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Trial registered on ANZCTR


Registration number
ACTRN12620000168954
Ethics application status
Approved
Date submitted
22/01/2020
Date registered
17/02/2020
Date last updated
17/02/2020
Date data sharing statement initially provided
17/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Reality pain psychology therapy as non-pharmacological analgesia for pain experienced in chest trauma patients (The VIPER-T study)
Scientific title
Virtual Reality pain psychology therapy as non-pharmacological analgesia for pain experienced in chest trauma patients (The VIPER-T study)
Secondary ID [1] 300315 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chest trauma 315920 0
Condition category
Condition code
Anaesthesiology 314193 314193 0 0
Pain management
Injuries and Accidents 314310 314310 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
VR-delivered pain psychology therapy
A new VR software program was created that incorporated the following three pain psychological modules:
(1) Patient education on the nature and type of pain, and methods to control pain;
(2) Teaching progressive muscle relaxation as a form of arousal reduction therapy; and
(3) Guided pain visualisation technique to reduce pain catastrophising and to reduce maladaptive responses to pain
These modules are selected by patients using their hand-motion controllers. Patients can advance, stop, or rewind the therapy. An electronic representation of a therapist (“avatar”) is projected through the VR gogglesthat will speak with the patient. Patients are required to be active participants, interacting with the avatar by choosing their therapy options in real time.

The VR set up includes an Oculus Rift S goggle and a HP Omen gaming laptop. The Oculus Rift S goggle goes over the patient's head and has adjustable head straps for a comfortable fit. There are 2 wireless controllers with wrist straps for security

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

Research team contact will occur on Day 1 of admission, after the patient has been seen and management initiated by the trauma and acute pain teams. The patient will be seen for the next 3 days of their admission. On each day, VR will be provided to patients and data collected for acceptability and effectiveness.

A total of 3 consecutive daily sessions will be provided to each patient enrolled in the intervention arm. Each session will last for a maximum of 30 minutes, as timed by a researcher.

The VR sessions will occur at the patient’s bedside. Researchers will wheel a cart with the VR equipment to each patient in the ward.
Intervention code [1] 316590 0
Treatment: Devices
Comparator / control treatment
Patients in the intervention arm will receive 3x 30min sessions of VR-pain psychology therapy. Each session will allow one module of the VR-pain therapy to be provided. The modules are detailed above.

Patients in the control arm will receive 3x 30min sessions of VR-delivered distraction therapy in the form of movies/videos filmed in VR. All movies are publicly accessible through the dedicated VR channel from YouTube. Example movies that can be chosen by the patient includes a documentary on jaguars in Brazil, a documentary on the Apollo 11 moonlanding, an animated cartoon in a snow environment and a car review
Control group
Active

Outcomes
Primary outcome [1] 322569 0
pain scores (modified brief pain inventory) in the VR therapy group versus the control distraction group
This study will use the modified Brief Pain Inventory (mBPI) which is part of the Australian English (version 2.0) of the Electronic Persistent Pain Outcomes Collaboration (ePPOC). ePPOC is an initiative of the Faculty of Pain Medicine, Australian and New Zealand College of Anaesthetists. It is the standardised national data collection form used to measure treatment outcomes and allow coordinated research activity in pain medicine.
Timepoint [1] 322569 0
baseline and daily for 3 days afterwards
Primary outcome [2] 322570 0
Oral morphine daily dose equivalent (oMEDD) doses in the VR therapy group versus the control distraction group
This study will use the analgesia conversion template published by the Faculty of Pain Medicine, Australian and New Zealand College of Anaesthetists.
Timepoint [2] 322570 0
baseline and daily for 3 days afterwards
Primary outcome [3] 322698 0
Incentive spirometry, as a measure of functional respiratory performance.
Patients are put in sitting position with a complete seal over mouthpiece. They take a full breath in and have a full constant exhalation – keep ball stationary for 3-5 seconds
Timepoint [3] 322698 0
baseline and daily for 3 days afterwards
Secondary outcome [1] 378971 0
Acceptability outcomes are based on patient reporting of side-effects including nausea, dizziness, and eyestrain from using VR
This is measured using a case reporting form developed for the study. The acceptability outcomes are assessed with visual analog scales ranging from 0 (not at all) to 10 (most of the time)
Timepoint [1] 378971 0
after each daily VR session

Eligibility
Key inclusion criteria
- no head injuries affecting cognition or behavioural state

- Chest Trauma Score greater than or equal to 4, representing significant chest trauma
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

- pre-existing cognitive impairment or delirium.

- Patients in chronic pain, defined as requiring opioid medication doses equivalent to greater than or equal to 20mg oral morphine daily dose equivalent (oMEDD), averaged over the previous week prior to admission to hospital.

- intubated patients in ICU.

- patients requiring continuous non-invasive positive pressure ventilatory support.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomised sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Acceptability results will be summated and averaged over all VR sessions, and presented as separate mean/SD or median/range data for the control and interventional groups. Analysis of acceptability will be performed using either t-test or the Mann-Whitney test. Primary statistical analysis of effectiveness endpoints will compare groups at follow up timepoints, using repeated measures ANOVA. Potential confounders, such as the baseline RFS, CTS, and ISS scores, will be analysed using a backwards stepwise regression to determine influences on effectiveness outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2020
Actual
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15650 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 29059 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 304742 0
Hospital
Name [1] 304742 0
Liverpool Hospital
Country [1] 304742 0
Australia
Primary sponsor type
Individual
Name
Dr Alwin Chuan
Address
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets LIVERPOOL NSW 2170.
Country
Australia
Secondary sponsor category [1] 305073 0
None
Name [1] 305073 0
Address [1] 305073 0
Country [1] 305073 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305161 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305161 0
Ethics committee country [1] 305161 0
Australia
Date submitted for ethics approval [1] 305161 0
12/11/2019
Approval date [1] 305161 0
18/11/2019
Ethics approval number [1] 305161 0
2019/ETH12955

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

Contacts
Principal investigator
Name 99446 0
A/Prof Alwin Chuan
Address 99446 0
Liverpool Hospital
75 Elizabeth St, Liverpool NSW 2170
Country 99446 0
Australia
Phone 99446 0
+61 407 743 668
Fax 99446 0
Email 99446 0
dr.chuan@iinet.net.au
Contact person for public queries
Name 99447 0
Alwin Chuan
Address 99447 0
Liverpool Hospital
75 Elizabeth St, Liverpool NSW 2170
Country 99447 0
Australia
Phone 99447 0
+61 407 743 668
Fax 99447 0
Email 99447 0
dr.chuan@iinet.net.au
Contact person for scientific queries
Name 99448 0
Alwin Chuan
Address 99448 0
Liverpool Hospital
75 Elizabeth St, Liverpool NSW 2170
Country 99448 0
Australia
Phone 99448 0
+61 407 743 668
Fax 99448 0
Email 99448 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
Ethics committee does not allow it


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.