Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001283167
Ethics application status
Approved
Date submitted
12/08/2019
Date registered
18/09/2019
Date last updated
18/09/2019
Date data sharing statement initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of Virtual-Reality Augmented Mindfulness in Reducing Acute Experimental Pain
Scientific title
The Efficacy of Virtual-Reality Augmented Mindfulness in Reducing Acute Experimental Pain in a Healthy Sample.
Secondary ID [1] 298930 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 313922 0
Condition category
Condition code
Musculoskeletal 312329 312329 0 0
Osteoarthritis
Musculoskeletal 312330 312330 0 0
Osteoporosis
Musculoskeletal 312331 312331 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will attend 1 session in the laboratory and will receive the interventions face-to-face. They will be randomised to 1 of 4 conditions.

Virtual reality (VR): Participants in the VR conditions will use ‘Oculus Quest’ VR goggles that display multiple relaxing scenes such as beaches or forests. Participants can choose which scene they prefer for the training. The VR only group will have the same VR scenes available as those in the VR-augmented mindfulness group but will not receive mindfulness instructions. Instead, they will be instructed to focus on the relaxing scene and try to immerse themselves in it. Both conditions will be matched on time (i.e. 15 minutes).

Mindfulness: The mindfulness instruction will be based on a guided mindfulness of breath and body scan instruction from mindfulness-based stress reduction (Kabat-Zinn, 2003), and will be pre-recorded for participants to listen to in session. The audio will be the same for the two mindfulness groups (VR and not VR) and will take approx. 15 minutes.

VR-augmented Mindfulness: Participants will listen to the mindfulness audio whilst simultaneously viewing the relaxing scene of their choice with the VR goggles.

During the final 5 minutes of the assigned intervention, participants will be asked to complete the cold pressor task, which involves placing their arm in a tank of cold water to assess for pain outcomes, such as threshold, tolerance and intensity.
Intervention code [1] 315210 0
Treatment: Other
Comparator / control treatment
Participants in the control condition will complete neither the mindfulness nor VR conditions. Rather, they will commence the cold pressor task directly after they finish the thermode task. At the conclusion of the study, participants in the control group will be given access to the mindfulness instruction if they wish.
Control group
Active

Outcomes
Primary outcome [1] 320957 0
Tolerance measurement during the cold pressor task. This is a measurement of time before the participant withdraws their arm from the cold pressor task, to a maximum of 4 minutes. This measure will be taken whilst participants are engaged in their assigned training condition (in the final 5 minutes), using a stopwatch.
Timepoint [1] 320957 0
During the cold pressor task (timepoint 3), which occurs in the last 5 minutes of the training session.
Primary outcome [2] 321027 0
Tolerance during thermode task. This is the maximum temperature participants can reach before stopping the thermode task (up to a maximum of 50 degrees Celsius). Participants will complete three trials and the average will form the final measurement.
Timepoint [2] 321027 0
Tolerance with the thermode will be recorded twice, as participants complete the task twice. Initially, it will be measured immediately before the training (timepoint 2), and subsequently it will measured after the cold pressor task (timepoint 4)
Secondary outcome [1] 373501 0
Hesitance during the cold pressor task. This is a timed measurement of how long the participant takes to fully immerse their arm (up to their elbow). It will be recorded using a stopwatch.
Timepoint [1] 373501 0
During the cold pressor task (timepoint 3), which occurs in the last 5 minutes of the training session.
Secondary outcome [2] 373502 0
Threshold. This is a measurement of time taken for the participant to first report pain. Threshold will be assessed during both instances of the thermode task, and similarly to tolerance an average of three trials will form the final outcomes. Threshold will also be measured during the cold pressor task and will be recorded using a stopwatch.
Timepoint [2] 373502 0
Threshold will be initially recorded during the first instance of the thermode task, which occurs before the training session (timepoint 2). It will then be recorded during the cold pressor task, which happens in the last 5 minutes of the training session. Finally, threshold will be recorded during the second and final thermode task, which occurs after the cold pressor task (timepoint 4).
Secondary outcome [3] 373505 0
Pain intensity will be measured on an 11-point visual analogue scale for both instances of the thermode task and during the cold pressor task.

For the thermode, 6 different temperature points will be pre-set and individualised to each participant (baseline - 32degrees, average threshold, average tolerance, 3 x midpoint between threshold and tolerance). Participants will receive these 6 temperatures in a randomised order and will be asked to rate their pain. The average of their 3 mid-point ratings will form the intensity outcome.

For the cold pressor task, pain intensity ratings will be taken at threshold, 30 seconds after immersion and at tolerance.
Timepoint [3] 373505 0
Pain intensity will initially be recorded during the first instance of the thermode task (after threshold and tolerance ratings), which occurs before the training session (timepoint 2). It will then be recorded during the cold pressor task, which happens in the last 5 minutes of the training session. Finally, intensity will be recorded during the second and final thermode task, which occurs after the cold pressor task (timepoint 4).
Secondary outcome [4] 373506 0
Pain-related distress will be recorded on an 11-point Likert scale during both instances of the thermode task and during the cold pressor task.

For the thermode task, distress will be measured during the pain intensity ratings. For the cold pressor, distress will be measured after the participant withdraws their arm from the cold pressor task (tolerance).
Timepoint [4] 373506 0
Pain-related distress will initially be recorded during the first instance of the thermode task (during intensity ratings), which occurs before the training session (timepoint 2). It will then be recorded at the very end of the cold pressor task, which happens in the last 5 minutes of the training session. Finally, pain-related distress will be recorded during the second and final thermode task, which occurs after the cold pressor task (timepoint 4).
Secondary outcome [5] 373507 0
Mindfulness. The Toronto Mindfulness Scale will be used to determine whether the mindfulness instruction has increased the targeted skill and therefore will be administered pre and post training.
Timepoint [5] 373507 0
Mindfulness will be measured while participants complete the baseline questionnaires at the beginning of the study (timepoint 1) and will also be measured immediately after the cold pressor task (timepoint 4) but before the second thermode task.
Secondary outcome [6] 373508 0
Credibility. The credibility and expectancy questionnaire (Devilly & Borkovec, 2000) will be administered to measure participants’ perceptions of their training condition credibility, specifically whether they find the VR-only condition to be credible.
Timepoint [6] 373508 0
Credibility will be assessed immediately after the cold pressor task (timepoint 4) but before the second thermode task.
Secondary outcome [7] 373509 0
Acceptability. At the conclusion of the study, participants will be asked to rate how acceptable they found their respective training condition on an 11 point scale, and will be asked how likely it is they would recommend it to a friend with a pain condition, also on an 11 point scale. This will help to inform whether VR-augmented mindfulness is indeed acceptable to people in the community, and therefore whether it could be used in a future clinical trial.
Timepoint [7] 373509 0
Acceptability will be measured immediately after the second thermode task (timepoint 5).

Eligibility
Key inclusion criteria
Participants must be pain-free, healthy adults (please see exclusion criteria)
Fluency in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of a chronic pain problem
- Recent (past 3 months) history of an acute pain condition
- Medical condition contraindicated for the cold pressor (e.g. Reynaud’s, cardiac conditions)
- Medical condition contraindicated for VR (e.g. increased risk of nausea, epilepsy, binocular visual abnormalities, inner ear infections or migraines)
- Pregnancy

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will analyze the main and interaction effects using a series of 2 (mindfulness: yes or no) x 2 (VR: yes or no) ANOVAs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/10/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27445 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 303474 0
University
Name [1] 303474 0
Faculty of Science, University of Sydney
Country [1] 303474 0
Australia
Primary sponsor type
University
Name
School of Psychology, University of Sydney
Address
Brennan MacCallum Building A18,
Manning Rd, Camperdown
NSW 2006
Country
Australia
Secondary sponsor category [1] 303532 0
None
Name [1] 303532 0
Address [1] 303532 0
Country [1] 303532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304004 0
University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 304004 0
Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006
Ethics committee country [1] 304004 0
Australia
Date submitted for ethics approval [1] 304004 0
Approval date [1] 304004 0
09/07/2019
Ethics approval number [1] 304004 0
2019/313

Summary
Brief summary
Considering the dearth of research in VR augmented mindfulness in general, and in the use of VR for the management of pain, it is necessary first to trial the training in healthy controls. Therefore, the aim of this study is to generate data on the feasibility and acceptability of VR-augmented mindfulness. We will test the relative efficacy of VR-augmented mindfulness, compared to mindfulness without VR augmentation, an experience of the VR environment without the mindfulness instruction (VR only) and a natural history control (tested with no training). These conditions will be well matched in terms of using the same audiotape (mindfulness and VR-augmented mindfulness) and the same VR scenes (VR-augmented mindfulness and VR-only). This would allow us to generate data on the effect sizes of VR-augmented mindfulness vs mindfulness; and VR-augmented mindfulness vs VR-only on which to power a definitive clinical trial. We hypothesize that VR-augmented mindfulness will be acceptable, feasible and associated with larger effects than mindfulness alone, and that the VR-only group will find the condition credible, but less effective than the two active training groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95526 0
Prof Louise Sharpe
Address 95526 0
Room 450, Brennan MacCallum (A18)
The University of Sydney
NSW 2006 Australia
Country 95526 0
Australia
Phone 95526 0
+61293514558
Fax 95526 0
Email 95526 0
[email protected]
Contact person for public queries
Name 95527 0
Prof Louise Sharpe
Address 95527 0
Room 450, Brennan MacCallum (A18)
The University of Sydney
NSW 2006 Australia
Country 95527 0
Australia
Phone 95527 0
+61293514558
Fax 95527 0
Email 95527 0
[email protected]
Contact person for scientific queries
Name 95528 0
Prof Louise Sharpe
Address 95528 0
Room 450, Brennan MacCallum (A18)
The University of Sydney
NSW 2006 Australia
Country 95528 0
Australia
Phone 95528 0
+61293514558
Fax 95528 0
Email 95528 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?
In the interest of transparency, fully anonymised data will be stored indefinitely for the purposes of open-access practice. This applies to all of the de-identified individual participant data collected during the trial.
When will data be available (start and end dates)?
From date of publication onward with no anticipated end date.
Available to whom?
Researchers who request the data from the principal investigator.
Available for what types of analyses?
Secondary analyses such as meta-analysis
How or where can data be obtained?
By emailing the 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.