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The Efficacy of using Virtual Reality for peri-operative anxiety during regional anaesthesia: A non-inferiority randomised controlled trial

The Efficacy of using Virtual Reality for peri-operative anxiety during regional anaesthesia: A non-inferiority randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001212549
Enrollment
28
Registered
2024-10-03
Start date
2025-02-25
Completion date
2026-01-26
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

(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 w

(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

Sponsors

South West Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Patients scheduled for hand surgery under general anaesthesia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026