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Trial registered on ANZCTR


Registration number
ACTRN12623000715673p
Ethics application status
Submitted, not yet approved
Date submitted
30/05/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Using Virtual Reality to manage patient anxiety during painful procedures in Emergency Department (VR-ED)
Scientific title
Feasibility of using Virtual Reality to manage patient anxiety during painful procedures in Emergency Department (VR-ED)
Secondary ID [1] 309699 0
None
Universal Trial Number (UTN)
Trial acronym
VR-ED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedure related anxiety 330078 0
Condition category
Condition code
Emergency medicine 326975 326975 0 0
Other emergency care
Mental Health 327129 327129 0 0
Anxiety
Public Health 327130 327130 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two-group parallel pilot Randomised Controlled Trial (RCT) will be conducted and reported in accordance with the CONSORT guidelines. 60 patients will be recruited (30 in the control arm, and 30 in the intervention arm). Participants will be provided the VR headset minimum of 3 minutes prior to the procedure and use the VR as long as tolerated. A few clam VR scenes (e.g. blue ocean, white winter, green meadows) will be available for participant to choose their preferred scene to watch. Each scene last 10 to 30 minutes. All patients will be supervised by research nurse to monitor adherence to the intervention if applicable.
Intervention code [1] 326211 0
Treatment: Other
Comparator / control treatment
Standard care - There is no intervention routinely used to support adult patients' anxiety in the study site.
Control group
Active

Outcomes
Primary outcome [1] 334914 0
Feasibility of a full powered trial will be determined based on percentage of eligible participants provided consent (>60%), tolerated the procedure (>70%), withdraw or lost follow up (<5%), adhere to protocol (>80%), participants and staff (nurses and doctors) satisfaction and acceptability (80% scored >=7 on a scale of 10), and effect size estimates. The percentage of eligible participants provided consent, tolerated the procedure, withdraw or lost follow up, adhere to protocol will be assessed via audit of study records. The percentage of participants and staff (nurses and doctors) satisfaction will be assess via 5 point Likert scale. The acceptability will be assessed using the Acceptability of Intervention Measure (AIM).
Timepoint [1] 334914 0
Upon conclusion of the study.
Secondary outcome [1] 422406 0
Pain level as measured by the Visual Analog Scale for for Pain (VAS-P).
Timepoint [1] 422406 0
Pain levels will be recorded at pre-Intervention (T1), during intervention whilst procedure is ongoing (T2) and immediately post-intervention when porcedure has finished (T3).
Secondary outcome [2] 422407 0
Procedural sedation and anesthetics will be measured as type and dose of sedation and anesthetics used, which will be recorded by research nurse, This will be assessed as a composite outcome.
Timepoint [2] 422407 0
Upon completion of procedure.
Secondary outcome [3] 422408 0
Procedure time will be counted total time during the procedure, which will be recorded by research nurse.
Timepoint [3] 422408 0
Upon completion of procedure.
Secondary outcome [4] 422409 0
ED length of stay refers the total length from triage to discharge via audit of patient medical records.
Timepoint [4] 422409 0
Upon discharge from ED.
Secondary outcome [5] 422410 0
Patient satisfaction will be measured on a 10 points Likert scale.
Timepoint [5] 422410 0
Upon completion of procedure.
Secondary outcome [6] 422411 0
Staff satisfaction will be measured on a 10 points Likert scale.
Timepoint [6] 422411 0
Upon completion of procedure.
Secondary outcome [7] 422412 0
Adverse events of VR use will be measured by Virtual Reality Symptom Questionnaire (VRSQ). The adverse events may include general discomfort, fatigue, boredom, drowsiness, headache, dizziness, concentration difficulties and nausea.
Timepoint [7] 422412 0
Upon completion of procedure.
Secondary outcome [8] 422663 0
Stress level will be measured by heart rate via pulse oximeter.
Timepoint [8] 422663 0
Heart rate will be recorded at pre-Intervention (T1), during intervention while procedure is ongoing (T2) and immediately post-intervention when procedure has finished (T3).
Secondary outcome [9] 422664 0
Anxiety level as measured by visual analog scale for anxiety (VAS-A) and State Trait Anxiety-Inventory (STAI). This will be assessed as a composite outcome.
Timepoint [9] 422664 0
VAS-A will be measured during initial screening.
STAI and VAS-A will be measured at pre-Intervention (T1), during intervention whilst procedure is ongoing (T2) and immediately post-intervention when porcedure has finished (T3).
Secondary outcome [10] 422676 0
The acceptability of the intervention by patient will be measured by Acceptability of Intervention Measure (AIM).
Timepoint [10] 422676 0
Upon completion of procedure.
Secondary outcome [11] 422677 0
The acceptability of the intervention by staff will be measured by Acceptability of Intervention Measure (AIM).
Timepoint [11] 422677 0
Upon completion of procedure.
Secondary outcome [12] 422678 0
The appropriateness of the intervention by staff will be measured by Intervention Appropriateness Measure (IAM).
Timepoint [12] 422678 0
Upon completion of procedure.
Secondary outcome [13] 422679 0
The feasibility of the intervention by staff will be measured by Feasibility of Intervention Measure (FIM).
Timepoint [13] 422679 0
Upon completion of procedure.

Eligibility
Key inclusion criteria
patients will be eligible for inclusion if they are greater than or equal to 18 years old, require needle related painful procedures (including venipuncture/cannulation, wound closure, drainage of abscess or knee joint aspiration), reported moderate or high anxiety level (VAS-A score greater than or equal to 40) and provided informed written consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they requiring urgent care; has a history of blindness, intellectual disability, cognitive impairment, dementia, severe motion sickness, claustrophobia, epilepsy; has nausea/vomiting, vertigo/dizziness, head or facial injury/head or facial wound, respiratory symptoms or in isolation, does not speak English, or has been previous enrolled in the study.

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)
Allocation concealment will be maintained via RedCap until as close as possible to the procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be block randomised via a REDCap with varied block sizes of 4 and 6, at 1:1 ratio of control to intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Characteristics of groups will be summarised using counts and percentages for categorical variables and means and standard deviations for continuous variables. The primary outcome will be compared between groups at each follow-up time points using a linear mixed effects regression model, with fixed effects including treatment arm time (categorical), the interaction between treatment and time, and the baseline value of the outcome variable. Differences in mean anxiety scores between groups at each time point will be presented together with 95% confidence intervals and p-value. Continuous secondary outcomes with repeated measurements will be compared using the same model. Patient satisfaction and the Virtual Reality Symptom Questionnaire (VRSQ) will be compared between groups using an independent sample t-test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24817 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 40466 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 313893 0
Charities/Societies/Foundations
Name [1] 313893 0
PA Research Foundation
Country [1] 313893 0
Australia
Primary sponsor type
Government body
Name
Metro South Healthcare Service
Address
199 Ipswich Road, Woolloongabba, QLD 4102
Country
Australia
Secondary sponsor category [1] 315743 0
None
Name [1] 315743 0
Address [1] 315743 0
Country [1] 315743 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313040 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 313040 0
199 Ipswich Road, Woolloongabba, QLD 4102
Ethics committee country [1] 313040 0
Australia
Date submitted for ethics approval [1] 313040 0
12/05/2023
Approval date [1] 313040 0
Ethics approval number [1] 313040 0

Summary
Brief summary
The pilot randomised controlled trial aims to test the feasibility of a large trial. The trial will evaluate the effectiveness of virtual reality headset in managing emergency department (ED) patients' painful procedure related anxiety. Clinical outcomes includes anxiety, stress, pain, procedural sedation and anaesethics, procedure time, ED length of stay, patient and staff satisfaction and acceptability, and adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126778 0
Dr Hui (Grace) Xu
Address 126778 0
Queen Elizabeth II Jubilee Hospital, Troughton Rd, Coopers Plains QLD 4108
Country 126778 0
Australia
Phone 126778 0
+61 7 3182 4584
Fax 126778 0
Email 126778 0
grace.xu@health.qld.gov.au
Contact person for public queries
Name 126779 0
Dr Hui (Grace) Xu
Address 126779 0
Queen Elizabeth II Jubilee Hospital, Troughton Rd, Coopers Plains QLD 4108
Country 126779 0
Australia
Phone 126779 0
+61 7 3182 4584
Fax 126779 0
Email 126779 0
grace.xu@health.qld.gov.au
Contact person for scientific queries
Name 126780 0
Dr Hui (Grace) Xu
Address 126780 0
Queen Elizabeth II Jubilee Hospital, Troughton Rd, Coopers Plains QLD 4108
Country 126780 0
Australia
Phone 126780 0
+61 7 3182 4584
Fax 126780 0
Email 126780 0
grace.xu@health.qld.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19307Study protocol    The protocol is currently under the peer-review pr... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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