Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001281482
Ethics application status
Approved
Date submitted
17/08/2016
Date registered
12/09/2016
Date last updated
12/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rhythm-centred Music Making in Community Living Elderly: A pilot study
Scientific title
Effects of Rhythm-centred Music Making on the quality of life in the Community Living Elderly: A pilot study
Secondary ID [1] 289953 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of Life 299937 0
Mental health 299938 0
Sleep Quality 299939 0
Social isolation 299940 0
Condition category
Condition code
Alternative and Complementary Medicine 299837 299837 0 0
Other alternative and complementary medicine
Mental Health 299921 299921 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants participated in RMM sessions of 1h per session, under the Rhythm Wellness Programme by OneHeartBeat, held once a week for a total of 10 sessions over 11 weeks where a break was scheduled in the 4th week to factor in a public holiday within the intervention period of one of the groups. All RMM sessions were facilitated by 3 experienced instructors. The instruments used include the conga, cowbell, Djembe, Ashiko Tan-tans, Dunun, Shakers, and Wood Blocks in all sessions.
Each session was carried out in a circle, with the participant seated comfortably and the drum or percussion instrument within reach in front of them. During each session, the instructors facilitated free play, and encouraged the participants to express themselves and interact with each other through the active playing of the instruments.

In Phase one of the study, participants in group A will attend the 10 RMM sessions while participants in group B serve as the control. In Phase two of the study, participants in group B will attend the 10 RMM sessions while participants in group A serve as the control. There was no washout period.
Intervention code [1] 295639 0
Lifestyle
Comparator / control treatment
This is a cross over study, participants served as their own control. The 2 groups has similar sociodemographic and will be serving as control for the other group.
Control group
Active

Outcomes
Primary outcome [1] 299312 0
Change in quality of life measured by the EQ5D questionnaire.
Timepoint [1] 299312 0
At baseline and 11 weeks post intervention
Secondary outcome [1] 326819 0
Change in depressive mood using GDS scale
Timepoint [1] 326819 0
At baseline and 11 weeks post intervention
Secondary outcome [2] 326820 0
Change in sleep quality using PSQI scale
Timepoint [2] 326820 0
At baseline and 11 weeks post intervention
Secondary outcome [3] 326821 0
Change in social isolation using the LSNS scale
Timepoint [3] 326821 0
At baseline and 11 weeks post intervention

Eligibility
Key inclusion criteria
(1) Aged 65 years and older; (2) Understands English or Mandarin
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals on palliative care and individuals who are bed-bound.

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization by random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study. Descriptive statistics will be presented in mean +- standard deviation or number (%). Changes post intervention between treatment and control will be analysed by student’s t test. Each group will be tracked and analysed by paired t test. All analyses will be done with Stata SE 12.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2015
Date of last participant enrolment
Anticipated
Actual
9/01/2016
Date of last data collection
Anticipated
14/06/2016
Actual
14/06/2016
Sample size
Target
48
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 8109 0
Singapore
State/province [1] 8109 0

Funding & Sponsors
Funding source category [1] 294331 0
Government body
Name [1] 294331 0
National Arts Council
Country [1] 294331 0
Singapore
Funding source category [2] 294332 0
University
Name [2] 294332 0
Duke-NUS Medical School
Country [2] 294332 0
Singapore
Primary sponsor type
Hospital
Name
KK Women's and Children's Hospital
Address
100 Bukit Timah Road, Singapore 229899
Country
Singapore
Secondary sponsor category [1] 293169 0
None
Name [1] 293169 0
NONE
Address [1] 293169 0
NONE
Country [1] 293169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295752 0
SingHealth Centralised Institutional Review Board
Ethics committee address [1] 295752 0
31 Third Hospital Avenue
#03-03 Bowyer Block C
Singapore 168753
Ethics committee country [1] 295752 0
Singapore
Date submitted for ethics approval [1] 295752 0
26/09/2015
Approval date [1] 295752 0
06/10/2015
Ethics approval number [1] 295752 0
2015/2837

Summary
Brief summary
This project has been approved by the SingHealth Centralised Institutional Review Board under reference number 2015/2837. The primary purpose of the study was to find out the effects of RMM on the quality of life of community living elderly. The hypothesis of the study was that participation in RMM would improve the quality of life of the elderly.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68326 0
Dr Ang Seng Bin
Address 68326 0
KK Women's and Children's Hospital
100 Bukit Timah Road, Singapore 229899
Country 68326 0
Singapore
Phone 68326 0
+65 63941102
Fax 68326 0
Email 68326 0
[email protected]
Contact person for public queries
Name 68327 0
Angela Frances Yap
Address 68327 0
Duke-NUS Medical School
8 College Road
Singapore 169857
Country 68327 0
Singapore
Phone 68327 0
+65 90286131
Fax 68327 0
Email 68327 0
[email protected]
Contact person for scientific queries
Name 68328 0
Angela Frances Yap
Address 68328 0
Duke-NUS Medical School
8 College Road
Singapore 169857
Country 68328 0
Singapore
Phone 68328 0
+65 90286131
Fax 68328 0
Email 68328 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
SourceTitleYear of PublicationDOI
EmbaseRhythm-centred music making in community living elderly: A randomized pilot study.2017https://dx.doi.org/10.1186/s12906-017-1825-x
N.B. These documents automatically identified may not have been verified by the study sponsor.