will be considered in the development of two longer soundtracks for use in Phase 3. The soundtracks will be of 30 minutes duration. One will be electronic/acoustic and one will be environmentally based.

Phase three (clinical trial) will investigate whether specific soundtracks and musical compositions decrease the anxiety of ED patients. Patients that are triaged as having a condition that is of moderate acuity (Australasian Triage Category 3) will be approached by a researcher during their ED visit for participation in the study. Consenting patients will be given two validated scales: one that rates their self-reported level of anxiety and one that assesses their level of satisfaction with emergency care received. They will then be randomly allocated to one of five groups based, one for each types of sound work to be tested. Patients in group 1 will be given no soundwork intervention. Group 2 will receive a 30 minute soundtrack of re-constructed ambient sound simulating the emergency department to listen to via headphones. Those allocated to group 3 will be given a 30 minute soundtrack of electronic/acoustic sound. Those in Group 4 will be given a 30 minute soundtrack of environmentally based sound, and those in group 5 will be given a 30 minute soundtrack that uses binaural beat (alternating frequency) which is known to induce a mild meditative state. At the conclusion of the 30 minute period, patients allocated to each of the four groups will be given the anxiety and satisfaction surveys to complete again.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28461 0
Address 28461 0
Country 28461 0
Phone 28461 0
Fax 28461 0
Email 28461 0
Contact person for public queries
Name 11618 0
Dr Tracey Weiland
Address 11618 0
Emergency Medicine
St. Vincent's Hospital
Fitzroy VIC 3065
Country 11618 0
Australia
Phone 11618 0
03 9288 2734
Fax 11618 0
Email 11618 0
[email protected]
Contact person for scientific queries
Name 2546 0
Dr Tracey Weiland
Address 2546 0
Emergency Medicine
St. Vincent's Hospital
Fitzroy VIC 3065
Country 2546 0
Australia
Phone 2546 0
03 9288 2734
Fax 2546 0
Email 2546 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.