ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001363279

Ethics application status

Approved

Date submitted

6/08/2018

Date registered

14/08/2018

Date last updated

17/12/2020

Date data sharing statement initially provided

19/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The use of a virtual reality headset for 4 year old immunisations to reduce pain and distress.

Scientific title

Virtual Reality for Immunisation Pain: A Randomised Controlled Clinical Trial in General Practice.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1218-6457

Trial acronym

VRIMM

Linked study record

Health condition

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

Immunisation pain

Condition category

Condition code

Public Health

Other public health

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Virtual reality (VR) headset for 4 year old immunisations.

Intervention will be delivered by General Practice Nurse Immunisers with a minimum of 5 years experience in vaccination of children.
Face-to-face intervention for individual patients receiving their 4 year old immunisation (once off intervention). The trial will take place in an urban General Practice (private clinic).

Participants will be randomised to either standard care or the intervention - Virtual reality headset. Participants and their parents/guardians in the intervention group will be shown the VR headset. The device and its function will be explained by the practice nurse. The nurse immuniser will fit the device over the child's head / eyes and activate the software program. The software program is an animated short video. The video is an interactive underwater adventure that begins with relaxation and progresses to marina scenes. The child interacts with the environment (ie. virtual fish) through gaze-based tracking. The device will be worn for up to 1-2 minutes during which time the vaccination will be given.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Behaviour

Comparator / control treatment

Control group are randomised to standard care. Usual distraction techniques used in managing 4 year olds when presenting for immunisation.
Usual distraction techniques include the practice nurses blowing bubbles or parents/ guardians reading books. The distraction technique used will be noted on the data collection form.

Control group

Active

Outcomes

Primary outcome [1]

The primary end-point is the difference in Faces pain scale - revised between the intervention and control groups.

Timepoint [1]

Upon completion of the vaccination.

Secondary outcome [1]

Self-reported pain using the poker chip tool.

Timepoint [1]

Upon completion of the vaccination.

Secondary outcome [2]

Observer ratings of pain and distress by parents/guardians recorded on a standard 100mm visual analogue scale (VAS).

Timepoint [2]

Upon completion of the vaccination

Secondary outcome [3]

Observer ratings by healthcare providers (nurse immunisers) recorded on a standard 100mm visual analogue scale (VAS).

Timepoint [3]

Upon completion of vaccination.

Eligibility

Key inclusion criteria

Children attending the general practice for their 4 year-old immunisations.
Judged by their treating doctor to be able to comply with the study protocol for its duration.
Written informed consent signed and dated by parent/legal according to local regulations.

Minimum age

42 Months

Maximum age

5 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Significant medical disease or condition that is likely to interfere with the child’s ability to participate in the study.
Inability to provide informed consent.

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)

Random allocation to either VR or standard care will occur through the use of blocked randomisation. This will occur in block sizes randomly varying from four to eight.

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

Continuous data such as the primary and secondary pain scores will be assessed to determine whether they are normally distributed. If normally distributed, results will be presented using mean and standard deviation, and analysed using two-tailed t-tests. If not normally distributed, then the data will be presented using median and interquartile range, and the Mann-Whitney test will be used to determine differences between treatment groups.
Categorical data will be presented using number and percentage, and analysed using the Chi-square test or Fisher’s exact test as appropriate.
Summary descriptive statistics (number and percentage) will be used for baseline demographic and clinical data.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/02/2019

Actual

4/07/2019

Date of last participant enrolment

Anticipated

2/02/2021

Actual

Date of last data collection

Anticipated

2/02/2021

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3178 - Rowville

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

RACGP Foundation Family Medical Care Education and Research (FMCER) Grant 2018

Address [1]

100 Wellington Rd
East Melbourne Victoria 3002

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Kirrily Ellerton

Address

Wellness on Wellington
1/1101 Wellington Rd
Rowville, Victoria 3178

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Assoc Professor Simon Craig

Address [1]

Monash Medical Centre
Paediatric Emergency Dept
246 Clayton Rd
Clayton Victoria 3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (EC00131)

Ethics committee address [1]

100 Wellington Pde
East Melbourne Victoria 3002

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2018

Approval date [1]

19/03/2019

Ethics approval number [1]

Summary

Brief summary


Our study aims to determine the effectiveness of the use of virtual reality to reduce the pain and distress associated with childhood vaccination in the general practice setting.
The hypothesis relating to our primary aim is that virtual reality content delivered through a headset will reduce pain and distress associated with childhood vaccination compared to the use of standard techniques used in the primary care setting.

Trial website

None

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kirrily Ellerton

Address

Wellness on Wellington
1/1101 Wellington Rd
Rowville, Vic 3178

Country

Australia

Phone

+61 3 9780 8900

Fax

[email protected]

Contact person for public queries

Name

Kirrily Ellerton

Address

Wellness on Wellington
1/1101 Wellington Rd
Rowville, Vic 3178

Country

Australia

Phone

+61 3 9780 8900

Fax

[email protected]

Contact person for scientific queries

Name

Kirrily Ellerton

Address

Wellness on Wellington
1/1101 Wellington Rd
Rowville, Vic 3178

Country

Australia

Phone

+61 3 9780 8900

Fax

[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?

We will share the de-identified final data set upon request. We do not intend to publish it online but it will be freely available on request.

When will data be available (start and end dates)?

We anticipate publication late 2020. Data will be available 6 months following this publication.

Available to whom?

Only researchers who provide a methodologically sound proposal.

Available for what types of analyses?

Only to achieve the aims in the approved proposal.

How or where can data be obtained?

Access subject to approvals by Principal Investigator (email: [email protected]).

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3769	Study protocol			[email protected]

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	The VRIMM study: Virtual Reality for IMMunisation pain in young children - Protocol for a randomised controlled trial.	2020	https://dx.doi.org/10.1136/bmjopen-2020-038354

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

Trial Review

Documents added manually

Documents added automatically