Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000617864
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
8/06/2012
Date last updated
20/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of music therapy on preoperative anxiety in day surgery.
Scientific title
A randomized controlled trial to assess the effectiveness of music therapy on anxiety in day surgery.
Secondary ID [1] 280586 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preoperative anxiety in day surgery 286577 0
Condition category
Condition code
Mental Health 286854 286854 0 0
Anxiety
Surgery 286911 286911 0 0
Other surgery
Alternative and Complementary Medicine 286912 286912 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is listening to music of the participant's choice for 30 minutes prior to surgery, using headphones and CD player.
Intervention code [1] 284965 0
Treatment: Other
Intervention code [2] 285014 0
Prevention
Comparator / control treatment
The control group receives routine care. That is, during thier wait for day surgery they either sit in chairs or lie on beds and are able to read and/or watch the television in one of the waiting areas.
Control group
Active

Outcomes
Primary outcome [1] 287267 0
Day surgery patients who listen to music during their preoperative wait will have statistically significantly lower levels of anxiety than patients who do not listen to music (placebo and usual care control group).
Timepoint [1] 287267 0
Participants in the study had levels of anxiety measure pre and post the 30 minute treatment arms. In the intervention group, listened to their choice of music for 30 minutes, the placebo group wore the headphones but received no music for 30 minutes and the control group received routine care only 30 minutes prior to surgery. Anxiety measured for all groups to compare anxietry levels using the State-Strait Anxiety Inventory- Form Y-1, State portion. anxiety .
Secondary outcome [1] 297638 0
Nil
Timepoint [1] 297638 0
Nil

Eligibility
Key inclusion criteria
Patients who are scheduled for day surgery only.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not like music.
Patients who had preoperative sedatives.
Patients who are hearing-impaired or have difficulty wearing headphones.
Patients who could not read and write English.
Patients undergoing eye surgery.
Patients who have an anticipated preoperative waiting time of under 45 minutes.

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)
Randomization were blocked to ensure equal numbers of participants assigned to intervention, placebo or control groups by gender. Males and females were randomized separately to ensure equal number in each group. A biostatistician and a research assistant not associated to data collection conducted the randomization procedures and prepared sequentially numbered sealed envelopes containing the randomized assignment of consenting patients.
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
Parallel
Other design features
The control group will allow the nurse (assessor) collecting outcome data to be blinded to group allocation, thus limiting the potential for detection bias. Because control group wore earphones with no music, those giving care were also blinded to treatment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2004
Actual
5/01/2004
Date of last participant enrolment
Anticipated
Actual
30/04/2004
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285412 0
University
Name [1] 285412 0
New Researcher Grant
Country [1] 285412 0
Australia
Primary sponsor type
University
Name
Griffith Univeristy
Address
170 Kessels Road
Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 284191 0
Hospital
Name [1] 284191 0
Princess Alexandra Hospital
Address [1] 284191 0
199 Ipswich Road
Woolloongabba
Brisbane
QLD 4102
Country [1] 284191 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287349 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 287349 0
170 Kessels Road
Nathan
QLD 4111
Ethics committee country [1] 287349 0
Australia
Date submitted for ethics approval [1] 287349 0
Approval date [1] 287349 0
12/08/2002
Ethics approval number [1] 287349 0
NRS/08/02/hec
Ethics committee name [2] 287389 0
Princess Alexandra Hospital Health Service District Research Protocol
Ethics committee address [2] 287389 0
199 Ipswich Road
Woolloongabba
Brisbane
QLD 4102
Ethics committee country [2] 287389 0
Australia
Date submitted for ethics approval [2] 287389 0
Approval date [2] 287389 0
16/10/2002
Ethics approval number [2] 287389 0
Research Protocol: 138/02

Summary
Brief summary
The primary purpose of the clinical trial is to test the hypothesis that day surgery patients who listen to music during their preoperative wait will have statistically significantly lower levels of anxiety than patients who receive routine care.
Trial website
Trial related presentations / publications
Cooke, M., Chaboyer, W., Hiratos, M. & Schluter, P. J. (2005). The effect of music on pre-operative anxiety in day surgery. Journal of Advanced Nursing. 52(1), 47-55.
Public notes

Contacts
Principal investigator
Name 34239 0
Prof Prof Marie Cooke
Address 34239 0
School of Nursing and Midwifery
Griffith University
170 Kessels Rd
Nathan, Q, 4111
Country 34239 0
Australia
Phone 34239 0
61 7 37355253
Fax 34239 0
Email 34239 0
[email protected]
Contact person for public queries
Name 17486 0
Prof Professor Marie Cooke
Address 17486 0
Professor of Nursing
School of Nursing and Midwifery
Griffith University
Nathan Campus
170 Kessels Road
Nathan
QLD 4111
Country 17486 0
Australia
Phone 17486 0
+61 7 3735 5253
Fax 17486 0
+61 7 3735 5431
Email 17486 0
[email protected]
Contact person for scientific queries
Name 8414 0
Prof Professor Marie Cooke
Address 8414 0
Professor of Nursing
School of Nursing and Midwifery
Griffith University
Nathan Campus
170 Kessels Road
Nathan
QLD 4111
Country 8414 0
Australia
Phone 8414 0
+61 7 3735 5253
Fax 8414 0
+61 7 3735 5431
Email 8414 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

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