Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001163998
Ethics application status
Approved
Date submitted
13/10/2011
Date registered
8/11/2011
Date last updated
8/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of mindfulness based stress reduction in total joint arthroplasty patients.
Scientific title
A pilot study of mindfulness based stress reduction in total joint arthroplasty patients.
Secondary ID [1] 273207 0
Nil
Universal Trial Number (UTN)
U1111-1125-2269
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total joint arthroplasty 278973 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279149 279149 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administation of an eight-session group mindfulness training intervention to 30 volunteers on the TJA waiting list (once a week over a total of 8 weeks).

The Mindfulness Intervention
The eight sessions (conducted by KM and SK) will be of 1.5 hours duration each (including breaks) and will have 3 components.
Supportive group – patients will share their illness experience
Psycho-education on the stress response and how it impacts on illness
Managing stress through mindfulness
The program content is outlined below. All session will be conducted in a group room at St Vincent Hospital in Melbourne.

Session 1
Introductions
Introduction to the program
Psych-education regarding the impact of joint problems on the body, quality of life and psychological health
Normalizing the “joint pain” experience and the relationship between stress and physical ill health


Session 2
Discussion of Stress Model and illness
Introduction to the mindfulness model
Introduction to awareness of breath


Session 3
Discussion regarding the stressors associated with illness
Body scan meditation (which is practiced during the session).
Discussion regarding body scan

Session 4
Discussion of experience of homework exercise.
Discussing of stress management strategies
Sitting mindfulness exercise.
Introduction to mindful walking (and practice during the session)
Discussion regarding walking meditation
Provision of homework exercise

Session 5
Discussion of experience of homework exercise.
Introduction to alternatives to the breath as a focus of attention during
sitting mindfulness
Practice of mindful stretching
Practice of mindful walking
Provision of homework exercise


Session 6
Discussion of experience of homework exercise.
Managing stresses involved in communicating with others
Introduction to mindfulness of emotions
Practice of sitting mindfulness
Practice of mindful stretching
Provision of homework exercise


Session 7
Discussion of experience of homework exercise.
Further elaboration of alternative foci of attention during meditation.
Practice of sitting mindfulness
Practice of mindful walking
Preparation for termination of the 8-week intervention
Provision of homework exercise

Session 8
Discussion of experience of homework exercise.
Review
Discussion on ongoing practice
Sitting mindfulness meditation.
Completion of questionnaires
Intervention code [1] 269541 0
Other interventions
Comparator / control treatment
Participants who wish to complete the study questionnaires, but not part of the mindfulness intervention will also be recruited; this treatment-as-usual group will provide a comparison to the TJA mindfulness group.
Control group
Active

Outcomes
Primary outcome [1] 279789 0
Primary outcome: will be self-reported pain and physical function measured on the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. The WOMAC consists of 24 items covering three subscales: pain (five items), stiffness (two items) and physical function (17 items). The pain and physical function subscale will be used, each subscale transformed to a score ranging from 0 to 100, with a higher score indicating greater pain and physical function. The WOMAC is a widely-used questionnaire specifically designed to evaluate knee and hip OA.
Timepoint [1] 279789 0
Measures and data collection will occur prior to commencement of the program, at program completion, three months following the intervention, and 3 months post surgery.
Secondary outcome [1] 294431 0
Quality of Life: Data will be derived from the 12 item WHOQOL Brief Survey.
Timepoint [1] 294431 0
Measures and data collection will occur prior to commencement of the program, at program completion, three months following the intervention, and 3 months post surgery.

Eligibility
Key inclusion criteria
Patients who are on the St Vincent’s TJA surgery waitlist.
Aged above 18 years old or older.
Fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have a diagnosed psychotic disorder, or have been diagnosed with dementia or intellectual disability.

If they are likely to be experiencing significant symptoms of substance intoxication or withdrawal during program sessions.

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)
Those who wish to participate in the 8 weekly group mindfulness intervention will indicate their interest on the study questionnaire and contacted by the researchers to organize the intake interview and commencement intervention details. Participants who wish to complete the study questionnaires, but not part of the mindfulness intervention will also be recruited; this treatment-as-usual group will provide a comparison to the TJA mindfulness group.
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
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270036 0
Self funded/Unfunded
Name [1] 270036 0
St Vincents Hospital
Country [1] 270036 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital
Address
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 269007 0
None
Name [1] 269007 0
Address [1] 269007 0
Country [1] 269007 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271989 0
St Vincent Hospital Human Ethics committee A
Ethics committee address [1] 271989 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 271989 0
Date submitted for ethics approval [1] 271989 0
23/03/2011
Approval date [1] 271989 0
Ethics approval number [1] 271989 0
HREC-037/11

Summary
Brief summary
The objectives of this project are to: (1) identify currently levels of distress in a waiting list for Total joint arthroplasty (TJA), and (2) administer an eight-session group mindfulness training intervention to 30 volunteers on the TJA waiting list.

It is hypothesised that (1) levels of pain will be adversely associated with depression, anxiety and lower Quality of Life; (2) the intervention will lead to better tolerance of symptoms, an improved quality of life. Mindfulness is “the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment by moment”. Training involves instruction in a number of meditation techniques as well as teaching on how to remain focused on the present moment in day to day activities. There is now extensive scientific evidence showing that mindfulness training leads to an improvement in emotional and physical symptoms in a variety of disorders such as chronic pain, cancer, depression, anxiety and substance use among others. To our knowledge, this technique has not previously been used with TJA patients.

135 participants (waiting list of TJA-surgery patients [Currently: 78 knees and 57 hips] who do not have a date for surgery as yet) will be mailed a PICF and study questionnaire (with pre-addressed-stamped envelope). Those who wish to participate in the 8 weekly group mindfulness intervention will indicate their interest on the study questionnaire and contacted by the researchers to organize the intake interview and commencement intervention details. 30 volunteer patients who identify as experiencing pain and emotional distress associated with their TJA who are on the St Vincent’s TJA surgery wait list will be recruited. Participants who wish to complete the study questionnaires, but not part of the mindfulness intervention will also be recruited; this treatment-as-usual group will provide a comparison to the TJA mindfulness group.

All participants will be aged 18 years or more, and will be fluent in English. Participants will be excluded if: (1) they experience psychotic symptoms, delirium or dementia, (2) they suffer drug or alcohol dependence; or (3) they have a diagnosis of intellectual disability. Based on the results of this study it is planned to apply for grant to conduct a randomized controlled trial of the piloted intervention. Surgical date will not be adversely impacted upon, if participants do (or do not) participate in this pilot study.

In addition to the initial questionnaire data, participants will also be asked to complete the questionnaire again at the program completion, three months following the intervention, and 3 months post-surgery.
Trial website
Trial related presentations / publications
None.
Public notes

Contacts
Principal investigator
Name 33268 0
Address 33268 0
Country 33268 0
Phone 33268 0
Fax 33268 0
Email 33268 0
Contact person for public queries
Name 16515 0
Michelle Dowsey
Address 16515 0
Department of Orthopaedic Surgery
Level 2, Clinical Sciences Building
29 Regent Street (corner of Princes and Regent Streets)
Fitzroy, Melbourne, VIC 3065
Australia
Country 16515 0
Australia
Phone 16515 0
613 9288 3955
Fax 16515 0
614 9416 3610
Email 16515 0
mmdowsey@unimelb.edu.au
Contact person for scientific queries
Name 7443 0
Michelle Dowsey
Address 7443 0
Department of Orthopaedic Surgery
Level 2, Clinical Sciences Building
29 Regent Street (corner of Princes and Regent Streets)
Fitzroy, Melbourne, VIC 3065
Australia
Country 7443 0
Australia
Phone 7443 0
613 9288 3955
Fax 7443 0
614 9416 3610
Email 7443 0
mmdowsey@unimelb.edu.au

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.