Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000854437p
Ethics application status
Submitted, not yet approved
Date submitted
11/07/2025
Date registered
7/08/2025
Date last updated
7/08/2025
Date data sharing statement initially provided
7/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a Culturally Adapted Sonas Programme in Australian Aged Care: A Pilot Randomised Controlled Trial for People with Dementia
Scientific title
Feasibility of a Culturally Adapted Sonas Programme in Australian Aged Care: A Pilot Randomised Controlled Trial for People with Dementia
Secondary ID [1] 314769 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
resident engagement 337995 0
Behavioural and Psychological Symptoms of Dementia (BPSD) of residents 337996 0
positive mood 337997 0
pain 337998 0
communication skills 337999 0
quality of life 338183 0
depression 338184 0
Condition category
Condition code
Mental Health 334310 334310 0 0
Depression
Neurological 334311 334311 0 0
Alzheimer's disease
Neurological 334312 334312 0 0
Dementias
Mental Health 334553 334553 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Culturally Adapted Sonas Programme
Participants with dementia will be identified by residential aged care facility staff based on their eligibility for the Sonas Programme. Initial contact will be made by the facility staff, who will approach the person with dementia (where appropriate) and/or their family members to inform them about the research project. If the resident and/or family expresses interest, a member of the research team will provide the Participant Information Letter and Consent Form to the residents and/or their family member or legal guardian. The Sonas intervention will be delivered in a group format of 7 over 16 weeks, with each cultural group receiving one 30-minute session per day, two days per week. This intervention schedule is informed by previous multisensory programs implemented for people with dementia (Octary et al., 2025). The Sonas Programme is a multi-sensory stimulation intervention that engages all five senses - touch, smell, taste, hearing, and sight. However, hearing is the primary focus, particularly through the use of music in this program. For example, each session includes familiar songs designed to stimulate memory and encourage engagement in participants with dementia. The activities are pre-determined and structured, delivered via pre-recorded sessions. However, a research assistant or chief investigator will be present at each session to facilitate delivery and provide individual support. Intervention sessions will be conducted in the mornings of week 1, 3, 5, 7, 9,11,13, and 15, and in the afternoons of week 2, 4, 6, 8, 10, 12, 14, and 16. They will be rotated to ensure each participant receives the intervention at different times to avoid any confounding medication effect. Sessions will be held in designated spaces, such as meeting rooms or facility living areas, with the support of the activity coordinator. The program content features multisensory activities, including music and group singalongs. Session attendance is required to assess adherence to the intervention.
Before data collection, the Chief Investigator (CI) will undergo training to become a Sonas
Programme Licensed Practitioner (SPLP). The CI will then culturally adapt the Sonas
Programme in consultation with residents, family members, and care staff.
To ensure cultural appropriateness, a team member or research assistant (RA) from the
same cultural background as participants will review the adapted program and if there are
any discrepancies, a third person will be consulted to reach a consensus.

Data will be collected at eight time points to monitor changes throughout the intervention and follow-up period: baseline (T0), Week 3 (T1), Week 6 (T2), Week 9 (T3), and Week 12 (T4), Week 15 (T5), three weeks post-intervention (T6) and six weeks post-intervention (T7) using the Engagement of a Person with Dementia Scale (Jones et al., 2018), Visual Analog Mood Scale (VAMS) (Stern et al., 2010), Neuropsychiatric Inventory - Nursing Home (NPI-NH) version (Wood et al., 2000), quality of life measured by DEMQOL (Smith et al., 2007), Cornell Scale for Depression in Dementia (CSDD) (Alexopoulos, et al., 1988) , Holden Communication Scale (Strøm et al., 2016), and Abbey Pain Scale (Abbey et al., 2004). This schedule allows for tracking short-term and longer-term effects of the intervention on residents' wellbeing.
Intervention code [1] 331387 0
Behaviour
Intervention code [2] 331539 0
Treatment: Other
Comparator / control treatment
Arm 2: Control Group - Participants receive usual care, including standard recreational activities (e.g., music therapy) offered by the facility, with no additional sensory-based intervention.
Control group
Active

Outcomes
Primary outcome [1] 342010 0
engagement
Timepoint [1] 342010 0
baseline (T0), Week 3 (T1), Week 6 (T2), Week 9 (T3), and Week 12 (T4), Week 15 (T5), three weeks post-intervention (T6) and six weeks post-intervention (T7)
Primary outcome [2] 342012 0
mood
Timepoint [2] 342012 0
baseline (T0), Week 3 (T1), Week 6 (T2), Week 9 (T3), and Week 12 (T4), Week 15 (T5), three weeks post-intervention (T6) and six weeks post-intervention (T7).
Primary outcome [3] 342016 0
behavioural and psychological symptoms of dementia - will be assessed as a composite primary outcome
Timepoint [3] 342016 0
baseline (T0), Week 3 (T1), Week 6 (T2), Week 9 (T3), and Week 12 (T4), Week 15 (T5), three weeks post-intervention (T6) and six weeks post-intervention (T7).
Secondary outcome [1] 449305 0
pain
Timepoint [1] 449305 0
baseline (T0), Week 3 (T1), Week 6 (T2), Week 9 (T3), and Week 12 (T4), Week 15 (T5), three weeks post-intervention (T6) and six weeks post-intervention (T7).
Secondary outcome [2] 449306 0
quality of life
Timepoint [2] 449306 0
baseline (T0), Week 3 (T1), Week 6 (T2), Week 9 (T3), and Week 12 (T4), Week 15 (T5), three weeks post-intervention (T6) and six weeks post-intervention (T7).
Secondary outcome [3] 449307 0
depression
Timepoint [3] 449307 0
baseline (T0), Week 3 (T1), Week 6 (T2), Week 9 (T3), and Week 12 (T4), Week 15 (T5), three weeks post-intervention (T6) and six weeks post-intervention (T7).
Secondary outcome [4] 449309 0
communication
Timepoint [4] 449309 0
baseline (T0), Week 3 (T1), Week 6 (T2), Week 9 (T3), and Week 12 (T4), Week 15 (T5), three weeks post-intervention (T6) and six weeks post-intervention (T7).

Eligibility
Key inclusion criteria
Residents will be eligible to participate if they: (1) are aged 65 years or older; and (2) have a confirmed or probable diagnosis of dementia, indicated by a Mini-Mental State Examination (MMSE) score below 24 (Folstein et al., 1975).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents will be excluded if they are at the end-of-life stage, have a major mental illness, or have previously participated in Sonas sessions.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation sequence generated in Microsoft Excel
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2026
Actual
Date of last participant enrolment
Anticipated
5/07/2027
Actual
Date of last data collection
Anticipated
29/11/2027
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319517 0
Self funded/Unfunded
Name [1] 319517 0
None
Country [1] 319517 0
Primary sponsor type
Individual
Name
Dr Wenhong Zhao - Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 322015 0
None
Name [1] 322015 0
Address [1] 322015 0
Country [1] 322015 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317900 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 317900 0
Ethics committee country [1] 317900 0
Australia
Date submitted for ethics approval [1] 317900 0
16/07/2025
Approval date [1] 317900 0
Ethics approval number [1] 317900 0

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

Contacts
Principal investigator
Name 142510 0
Dr Wenhong Zhao
Address 142510 0
Edith Cowan University 270 Joondalup Drive, Joondalup WA 6027
Country 142510 0
Australia
Phone 142510 0
+61 8 6304 3394
Fax 142510 0
Email 142510 0
[email protected]
Contact person for public queries
Name 142511 0
Wenhong Zhao
Address 142511 0
Edith Cowan University 270 Joondalup Drive, Joondalup WA 6027
Country 142511 0
Australia
Phone 142511 0
+61 8 6304 3394
Fax 142511 0
Email 142511 0
[email protected]
Contact person for scientific queries
Name 142512 0
Wenhong Zhao
Address 142512 0
Edith Cowan University 270 Joondalup Drive, Joondalup WA 6027
Country 142512 0
Australia
Phone 142512 0
+61 8 6304 3394
Fax 142512 0
Email 142512 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.