Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001385538p
Ethics application status
Not yet submitted
Date submitted
15/10/2024
Date registered
22/11/2024
Date last updated
22/11/2024
Date data sharing statement initially provided
22/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
MindArt: An art-based relaxation programme for stroke survivors and supporters
Scientific title
MindArt: A pilot study of acceptability and feasibility of an art-based relaxation programme with stroke survivors and supporters
Secondary ID [1] 313191 0
HRC 23/952
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 335480 0
Condition category
Condition code
Stroke 332039 332039 0 0
Ischaemic
Stroke 332101 332101 0 0
Haemorrhagic
Mental Health 332102 332102 0 0
Anxiety
Mental Health 332103 332103 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: MindArt

Why: Mindfulness-based art therapy integrates mindfulness techniques with art-making (Mak et al., 2023; Irons et al., 2020), offering the potential to reduce stress and improve well-being

What: MinDArT is a dual-care programme for people with dementia and their supporters. Each weekly session involves people with neurological impairment undertaking custom-designed traditional and digital art-making exercises, while their supporters in an adjacent room undertake the same programme. The programme is inspired by nature, engaging as many senses as possible and applying repetitive drawing movements to relax, stimulate and engage participants. Each session utilises natural resources, traditional drawing materials, and a specially designed digital drawing application. The description of the materials and procedures involved is available in a manual (available on request). For example, as part of session 1, participants listen to the sound of ‘waves and seagull sounds’ and touch and smell the seaweed on a tray. They discuss memories of the sea.
Then make patterns in sand trays with miniature ‘zen garden’ rakes. They use sand and glue to make patterns on dark paper. They use a digital ‘Touch Scape’ application that mimics making patterns in a zen garden.

Who: The MindArt is run by a trained facilitator. MindArt training is provided by the developer of MindArt. The facilitators in this research activity are registered allied health professionals (speech-language therapists). They are supported by a volunteer in each group, recruited through the participating Stroke Club, with personal experience of supporting a person living with stroke.



How: MindArt is delivered face-to-face in a group of up to 8 people.
Where: MindArt is delivered in a community venue.
When and how much: MindArt is delivered in 8 weekly sessions of 90 minutes per session.

Tailoring / modifications: The MindArt sessions have been designed for people with neurological impairments with principles including use of senses to increase engagement, repetition, familiar actions and skills and awareness of ‘graphic Indicators’ of cognitive impairment (for example: regression, perseveration, simplification, fragmentation, disorganization, distortions, perceptual rotation, overlapping configurations, confused perspective, the presence of short scattered lines, and lack of detail). In addition, there is an emphasis on versatile outcomes for each activity to avoid frustration. There will be individual discussions with people with stroke-related communication changes (aphasia) prior to the programme to ensure an awareness of individual communication strategies and support needs.

The facilitators and research team will document any modification required during the course of the study to ensure that MindArt is acceptable and feasible for stroke survivors, including stroke-related communication changes. They will document any activities that a participant finds difficult to understand or perform, as well as any adaptations or accommodations that were useful.


Intervention code [1] 329762 0
Lifestyle
Intervention code [2] 329807 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339640 0
Acceptability
Timepoint [1] 339640 0
At the end of each session (0,1,2,3,4,5,6,7 weeks after intervention commencement), at the end of intervention (primary)
Primary outcome [2] 339641 0
Feasibility
Timepoint [2] 339641 0
Feasibility of intervention: Each session (0,1,2,3,4,5,6,7 after commencement). (primary)
Primary outcome [3] 339691 0
Feasibility of proposed measures:
Timepoint [3] 339691 0
Baseline, post-completion of 8-week intervention program (primary)
Secondary outcome [1] 440895 0
Nil
Timepoint [1] 440895 0
No secondary outcome

Eligibility
Key inclusion criteria
• Capacity to give informed consent to participate in this research.
• Has experienced a stroke or supports someone who has experienced a stroke (no time limit)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Significant visual / hearing to an extent that would make engagement in a group environment difficult.
• An activated enduring power of attorney for personal welfare and care (or clinician advice that they are cognitively unable to give informed consent).
• Requires an interpreter from English to another language (i.e., not because of aphasia)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2025
Actual
Date of last participant enrolment
Anticipated
25/04/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 26636 0
New Zealand
State/province [1] 26636 0

Funding & Sponsors
Funding source category [1] 317638 0
Government body
Name [1] 317638 0
New Zealand Health Research Council
Country [1] 317638 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Burwood Academy Trust
Address
Country
New Zealand
Secondary sponsor category [1] 319950 0
None
Name [1] 319950 0
Address [1] 319950 0
Country [1] 319950 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316336 0
To be allocated after submission to the NZ Health and Disability Ethics Committee system
Ethics committee address [1] 316336 0
Ethics committee country [1] 316336 0
New Zealand
Date submitted for ethics approval [1] 316336 0
29/01/2025
Approval date [1] 316336 0
Ethics approval number [1] 316336 0

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

Contacts
Principal investigator
Name 137570 0
Dr Susan Gee
Address 137570 0
300 Burwood Road, Burwood Hospital, Burwood, Christchurch 8083
Country 137570 0
New Zealand
Phone 137570 0
+64 027 289 7714
Fax 137570 0
Email 137570 0
susan.gee@cdhb.health.nz
Contact person for public queries
Name 137571 0
Susan Gee
Address 137571 0
300 Burwood Road, Burwood Hospital, Burwood, Christchurch 8083
Country 137571 0
New Zealand
Phone 137571 0
+64 027 289 7714
Fax 137571 0
Email 137571 0
susan.gee@cdhb.health.nz
Contact person for scientific queries
Name 137572 0
Susan Gee
Address 137572 0
300 Burwood Road, Burwood Hospital, Burwood, Christchurch 8083
Country 137572 0
New Zealand
Phone 137572 0
+64 027 289 7714
Fax 137572 0
Email 137572 0
susan.gee@cdhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Feasibility study with only 8 participants of each type, not powered for analysis


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.