Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000168651
Ethics application status
Approved
Date submitted
8/02/2014
Date registered
11/02/2014
Date last updated
11/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Music therapy for older adults
Scientific title
Music therapy to relieve pain and depressive symptoms for community-dwelling frail older adults: study protocol for a randomised controlled trial
Secondary ID [1] 284044 0
Nil
Universal Trial Number (UTN)
U1111-1153-0886
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain in frail older adults
 291095 0
depressive symptoms in frail older adults 291096 0
health-related quality of life in frail older adults 291097 0
Condition category
Condition code
Alternative and Complementary Medicine 291440 291440 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group: 30 minutes music therapy per session will be offered in groups of 6-9 older adults two days a week for 8 weeks. Participants will listen to 30-minute music during each session. The type of music used include Meditative music, Chinese classical, Asian classical and Western classical music.

A record book will be given to each participant in the first session. Participants will be given a stamp every time they participate in a session.
Intervention code [1] 288734 0
Treatment: Other
Comparator / control treatment
Control group: 6-9 participants will be gathered in group two days a week over 8 weeks for a 30-minute uninterrupted rest period.
Control group
Active

Outcomes
Primary outcome [1] 291423 0
Pain intensity as measured by Numeric Rating Scale
Timepoint [1] 291423 0
baseline, beginning of each session during week 1-8, 8 and 12 weeks after intervention commencement
Secondary outcome [1] 306744 0
Depressive symptoms as measured by the Chinese short version Geriatric Depression Scale (GDS-15)
Timepoint [1] 306744 0
baseline, 8 and 12 weeks after intervention commencement
Secondary outcome [2] 306745 0
Perceived health-related quality of life as assessed by Short Form Health Survey-12 (SF-12)
Timepoint [2] 306745 0
baseline, 8 and 12 weeks after intervention commencement
Secondary outcome [3] 306746 0
perception of music therapy as assessed by simple questions
Timepoint [3] 306746 0
end of each session during week 1-8

Eligibility
Key inclusion criteria
- scored at least one in the frailty index
- scored >6 in the Abbreviated Mental Test
- non-malignant physical pain for more than 3 months
- scored >3 in the GDS-15
- able to hear music
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- patients with cognitive impairment
- history of mental disorders
- patients with cancer and currently on cancer treatment

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study and therefore only 40 participants will be included.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5808 0
Hong Kong
State/province [1] 5808 0

Funding & Sponsors
Funding source category [1] 288672 0
Government body
Name [1] 288672 0
Pending approval from the Health and Medical Research Fund, Food and Health Bureau
Country [1] 288672 0
Hong Kong
Primary sponsor type
Individual
Name
Dr. Mun Yee Tse
Address
FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country
Hong Kong
Secondary sponsor category [1] 287380 0
None
Name [1] 287380 0
Address [1] 287380 0
Country [1] 287380 0
Other collaborator category [1] 277808 0
Individual
Name [1] 277808 0
Dr. Hong Lee
Address [1] 277808 0
PG433, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country [1] 277808 0
Hong Kong
Other collaborator category [2] 277809 0
Individual
Name [2] 277809 0
Dr. Sze Mon Lo
Address [2] 277809 0
A006, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country [2] 277809 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290522 0
Departmental Research Committee, The Hong Kong Polytechnic University
Ethics committee address [1] 290522 0
Ethics committee country [1] 290522 0
Hong Kong
Date submitted for ethics approval [1] 290522 0
Approval date [1] 290522 0
30/12/2013
Ethics approval number [1] 290522 0
HSEARS20131212001

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

Contacts
Principal investigator
Name 46066 0
Dr Mun Yee Tse
Address 46066 0
FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country 46066 0
Hong Kong
Phone 46066 0
+852 27666541
Fax 46066 0
Email 46066 0
[email protected]
Contact person for public queries
Name 46067 0
Mun Yee Tse
Address 46067 0
FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country 46067 0
Hong Kong
Phone 46067 0
+852 27666541
Fax 46067 0
Email 46067 0
[email protected]
Contact person for scientific queries
Name 46068 0
Mun Yee Tse
Address 46068 0
FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country 46068 0
Hong Kong
Phone 46068 0
+852 27666541
Fax 46068 0
Email 46068 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.