NCT06962046 Can the Use of Virtual Reality Improve TKA Outcomes
| NCT ID | NCT06962046 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Belfast Health and Social Care Trust |
| Condition | Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-10-16 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Patients ≥ 18 years old who are American Society of Anaesthesiologists (ASA) grade 1 or 2 scheduled for routine primary elective knee arthroplasty. Exclusion Criteria: * 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.
Contact & Investigator
David Johnston
PRINCIPAL INVESTIGATOR
Belfast Health and Social Care Trust
Frequently Asked Questions
Who can join the NCT06962046 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06962046 currently recruiting?
Yes, NCT06962046 is actively recruiting participants. Contact the research team at nicola.gallagher@belfasttrust.hscni.net for enrollment information.
Where is the NCT06962046 trial being conducted?
This trial is being conducted at Belfast, United Kingdom.
Who is sponsoring the NCT06962046 clinical trial?
NCT06962046 is sponsored by Belfast Health and Social Care Trust. The principal investigator is David Johnston at Belfast Health and Social Care Trust. The trial plans to enroll 40 participants.