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Trial registered on ANZCTR


Registration number
ACTRN12619000728134p
Ethics application status
Submitted, not yet approved
Date submitted
9/05/2019
Date registered
14/05/2019
Date last updated
14/05/2019
Date data sharing statement initially provided
14/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Paint the Pain: Investigating the physiological, psychological, and social impacts of a visual art creation on individuals living with chronic pain
Scientific title
Paint the Pain: Investigating the biopsychosocial impacts of a guided self-reflective visual art creation on individuals living with chronic pain– a pilot randomised controlled trial study
Secondary ID [1] 298195 0
Nil Known
Universal Trial Number (UTN)
U1111-1233-2338
Trial acronym
Linked study record
Nil Known

Health condition
Health condition(s) or problem(s) studied:
Chronic/Persistent Pain related to a musculoskeletal region 312777 0
Condition category
Condition code
Musculoskeletal 311278 311278 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 311300 311300 0 0
Other physical medicine / rehabilitation
Neurological 311301 311301 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After receiving consent, participants will be randomised into an intervention or a control group.
Our randomisation approach will be impacted by the number of participants recruited from the STEPs Program.
o If we are successful in recruiting 20 patients after attending one of the monthly STEPs programs, participants will be randomly allocated by the research team to either intervention or control group, using a computer-generated sequence and a 1:1 allocation ratio.

o If we are not successful in recruiting 20 patients from one STEPs program, we aim to use the quasi-randomisation approach. That is, the first group of participants recruited from the first STEPs program will be allocated to the intervention group and participants recruited from the next STEPs program will be allocated to the control group.

This approach will not extend the waiting time of patients to receive their pain assessment and treatment, should we not succeed in recruiting 20 participants via the first STEPs program.

After randomisation/group allocation, the intervention group will undergo five sessions of art intervention (3hrs/1 session per week) detailed below.
Intervention Group
Participants randomised/allocated to the art intervention group will be asked to attend five sessions of art observation and creation at the Art Gallery of NSW (3hrs per session, 1 session per week) for over five weeks. To monitor adherence, participants will be contacted by our research assistant two days prior to the session and will be sent a text message requesting to confirm their attendance 24 hours prior to the session.
The first hour of the session, will be allocated to observation and discussion of 3 art works at the art gallery of NSW. This session will be guided by two artists at the gallery.
The second hour of the session is allocated to creation of the art works guided by an artist, and two researchers experienced in the field of arts and health, and a rehabilitation counselling researcher. During these sessions, participants will be guided to explore and communicate their pain experiences through the creation of visual artworks including each individual's pain and its impact on their well-being, personal and social life. Participants may also depict their 'ideal' self and life if they could 'tame' their pain. Participants will be guided to share and discuss these art creations and experiences with family, others with chronic pain, and with community members. The themes for the five art making sessions will be decided upon iteratively by the research team from the following list:
1. Express your pain in paint. Explore any of its dimensions.
2. Paint yourself with your pain in your present life.
3. Paint the self you hope to be/ you could be in relation to moving beyond pain /taming pain
4. Paint all the places the pain has come from or are connected with
5. What do you need most in order to live with pain?
6. Paint your future self and how you would like to live
7. Paint what is meaningfully connected to your pain – in any way.
The final hour of the art-making sessions will be a group discussion and reflection on the art creation process, effectively a group interview, conducted jointly by team members, a rehabilitation counsellor and a qualitative arts and health researcher. This group interview is similar to a ‘focus group’ and is understood partly as ‘action research’ in which reflections prompted by the discussion may influence their experiences in the subsequent session.
Intervention code [1] 314426 0
Treatment: Other
Intervention code [2] 314427 0
Rehabilitation
Intervention code [3] 314428 0
Behaviour
Comparator / control treatment
Control Group

Participants randomised/allocated to the control group can continue with any usual treatment they were receiving, while on the waiting list to receive their multidisciplinary pain management program at the RPAH Pain Management Clinic. Their usual treatment includes, pain medication, physiotherapy or any conservative pain management they were receiving when enrolled in the study.
Outcome measures will be collected at baseline (enrolment in the study) and at five weeks (corresponding with the length of the art intervention for the intervention group) time points.
At conclusion of the study, participants in this group will be provided with an art making kit and tickets to the Art Gallery of NSW, as compensation for their time and participation in the project. No further instructions on how to use the Kit will be provided to the control group. However, if they had any questions regarding how to be engaged with the gallery, or how to create visual arts, the lead researcher and the artists will support them and provide them with this information.
Control group
Active

Outcomes
Primary outcome [1] 320020 0
Pain severity:
This is a Composite Primary outcome measure. The patient is asked to rate the intensity of their pain at its worst in the last week, at its least in the last week, on average, and right now. For each of the four questions above, the patient rates their pain on a scale of 0 to 10, where 0 = ‘No pain’ and 10 = ‘Pain as bad as you can imagine’.
Timepoint [1] 320020 0
Before the commencement, after the conclusion of study, and at three and 6 months follow up.
Primary outcome [2] 320021 0
Saliva Cortisol Level
Saliva Cortisol level will be assessed using the IPRO Cortisol LFD.
Timepoint [2] 320021 0
In the intervention group, participants’ saliva samples will be collected before, during and after each art intervention session, at specific time points (3 samples over each session, for each participant). Our trained research assistant will read and record the saliva Cortisol levels after collection of saliva.
In the control group, saliva Cortisol level will be once at baseline and once within five weeks. We intend to collect Saliva samples from the control group at a specific time point that matches the time point of intervention group during the day, after art intervention. The specific time points will be finalised once the art sessions are confirmed and commenced at the Art Gallery.
Primary outcome [3] 320022 0
Heart Rate
To record the heart rate, the Instant Heart Rate mobile application will be used. The application uses mobile phone's camera flash to measure heart rate in seconds. Participants place the tip of their index finger over the camera and wait for Instant Heart Rate to detect colour changes in the fingertip each time the heart beats.
Timepoint [3] 320022 0
Participants’ heart rate will be monitored and recorded at the same time as the collection of saliva samples.
Secondary outcome [1] 370261 0
An exploratory, open ended qualitative group interview that seeks to understand the social, psychological and experiential dimensions of visual arts creation in individuals with chronic pain. The group interviews will be conducted by two members of the research team.
Timepoint [1] 370261 0
Only in the intervention group, the final hour of each art intervention session will be allocated to group interview and recording of participants responses.
Secondary outcome [2] 370323 0
Frequency of their pain (e.g., always present, occasionally present, etc).
This out come is primary
Timepoint [2] 370323 0
Before the commencement, after the conclusion of study, and at three and 6 months follow up.
Secondary outcome [3] 370324 0
Pain site: report of where on a body map the patient feels pain.
This outcome is primary.
Timepoint [3] 370324 0
Before the commencement, after the conclusion of study, and at three and 6 months follow up.
Secondary outcome [4] 370325 0
Rating of individual's change-overall (on a scale of -3 to 3 where -3 is ‘very much worse’, 0 is ‘unchanged’ and ‘3’ is ‘very much better’.)
Timepoint [4] 370325 0
Before the commencement, after the conclusion of study, and at three and 6 months follow up.
This outcome is primary.
Secondary outcome [5] 370326 0
Pain interference: The patient is asked to rate how much their pain has interfered with the following in the past week: general activity, mood, walking ability, normal work (both outside the home and housework), relations with other people, sleep, enjoyment of life. For each of the seven questions above, the patient rates their pain on a scale of 0 to 10, where 0 = ‘Does not interfere’ and 10 = ‘Completely interferes’. An average rating of pain interference is calculated by summing the scores for the seven questions above, divided by the number of questions the patient completed. If more than one number has been circled for a question, use the highest score.
Timepoint [5] 370326 0
Before the commencement, after the conclusion of study, and at three and 6 months follow up.
This outcome is primary.
Secondary outcome [6] 370327 0
Depression, Anxiety, Stress Scale 21 (DASS21)
Timepoint [6] 370327 0
Before the commencement, after the conclusion of study, and at three and 6 months follow up.
This outcome is primary.
Secondary outcome [7] 370328 0
Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [7] 370328 0
Before the commencement, after the conclusion of study, and at three and 6 months follow up.
This outcome is primary.
Secondary outcome [8] 370329 0
Pain catastrophising scale (PCS)
Timepoint [8] 370329 0
Before the commencement, after the conclusion of study, and at three and 6 months follow up.
This outcome is primary.
Secondary outcome [9] 370330 0
Medications related information: Records whether the patient is taking medications.
Please refer to our protocol for further details on these outcome measures
Timepoint [9] 370330 0
Before the commencement, after the conclusion of study, and at three and 6 months follow up.
This outcome is primary.
Secondary outcome [10] 370333 0
Participants in both groups will be provided with a journal to qualitatively and quantitatively document any changes or improvements relevant to:

1. Pain, by answering the following question:
Describe and rate your pain (e.g. how long it lasts, where it is, what it feels like – dull, sharp, stabbing, rate 0-10)
Timepoint [10] 370333 0
Over five weeks, from the enrolment in the study until the conclusion of art creation sessions for the intervention group.
Secondary outcome [11] 370334 0
Participants in both groups will be provided with a journal to qualitatively document any changes or improvements relevant to:
2. Pain aggravating factors, by answering the following question:
What made your pain worse?
Timepoint [11] 370334 0
Over five weeks, from the enrolment in the study until the conclusion of art creation sessions for the intervention group.
Secondary outcome [12] 370335 0
Participants in both groups will be provided with a journal to qualitatively document any changes or improvements relevant to:
3. Feelings/emotions towards their pain, by answering the following question:
What did your pain make you feel? What were you fearful of?
Timepoint [12] 370335 0
Over five weeks, from the enrolment in the study until the conclusion of art creation sessions for the intervention group.
Secondary outcome [13] 370336 0
Participants in both groups will be provided with a journal to qualitatively document any changes or improvements relevant to:
4. Behaviours towards their pain by answering the following question:
What were you confident about? What helped you get through your day?
Timepoint [13] 370336 0
Over five weeks, from the enrolment in the study until the conclusion of art creation sessions for the intervention group.
Secondary outcome [14] 370338 0
Participants in both groups will be provided with a journal to qualitatively document any changes or improvements relevant to:
5. Activity level and mood, by answering the following question
Describe your activity level and mood (Has the pain affected your daily life, such as sleep, work social life etc).
Timepoint [14] 370338 0
Over five weeks, from the enrolment in the study until the conclusion of art creation sessions for the intervention group.

Eligibility
Key inclusion criteria
Individuals above the age of 18, who have been diagnosed with chronic musculoskeletal pain, whose pain has been stable over the past 3 months will be included in this study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who have started any new pain-related medications within 3 months prior to recruitment will be excluded from the study.

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
If we were successful in recruiting 20 participants in a short period of time, we aim to randomise our participants.
We aim to use concealment allocation, if the use of true randomisation was possible. If true randomisation was possible (instead of quasi randomisation), allocation will involve contacting the holder of the allocation schedule who was “off-site”. If true randomisation: Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: Pilot study. The data provided by this study will inform the sample size for future studies.

Data analysis (Quantitative)
Descriptive statistics will be used to describe the population, patient-reported outcome measures and physiological outcome measures. Data will be assessed for normality. Generalised linear models will be used to compare the mean change in outcomes (continuous variables) from baseline to each time point between the intervention and control groups. This will provide effect estimates and 95% confidence intervals for any difference between the intervention and control group.

Data analysis (Qualitative)
All 3-hour art making sessions, including the concluding hour of group discussion, will be audio recorded and the audio recordings transcribed. Analysis will be iterative and interpretive, with the analysis team using processes of close coding, memoing, and building categories and themes, triangulating findings constructed following the first art making session through initial independent analysis and iteratively building an analytic framework through comparison and discussion across the team after each subsequent session.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13726 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 26469 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 302737 0
University
Name [1] 302737 0
The University of Sydney Industry and Community Engagement Seed Fund
Address [1] 302737 0
The University of Sydney, Camperdown, NSW, 2006
Country [1] 302737 0
Australia
Funding source category [2] 302740 0
Other Collaborative groups
Name [2] 302740 0
The Art Gallery of NSW
Address [2] 302740 0
Art Gallery Rd, Sydney NSW 2000
Country [2] 302740 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 302673 0
Other Collaborative groups
Name [1] 302673 0
The Art Gallery of NSW
Address [1] 302673 0
The Art Gallery Rd, Sydney, 2000
Country [1] 302673 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303339 0
Sydney Local Health District Ethics Committee
Ethics committee address [1] 303339 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 303339 0
Australia
Date submitted for ethics approval [1] 303339 0
08/05/2019
Approval date [1] 303339 0
Ethics approval number [1] 303339 0

Summary
Brief summary
This study aims to investigate the biopsychosocial impacts of visual arts on individuals with chronic pain. Twenty participants on the waiting list of pain management program at Royal Prince Alfred Hospital will be recruited and randomised into intervention and control groups. The intervention group will receive five sessions (3hrs/session) of art observation and reflective art creation at the Art Gallery of NSW. Stress and inflammatory bio-marker (saliva cortisol-level) and several patient reported outcome measures will be recorded before, during and after the intervention. Each art-making session will be followed by a semi-structured group discussion. The discussions will be recorded for further analysis. The control group will continue with their usual medical care.
We hypothesise that this research will identify :
(a) whether making visual art produces physiological benefits for chronic pain sufferers, and
(b) whether art-making is experienced as beneficial by chronic pain sufferers and identify why or why not.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93330 0
Dr Fereshteh Pourkazemi
Address 93330 0
O221, Faculty of Health Sciences, The University of Sydney
75 East Street, Lidcombe, NSW, 1825

Country 93330 0
Australia
Phone 93330 0
+61293519207
Fax 93330 0
+61 293519601
Email 93330 0
fereshteh.pourkazemi@sydney.edu.au
Contact person for public queries
Name 93331 0
Dr Fereshteh Pourkazemi
Address 93331 0
O221, Faculty of Health Sciences, The University of Sydney
75 East Street, Lidcombe, NSW, 1825

Country 93331 0
Australia
Phone 93331 0
+61293519207
Fax 93331 0
+61 293519601
Email 93331 0
fereshteh.pourkazemi@sydney.edu.au
Contact person for scientific queries
Name 93332 0
Dr Fereshteh Pourkazemi
Address 93332 0
O221, Faculty of Health Sciences, The University of Sydney
75 East Street, Lidcombe, NSW, 1825

Country 93332 0
Australia
Phone 93332 0
+61293519207
Fax 93332 0
+61 293519601
Email 93332 0
fereshteh.pourkazemi@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study is a small pilot study, 10 participants will be allocated to the intervention group and they will the art intervention together. By providing individual data, participants may identify individual responses, leading to breach of confidentiality.
What supporting documents are/will be available?
Study protocol
Informed consent form
Other
'Other' documents specified
The Recruitment overview document, ePPOC Clinical Reference Manual, and My Pain Diary are also available.
How or where can supporting documents be obtained?
Type [1] 2037 0
Study protocol
Citation [1] 2037 0
Link [1] 2037 0
Email [1] 2037 0
Other [1] 2037 0
Please be advised that sections relevant to ePPOC are provided from the ePPOC Clinical
Reference Manual. This manual is attached as an appendix 2 and can be accessed via: https://ahsri.uow.edu.au/content/groups/public/@web/@chsd/documents/doc/uow169773.pdf
Type [2] 2038 0
Informed consent form
Citation [2] 2038 0
Link [2] 2038 0
Email [2] 2038 0
Other [2] 2038 0
Type [3] 2052 0
Other
Citation [3] 2052 0
Link [3] 2052 0
Email [3] 2052 0
Other [3] 2052 0
Appendix 1. Recruitment overview
Type [4] 2053 0
Other
Citation [4] 2053 0
Link [4] 2053 0
Email [4] 2053 0
Other [4] 2053 0
Appendix 2. ePPOC Clinical Reference Manual
This manual can be accessed via: https://ahsri.uow.edu.au/content/groups/public/@web/@chsd/documents/doc/uow169773.pdf
Type [5] 2054 0
Other
Citation [5] 2054 0
Link [5] 2054 0
Email [5] 2054 0
Other [5] 2054 0
Appendix 3.My Pain Diary
Summary results
No Results