Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000597594
Ethics application status
Approved
Date submitted
15/05/2015
Date registered
9/06/2015
Date last updated
9/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of a novel attention bias modification paradigm on pain outcomes
Scientific title
The impact on healthy individuals of a novel attention bias modification paradigm on responses to a cold pressor task
Secondary ID [1] 286717 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute pain 295079 0
Condition category
Condition code
Musculoskeletal 295329 295329 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a computerized task involves matching the identity of two faces that have either a painful expression (pain training group) or a happy expression (happy training group). This is intended to train the participant implicitly to attend either towards happy or painful facial expressions

A one-off 20-30 minute session
Intervention code [1] 291874 0
Other interventions
Comparator / control treatment
The comparator treatment is a placebo where participants are trained equally often to match the identity of the painful/happy faces.

A one-off 20-30 minute session
Control group
Placebo

Outcomes
Primary outcome [1] 295075 0
Threshold: The amount of time (measured by a stopwatch) that the participant takes to report pain once the hand is immersed in the cold pressor apparatus (5 degrees celcius).
Timepoint [1] 295075 0
Immediately post-treatment
Primary outcome [2] 295076 0
Pain levels: Pain is assessed at threshold (when the participants first report pain) and tolerance (when they remove their arm from the cold pressor) on a visual analog scale. An average is used.
Timepoint [2] 295076 0
immediately post-treatment
Primary outcome [3] 295077 0
Tolerance: Tolerance is the time that the participant leaves their arm in the cold pressor (maximum time 4 minutes). Recorded by stopwatch.
Timepoint [3] 295077 0
Immediately post-interveniton
Secondary outcome [1] 314709 0
HesitanceThe time taken to fully immerse the hand in the cold pressor from the instruction to do so (timed with a stopwatch).
Timepoint [1] 314709 0
Immediately post intervention

Eligibility
Key inclusion criteria
First year psychology students
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Reynauld's phenomena, epilepsy, cardiovascular problems, chronic pain disorders

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 consecutive number which has, in advance been linked to a set of random numbers 1-3 corresponding to the conditions. These are concealed until the participant has consented to take part.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomizer.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The results will be analyzed with a one-way ANOVA on outcomes. We will also use regressions to determine whether the attentional bias of participants following training predicts their pain outcomes. Our power analyses, based on an effect size of f = 0.327, achieved in the only other study to use this task in anxiety, indicates that we require 75 participants in total using an alpha of 0.05 to achieve 80% power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/08/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9687 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 291280 0
Self funded/Unfunded
Name [1] 291280 0
Nil
Country [1] 291280 0
Primary sponsor type
University
Name
The University of Sydney
Address
Brennan Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 289955 0
None
Name [1] 289955 0
Address [1] 289955 0
Country [1] 289955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292846 0
The University of Sydney
Ethics committee address [1] 292846 0
Jane Foss Russell Building
The University of Sydney
NSW 2006
Ethics committee country [1] 292846 0
Australia
Date submitted for ethics approval [1] 292846 0
Approval date [1] 292846 0
08/05/2015
Ethics approval number [1] 292846 0
2015/300

Summary
Brief summary
Attention modification training refers to training participants to attend away from emotionally relevant information. In the pain literature, ABM has been shown to improve pain outcomes. However, all research has used the dot-probe paradigm, the reliability of which has been questioned. This project aims to trial a novel ABM procedure using painful faces.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57294 0
Prof Ann Louise Sharpe
Address 57294 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 57294 0
Australia
Phone 57294 0
61293514558
Fax 57294 0
Email 57294 0
[email protected]
Contact person for public queries
Name 57295 0
Prof Louise Sharpe
Address 57295 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 57295 0
Australia
Phone 57295 0
61293514558
Fax 57295 0
Email 57295 0
[email protected]
Contact person for scientific queries
Name 57296 0
Prof Louise Sharpe
Address 57296 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 57296 0
Australia
Phone 57296 0
61293514558
Fax 57296 0
Email 57296 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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