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Trial registered on ANZCTR


Registration number
ACTRN12620001087943
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
20/10/2020
Date last updated
20/10/2020
Date data sharing statement initially provided
20/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Validating the use of pain psychology therapy delivered through Virtual Reality in healthy adults without acute or chronic pain
Scientific title
Validation of a novel Virtual Reality-delivered pain psychology therapy program: a randomised controlled study in healthy adults without acute or chronic pain
Secondary ID [1] 302108 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 318735 0
Condition category
Condition code
Anaesthesiology 316749 316749 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: VR-delivered pain therapy

Participants in the intervention arm will receive 2 x 30 min modules of pain therapy delivered by virtual reality hardware. The pain therapy program is self contained and consists of 2 modules (1) progressive muscle relaxation and (2) guided pain visualisation. Each module takes a maximum of 30 minutes duration. Participants will be asked to undertake both therapies consecutively, with a 10 minute rest break.

The VR session will occur in the UNSW simulation laboratory at Liverpool Hospital. Each participant will be allocated one session, lasting 70 minutes long. Each participant will undergo their session individually.

The pain therapy program is interactive and video-based. It is delivered using voice-overs and virtual avatars, who teach each therapy using step-by-step exercises reinforced with graphical information. Participants interact with these avatars using their hand-motion controllers.

The interaction between the participant and the VR-delivered pain therapy does not require external intervention from a researcher. However, the view experienced by the participant is projected onto an external TV. This will be monitored by a researcher who can intervene if necessary.

In order to monitor adherence to the intervention, a session attendance checklist will be administered, and follow-up emails will be sent to all participants.
Intervention code [1] 318410 0
Treatment: Other
Intervention code [2] 318668 0
Treatment: Devices
Comparator / control treatment
Name: PC-delivered pain therapy

Participants in the control arm will receive 2 x 30 min modules of the same pain therapy, except delivered by a traditional personal computer and monitor. The same interactive video-based modules will be displayed, but in contrast to the intervention arm, it is viewed on a 2D traditional monitor (unlike 3D in VR-delivered pain therapy) and interaction occurs using a mouse (instead of hand motion controllers that track the movement of the participant).


The PC session will occur in the UNSW simulation laboratory at Liverpool Hospital. Each participant will be allocated one session, lasting 70 minutes long. Each participant will undergo their session individually.
Control group
Active

Outcomes
Primary outcome [1] 324893 0
Presence, as assessed by Presence Questionnaire-22 created by Witmer & Singer. In this study, presence is defined as the "subjective experience of being in one place or environment, even when one is physically situated in another" (Witmer & Singer, 1998).
Timepoint [1] 324893 0
Immediately after end of intervention completion
Secondary outcome [1] 386128 0
Information recall as measured by percentage correct in a multiple choice questionnaire designed for this study. There are 3 sets of multiple choice questionnaires, each 10 questions each and to be completed within 10 minutes. These questionnaires are assessing a composite outcome: serial recall.
Timepoint [1] 386128 0
Immediately after, and 2 weeks after intervention

Eligibility
Key inclusion criteria
- Adult (greater than or equal to 18yo) participants, healthy without acute or chronic pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Insufficient written English language proficiency to complete questionnaires.
- Insufficient verbal English language proficiency to interact with the VR software avatar.
- Psychological or psychiatric illness not stabilised with therapy and/or medications.
- Uncertainty or unable to be followed up for subsequent two months after recruitment.

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)
A computer generated randomised sequence, in blocks of 4, will be created and placed in sequentially numbered opaque envelopes. Each envelope will have a unique alphanumeric code to allow participants to be de-identified.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomised sequence, in blocks of 4, will be created and placed in sequentially numbered opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using the mean and standard deviation of the Presence Questionnaire by Witmer and Singer, a sample size of 16 participants per group is necessary to demonstrate a difference in presence, with a power of 0.80 and two-tailed significance of 0.05. To account for drop outs, we will increase the group allocation to 20 participants with a total sample size of 40 participants to be recruited.

Statistical analysis:
The primary outcome is presence in the intervention versus control groups. The Presence Questionnaire-22 scores will be analysed with t test. The secondary outcome of information recall will be measured as percentage correct, and analysed using repeated measures ANOVA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
1/04/2021
Actual
Date of last data collection
Anticipated
22/04/2021
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17325 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 31051 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 306533 0
Hospital
Name [1] 306533 0
Department of Anaesthesia, Liverpool Hospital
Country [1] 306533 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney LHD
Address
South Western Sydney Local Health District Executive Office
Locked Bag 7279
LIVERPOOL BC 1871
Country
Australia
Secondary sponsor category [1] 307366 0
None
Name [1] 307366 0
Address [1] 307366 0
Country [1] 307366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306729 0
South West Sydney LHD HREC
Ethics committee address [1] 306729 0
Ethics committee country [1] 306729 0
Australia
Date submitted for ethics approval [1] 306729 0
30/08/2020
Approval date [1] 306729 0
16/10/2020
Ethics approval number [1] 306729 0
2020/ETH02310

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

Contacts
Principal investigator
Name 104818 0
A/Prof Alwin Chuan
Address 104818 0
Department of Anaesthesia
Level 1 New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 104818 0
Australia
Phone 104818 0
+61 407 743 668
Fax 104818 0
Email 104818 0
dr.chuan@iinet.net.au
Contact person for public queries
Name 104819 0
Alwin Chuan
Address 104819 0
Department of Anaesthesia
Level 1 New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 104819 0
Australia
Phone 104819 0
+61 407 743 668
Fax 104819 0
Email 104819 0
dr.chuan@iinet.net.au
Contact person for scientific queries
Name 104820 0
Alwin Chuan
Address 104820 0
Department of Anaesthesia
Level 1 New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 104820 0
Australia
Phone 104820 0
+61 407 743 668
Fax 104820 0
Email 104820 0
dr.chuan@iinet.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.