Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
mimi.tse@polyu.edu.hk
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
mimi.tse@polyu.edu.hk
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
mimi.tse@polyu.edu.hk

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.