Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001555842
Ethics application status
Approved
Date submitted
11/09/2021
Date registered
16/11/2021
Date last updated
3/04/2024
Date data sharing statement initially provided
16/11/2021
Date results provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility/Acceptability of Virtual Reality Preparation in Children prior to Magnetic Resonance Imaging
Scientific title
Feasibility/Acceptability of Virtual Reality Preparation in Children Aged 4-10 years prior to Magnetic Resonance Imaging.
Secondary ID [1] 305286 0
none
Universal Trial Number (UTN)
Trial acronym
VRMRI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 323957 0
Condition category
Condition code
Mental Health 321134 321134 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A virtual reality experience (approximately 10 minutes) mimicking the magnetic resonance imaging scan will be offered to the child by a research assistant on the day of the scan. This will be done at least 30 minutes prior to the actual magnetic resonance imaging scan.
Intervention code [1] 321691 0
Treatment: Devices
Intervention code [2] 321843 0
Behaviour
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328921 0
Proportion of children who provide positive polarity feedback on the feasibility/acceptability of the virtual reality experience as measured by semi-structured recorded interview lasting about 10 minutes
Timepoint [1] 328921 0
Immediately after MRI scan
Primary outcome [2] 329459 0
Proportion of caregivers who provide positive polarity feedback on the feasibility/acceptability of the virtual reality experience as measured by semi-structured recorded interview lasting about 10 minutes
Timepoint [2] 329459 0
Immediately after MRI scan
Primary outcome [3] 329460 0
Proportion of healthcare workers who provide positive polarity feedback on the feasibility/acceptability of the virtual reality experience as measured by semi-structured recorded interview lasting about 5 minutes
Timepoint [3] 329460 0
Immediately after MRI scan
Secondary outcome [1] 400873 0
Qualitative thematic feedback gathered by semi-structured recorded interview lasting about 5-10 minutes.
Timepoint [1] 400873 0
Immediately after MRI scan

Eligibility
Key inclusion criteria
Clinically indicated non-contrast head magnetic resonance imaging
Minimum age
4 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to complete study instruments
Critically unwell at the time of magnetic resonance imaging scan
Patient has had a previous awake magnetic resonance imaging scan
Diagnosed non-neurotypical development
Other disorder or condition that would in the Investigator or caregiver’s opinion preclude study procedure completion

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/11/2021
Actual
10/05/2022
Date of last participant enrolment
Anticipated
29/11/2022
Actual
26/07/2022
Date of last data collection
Anticipated
29/11/2022
Actual
26/07/2022
Sample size
Target
12
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20509 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 35286 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 309658 0
Commercial sector/Industry
Name [1] 309658 0
Smileyscope Pty Ltd
Country [1] 309658 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Smileyscope Pty Ltd
Address
Level 1/333 Exhibition St
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 310956 0
None
Name [1] 310956 0
Address [1] 310956 0
Country [1] 310956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309425 0
Monash Health HREC
Ethics committee address [1] 309425 0
Ethics committee country [1] 309425 0
Australia
Date submitted for ethics approval [1] 309425 0
17/08/2021
Approval date [1] 309425 0
22/09/2021
Ethics approval number [1] 309425 0
RES-21-0000-545A

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

Contacts
Principal investigator
Name 114118 0
Prof Michael Ditchfield
Address 114118 0
Monash Children's Hospital
246 Clayton Rd
Clayton VIC 3168
Country 114118 0
Australia
Phone 114118 0
+61 3 9594 2200
Fax 114118 0
Email 114118 0
Michael.Ditchfield@monashhealth.org
Contact person for public queries
Name 114119 0
Michael Ditchfield
Address 114119 0
Monash Children's Hospital
246 Clayton Rd
Clayton VIC 3168
Country 114119 0
Australia
Phone 114119 0
+61 3 9594 2200
Fax 114119 0
Email 114119 0
Michael.Ditchfield@monashhealth.org
Contact person for scientific queries
Name 114120 0
Michael Ditchfield
Address 114120 0
Monash Children's Hospital
246 Clayton Rd
Clayton VIC 3168
Country 114120 0
Australia
Phone 114120 0
+61 3 9594 2200
Fax 114120 0
Email 114120 0
Michael.Ditchfield@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data will be included the publication. Data will be de-identified such that no individual(s) will be individually identifiable unless written consent is gained from that person (assent in the case of a child, and written consent from the legal guardian/caregiver). Original IPD will be available upon request from the authors for a period of 24 months.
When will data be available (start and end dates)?
Publication is anticipated 6-12 months following trial conclusion.
Available to whom?
Readers of the publication.
Available for what types of analyses?
Any.
How or where can data be obtained?
Publication will contain all relevant data.


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.