Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000385640
Ethics application status
Not yet submitted
Date submitted
10/03/2014
Date registered
9/04/2014
Date last updated
9/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The moderating influence of attentional bias on the efficacy of distraction vs mindfulness in an experimental pain task
Scientific title
The moderating influence of attentional bias on the efficacy of distraction vs mindfulness in an experimental pain task
Secondary ID [1] 284225 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 291338 0
Condition category
Condition code
Musculoskeletal 291699 291699 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Mindfulness: A 10-15 minute mindfulness exercise will be delivered in a laboratory setting. The exercise will teach undergraduate students to focus on mindfulness of breath and body scanning. Hence, they will learn to focus on internal sensations non-judgementally immediately before completing two acute experimental pain tasks.

Two water tanks manufactured by Thermoline Scientific Australia were used to conduct the cold pressor task. Each tank was comprised of a 20L circulating water bath chamber (model TLWB-30), immersion cooler (TIC-400) and a heat circulator (TU-3). In order to ensure participants initial arm temperature was controlled for, they were firstly asked to submerge their arm up to the elbow for 30 seconds in the warm tank, with a maintained temperature of 37degrees C ( plus or minus 0.5). Following this, they submerged the same arm up to the elbow into the tank of cold water, maintained at 5 degrees C(plus or minus 0.5). Research in the past indicates the cold pressor task produces the “Lewis Effect”, whereby pain is produced by vasodilation of the blood vessels due to warm water, quickly followed by vasoconstriction due to cold water.

A series of shocks a 0.5, 1.5 and 3.0 microamps will be administered and a pain rating will be recorded.
Intervention code [1] 288931 0
Other interventions
Comparator / control treatment
Distraction: Another group will be given an audiotape of a sound array and asked to focus their attention on the different sounds that they can hear. They will practice this for a matched period of time (10-15 minutes) as the mindfulness group. Their pain will be assessed immediately after receiving the intervention.

The audiotape will play when the pain tasks are undertaken.
Control group
Active

Outcomes
Primary outcome [1] 291635 0
Pain: Average pain ratings (on a visual analogue scale; VAS) observed in response to electric shocks and in response to the cold pressor task
Timepoint [1] 291635 0
Immediately following completion of each acute experimental pain task
Primary outcome [2] 291636 0
Threshold: Time taken for the participant to report experiencing pain during the cold pressor task (We use a stopwatch)
Timepoint [2] 291636 0
During the cold pressor task
Primary outcome [3] 291637 0
Pain-related distress: Ratings (0-10) of Subjective Units of Distress associated with pain, rated following task.
Timepoint [3] 291637 0
Immediately following the acute experimental pain task
Secondary outcome [1] 307209 0
Hesitance: The time taken to emerge arm fully in the cold pressor task (we measure time using a stopwatch)
Timepoint [1] 307209 0
During the cold pressor task
Secondary outcome [2] 307210 0
Tolerance: time that arm is left in the cold pressor task (max 4 minutes) (We use a stopwatch to measure time)
Timepoint [2] 307210 0
During the cold pressor task

Eligibility
Key inclusion criteria
Undergraduate psychology student
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cardiac problems
History of chronic pain
Current pain on a visual analogue scale of greater than 3 out of 10 (i.e. > 3/10)

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)
Participants will be given a participant number upon recruitment and these numbers will be linked to a set of random numbers (1 and 2) and placed in sealed, opaque envelopes. Once the participant has consented to take part, their allocation will be revealed by the experimenter.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomizer.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will all complete an assessment of attentional bias at baseline. On the basis of these scores, they will then be divided into a high and low attentional bias group in order to determine the potential moderating impact of attentional bias on the relative efficacy of mindfulness versus distraction
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
2 (attention bias) x 2 (Mindfulness vs distraction) AN(C)OVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2014
Actual
Date of last participant enrolment
Anticipated
31/08/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7858 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 288851 0
Self funded/Unfunded
Name [1] 288851 0
Country [1] 288851 0
Primary sponsor type
University
Name
The University of Sydney
Address
Parramatta Rd.
Camperdown
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 287543 0
None
Name [1] 287543 0
Address [1] 287543 0
Country [1] 287543 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290686 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 290686 0
Jane Foss Russell Building
City Rd
The University of Sydney
NSW 2037
Ethics committee country [1] 290686 0
Australia
Date submitted for ethics approval [1] 290686 0
10/03/2014
Approval date [1] 290686 0
Ethics approval number [1] 290686 0

Summary
Brief summary
This study aims to examine the moderating impact of baseline attentional bias on the relative efficacy of two brief interventions: mindfulness vs distraction. Participants will have their attention biases towards painful stimuli assessed and will then be randomized to receive either distraction or mindfulness before completing two experimental pain tasks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46798 0
Prof Louise Sharpe
Address 46798 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 46798 0
Australia
Phone 46798 0
61 2 93514558
Fax 46798 0
Email 46798 0
[email protected]
Contact person for public queries
Name 46799 0
Miss Jennifer Samson
Address 46799 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 46799 0
Australia
Phone 46799 0
61 293514558
Fax 46799 0
Email 46799 0
[email protected]
Contact person for scientific queries
Name 46800 0
Prof Louise Sharpe
Address 46800 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 46800 0
Australia
Phone 46800 0
61293514558
Fax 46800 0
Email 46800 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.