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Trial registered on ANZCTR


Registration number
ACTRN12624001212549
Ethics application status
Approved
Date submitted
5/09/2024
Date registered
3/10/2024
Date last updated
3/10/2024
Date data sharing statement initially provided
3/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of using Virtual Reality for peri-operative anxiety during regional anaesthesia: A non-inferiority randomised controlled trial
Scientific title
The Efficacy of using Virtual Reality for peri-operative anxiety during regional anaesthesia: A non-inferiority randomised controlled trial
Secondary ID [1] 312701 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety during medical procedures 334727 0
Condition category
Condition code
Anaesthesiology 331288 331288 0 0
Anaesthetics
Mental Health 331679 331679 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) Baseline demographics
At the point of recruitment, the following demographic data for each patient will be collected: age, gender, type of surgery, and pre-operative Amsterdam pre-operative anxiety and information scale (APAIS).

(2) VR Group procedures
The patient is brought into the anaesthetic bay as per normal.

The VR head-mounted display system used in this study is the Meta Quest 2 unit. It is a standalone unit (no accompanying personal computer required) which minimises issues with cables and another device. It will be preloaded with Nature Treks VR, a program designed specifically for the Meta Quest headset and allows the user to choose from 9 different nature environments (tropical island, underwater, safari, outer space etc).
A researcher will introduce the patient to the headset, adjust the straps for comfort, and allow the patient to choose their favourite nature environment for maximum distraction. The headset will be placed on the patient prior to intravenous cannulation and continues throughout the cannulation procedure.
After intravenous access has been secured, the VR headset is removed and the patient will repeat the APAIS.

Similarly, the VR headset is placed back on the patient prior to the nerve block and the Nature Treks VR program is played throughout the nerve block procedure. After the nerve block is completed, the VR headset is removed and the patient asked to repeat the APAIS.

In the VR group, anaesthetists are asked not to provide anxiolytic medications unless the VR is not tolerated and there is a specific patient request for additional medications to help with reducing anxiety and pain from either of these two procedures. If rescue anxiolytic medications were required, this will be noted in the case reporting form.

After checking that the nerve block is effective for surgical anaesthesia, the patient is moved from the anaesthetic bay into the operating theatre for their hand surgery. Management of the patient during their surgery is pragmatic and anaesthetists and surgeons are able to continue management as usual of the patient.


(3) Intravenous cannulation procedure
Site and size of the intravenous cannula is at the discretion of the treating anaesthetist

(4) Nerve block procedure
Site and type of nerve block is at the discretion of the treating anaesthetist, and would vary depending on clinical indications: type of surgery, predicted duration of surgery, and optimal location of nerve blockade.

All anaesthetists would perform these nerve blocks using ultrasound-guidance of the brachial plexus or of peripheral nerves in the forearm. The type of block will be recorded in the case reporting form

(5) Surgery and Intra-operative anaesthesia management
Surgical and anaesthesia management intra-operatively is pragmatic and is at the discretion of the treating clinical teams
Intervention code [1] 329230 0
Treatment: Devices
Comparator / control treatment
Control groups: Medication therapy as usual (Medication). Medication group patients will have intravenous access secured, then provided with sedation (benzodiazepines with/without propofol) for their regional anaesthesia procedure.

Medication Group procedures
The medication group received treatment as usual:
Some patients may have been prescribed oral anxiolytic medications prior to being brought into the anaesthetic bay as a pre-medication for their intravenous cannulation, usually based on a pre-surgical discussion between the patient and the anaesthetic team.

After patients have intravenous access secured, anaesthetists normally give a dose of benzodiazepines (usually midazolam with/without a short acting opioid such as fentanyl or alfentanil; and less commonly propofol or ketamine) for procedural anxiolysis prior to performing a nerve block. These doses will be recorded in the case reporting form.

The medical procedures are otherwise performed as per the VR group. APAIS will be recorded from patients after intravenous cannulation and after the nerve block.
Control group
Active

Outcomes
Primary outcome [1] 339221 0
Anxiety
Timepoint [1] 339221 0
assessed immediately after regional anaesthesia procedure
Secondary outcome [1] 439120 0
post operative anxiety
Timepoint [1] 439120 0
Day 2 post-operative
Secondary outcome [2] 439121 0
Quality of Recovery
Timepoint [2] 439121 0
Day 2 post-operative
Secondary outcome [3] 439125 0
anxiety
Timepoint [3] 439125 0
after IV cannulation approximately 30min prior to surgery
Secondary outcome [4] 439126 0
cumulative opioid consumption
Timepoint [4] 439126 0
Day 2 postoperative

Eligibility
Key inclusion criteria
Adult patients (>18yo) scheduled for awake day-stay hand surgery under regional anaesthesia (nerve block)
Sufficient English proficiency to understand the study protocol, ask questions, answer the questionnaires, and competent to provide informed consent
Be able to be followed up at Day 2 post-operative
There is no restriction to age or gender.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients scheduled for hand surgery under general anaesthesia.

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)
Computer generated concealed randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated concealed randomisation
1:1 allocation in blocks of 4
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/02/2025
Actual
Date of last participant enrolment
Anticipated
26/01/2026
Actual
Date of last data collection
Anticipated
29/01/2026
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27032 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 43101 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 317134 0
Hospital
Name [1] 317134 0
Department of Anaesthesia Liverpool Hospital
Country [1] 317134 0
Australia
Primary sponsor type
Government body
Name
South West Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 319401 0
None
Name [1] 319401 0
Address [1] 319401 0
Country [1] 319401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315886 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315886 0
https://www.swslhd.health.nsw.gov.au/ethics/
Ethics committee country [1] 315886 0
Australia
Date submitted for ethics approval [1] 315886 0
19/07/2024
Approval date [1] 315886 0
07/08/2024
Ethics approval number [1] 315886 0
2024/ETH01446

Summary
Brief summary
This randomised controlled trial of VR versus traditional care using pharmacological anxiolytics aims to test the hypothesis that immersive VR distraction is non-inferior to drug therapy when used to provide peri-operative anxiolysis for patients admitted for hand surgery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136098 0
Dr Alwin Chuan
Address 136098 0
Liverpool Hospital Cnr of Elizabeth and Goulbourn St, Liverpool NSW 2170
Country 136098 0
Australia
Phone 136098 0
+61 2 8738 3173
Fax 136098 0
Email 136098 0
[email protected]
Contact person for public queries
Name 136099 0
Dr Alwin Chuan
Address 136099 0
Liverpool Hospital Cnr of Elizabeth and Goulbourn St, Liverpool NSW 2170
Country 136099 0
Australia
Phone 136099 0
+61 2 8738 3173
Fax 136099 0
Email 136099 0
[email protected]
Contact person for scientific queries
Name 136100 0
Dr Alwin Chuan
Address 136100 0
Liverpool Hospital Cnr of Elizabeth and Goulbourn St, Liverpool NSW 2170
Country 136100 0
Australia
Phone 136100 0
+61 2 8738 3173
Fax 136100 0
Email 136100 0
[email protected]

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
24168Ethical approval2024   388260-(Uploaded-28-08-2024-12-56-54)-ETH01446_ Application HREA - Approved-Ethics[52].pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.