Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 295752 0
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 309152 0
Condition category
Condition code
Public Health 308034 308034 0 0
Other public health
Anaesthesiology 308090 308090 0 0
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] 312085 0
Treatment: Devices
Intervention code [2] 312086 0
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] 307026 0
The primary end-point is the difference in Faces pain scale - revised between the intervention and control groups.
Timepoint [1] 307026 0
Upon completion of the vaccination.
Secondary outcome [1] 350422 0
Self-reported pain using the poker chip tool.
Timepoint [1] 350422 0
Upon completion of the vaccination.
Secondary outcome [2] 350423 0
Observer ratings of pain and distress by parents/guardians recorded on a standard 100mm visual analogue scale (VAS).
Timepoint [2] 350423 0
Upon completion of the vaccination
Secondary outcome [3] 350550 0
Observer ratings by healthcare providers (nurse immunisers) recorded on a standard 100mm visual analogue scale (VAS).
Timepoint [3] 350550 0
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
79
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 23659 0
3178 - Rowville

Funding & Sponsors
Funding source category [1] 300343 0
Charities/Societies/Foundations
Name [1] 300343 0
RACGP Foundation Family Medical Care Education and Research (FMCER) Grant 2018
Country [1] 300343 0
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] 299786 0
Individual
Name [1] 299786 0
Assoc Professor Simon Craig
Address [1] 299786 0
Monash Medical Centre Paediatric Emergency Dept 246 Clayton Rd Clayton Victoria 3168
Country [1] 299786 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301158 0
Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (EC00131)
Ethics committee address [1] 301158 0
Ethics committee country [1] 301158 0
Australia
Date submitted for ethics approval [1] 301158 0
01/10/2018
Approval date [1] 301158 0
19/03/2019
Ethics approval number [1] 301158 0

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

Contacts
Principal investigator
Name 86042 0
Dr Kirrily Ellerton
Address 86042 0
Wellness on Wellington 1/1101 Wellington Rd Rowville, Vic 3178
Country 86042 0
Australia
Phone 86042 0
+61 3 9780 8900
Fax 86042 0
Email 86042 0
[email protected]
Contact person for public queries
Name 86043 0
Kirrily Ellerton
Address 86043 0
Wellness on Wellington 1/1101 Wellington Rd Rowville, Vic 3178
Country 86043 0
Australia
Phone 86043 0
+61 3 9780 8900
Fax 86043 0
Email 86043 0
[email protected]
Contact person for scientific queries
Name 86044 0
Kirrily Ellerton
Address 86044 0
Wellness on Wellington 1/1101 Wellington Rd Rowville, Vic 3178
Country 86044 0
Australia
Phone 86044 0
+61 3 9780 8900
Fax 86044 0
Email 86044 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal.

Conditions for requesting access:
• -

What individual participant data might 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.

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?
From:
We anticipate publication late 2020. Data will be available 6 months following this publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator (email: [email protected]).

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3769Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe VRIMM study: Virtual Reality for IMMunisation pain in young children - Protocol for a randomised controlled trial.2020https://dx.doi.org/10.1136/bmjopen-2020-038354
N.B. These documents automatically identified may not have been verified by the study sponsor.