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Trial registered on ANZCTR


Registration number
ACTRN12619000568112p
Ethics application status
Not yet submitted
Date submitted
3/04/2019
Date registered
11/04/2019
Date last updated
11/04/2019
Date data sharing statement initially provided
11/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual reality for the treatment of cancer pain
Scientific title
The effects of virtual reality on pain intensity in people with cancer-related pain
Secondary ID [1] 297879 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer-related pain 312252 0
Condition category
Condition code
Cancer 310797 310797 0 0
Any cancer
Anaesthesiology 310860 310860 0 0
Pain management
Neurological 310861 310861 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) A postdoctoral fellow with expertise in chronic pain research with deliver both virtual reality intervention and control protocols at Greenwich Hospital (Northern Sydney Local Health District).

2) To account for circadian influences on wakefulness, all study interventions will take place between 10.00am and 1.00pm. We will use a randomised crossover design. One hour will be required to collect baseline information, administer questionnaires and familiarise the participant with the VR set-up.

3) The participant will then undergo two interventions in randomised order. Each intervention will be 15 minutes duration with a 60-minute washout period between interventions.

4) Concerning the immersive intervention, participants will use Oculus Rift ® headsets to view and interact in an immersive virtual reality (VR) application. Using an easy-to-use hand-held touch controller, participants are able to move around a summer meadow environment (Nature Trek VR®) using simple hand movements that govern direction and speed.

6) During the set up period immediately prior to the start of the intervention, participants will be shown how to control their movement and speed within the VR environment. During the intervention, researchers will supervise both immersive VR and non-immersive computer display experiences in order to ensure participants are using the handheld devices correctly and to help if they get into difficulty using the hand-held devices

7) In a subset of participants, during each virtual reality session, a 32-channel wireless EEG recording will be administered to allow analysis of cortical regions that may be involved in cancer-related pain. Linear and non-linear EEG analyses will be performed to determine relationships between brainwave changes, cancer-related pain and influence of virtual reality.
Intervention code [1] 314108 0
Rehabilitation
Intervention code [2] 314109 0
Treatment: Devices
Comparator / control treatment
For the control, participants will watch the same 15 minute VR experience on a computer screen (“flat”/non-3D).

This control intervention is one of two 15 minute VR applications separated by a 60 minute washout period over one session only.

Participants will have interaction using a handheld device that enables them to move around the VR experience during both intervention and control protocols.

As stated above, both immersive and non-immersive VR experiences will be supervised by researchers
Control group
Active

Outcomes
Primary outcome [1] 319643 0
Numerical pain rating scale (11-point scale)
Timepoint [1] 319643 0
Numerical pain ratings (11-point scale) will be gained immediately prior to and directly after treatment and control interventions
Secondary outcome [1] 368989 0
In addition to pain intensity scores, we will also include psychological questionnaires that assess mood, cognitive and behavioural features, strongly associated with cancer-related pain.

1) Pain Self-Efficacy Questionnaire
Timepoint [1] 368989 0
These psychological questionnaires will be administered only at baseline in order to analyse potential predicting factors determining pre and post pain intensity scores and levels of immersion (Igroup Presence Questionnaire) see below
Secondary outcome [2] 369179 0
The Igroup Presence Questionnaire is being administered so we can understand the sense of presence as a subjective sense of being in a virtual environment. This questionnaire assesses 1) spatial presence (sense of being physically present),
2) Involvement (attention devoted to the virtual reality experience)
3) Experience realism (subjective experience of realism)
Timepoint [2] 369179 0
The Igroup Presence Questionnaire will be used within five minutes of completing both treatment and control interventions.
Secondary outcome [3] 369271 0
Depression, Anxiety and Stress Scale
Timepoint [3] 369271 0
Baseline test immediately prior to study
Secondary outcome [4] 369272 0
Pain Catastrophising Scale
Timepoint [4] 369272 0
Baseline testimmediately prior to study

Eligibility
Key inclusion criteria
1) Pain intensity equal or over 4/10 on numerical pain rating scale on enrolment for at least one month
2) Ambulatory from both home or research- based hospital
3) Life expectancy - 6 months and over
4) current or previous cancer diagnosis
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) psychiatric comorbidities (not including anxiety and depression)
2) substance abuse
3) significant non-cancer pain
4) reduced ability to understand experimental tasks (e.g., lack of English language, dementia)

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)
Allocation concealment will be done using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
There have been no studies investigating the sole use of VR on people with cancer-related pain. Based on a recent meta-analysis investigating the use of virtual reality on experimental and and acute pain, we estimated a medium effect size of 0.58 and a standard deviation of pre-post scores of 1.0. Our calculation produced a sample size of 25

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13540 0
Greenwich Hospital - Greenwich
Recruitment postcode(s) [1] 26163 0
2065 - Greenwich

Funding & Sponsors
Funding source category [1] 302404 0
Self funded/Unfunded
Name [1] 302404 0
Address [1] 302404 0
Country [1] 302404 0
Primary sponsor type
Hospital
Name
Greenwich Hospital
Address
Greenwich Hospital, 97-115 River Road, Greenwich, NSW 2065
Country
Australia
Secondary sponsor category [1] 302295 0
Charities/Societies/Foundations
Name [1] 302295 0
HammondCare Health and Hospitals
Address [1] 302295 0
97-115 River Road, Greenwich, 2065, NSW
Country [1] 302295 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303073 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 303073 0
NSLHD Research Office Level 13, Kolling Building Royal North Shore Hospital St Leonards NSW 2065
Ethics committee country [1] 303073 0
Australia
Date submitted for ethics approval [1] 303073 0
06/05/2019
Approval date [1] 303073 0
Ethics approval number [1] 303073 0

Summary
Brief summary
This study will evaluate the effects of virtual reality on pain intensity in people with cancer-related pain

Who is it for?
You may be eligible to join this study if you are aged 18 and above, have a current or previous cancer diagnosis and are experiencing pain for at least a month

Study details
Participants in this study will receive both immersive and non-immersive virtual reality (VR) experiences but in a random sequence. Participants will attend once only where they undergo two 15-minute VR sessions with a one-hour washout period between sessions. The immersive session will comprise the use of immersive VR exploring a scene using an Oculus headset attached to a laptop. The non-immersive session will comprise viewing the same scene but directly watching the laptop screen. After each session, participants will be asked to answer questionnaires regarding pain intensity. A subset of participants will also undergo linear and non-linear electroencephalogram (EEG) analyses using a wireless EEG during the VR sessions to analyse regions of the brain that may be involved with pain.

It is hoped that this research will contribute to the management of cancer-related pain using commercially available, non-pharmacological treatment applications that may improve health outcomes giving patients more control over their symptoms.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92374 0
Prof Melanie Lovell
Address 92374 0
Department of Palliative Care, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW
Country 92374 0
Australia
Phone 92374 0
+61 2 8788 3943
Fax 92374 0
Email 92374 0
mlovell@hammond.com.au
Contact person for public queries
Name 92375 0
Dr Philip Austin
Address 92375 0
Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW
Country 92375 0
Australia
Phone 92375 0
+61 288783943
Fax 92375 0
Email 92375 0
paustin@hammond.com.au
Contact person for scientific queries
Name 92376 0
Dr Philip Austin
Address 92376 0
Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW
Country 92376 0
Australia
Phone 92376 0
+61 288783943
Fax 92376 0
Email 92376 0
paustin@hammond.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only descriptive and inferential data to be available in publication form
What supporting documents are/will be available?
Study protocol
Informed consent form
Clinical study report
Ethical approval
Summary results
No Results