Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000147785
Ethics application status
Approved
Date submitted
5/02/2013
Date registered
7/02/2013
Date last updated
10/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Facilitating Older-Adults' Resilience: A Pilot study of a Mindfulness Intervention for Chronic Pain
Scientific title
Facilitating Older-Adults' Resilience: A Pilot study of a Mindfulness Intervention for Chronic Pain
Secondary ID [1] 281905 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 288305 0
Condition category
Condition code
Alternative and Complementary Medicine 288653 288653 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mindfulness intervention will include formal and informal mindfulness techniques, and psycho-education about the relationship between chronic pain and the mind and the body. Intervention-group participants' will be seen in a group format for one hour a week, for 6-weeks.
The intervention group sessions will be facilitated by a provisionally registered psychologist. Formal mindfulness techniques will include a) a sitting breathing meditation, b) a body scan meditation, and c) a three-minute mini-meditation. Non-formal mindfulness techniques will include activities from daily living - such as drinking a cup of tea or coffee. Psycho-education will involve describing aspects of the biopsychosocial model of pain, and elucidating the relationship between thoughts, emotions, and responses (physical and behavioural).
Intervention code [1] 286473 0
Treatment: Other
Comparator / control treatment
Wait-list control group participants will be administered the 6-week mindfulness meditation intervention after the 1-month follow-up data has been collected and analysed.
Control group
Active

Outcomes
Primary outcome [1] 288806 0
Mean pain severity and pain interference will be measured by the brief pain inventory - short form.
Timepoint [1] 288806 0
To be administered at pre-test, post-test the 6-week mindfulness intervention, and at follow-up one-month post mindfulness intervention.
Secondary outcome [1] 301035 0
Mean depression score as measured by the geriatric depression scale - short form.
Timepoint [1] 301035 0
To be administered at pre-test, post-test the 6-week mindfulness intervention, and at follow-up one-month post mindfulness intervention.
Secondary outcome [2] 301036 0
Mean 'present-moment awareness' and 'acceptance' scores will be measured using the Philadelphia mindfulness scale.
Timepoint [2] 301036 0
To be administered at pre-test, post-test the 6-week mindfulness intervention, and at follow-up one-month post mindfulness intervention.

Eligibility
Key inclusion criteria
1) Experiencing chronic or recurrent nociceptive or neuropathic pain for at least 3-months; 2) A non-demented status; and, 3) agreement to wear own sensory hearing and/or visual aids for group participation.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Demented status.

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)
Sealed non-transparent envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random number generating computer program to allocate participants to either the intervention or wait-list control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The assignment is either to the 'intervention group', or to a 'wait-list control group'. The wait-list control group, functions as the control group throughout the 6-week intervention period and the 4 week follow up time-frame. The wait-list control group will receive the intervention after the 1-month follow-up measurements have been collected.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A generalised linear mixed model will be utilised to analyse the mindfulness intervention effects and the group differences.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 6288 0
6102 - Bentley
Recruitment postcode(s) [2] 6673 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 286696 0
Self funded/Unfunded
Name [1] 286696 0
Country [1] 286696 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University, Bentley, WA, 6102.
Country
Australia
Secondary sponsor category [1] 285467 0
None
Name [1] 285467 0
Address [1] 285467 0
Country [1] 285467 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288758 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 288758 0
c/- Office of Research and Development, Curtin University, GPO Box U1987, Perth, Western Australia, 6845.
Ethics committee country [1] 288758 0
Australia
Date submitted for ethics approval [1] 288758 0
14/01/2013
Approval date [1] 288758 0
15/02/2013
Ethics approval number [1] 288758 0
HR 28/2013

Summary
Brief summary
This proposed pilot study's purpose is to explore the viability of a mindfulness meditation intervention in a sample of older-adults residing in a residential aged-care home who have chronic pain. It is hypothesised that for those older adults in the intervention group, mindfulness meditation will have a beneficial effect and decrease these older-adults scores on measures of pain and depression, while also demonstrating a tendency for increased post-study scores of acceptance and awareness.
Trial website
Trial related presentations / publications
The information gathered in the study will be used to complete a student report, if this report is published, in no way will the individuals who participated in this research be identifiable.
Public notes

Contacts
Principal investigator
Name 37630 0
A/Prof Jennifer Thornton
Address 37630 0
School of Psychology,
Curtin University
GPO Box U1987,
Perth, Western Australia,
6845.
Country 37630 0
Australia
Phone 37630 0
+61 8 92667279
Fax 37630 0
Email 37630 0
[email protected]
Contact person for public queries
Name 37631 0
Tracy Evans
Address 37631 0
School of Psychology,
Curtin University
GPO Box U1987,
Perth, Western Australia,
6845.
Country 37631 0
Australia
Phone 37631 0
+61 8 92667279
Fax 37631 0
Email 37631 0
[email protected]
Contact person for scientific queries
Name 37632 0
Jennifer Thornton
Address 37632 0
School of Psychology,
Curtin University
GPO Box U1987,
Perth, Western Australia,
6845.
Country 37632 0
Australia
Phone 37632 0
+61 8 92667279
Fax 37632 0
Email 37632 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
No additional documents have been identified.