Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000138785
Ethics application status
Approved
Date submitted
10/01/2022
Date registered
27/01/2022
Date last updated
27/01/2022
Date data sharing statement initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does threat affect how we feel heat?
Scientific title
Weighting of thermal sensory information with imminent threat perception in healthy adults
Secondary ID [1] 306157 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 324862 0
Condition category
Condition code
Neurological 322296 322296 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study investigates sensory weighting under expected pain or threat induced by noxious cold-water immersion using a randomised controlled trial design. Healthy, pain-free participants will be recruited under the impression they are participating in a study examining responses to cold water immersion. They will be randomised to one of two groups. One group of participants will be led to believe their hand will be placed in a bucket of noxiously cold water and another group will be lead to believe that their hand will be placed in neutral, comfortable water. Though, in reality, their hand will not be immersed at any point.

Conditioning Phase:
In the week before the testing session, all eligible volunteers will be e-mailed information about the study including detail that immersion of the hand into either noxious/non-noxious cold water would be required. This e-mail will state that blue coloured water will be cold and noxious, whereas green coloured water will be a neutral (no sensation of cold) temperature and non-noxious. The email will contain photos of a grimacing participant with their hand immersed in a container of blue water and an unconcerned participant with their hand in green water. Attached to the e-mail will be a video link to the experimental setup, which the participants will be asked to watch before attendance. This video will show a participant displaying overt pain behaviour during a blue water hand immersion task and no distress or pain behaviours during green water immersion. A large poster will also be attached to the test venue wall, illustrating the experimental set up in pictorial form identical to the e-mails.

Testing Session:
The study protocol will be briefly reviewed with the participant prior to testing to ensure they understand. All relevant information will be fully reviewed and it will be reiterated that participants will be expecting to immerse their hand in either blue (noxious cold) or green coloured (neutral, non-noxious) water. Written informed consent will be obtained.

Intervention:
The intervention arm will be assigned to expect immersion in the blue-coloured (noxious cold) water. Though, in reality, their hand will not be immersed at any point.

Testing will occur in a single session lasting less than one hour in a research lab at the University of Notre Dame Australia, Fremantle Campus. The intervention will be administered only once, by a member of the research team.
Intervention code [1] 322566 0
Treatment: Other
Comparator / control treatment
The control arm will be assigned to expect the green coloured (neutral, non-noxious) water. Though, in reality, their hand will not be immersed at any point.
Control group
Active

Outcomes
Primary outcome [1] 330063 0
Warmth detection threshold:
Temperature thresholds for warmth will be measured. The thermal stimuli will be applied using the Medoc TSA thermo-sensory stimulation unit with a 3x2 cm peltier thermode (Somedic AB, Sweden), lightly strapped to the participant to ensure even contact. Testing will occur at the dorsum of the forearm (midway between the elbow and wrist) on the side that is suggested to be immersed in the water. All stimuli will be applied to the participant sitting in a chair with the forearm resting on a table.
The standard Method of Limits methodology will be used with the baseline (starting) temperature set at 32°C and a ramp up and down of 1°C/second for all tests. The thermode will be set to automatically return to baseline 32°C if the maximum 51°C is reached. Participants will be given a hand-held button and instructed to press the button as soon as they first feel a sensation of warmth. One practice will be followed by 3 trials, with 20 second pauses between each trial. The mean temperature for each sensation threshold will be calculated for analysis.
Timepoint [1] 330063 0
Immediately after randomization.
Primary outcome [2] 330164 0
Heat-pain detection threshold:
Temperature thresholds for heat pain will be measured. The thermal stimuli will be applied using the Medoc TSA thermo-sensory stimulation unit with a 3x2 cm peltier thermode (Somedic AB, Sweden), lightly strapped to the participant to ensure even contact. Testing will occur at the dorsum of the forearm (midway between the elbow and wrist) on the side that is suggested to be immersed in the water. All stimuli will be applied to the participant sitting in a chair with the forearm resting on a table.
The standard Method of Limits methodology will be used with the baseline (starting) temperature set at 32°C and a ramp up and down of 1°C/second for all tests. The thermode will be set to automatically return to baseline 32°C if the maximum 51°C is reached. Participants will be given a hand-held button and instructed to press the button as soon as they first feel an unpleasant or painful heat. For each sensation type, one practice will be followed by 3 trials, with 20 second pauses between each trial. The mean temperature for each sensation threshold will be calculated for analysis.
Timepoint [2] 330164 0
Immediately post-randomisation
Secondary outcome [1] 404783 0
we will ask the participants to answer the following question:
How painful did you expect the immersion to be? It will be answered using a numerical rating scale anchored as 0=no pain and 10=extreme pain
Timepoint [1] 404783 0
Immediately after testing,

Eligibility
Key inclusion criteria
We seek to recruit healthy, pain free adult volunteers.
We will recruit within the Notre Dame and related community via advertisement, email, social media and snowball techniques. There is no other specific targeting of any group beyond this healthy pain-free sample
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with any current pain complaint, ongoing medical problems or a history of any musculoskeletal pain problem affecting the neck or arm requiring medical attention within the last two years will be excluded.

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)
Randomisation and allocation concealment
A randomisation schedule will be created using a computer-generated random number table, to allocate participants to one of the two treatment arms: ‘noxious water’ or ‘neutral water’. Sealed, sequentially numbered opaque envelopes will be used to ensure allocation concealment. A member of the research team, not involved in the recruitment or data collection, will generate the sequence and prepare the envelopes. After baseline testing, the participant will be randomly assigned by opening the next sealed, sequentially numbered, opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation and allocation concealment
A randomisation schedule will be created using a computer-generated random number table, to allocate participants to one of the two treatment arms: ‘noxious water’ or ‘neutral water’. Sealed, sequentially numbered opaque envelopes will be used to ensure allocation concealment. A member of the research team, not involved in the recruitment or data collection, will generate the sequence and prepare the envelopes. After baseline testing, the participant will be randomly assigned by opening the next sealed, sequentially numbered, opaque envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
The participants will be told they are participating in a study investigating sensitivity of the skin after immersion in different water temperatures. They will be led to believe that they will be randomised to a group either immersing their hand in the blue (noxious cold) or green coloured (non-noxious) water.
The design of the study is such that the participant will not have the hand immersed in the water despite the fact that they will be expecting this, which may be viewed as concealment. This concealment is fundamental to the question we seek to answer.
It is only by inducing the expectation of pain that we can assess whether we can elicit a threat induced change in sensory processing of noxious and non-noxious stimuli.
Participants will have the true hypothesis of the study explained to them immediately after the completion of testing and will be afforded the opportunity to ask questions.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous variables will be described as means/standard deviations of medians/interquartile ranges as appropriate to the distribution. Categorical variables will be described as frequencies/percentages. All available data will be included in the analysis when possible.
Warmth and pain detection thresholds on the second occasion (post group allocation) will be the co-primary outcome variables. A generalised linear model for each of these outcomes will include the group allocation (neutral or cold) and the baseline value to control for differences in baseline perception.
Secondary and exploratory analyses will include consideration the impact of adjusting the models described above for potential confounding variables (e.g. pain beliefs, demographic factors) in order to further investigate the role of these variables.

Analyses will be conducted in Stata v17 and/or SPSS v26. p<0.05 will be considered evidence of an effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
Date of last participant enrolment
Anticipated
27/01/2023
Actual
Date of last data collection
Anticipated
27/01/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 310499 0
University
Name [1] 310499 0
Faculty of Medicine, Nursing & Midwifery and Health Sciences
Country [1] 310499 0
Australia
Primary sponsor type
University
Name
Faculty of Medicine, Nursing & Midwifery and Health Sciences
Address
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country
Australia
Secondary sponsor category [1] 311666 0
None
Name [1] 311666 0
Address [1] 311666 0
Country [1] 311666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310128 0
The University of Notre Dame Australia Human Research Ethics Committee,
Ethics committee address [1] 310128 0
Ethics committee country [1] 310128 0
Australia
Date submitted for ethics approval [1] 310128 0
24/11/2021
Approval date [1] 310128 0
10/01/2022
Ethics approval number [1] 310128 0
2020-170F

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116574 0
Dr Mervyn Travers
Address 116574 0
Faculty of Medicine, Nursing & Midwifery and Health Sciences
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country 116574 0
Australia
Phone 116574 0
+61 8 9433 0561
Fax 116574 0
Email 116574 0
[email protected]
Contact person for public queries
Name 116575 0
Mervyn Travers
Address 116575 0
Faculty of Medicine, Nursing & Midwifery and Health Sciences
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country 116575 0
Australia
Phone 116575 0
+61 8 9433 0561
Fax 116575 0
Email 116575 0
[email protected]
Contact person for scientific queries
Name 116576 0
Mervyn Travers
Address 116576 0
Faculty of Medicine, Nursing & Midwifery and Health Sciences
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country 116576 0
Australia
Phone 116576 0
+61 8 9433 0561
Fax 116576 0
Email 116576 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator [email protected]


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.