Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000085774
Ethics application status
Approved
Date submitted
13/12/2021
Date registered
21/01/2022
Date last updated
16/09/2022
Date data sharing statement initially provided
21/01/2022
Date results information initially provided
16/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Video image vs virtual reality in theatre to distract children: the VIVID trial
Scientific title
A single-centre, randomised controlled trial investigating the effect of 3D virtual reality technology compared to 2D video images on distress during anaesthetic induction in children
Secondary ID [1] 306027 0
Nil
Universal Trial Number (UTN)
Trial acronym
VIVID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children undergoing elective or emergency surgery 324660 0
Condition category
Condition code
Anaesthesiology 322111 322111 0 0
Other anaesthesiology
Surgery 322294 322294 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing general anaesthesia will be block randmonised in a 1:1 ratio to receive distraction either using the 3D virtual reality goggles(Smileyscope) or a 2D video during their anaesthetic induction. Randomisaton will be stratified by age (younger 4-8 years) and older (9-13 years). Children allocated to the virtual reality (VR) group will receive the 3D VR headset once they have entered the induction room and are seated on the bed. The goggles will be secured to the child’s head once they are comfortable, and the 5-minute breathing video of a relaxing underwater world option on the 3D VR goggles will be played. The anaesthetist is positioned beside the child in the anaesthetic induction room and therefore will be able to monitor the adherence to the intervention. The anaesthetist will also be able to hear the video playing while in use. The headset will be worn until the anaesthetist deems the child to be sufficiently anaesthetised. After each use, the 3D VR headset will be removed, and sanitised as per institutional guidelines and recharged.
For those children having a gas induction, the method of gas delivery will be left to the anaesthetist’s discretion (turning mask upside down etc.) The virtual reality headsets will be sourced from Smileyscope Pty ltd (Smileyscope Pty Ltd, Melbourne, Australia, VIC300), a leading healthcare technology company. The goggles consist of a headband and headset attached to a smart phone device.
Intervention code [1] 322426 0
Treatment: Devices
Intervention code [2] 322563 0
Prevention
Comparator / control treatment
Participants in the 2D video group will view the same breathing video of a relaxing underwater world as the 3D VR group on an iPad. The 3D breathing function from the SmileyScope Pty ltd VR software has been adapted by the company to a 2D version that can be viewed on an iPad. The iPad will be held for them by their caregiver/technician/independent observer or the participant may hold it for themselves if they wish to.
Control group
Active

Outcomes
Primary outcome [1] 329878 0
Change in anxiety levels from baseline to anaesthetic induction between the 3D VR and 2D video groups, assessed using the modified Yale Perioperative Anxiety Scale (mYPAS) during sign-in to theatre (T1) and anaesthetic induction (T2)
Timepoint [1] 329878 0
During sign-in to theatre (T1) and anaesthetic induction (T2)
Secondary outcome [1] 404139 0
Anaesthetist perceived usefulness of the intervention in helping the child cope with the induction process, assessed using a 6-point Likert scale from not useful at all (0) to extremely useful (5).
Timepoint [1] 404139 0
Anaesthetists will be asked this during the child’s surgery.
Secondary outcome [2] 404140 0
Child perceived usefulness of the intervention in helping them cope with their induction, using the Smiley-o-meter scale 44 from awful (1) to brilliant (5). This scale is specifically designed to measure children’s opinions of technology, comprising of a 1 – 5 Likert scale using smiley faced pictorial representations.
Timepoint [2] 404140 0
After their procedure, while they are on the recovery ward in the hospital
Secondary outcome [3] 404141 0
Induction compliance will be assessed using the induction compliance checklist (ICC) immediately after anaesthetic induction by the patient’s anaesthetist. The induction compliance checklist contains 11 items, giving a score from 0 (extremely compliant) to 11 (extremely uncompliant). Item 3 on the scale will be amended for IV inductions to state: “Moves arm away from the needle”. Item 6 will also be amended for IV inductions to state: “Pushes anaesthetist with needle away, pushes nurses/anaesthetist with hands or feet”.
Timepoint [3] 404141 0
Immediately after anaesthetic induction
Secondary outcome [4] 404142 0
Post-operative satisfaction with the intervention, assessed through questionnaire on day 7 post-surgery. This will be assessed by a study specific questionnaire.
Timepoint [4] 404142 0
On day 7 post-surgery
Secondary outcome [5] 404143 0
Incidence of emergence delirium using the Cornell Assessment of Pediatric Delirium (CAP-D)The CAP-D consists of 8 items scored on a 5-point Likert scale ranging from always (0) to Never (4). This will be assessed in the post anaesthetic care unit (PACU) by the patient’s nurse.
Timepoint [5] 404143 0
On arrival to PACU ( 1 –10 mins); 11 – 20 mins; 21 – 40 mins; 41 – 60 mins; 61 – 90 mins (until PACU discharge). It will be assessed once at each time point.
Secondary outcome [6] 404144 0
Post-operative behavioural outcomes using the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS). Parents/carers will be asked to compare their child to their usual behaviour pre-surgery.
Timepoint [6] 404144 0
On day 7 post-surgery
Secondary outcome [7] 404754 0
Technician perceived usefulness of the intervention in helping the child cope with the induction process, assessed using a 6-point Likert scale from not useful at all (0) to extremely useful (5).
Timepoint [7] 404754 0
Technicians will be asked this during the child’s surgery.
Secondary outcome [8] 404755 0
Parent perceived usefulness of the intervention in helping the child cope with the induction process, assessed using a 6-point Likert scale from not useful at all (0) to extremely useful (5).
Timepoint [8] 404755 0
Parents will be asked this when their child is on the recovery ward, after their surgery.
Secondary outcome [9] 404756 0
Induction compliance will be assessed using the induction compliance checklist (ICC) immediately after anaesthetic induction by the patient’s technician. The induction compliance checklist contains 11 items, giving a score from 0 (extremely compliant) to 11 (extremely uncompliant). Item 3 on the scale will be amended for IV inductions to state: “Moves arm away from the needle”. Item 6 will also be amended for IV inductions to state: “Pushes anaesthetist with needle away, pushes nurses/anaesthetist with hands or feet”.
Timepoint [9] 404756 0
Immediately after anaesthetic induction
Secondary outcome [10] 404757 0
Induction compliance will be assessed using the induction compliance checklist (ICC) immediately after anaesthetic induction by the independent observer. The induction compliance checklist contains 11 items, giving a score from 0 (extremely compliant) to 11 (extremely uncompliant). Item 3 on the scale will be amended for IV inductions to state: “Moves arm away from the needle”. Item 6 will also be amended for IV inductions to state: “Pushes anaesthetist with needle away, pushes nurses/anaesthetist with hands or feet”.
Timepoint [10] 404757 0
Immediately after anaesthetic induction.
Secondary outcome [11] 404758 0
Patient memories of experience. Assessed by follow up phone call to parent with study specific questionnaire.
Timepoint [11] 404758 0
Day 7 post surgery
Secondary outcome [12] 404759 0
Parent's willingness to use the study intervention again.
Assessed by follow up phone call to parent with study specific questionnaire.
Timepoint [12] 404759 0
On day 7 post-surgery
Secondary outcome [13] 404760 0
Child's willingness to use the study intervention again.
Assessed by follow up phone call to parent with study specific questionnaire.
Timepoint [13] 404760 0
On day 7 post-surgery

Eligibility
Key inclusion criteria
Children aged 4- 13 years of age undergoing elective or emergency surgery at Perth Children's Hospital
Minimum age
4 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any visual, auditory, or cognitive impairments preventing interaction with the VR intervention, particularly a history of epilepsy or seizures

Any critical medical condition or condition that precludes the use of VR

Methicillin resistant Staphylococcus aureus infection or symptoms of respiratory or gastrointestinal infection that may contaminate VR equipment. VR equipment and the iPad will be cleaned with standard equipment cleaning policies aligned with all theatre equipment.

Children receiving midazolam or ketamine as a premedication

VR headset does not fit patient at the researchers discretion

Any concern in the ability of the parents/guardian or child to appropriately adhere to the study protocol or any issues which, in the investigator’s opinion, would increase the risks of study participation to the child.

Language barriers impeding data collection

Department for child Protection and Family Support is involved in their care

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study group allocations will be placed in serially numbered envelopes for the researcher to open after consent, baseline demographics and initial study questionnaires have been obtained. Blinding of the researcher, child or nurse is not possible for this study. Participants will be provided with an image of the 3D VR Goggles or iPad on the consent form, but will not be introduced to the treatment until they enter the induction room.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation in a 1:1 ratio
Randomisation will be stratified by age; younger (4 – 8 years) and older (9 – 13 years).
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
All data will be analysed using R. Data will be analysed on an intention to treat basis. A linear statistical model will be used to explore the relationship between sex, age, length of procedure, baseline anxiety scores and induction type on anxiety scores. Parental, anaesthetist, technician and patient usefulness and satisfaction scores for each treatment will be compared using an appropriate statistical model. Total analgesic consumption will also be compared between each group, after adjusting for age and weight. CAP-D scores will also be compared between the 3D VR and 2D group using a linear statistical model. Patient’s memories of their procedure will be coded and grouped into themes (positive memories, negative memories, no memories).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/01/2022
Actual
28/01/2022
Date of last participant enrolment
Anticipated
29/12/2023
Actual
16/06/2022
Date of last data collection
Anticipated
13/01/2024
Actual
15/07/2022
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21316 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 36201 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 310367 0
Hospital
Name [1] 310367 0
Perth Children's Hospital
Country [1] 310367 0
Australia
Primary sponsor type
Government body
Name
Child & Adolescent Health Service Executive at Perth Children's Hopsital
Address
Perth Children's Hospital,
15 Hospital Avenue,
Nedlands
6009
WA
Australia
Country
Australia
Secondary sponsor category [1] 311504 0
None
Name [1] 311504 0
Address [1] 311504 0
Country [1] 311504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310020 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 310020 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Ethics committee country [1] 310020 0
Australia
Date submitted for ethics approval [1] 310020 0
21/09/2021
Approval date [1] 310020 0
18/11/2021
Ethics approval number [1] 310020 0
RGS0000003679

Summary
Brief summary
This randomised controlled study will examine the impact of a 3D virtual reality (VR) intervention versus a two-dimensional (2D) video on pre-operative anxiety and induction compliance. .This study will provide evidence on the ongoing clinical use of 3D VR Goggles during the preoperative period at Perth Children's Hospital (PCH), to reduce anxiety and improve coping of children undergoing surgery. Given preoperative anxiety is so common amongst children, it is vital to find suitable strategies to control and reduce this anxiety in order to improve the overall patient experience. Children exposed to negative medical experiences may have a higher incidence of negative post-operative behavioural outcomes and often display increased fear and poor coping during subsequent medical procedures. By fostering a more positive and fun environment for children through the use of 3D VR goggles, there is potential to reduce negative post-operative outcomes and help children to recall their surgical journey as a more positive, exciting and non-threatening experience.
Primary hypothesis: Children allocated to the 3D VR intervention group will display a significantly smaller increase in anxiety during anaesthetic induction from baseline, compared to the 2D video group
Secondary hypotheses:
1. Children allocated to the 3D VR intervention group will display better induction compliance than children in the 2D video group
2. The 3D VR intervention will be more useful than the 2D intervention in helping the child cope with the induction process
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116206 0
Prof Britta von Ungern-Sternberg
Address 116206 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 116206 0
Australia
Phone 116206 0
+61 08 64564805
Fax 116206 0
Email 116206 0
britta.regli-vonungern@health.wa.gov.au
Contact person for public queries
Name 116207 0
Prof Britta von Ungern-Sternberg
Address 116207 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 116207 0
Australia
Phone 116207 0
+61 08 64564805
Fax 116207 0
Email 116207 0
britta.regli-vonungern@health.wa.gov.au
Contact person for scientific queries
Name 116208 0
Prof Britta von Ungern-Sternberg
Address 116208 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 116208 0
Australia
Phone 116208 0
+61 08 64564805
Fax 116208 0
Email 116208 0
britta.regli-vonungern@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The investigators have not yet considered data sharing


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.