Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000692538
Ethics application status
Approved
Date submitted
11/06/2015
Date registered
3/07/2015
Date last updated
3/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Emotion regulatory skills in pain
Scientific title
The effects of acute pain on emotional regulatory skill for chronic-pain patients in comparison to controls matched by age and gender.
Secondary ID [1] 286894 0
None
Universal Trial Number (UTN)
U1111-1169-1486
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 295298 0
Condition category
Condition code
Other 295564 295564 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will comprise a weight lifting task. This task will involve:

a) A modified dead-lift from the floor to standing of a bag containing a weight. The bag will be held whilst in a standing position until the end of the task.

b) A 6kg weight will be used as this is tolerated easily by most people, including those people with chronic pain.

c) There is only one repetition, with the maximum time able to hold the weight in standing until failure, with participants encouraged to do their best.

d) The task will be individually supervised by a physiotherapist.

e) The task will involve only a single session, with the time determined by the participants endurance.
Intervention code [1] 292072 0
Diagnosis / Prognosis
Intervention code [2] 292073 0
Behaviour
Comparator / control treatment
Two comparisons will be used. The first is assessment of emotional-regulatory skill before and after the weight lifting task. This will determine the effects of discomfort on baseline emotional-regulatory skill.

The second comparison is of the chronic-pain sample against a control group matched on gender and age. Both the chronic-pain and control groups will complete exactly the same tasks in the same order. This will determine if chronic-pain is associated with emotional-regulatory skill differences both at baseline and after experiencing discomfort.
Control group
Active

Outcomes
Primary outcome [1] 295281 0
Emotional regulatory skill as assessed by speed and accuracy of posing facial expressions of emotion. Participants will be prompted to make these expressions and a webcam will record these expressions. Participants will press a key to take a photo when they decide they are posing that particular expression. Speed will be determined by the delay between stimuli presentation and this key press.

The expression photos will be rated for accuracy to an emotional prototype using a 0 to 3 scale, with 3 indicating perfect reproduction of the expression. At least two people will code the expressions with degree of inter-rater agreement determining the final rating for the expression. If agreement cannot be obtained then the expression will be removed from the dataset.
Timepoint [1] 295281 0
Immediately after the weight-lifting task whilst discomfort still has a detectable effect on emotional-regulatory skill.
Secondary outcome [1] 315582 0
Several other measures will be taken of factors that might influence emotional regulatory skill. Although technically predictor variables, these are noted here are secondary outcomes so they can be included in this form.

The first is the level of attention given to pain. This will be assessed primarily by the Pain Vigilance and Awareness Questionnaire.
Timepoint [1] 315582 0
This will be assessed prior to engaging in the emotion expression and weight-lifting tasks.
Secondary outcome [2] 315583 0
The level of attention given to pain will also be assessed by a 0-10 numerical rating scale in response to a question about how much pain was noticed during the weight-lifting task.
Timepoint [2] 315583 0
This will be assessed after the weight-lifting task and prior to engaging in the second emotion expression tasks.
Secondary outcome [3] 315584 0
The presence of Depression and Anxiety symptoms will be assessed with the Depression Anxiety Stress Scale.
Timepoint [3] 315584 0
This will be assessed prior to engaging in the emotion expression and weight-lifting tasks.
Secondary outcome [4] 315585 0
General level of emotionality will be assessed with the Differential Emotions Scale.
Timepoint [4] 315585 0
This will be assessed prior to engaging in the emotion expression and weight-lifting tasks.
Secondary outcome [5] 315587 0
Participants' typical emotion regulation strategies will be assessed with the Present Personality Scale.
Timepoint [5] 315587 0
This will be assessed prior to engaging in the emotion expression and weight-lifting tasks.
Secondary outcome [6] 315588 0
State emotional intelligence will be assessed with the Mayer-Salovey-Caruso Emotional Intelligence Test.
Timepoint [6] 315588 0
This will be assessed prior to engaging in the emotion expression and weight-lifting tasks.
Secondary outcome [7] 315591 0
Duration of weight-lifting task. This will be timed from the start of the task until participants indicate they are no longer able to hold the weight.
Timepoint [7] 315591 0
This will be assessed at the termination of the weight-lifting task.

Eligibility
Key inclusion criteria
Inclusion criteria for the chronic pain sample are: that the participant has had pain for at least six months; and be fluent in English so they can complete the English-language validated questionnaire measures. Inclusion criteria for the matched, pain-free sample are the same as the chronic pain sample, with the exception of not experiencing more than seven consecutive days of pain within the last month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria identify those participant characteristics that might lead to adverse effects from the weight-lifting task or confound interpretation of the study findings. These criteria apply equally to both the chronic-pain and matched control samples. Exclusion criteria include: physical comorbidities that might hinder participation, such as facial nerve pathology that prevents emotional expression and mobility issues that have not been adequately addressed in the study design; psychological comorbidities that expert clinicians judge as possibly leading to adverse pain experiences, emotional distress or that confound interpretation of findings (e.g. psychosis, disorders of thought or disorders of motivation); and clinically identified severe health complications (e.g. cancers) from which study participation may cause needless distress and that would also could confound interpretation of findings.

Study design
Purpose of the study
Diagnosis
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
There are two groups of participants, with non-random allocation between groups. Group allocation is based on the presence or absence of a health-condition.

As in a single group study, both groups will complete exactly the same tasks and measures, and are expected to be similarly affected by the weight-lifting task. The duration of the weight-lifting task is idiosyncratically determined and although duration is expected to be shorter for the chronic-pain participants, group differences cannot be determined beforehand.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There is currently no research indicating the effect size of pain’s effects on emotional regulatory ability, so the sample size calculations are based on a review of the literature on the effects of pain on cognitive ability. This literature was used as emotional regulatory ability and cognitive ability are expected to be similarly affected by pain. Based on this literature a medium to large effect is expected and 40 participants will be recruited into each arm of the study, giving a total of 80 participants in the study. This should provide sufficient power to detect the expected effects, and allow for some participant exclusion due to data incompleteness or other unforeseen reasons.
The data will be analysed with both between-groups and within-groups statistical methods. Comparisons of attention given to pain, depression, anxiety, stress, emotionality, emotion-regulation strategies and emotional intelligence will be made between the chronic-pain and case-matched-control participants at baseline to determine if chronic pain is associated with these factors. Comparisons of emotional regulatory skill will be made between the chronic-pain and case-matched-control participants at baseline to determine is group differences exist and after the weight lifting task to determine if each group is differentially affected by this task. Comparisons will also be made for each participant’s emotional regulatory skill before and after the weight lifting task to determine if this has any detectable effect on emotional regulatory skill.
If the weight lifting task is found to have a significant effect on emotional regulatory skill, then regression analyses will be undertaken using attention given to pain, depression, anxiety, stress, emotionality, emotion-regulation strategies and emotional intelligence and group membership as predictor variables of emotional regulatory skill after the weight-lifting task.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/07/2015
Actual
Date of last participant enrolment
Anticipated
18/09/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 6969 0
New Zealand
State/province [1] 6969 0
Auckland

Funding & Sponsors
Funding source category [1] 291449 0
University
Name [1] 291449 0
Department of Health Psychology
Faculty of Medical and Health Sciences
University of Auckland
Country [1] 291449 0
New Zealand
Primary sponsor type
University
Name
Department of Health Psychology, University of Auckland
Address
Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 290124 0
None
Name [1] 290124 0
Address [1] 290124 0
Country [1] 290124 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292999 0
Health and Disability Ethics Committees
Ethics committee address [1] 292999 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 292999 0
New Zealand
Date submitted for ethics approval [1] 292999 0
Approval date [1] 292999 0
26/05/2015
Ethics approval number [1] 292999 0
15/NTA/60

Summary
Brief summary
When people experience pain, attention is continually sequestered by pain, or the expectation of pain. This attentional priority places a demand on cognitive resources and impairs people’s performance at cognitively demanding tasks, including regulating the strong negative emotions often associated with pain. The long-term demands that chronic pain places on attention can eventually deplete self-regulatory resources and increase pain-related cognitive impairment. It is yet unclear if such an effect holds for emotional-regulatory ability. Given the cognitive demands of pain, it is expected that emotional-regulatory ability will be impaired to varying degrees by both acute and chronic physical discomfort, similar to that occurring in pain.
To determine this, chronic pain patients and age/gender matched controls will be compared on measures of personality characteristics, and their ability to regulate their emotional expressions before and after a task designed to evoke sensations similar to pain. This matched control group will help determine if any effects on emotional-regulatory ability associated with the pain-like task are unique to chronic pain or due to the effects of the pain-like task in general.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58018 0
Mr Duncan Edwards
Address 58018 0
Room 599 12.004
Department of Psychological Medicine,
Faculty of Medicine and Health Sciences,
University of Auckland
Level 12
Auckland City Hospital Support Building,
Park Road
Grafton
Auckland 1023
Country 58018 0
New Zealand
Phone 58018 0
+64 9 923 7284
Fax 58018 0
Email 58018 0
[email protected]
Contact person for public queries
Name 58019 0
Mr Duncan Edwards
Address 58019 0
Room 599 12.004
Department of Psychological Medicine,
Faculty of Medicine and Health Sciences,
University of Auckland
Level 12
Auckland City Hospital Support Building,
Park Road
Grafton
Auckland 1023
Country 58019 0
New Zealand
Phone 58019 0
+64 9 923 7284
Fax 58019 0
Email 58019 0
[email protected]
Contact person for scientific queries
Name 58020 0
Mr Duncan Edwards
Address 58020 0
Room 599 12.004
Department of Psychological Medicine,
Faculty of Medicine and Health Sciences,
University of Auckland
Level 12
Auckland City Hospital Support Building,
Park Road
Grafton
Auckland 1023
Country 58020 0
New Zealand
Phone 58020 0
+64 9 923 7284
Fax 58020 0
Email 58020 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

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