Can the Use of Virtual Reality Improve TKA Outcomes

NCT06962046 | Recruiting

• 1 other identifier: 19066DJ-SW
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual reality (VR) uses computer technology to create a three-dimensional environment which the user can explore and interact with. VR can be used to distract the patient during an operation and has been used to avoid sedative premedication, increase patient satisfaction and decrease pain during nerve blocks. VR used alongside spinal anaesthetic for hip, knee and ankle operations has shown a trend of less sedation being required with no decrease in patient satisfaction. The most common type of anaesthesia given during total knee arthroplasty (TKA) is spinal. Spinal anaesthesia is given unless there are complications or other conditions present, and general anaesthesia is given instead. General anaesthesia puts the patient to sleep during the operation, whereas spinal anaesthesia allows the patient to stay awake, but numbs the lower half of the body so no pain is felt. Sedation is usually given with spinal anaesthesia to make the patient relaxed and sleepy. Light sedation will allow the patient to be awake but relaxed, whereas deeper sedation means the patient is more likely to be asleep and less likely to recall what happened during the operation. Sedation can cause a number of side effects including nausea, vomiting, headache, drowsiness, pain, confusion, memory loss and breathing difficulties. In this study, all patients will receive spinal anaesthesia. Group 1 will receive VR and a light level of sedation, whilst Group 2 will not receive VR but will receive a deeper level of sedation (standard of care). When using VR during TKA, a lighter level of sedation should be required. This could help to reduce side effects and aid quicker patient recovery. This pilot study aims to investigate this further.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Feasibility of using VR during total knee arthroplasty with spinal anaesthesia

  Feasibility of using VR during total knee arthroplasty will be assessed by recruitment numbers to the study and staff and patients will be asked for their views of using the VR equipment.

  Postoperative Day 1

Secondary Outcomes (12)

• 4AT

  1 hour, 24 hours and 48 hours following skin closure.

• Logical Memory subtest of the WMS-IV UK

  1 hour and 24 hours following skin closure.

• Total Propofol during operation

  1 hour following skin closure.

• E-entropy

  1 hour following skin closure.

• Discharge from Recovery

  Every 15 minutes in recovery up until 2 hours.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Procedure: Virtual Reality

Control

NO INTERVENTION

Standard Care

Interventions

Virtual Reality PROCEDURE

* VR * Spinal anaesthesia * Limited propofol aiming for OAA/S of 4-5 (light sedation)

Virtual Reality

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old who are American Society of Anaesthesiologists (ASA) grade 1 or 2 scheduled for routine primary elective knee arthroplasty.

You may not qualify if:

• Patients who are ASA grade 3 or 4.
• Patients who cannot use VR e.g. those with dementia.
• Patients with an existing diagnosis of delirium.
• Patients with visual impairment if degree of myopia/hyperopia exceeds the corrective power of the VR headset.
• Patients with hearing aids.
• Patients with previous history of motion sickness.
• Patients with epilepsy, history of black outs or fitting.
• Patients who will have an operation over 1 hour in duration or any patient who requires more complex surgery.
• Patients who have requested no sedation during the operation.
• Patients who have received premedication.
• Patients who have a general anaesthetic.
• Patients who do not adequately understand verbal explanations or written information given in English, or who have special communication needs.
• Patients who are not capable of informed consent.

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead

Study Sites (1)

Musgrave Park Hospital

Belfast, United Kingdom

RECRUITING

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Related Links

• National Early Warning Score (NEWS)
• Pearson Education Ltd. Wechsler Memory Scale - Fourth UK Edition (WMS-IV UK).

Study Officials

• David Johnston

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Gallagher

CONTACT

02895043746; nicola.gallagher@belfasttrust.hscni.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single centred, parallel group, randomised controlled tria

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: May 8, 2025
• Study Start: October 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)