An interventional study of Virtual Reality in Total Knee Arthroplasty, sponsored by Belfast Health and Social Care Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Belfast Health and Social Care Trust · Not applicable, Interventional, and Treatment
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.
Total joint arthroplasty (TJA) is a successful surgical intervention to reduce pain and immobility from osteoarthritis. Mortality rates following TJA are low and survival has been increasing over the last two and a half decades despite an ageing population with a higher frequency of comorbidities.
Perioperative virtual reality (VR) is a non-pharmacological technique which has been used effectively to avoid sedative pre-medication, increase patient satisfaction and alleviate procedural pain during nerve blocks. VR has been successfully utilised across different medical specialties to reduce patient anxiety associated with interventions including magnetic resonance imaging (MRI), physical therapy, dental pain, and change of burns dressings. Furthermore, a trend towards less propofol sedation with use of VR has been found in spinal anaesthetic for hip, knee and ankle operations, with no decrease in patient satisfaction. However, this small pilot study did not investigate any other outcomes other than type and amount of sedation and duration of surgery. VR use has also been shown to reduce fentanyl dose, midazolam use and pain in elective total knee arthroplasty (TKA) patients who received a pre-operative adductor canal catheter. Satisfaction of patient, surgeon and anaesthetist has also been compared when using VR and using sedation with midazolam in patients undergoing urologic surgery under spinal anaesthesia. The patient and anaesthetist satisfaction scores were significantly higher in the VR group than in the sedation group.
Sedation is associated with a number of post-operative complications including nausea, hypo/hypertension, lower respiratory tract infection, cardiac arrhythmias, peripheral nerve damage, and post-operative delirium (PD). Nausea is a common occurrence following surgery with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. Dose dependent hypotension is the common complication in patients who have received propofol sedation, particularly in volume depleted patients. A common cardiovascular complication during anaesthesia is arrhythmia, with 70% of patients having arrhythmia undergoing general anaesthesia for various surgical procedures. Further complications associated with propofol, although more uncommon, include hypertriglyceridemia, pancreatitis and allergic complications.
The incidence of PD is generally higher after hip fracture surgery (4-53.3%) compared to elective hip surgery (3.6-28.3%). Independent risk factors for developing inpatient delirium include dementia, age, visual impairment, functional impairment and increased comorbidities. While most studies measuring effect of propofol on sleep disturbance and PD have focussed on the critical care setting, light propofol sedation (to target a bispectral index (BIS) >80) decreased the prevalence of PD by 50% compared to deep sedation (BIS target of 50) in patients undergoing hip surgery with spinal anaesthesia. A further RCT investigated whether limiting propofol sedation with spinal anaesthesia in non-elective hip fracture repair patients reduced risk of delirium post-operatively. Patients were randomised to receive either heavier sedation (modified observer's assessment of alertness/sedation score (OAA/S) of 0-2) or lighter sedation (OAA/S of 4-5). There were no significant differences in risk of incident delirium between the heavier and lighter sedation groups. However, when stratified by Charlson comorbidity index (CCI), in low comorbid states, heavier sedation levels doubled the risk of delirium compared to lighter sedation. This randomised controlled trial (RCT) recruited hip fracture patients with a mean age of 82 years. Therefore, a similar study should be conducted in younger, less comorbid patients undergoing elective joint arthroplasty.
Sedation can also affect recovery following surgery. Being male, nausea, vomiting and pain during the ward stay have been reported to be risk factors for poor quality of recovery after sedation with midazolam for lower limb orthopaedic surgeries. Poor quality of recovery following surgery can also increase hospital stay and health care resources. No significant difference in quality of recovery has been reported between those who experienced immersive VR and those who underwent conventional care.
Propofol infusions are commonly administered alongside spinal anaesthesia for orthopaedic surgery. It is commonly given with no specific objective clinical target end point. This gives rise to the potential of administering excess propofol which may result in inadvertent deep levels of sedation. This can cause prolonged periods of inadvertent general anaesthesia depth during 'regional' cases (often without insertion of an airway device). Therefore, it is important to investigate potential ways of lowering propofol infusions during surgery, without increasing patient risk, anxiety or pain, such as through the use of VR.
Aims of Study
The aims of this pilot study are to determine:
Belfast Health and Social Care Trust is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Virtual Reality
Standard Care
* VR * Spinal anaesthesia * Limited propofol aiming for OAA/S of 4-5 (light sedation)
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.
Time frame: Postoperative Day 1
4AT
The 4AT includes alertness, Abbreviated Mental Test 4 (AMT4), attention and acute change or fluctuating course. A score of 4 or above indicates possible delirium and/or cognitive impairment, a score of 1-3 indicates possible cognitive impairment and a score of 0 indicates that delirium or severe cognitive impairment is unlikely.
Time frame: 1 hour, 24 hours and 48 hours following skin closure.
Logical Memory subtest of the WMS-IV UK
The Logical Memory subtest of the WMS-IV UK will be used to assess memory recall pre-operatively, at 1 hour (+/- 30 minutes) in recovery and at 24 hours (+/- 2 hours) following skin closure. Logical Memory I assesses narrative memory under a free recall condition. Logical Memory II is a delayed condition assessing long-term narrative memory with free recall and recognition tasks.
Time frame: 1 hour and 24 hours following skin closure.
Total Propofol during operation
Total propofol administered during the operation will be recorded in mg/kg.
Time frame: 1 hour following skin closure.
E-entropy
The e-entropy system uses a disposable 4-electrode sensor on the patient\'s forehead to measure electrical activity in the brain before using a proprietary algorithm to process the electroencephalogram data and calculate a number between 0 (absence of brain electrical activity) and 100 (wide awake) providing an objective measure of the patient's depth of consciousness. The average e-entropy score during the operation will be recorded by calculating a mean of the trend data from the monitor log.
Time frame: 1 hour following skin closure.
Discharge from Recovery
The time until ready for discharge from recovery will be recorded using the NEWS criteria. The time point that the following objectives are met will also be recorded; spinal regression below T4, temperature ≥36 degrees, pain score \<3, nausea score between 0-1 and NEWS criteria ≤ 3.
Time frame: Every 15 minutes in recovery up until 2 hours.
Mobilisation
Mobilisation will be assessed by a physiotherapist using the Timed Up and Go (TUG) test at 4 hours (+/- 1 hour) following skin closure. This will be recorded as the time in seconds which it takes a patient to stand up from a chair with armrests, walk 3 metres at a comfortable and safe pace, turn, walk back to the chair and sit back down again.
Time frame: 4 hours following skin closure.
Quality of Recovery
Quality of recovery will be measured using the Quality of Recovery (QoR)-15 survey (Appendix 4) at 4 hours (+/- 1 hour) and at 24 hours (+/- 2 hours) following skin closure. The QoR-15 score ranges from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).
Time frame: 4 hours (+/- 1 hour) and at 24 hours (+/- 2 hours) following skin closure.
IV fluids
Total IV fluids will be measured in ml/kg for the duration of the patient's hospital stay.
Time frame: Up to 1 week post operation.
Length of stay
Total length of stay will be calculated using date of discharge and date of operation.
Time frame: Up to 1 week post operation.
Post-operative analgesia
Patient notes will be assessed retrospectively for post-operative analgesia. Type and total dose of analgesia taken on each post operative 24 hour period up until discharge or up until 1 week post operation will be recorded.
Time frame: Up to 1 week post operation.
Anti-emetic use
Patient notes will be assessed retrospectively for anti-emetic use. Type and total dose of anti-emetics taken on each post operative 24 hour period up until discharge or up until 1 week post operation will be recorded.
Time frame: Up to 1 week post operation.
Any inpatient complications
Patient notes will be assessed retrospectively for any inpatient complications including vasovagal, fall, arrthymia, bleed, take back, and escalation of care.
Time frame: Up to 1 week post operation.
Plan to share: No
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Belfast Health and Social Care Trust