ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000568112

Ethics application status

Approved

Date submitted

3/04/2019

Date registered

11/04/2019

Date last updated

23/05/2022

Date data sharing statement initially provided

11/04/2019

Date results provided

23/05/2022

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer-related pain

Condition category

Condition code

Cancer

Any cancer

Anaesthesiology

Pain management

Neurological

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]

Rehabilitation

Intervention code [2]

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]

Numerical pain rating scale (11-point scale)

Timepoint [1]

Numerical pain ratings (11-point scale) will be gained immediately prior to and directly after treatment and control interventions

Secondary outcome [1]

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]

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]

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]

The Igroup Presence Questionnaire will be used within five minutes of completing both treatment and control interventions.

Secondary outcome [3]

Depression, Anxiety and Stress Scale

Timepoint [3]

Baseline test immediately prior to study

Secondary outcome [4]

Pain Catastrophising Scale

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/10/2019

Actual

8/04/2020

Date of last participant enrolment

Anticipated

3/05/2021

Actual

7/05/2021

Date of last data collection

Anticipated

1/10/2021

Actual

13/05/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Greenwich Hospital - Greenwich

Recruitment postcode(s) [1]

2065 - Greenwich

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Sydney Vital

Address [1]

Level 8, Kolling Building, RNSH, St Leonards, NSW, 2065

Country [1]

Australia

Primary sponsor type

Hospital

Name

Greenwich Hospital

Address

Greenwich Hospital, 97-115 River Road, Greenwich, NSW 2065

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

HammondCare Health and Hospitals

Address [1]

97-115 River Road, Greenwich, 2065, NSW

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

NSLHD Research Office Level 13, Kolling Building Royal North Shore Hospital St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/05/2019

Approval date [1]

11/03/2020

Ethics approval number [1]

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

Prof Melanie Lovell

Address

Department of Palliative Care, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW

Country

Australia

Phone

+61 2 8788 3943

Fax

mlovell@hammond.com.au

Contact person for public queries

Name

Philip Austin

Address

Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW

Country

Australia

Phone

+61 288783943

Fax

paustin@hammond.com.au

Contact person for scientific queries

Name

Philip Austin

Address

Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW

Country

Australia

Phone

+61 288783943

Fax

paustin@hammond.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Only descriptive and inferential data to be available in publication form

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email	Other Details	Attachment
16166	Study protocol				377329-(Uploaded-26-10-2021-14-24-30)-Study-related document.docx
16167	Statistical analysis plan	Statistical methods			377329-(Uploaded-26-10-2021-14-29-35)-Study-related document.docx
16168	Informed consent form				377329-(Uploaded-26-10-2021-14-30-24)-Study-related document.docx
16169	Ethical approval				377329-(Uploaded-26-10-2021-14-31-23)-Study-related document.docx
16170	Statistical analysis plan	No data file and not applicable	paustin@hammond.com.au	Not applicable
16172	Statistical analysis plan				377329-(Uploaded-17-03-2022-09-41-22)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Feasibility and acceptability of virtual reality for cancer pain in people receiving palliative care: a randomised cross-over study.	2022	https://dx.doi.org/10.1007/s00520-022-06824-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically