Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001322325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
4/09/2026
Date registered
Help: Date registered
3/11/2026
Date last updated
Help: Date last updated
3/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
3/11/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual reality for pain and distress in paediatric emergency department procedures
Scientific title
Multi-site hYbrid rct of Virtual Reality for pain and distress in PAediatric Emergency Department procedureS: Tertiary, urban and rural evaluation: MY VR in PAEDs
Additional trial identifiers [1] 318285 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MY VR in PAEDs
Related trial records

Health condition
Health condition(s) studied:
Pain 343406 0
Anxiety 343407 0
Distress 343611 0
Condition category
Condition code
Mental Health 339714 339714 0 0
Anxiety
Mental Health 339887 339887 0 0
Other mental health disorders
Anaesthesiology 339888 339888 0 0
Pain management
Emergency medicine 339889 339889 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Virtual Reality (VR) is the intervention in this study. Virtual reality (VR) delivered via immersive and interactive head-mounted displays, has emerged as a promising non-pharmacological tool for procedural pain and distress management. By engaging children in rich, interactive virtual environments, VR distracts attention from procedural stimuli and may induce neurophysiological changes that reduce pain perception, distress and anxiety.

Phase 1 Co-design process
Phase 1 will occur prior to commencement of the Phase 2 randomised controlled trial (RCT). Phase 1 includes stakeholder surveys, experience-based co-design workshops/focus groups, VR usability testing, workflow observations and implementation planning involving children aged 8-16 years, parents/caregivers, and clinicians across participating sites.

The process includes:
1. Surveys of children, caregivers and clinicians to identify barriers, enablers, acceptability, appropriateness and feasibility of VR implementation.
2. Two structured co-design workshops/focus groups per site (4-8 participants per workshop), with separate clinician and consumer groups.
- Conducted over 2 days per site within a 3-week period and completed 4 weeks prior to Phase 2.
- VR content review and testing, where participants trial selected VR programs (Smileyscope or Invincikids) and provide feedback regarding engagement, immersion, clinical appropriateness and tolerability. All participants will be asked for their preference between Smileyscope and Invincikids. Preferences will be recorded alongside usability, tolerability, acceptability and implementation feedback and will inform selection of the final VR content library.
3. Usability and fidelity simulations involving staff trialling VR within realistic emergency department workflows and one consumer walk-through at each site.
4. Site-specific process mapping and workflow observations to identify opportunities for integration of VR into routine care.

Before commencement of Phase 2, a small feasibility test involving approximately 3-4 children per site during real procedures will assess workflow integration, headset tolerability, set-up efficiency and protocol adherence. Any refinements identified through the feasibility testing will be incorporated before Phase 2 commences.

The final outputs of Phase 1 will include:
- a stakeholder-endorsed VR content library;
- site-specific implementation plans;
- training resources and site champion packages;
- fidelity checklists; and
- feasibility testing data used to inform readiness for Phase 2.

Examples of VR programs
The Phase 1 co-design process will determine the final program library for Phase 2. The VR programs under consideration (Smileyscope and Invincikids) will be delivered according to the manufacturer's/developer's standard specifications. No modifications to core software functionality are planned as part of this study. Candidate programs include Smileyscope and Invincikids immersive virtual reality experiences designed for paediatric healthcare settings. Programs provide age-appropriate, interactive, immersive experiences intended to distract children during procedures and may include exploratory environments, animated adventures, interactive games and calming immersive experiences. VR programs are generally short and procedure-specific, with most lasting approximately 2-5 minutes, and up to 10 minutes, designed to guide the patient through the start, duration and completion of the procedure. Where clinically required, programs may be repeated or continued throughout the procedure. VR may be delivered pre-procedurally, intra-procedurally, or both, depending on the procedure type and clinical context.

Site champion training packages
Training resources developed during Phase 1 for local clinical champions to support implementation of the VR intervention. Resources will support staff competency, protocol adherence, implementation consistency and integration into routine emergency department workflows across sites.

Workflow integration plans
Site-specific implementation resources developed during Phase 1 based on workflow observations and process mapping with participating sites. These resources are designed to support integration of VR into routine emergency department workflows while maintaining consistent delivery of the intervention across sites.

Fidelity tools
Standardised fidelity checklists developed during Phase 1 to assess protocol adherence, and consistency of intervention delivery across participating sites.

Phase 2 Implementation
Phase 2 will be a two-arm, multi-site, Type I Hybrid effectiveness–implementation randomised controlled trial across Queensland Children’s Hospital (tertiary), Caboolture Hospital (urban), and Kingaroy Hospital (rural). Participants include children aged 4–16 years undergoing painful emergency department (ED) procedures, their caregivers, and treating clinicians. Children will be randomised 1:1 to VR distraction or standard care, stratified by site, age, and procedure type. Children allocated to the VR arm will receive a VR headset with an age-appropriate program selected from the Phase 1–curated library, delivered before and/or during the procedure as clinically appropriate. Guided by the Phase 1 co-design process, the intervention will typically be delivered by the Registered Nurse or Medical Doctor responsible for patient care, and may be supported by available clinical site champions (e.g. Clinical Nurse Consultant or Clinical Nurse). Children will be offered limited choice within the curated menu. Blinding is not feasible given the nature of the intervention.
Intervention code [1] 335201 0
Treatment: Devices
Description of the comparator or control
Children allocated to usual care will receive standard procedural care per local protocols, which may include routine analgesia, child life support, and age-appropriate distraction.
Control group
Active

Outcomes
Primary outcome [1] 346701 0
Child pain - Peak procedural pain intensity
Timepoint [1] 346701 0
10 minutes before the procedure, once during the procedure, and 10 minutes after the procedure
Primary outcome [2] 347065 0
Observed child pain intensity (guardian/carer-rated)
Timepoint [2] 347065 0
10 minutes before the procedure, once during the procedure, and 10 minutes after the procedure
Primary outcome [3] 347066 0
Observed child pain intensity (clinician-rated)
Timepoint [3] 347066 0
10 minutes before the procedure, once during the procedure, and 10 minutes after the procedure
Secondary outcome [1] 467083 0
Child anxiety
Timepoint [1] 467083 0
10 minutes before the procedure, once during the procedure, and 10 minutes after the procedure
Secondary outcome [2] 467084 0
Observed child anxiety
Timepoint [2] 467084 0
10 minutes before the procedure, once during the procedure, and 10 minutes after the procedure
Secondary outcome [3] 467085 0
Parent anxiety
Timepoint [3] 467085 0
10 minutes before the procedure, once during the procedure, and 10 minutes after the procedure
Secondary outcome [4] 467086 0
Procedural distress
Timepoint [4] 467086 0
Once during the procedure
Secondary outcome [5] 467087 0
Procedure duration (minutes)
Timepoint [5] 467087 0
Once during the procedure
Secondary outcome [6] 467089 0
Procedure completion status
Timepoint [6] 467089 0
Once during the procedure
Secondary outcome [7] 467090 0
Adverse events
Timepoint [7] 467090 0
Once during the procedure
Secondary outcome [8] 467091 0
Sedation use - composite outcome comprising the components sedation type, dose and timing.
Timepoint [8] 467091 0
Once during the procedure
Secondary outcome [9] 467092 0
Procedural support strategies - composite outcome comprising the components pharmacological and non-pharmacological interventions, restrictive practices (parental holding, clinician physical restraint)
Timepoint [9] 467092 0
Once during the procedure
Secondary outcome [10] 468761 0
Child Post-Traumatic Stress Symptoms (PTSS)
Timepoint [10] 468761 0
1-month post-procedure follow-up
Secondary outcome [11] 468762 0
Carer Post-Traumatic Stress Symptoms (PTSS)
Timepoint [11] 468762 0
1-month post-procedure follow-up
Secondary outcome [12] 468898 0
Child Health-related Quality of Life (HRQoL) (parent-proxy)
Timepoint [12] 468898 0
1-month post-procedure follow-up
Secondary outcome [13] 468901 0
Acceptability - Clinician satisfaction with VR intervention delivery
Timepoint [13] 468901 0
Post intervention implementation
Secondary outcome [14] 468902 0
Feasibility of VR implementation - composite outcome comprising the components recruitment rate, consent rate, protocol adherence, headset usage rates across sites
Timepoint [14] 468902 0
Post intervention implementation
Secondary outcome [15] 468903 0
Intervention fidelity
Timepoint [15] 468903 0
Once during the procedure
Secondary outcome [16] 468904 0
Child physiological stress - Peak acute stress response
Timepoint [16] 468904 0
Prior to the procedure (baseline), 20-30 minutes after the procedure, and at 1-month follow-up for Queensland Children's Hospital participants only.
Secondary outcome [17] 468905 0
Parent physiological stress - Peak acute stress response
Timepoint [17] 468905 0
Prior to the procedure (baseline), 20-30 minutes after the procedure, and at 1-month follow-up for Queensland Children's Hospital participants only.
Secondary outcome [18] 468909 0
Emergency Department (ED) length of stay
Timepoint [18] 468909 0
At completion of ED presentation
Secondary outcome [19] 468911 0
Cost-effectiveness of VR integration in ED workflows
Timepoint [19] 468911 0
At completion of study data collection
Secondary outcome [20] 469328 0
Acceptability of VR implementation: composite outcome comprising child-, caregiver- and clinician-reported acceptabilit
Timepoint [20] 469328 0
During Phase 1 surveys, co-design workshops/focus groups and usability testing; prior to commencement of Phase 2 RCT.
Secondary outcome [21] 469329 0
Feasibility of VR implementation (children and clinicians): composite outcome comprising headset tolerability, set-up efficiency, workflow integration and protocol adherence,
Timepoint [21] 469329 0
During Phase 1 usability testing, workflow simulations and feasibility testing, prior to commencement of Phase 2 RCT.
Secondary outcome [22] 469330 0
Appropriateness of VR for ED procedures: composite outcome comprising perceived suitability, relevance and fit within ED procedural care among children, caregivers and clinicians.
Timepoint [22] 469330 0
During Phase 1 surveys and co-design workshops/focus groups, prior to commencement of the Phase 2 RCT.
Secondary outcome [23] 469331 0
Implementation barriers and enablers to VR implementation: composite outcome comprising child-, caregiver- and clinician-reported barriers and facilitators to implementation.
Timepoint [23] 469331 0
During Phase 1 surveys, co-design workshops, workflow observations and implementation planning activities, prior to commencement of the Phase 2 RCT

Eligibility
Key inclusion criteria
Phase 1: Co-design and Implementation Preparation
- Children aged 8–16 years presenting to a participating ED requiring a procedural intervention
- Parents and caregivers of eligible children
- Multidisciplinary clinical and procedural support staff at participating sites, including ED nurses, medical officers, pain service staff, child life therapists, patient ambassadors, and cultural health workers (e.g. Mob ED)

Phase 2: Multi-Site Hybrid Type I Effectiveness–Implementation RCT
- Children aged 4–16 years presenting to a participating ED requiring a painful or anxiety-provoking procedure
- Parent or caregiver present and able to provide informed consent
- Treating clinicians and procedural support staff involved in the procedure
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Phase 1: Co-design and Implementation Preparationn
No clinical exclusion criteria apply to Phase 1 survey and workshop participation.

Phase 2: Multi-Site Hybrid Type I Effectiveness–Implementation RCT
- Children with:
1. An existing procedural support or pain management plan (e.g. established CALM plan)
2. Head or facial injuries that prevent comfortable headset placement
3. A history of severe motion sickness
4. Cervical spine immobilisation
5. Reduced level of consciousness
6. Significant visual impairment preventing use of a head-mounted display
- Persons unable to provide informed consent
- Clinicians not currently working in a clinical or procedural support capacity within the ED
- Clinician discretion: cases where participation is deemed clinically inappropriate (to be documented)

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)
Sequentially numbered, sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence; stratified by analgesic group, site, age and procedure type
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Phase 1 will involve approximately 60 participants across three sites, including survey participants (minimum 10 per site), co-design workshop participants (4-8 participants per site attending two workshops and associated usability/fidelity activities), and feasibility testing participants (approximately 3-4 children per site).

Phase 2 will recruit 100 children across three sites. A sample of 100 children (allowing for 10% attrition) provides 80% power to detect a clinically meaningful 1.5-point reduction in peak pain scores (SD 2.5). The trial is powered for the primary outcome across the overall cohort. The study is not designed or powered to detect statistically significant differences within strata (by procedure group, age, or site); subgroup analyses will generate indicative effect sizes and variability estimates to inform a future definitive trial.

In Phase 2, Parents/caregivers of enrolled children and treating clinicians will also contribute to study data, including survey responses, implementation outcomes, clinician-rated measures and qualitative interviews. Recruitment of these participants is expected to correspond to the paediatric sample, comprising 100 parents/caregivers and 100 treating clinicians across participating sites.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 30130 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 30131 0
Caboolture Hospital - Caboolture
Recruitment hospital [3] 30132 0
Kingaroy Hospital & Community Health Centre - Kingaroy
Recruitment postcode(s) [1] 46525 0
4101 - South Brisbane
Recruitment postcode(s) [2] 46526 0
4510 - Caboolture
Recruitment postcode(s) [3] 46527 0
4610 - Kingaroy

Funding & Sponsors
Funding source category [1] 322840 0
Charities/Societies/Foundations
Name [1] 322840 0
Emergency Medicine Foundation
Country [1] 322840 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 325773 0
None
Name [1] 325773 0
Address [1] 325773 0
Country [1] 325773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321279 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 321279 0
Ethics committee country [1] 321279 0
Australia
Date submitted for ethics approval [1] 321279 0
25/05/2026
Approval date [1] 321279 0
10/08/2026
Ethics approval number [1] 321279 0
HREC/2026/QCHQ/126175

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

Contacts
Principal investigator
Name 153226 0
Ms Ashleigh Barr
Address 153226 0
Caboolture Hospital, Emergency Department, 871/129 McKean Street, Caboolture QLD 4510
Country 153226 0
Australia
Phone 153226 0
+61 422 362 018
Fax 153226 0
Email 153226 0
[email protected]
Contact person for public queries
Name 153227 0
Professor Bronwyn Griffin
Address 153227 0
Griffith University, School of Nursing and Midwifery, 170 Kessels Road, Nathan QLD 4111
Country 153227 0
Australia
Phone 153227 0
+61 404 892 517
Fax 153227 0
Email 153227 0
[email protected]
Contact person for scientific queries
Name 153228 0
Professor Bronwyn Griffin
Address 153228 0
Griffith University, School of Nursing and Midwifery, 170 Kessels Road, Nathan QLD 4111
Country 153228 0
Australia
Phone 153228 0
+61 404 892 517
Fax 153228 0
Email 153228 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data (IPD) for this trial (including data dictionaries) will not be available as a condition of ethics approval.



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.