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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

Condition category

Condition code

Mental Health

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]

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]

state anxiety measured using the State Trait Anxiety Inventory

Timepoint [1]

Pretest (baseline) and immediately after exposure.

Secondary outcome [1]

Patient satisfaction assessed using the Davis Consumer Emergency Care Satisfaction Scale

Timepoint [1]

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?

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]

Government body

Name [1]

Australian Research Council

Address [1]

1st Floor, 8 Brindabella Circuit
Brindabella Business Park ACT 2609

Country [1]

Australia

Primary sponsor type

Hospital

Name

St. Vincent's Hospital Melbourne

Address

41 Victoria Pde
Fitzroy VIC 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Royal Melbourne Institute of Technology

Address [1]

RMIT University
GPO Box 2476V
Melbourne VIC 3001
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

St. Vincent's Hospital Melbourne

Ethics committee address [1]

41 Victoria Pde
Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/06/2008

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Tracey Weiland

Address

Emergency Medicine
St. Vincent's Hospital
Fitzroy VIC 3065

Country

Australia

Phone

03 9288 2734

Fax

[email protected]

Contact person for scientific queries

Name

Dr Tracey Weiland

Address

Emergency Medicine
St. Vincent's Hospital
Fitzroy VIC 3065

Country

Australia

Phone

03 9288 2734

Fax

[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.

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