Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
The Efficacy of using Virtual Reality for peri-operative anxiety during regional anaesthesia: A non-inferiority randomised controlled trial
Query!
Secondary ID [1]
312701
0
nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Anxiety during medical procedures
334727
0
Query!
Condition category
Condition code
Anaesthesiology
331288
331288
0
0
Query!
Anaesthetics
Query!
Mental Health
331679
331679
0
0
Query!
Anxiety
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
329230
0
Treatment: Devices
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
339221
0
Anxiety
Query!
Assessment method [1]
339221
0
Amsterdam Preoperative Anxiety and Information Scale (APAIS) scores
Query!
Timepoint [1]
339221
0
assessed immediately after regional anaesthesia procedure
Query!
Secondary outcome [1]
439120
0
post operative anxiety
Query!
Assessment method [1]
439120
0
APAIS scores
Query!
Timepoint [1]
439120
0
Day 2 post-operative
Query!
Secondary outcome [2]
439121
0
Quality of Recovery
Query!
Assessment method [2]
439121
0
QoR-15 scores
Query!
Timepoint [2]
439121
0
Day 2 post-operative
Query!
Secondary outcome [3]
439125
0
anxiety
Query!
Assessment method [3]
439125
0
APAIS scores
Query!
Timepoint [3]
439125
0
after IV cannulation approximately 30min prior to surgery
Query!
Secondary outcome [4]
439126
0
cumulative opioid consumption
Query!
Assessment method [4]
439126
0
oral morphine equivalents (mg)
morphine use will be recorded using hospital records
Query!
Timepoint [4]
439126
0
Day 2 postoperative
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Patients scheduled for hand surgery under general anaesthesia.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated concealed randomisation
Query!
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
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
25/02/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
26/01/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
29/01/2026
Query!
Actual
Query!
Sample size
Target
28
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
27032
0
Fairfield Hospital - Prairiewood
Query!
Recruitment postcode(s) [1]
43101
0
2176 - Prairiewood
Query!
Funding & Sponsors
Funding source category [1]
317134
0
Hospital
Query!
Name [1]
317134
0
Department of Anaesthesia Liverpool Hospital
Query!
Address [1]
317134
0
Query!
Country [1]
317134
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
South West Sydney Local Health District
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
319401
0
None
Query!
Name [1]
319401
0
Query!
Address [1]
319401
0
Query!
Country [1]
319401
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315886
0
South Western Sydney Local Health District Human Research Ethics Committee
Query!
Ethics committee address [1]
315886
0
https://www.swslhd.health.nsw.gov.au/ethics/
Query!
Ethics committee country [1]
315886
0
Australia
Query!
Date submitted for ethics approval [1]
315886
0
19/07/2024
Query!
Approval date [1]
315886
0
07/08/2024
Query!
Ethics approval number [1]
315886
0
2024/ETH01446
Query!
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
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
136098
0
Dr Alwin Chuan
Query!
Address
136098
0
Liverpool Hospital Cnr of Elizabeth and Goulbourn St, Liverpool NSW 2170
Query!
Country
136098
0
Australia
Query!
Phone
136098
0
+61 2 8738 3173
Query!
Fax
136098
0
Query!
Email
136098
0
[email protected]
Query!
Contact person for public queries
Name
136099
0
Dr Alwin Chuan
Query!
Address
136099
0
Liverpool Hospital Cnr of Elizabeth and Goulbourn St, Liverpool NSW 2170
Query!
Country
136099
0
Australia
Query!
Phone
136099
0
+61 2 8738 3173
Query!
Fax
136099
0
Query!
Email
136099
0
[email protected]
Query!
Contact person for scientific queries
Name
136100
0
Dr Alwin Chuan
Query!
Address
136100
0
Liverpool Hospital Cnr of Elizabeth and Goulbourn St, Liverpool NSW 2170
Query!
Country
136100
0
Australia
Query!
Phone
136100
0
+61 2 8738 3173
Query!
Fax
136100
0
Query!
Email
136100
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24168
Ethical approval
2024
388260-(Uploaded-28-08-2024-12-56-54)-ETH01446_ Application HREA - Approved-Ethics[52].pdf
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.
Download to PDF