Total Knee ArthroplastyVR-TKANCT06962046
Can the Use of Virtual Reality Improve TKA Outcomes
A study testing Virtual Reality in people with Total Knee Arthroplasty, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Virtual Reality
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old who are American Society of Anaesthesiologists (ASA) grade 1 or 2 scheduled for routine primary elective knee arthroplasty.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Musgrave Park Hospital
Belfast
Nicola Gallagher, 02895043746, nicola.gallagher@belfasttrust.hscni.net
Janet Hill, 02895046799, janet.hill@belfasttrust.hscni.net
About this study
Official title: Can the Use of Virtual Reality Improve Outcomes Following Total Knee Arthroplasty With Spinal Anaesthesia? - A Pilot Study
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.
Read the detailed description
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:
- the feasibility of using VR during TKA with spinal anaesthesia.
- what outcomes, if any, can be influenced using VR during TKA with spinal anaesthesia.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityProcedure or surgery
- VR
- Spinal anaesthesia
- Limited propofol aiming for OAA/S of 4-5 (light sedation)
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Not described Receives: Procedure: Virtual Reality |
| Control | No intervention | Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 1
Secondary outcomes (12)
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.
Measured: 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.
Measured: 1 hour and 24 hours following skin closure.
Total Propofol during operation
Total propofol administered during the operation will be recorded in mg/kg.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 1 week post operation.
Length of stay
Total length of stay will be calculated using date of discharge and date of operation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 week post operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start16 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single centred, parallel group, randomised controlled tria
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Johnston, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962046
- Sponsor's protocol ID
- 19066DJ-SW
- Acronym
- VR-TKA
- Status last verified
- Jan 2025
- First submitted
- 28 Aug 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamel MB, Toth M, Legedza A, Rosen MP. Joint replacement surgery in elderly patients with severe osteoarthritis of the hip or knee: decision making, postoperative recovery, and clinical outcomes. Arch Intern Med. 2008 Jul 14;168(13):1430-40. doi: 10.1001/archinte.168.13.1430.
PubMed 18625924Lalmohamed A, Vestergaard P, de Boer A, Leufkens HG, van Staa TP, de Vries F. Changes in mortality patterns following total hip or knee arthroplasty over the past two decades: a nationwide cohort study. Arthritis Rheumatol. 2014 Feb;66(2):311-8. doi: 10.1002/art.38232.
PubMed 24504803Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.
PubMed 27906757Pandya PG, Kim TE, Howard SK, Stary E, Leng JC, Hunter OO, Mariano ER. Virtual reality distraction decreases routine intravenous sedation and procedure-related pain during preoperative adductor canal catheter insertion: a retrospective study. Korean J Anesthesiol. 2017 Aug;70(4):439-445. doi: 10.4097/kjae.2017.70.4.439. Epub 2017 Mar 15.
PubMed 28794840Brown RKJ, Petty S, O'Malley S, Stojanovska J, Davenport MS, Kazerooni EA, Fessahazion D. Virtual Reality Tool Simulates MRI Experience. Tomography. 2018 Sep;4(3):95-98. doi: 10.18383/j.tom.2018.00023.
PubMed 30320208Ashmore J, Di Pietro J, Williams K, Stokes E, Symons A, Smith M, Clegg L, McGrath C. A Free Virtual Reality Experience to Prepare Pediatric Patients for Magnetic Resonance Imaging: Cross-Sectional Questionnaire Study. JMIR Pediatr Parent. 2019 Apr 18;2(1):e11684. doi: 10.2196/11684.
PubMed 31518319Carrougher GJ, Hoffman HG, Nakamura D, Lezotte D, Soltani M, Leahy L, Engrav LH, Patterson DR. The effect of virtual reality on pain and range of motion in adults with burn injuries. J Burn Care Res. 2009 Sep-Oct;30(5):785-91. doi: 10.1097/BCR.0b013e3181b485d3.
PubMed 19692911Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102.
PubMed 19955069Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5.
PubMed 18325675Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169.
PubMed 28598921Moon JY, Shin J, Chung J, Ji SH, Ro S, Kim WH. Virtual Reality Distraction during Endoscopic Urologic Surgery under Spinal Anesthesia: A Randomized Controlled Trial. J Clin Med. 2018 Dec 20;8(1):2. doi: 10.3390/jcm8010002.
PubMed 30577461Inverso G, Dodson TB, Gonzalez ML, Chuang SK. Complications of Moderate Sedation Versus Deep Sedation/General Anesthesia for Adolescent Patients Undergoing Third Molar Extraction. J Oral Maxillofac Surg. 2016 Mar;74(3):474-9. doi: 10.1016/j.joms.2015.10.009. Epub 2015 Oct 16.
PubMed 26546845Amornyotin S. Sedation-related complications in gastrointestinal endoscopy. World J Gastrointest Endosc. 2013 Nov 16;5(11):527-33. doi: 10.4253/wjge.v5.i11.527.
PubMed 24255744De Gaudio AR, Rinaldi S. Sedation in PACU: indications, monitoring, complications. Curr Drug Targets. 2005 Nov;6(7):729-40. doi: 10.2174/138945005774574542.
PubMed 16305450Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469.
PubMed 20042557
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Use of Virtual Reality Improve Outcomes Following Total Knee Arthroplasty With Spinal Anaesthesia? - A Pilot Study
- ClinicalTrials.gov ID
- NCT06962046
- Acronym / sponsor ID
- VR-TKA / 19066DJ-SW
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- the feasibility of using VR during TKA with spinal anaesthesia.
- what outcomes, if any, can be influenced using VR during TKA with spinal anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single centred, parallel group, randomised controlled tria
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Procedure: Virtual Reality |
| Control | No intervention | –Standard Care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥ 18 years old who are American Society of Anaesthesiologists (ASA) grade 1 or 2 scheduled for routine primary elective knee arthroplasty.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality* VR * Spinal anaesthesia * Limited propofol aiming for OAA/S of 4-5 (light sedation) | Procedure or surgery | Virtual Reality |
Primary outcome
Feasibility of using VR during total knee arthroplasty with spinal anaesthesia
Time frame: Postoperative Day 1
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.
12 secondary outcomes
4AT
Time frame: 1 hour, 24 hours and 48 hours following skin closure.
Logical Memory subtest of the WMS-IV UK
Time frame: 1 hour and 24 hours following skin closure.
Total Propofol during operation
Time frame: 1 hour following skin closure.
E-entropy
Time frame: 1 hour following skin closure.
Discharge from Recovery
Time frame: Every 15 minutes in recovery up until 2 hours.
Mobilisation
Time frame: 4 hours following skin closure.
Quality of Recovery
Time frame: 4 hours (+/- 1 hour) and at 24 hours (+/- 2 hours) following skin closure.
IV fluids
Time frame: Up to 1 week post operation.
Length of stay
Time frame: Up to 1 week post operation.
Post-operative analgesia
Time frame: Up to 1 week post operation.
Anti-emetic use
Time frame: Up to 1 week post operation.
Any inpatient complications
Time frame: Up to 1 week post operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Background: PubMed 18625924Hamel MB, Toth M, Legedza A, Rosen MP. Joint replacement surgery in elderly patients with severe osteoarthritis of the hip or knee: decision making, postoperative recovery, and clinical outcomes. Arch Intern Med. 2008 Jul 14;168(13):1430-40. doi: 10.1001/archinte.168.13.1430.
- Background: PubMed 24504803Lalmohamed A, Vestergaard P, de Boer A, Leufkens HG, van Staa TP, de Vries F. Changes in mortality patterns following total hip or knee arthroplasty over the past two decades: a nationwide cohort study. Arthritis Rheumatol. 2014 Feb;66(2):311-8. doi: 10.1002/art.38232.
- Background: PubMed 27906757Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.
- Background: PubMed 28794840Pandya PG, Kim TE, Howard SK, Stary E, Leng JC, Hunter OO, Mariano ER. Virtual reality distraction decreases routine intravenous sedation and procedure-related pain during preoperative adductor canal catheter insertion: a retrospective study. Korean J Anesthesiol. 2017 Aug;70(4):439-445. doi: 10.4097/kjae.2017.70.4.439. Epub 2017 Mar 15.
- Background: PubMed 30320208Brown RKJ, Petty S, O'Malley S, Stojanovska J, Davenport MS, Kazerooni EA, Fessahazion D. Virtual Reality Tool Simulates MRI Experience. Tomography. 2018 Sep;4(3):95-98. doi: 10.18383/j.tom.2018.00023.
- Background: PubMed 31518319Ashmore J, Di Pietro J, Williams K, Stokes E, Symons A, Smith M, Clegg L, McGrath C. A Free Virtual Reality Experience to Prepare Pediatric Patients for Magnetic Resonance Imaging: Cross-Sectional Questionnaire Study. JMIR Pediatr Parent. 2019 Apr 18;2(1):e11684. doi: 10.2196/11684.
- Background: PubMed 19692911Carrougher GJ, Hoffman HG, Nakamura D, Lezotte D, Soltani M, Leahy L, Engrav LH, Patterson DR. The effect of virtual reality on pain and range of motion in adults with burn injuries. J Burn Care Res. 2009 Sep-Oct;30(5):785-91. doi: 10.1097/BCR.0b013e3181b485d3.
- Background: PubMed 19955069Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102.
- Background: PubMed 18325675Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5.
- Background: PubMed 28598921Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169.
- Background: PubMed 30577461Moon JY, Shin J, Chung J, Ji SH, Ro S, Kim WH. Virtual Reality Distraction during Endoscopic Urologic Surgery under Spinal Anesthesia: A Randomized Controlled Trial. J Clin Med. 2018 Dec 20;8(1):2. doi: 10.3390/jcm8010002.
- Background: PubMed 26546845Inverso G, Dodson TB, Gonzalez ML, Chuang SK. Complications of Moderate Sedation Versus Deep Sedation/General Anesthesia for Adolescent Patients Undergoing Third Molar Extraction. J Oral Maxillofac Surg. 2016 Mar;74(3):474-9. doi: 10.1016/j.joms.2015.10.009. Epub 2015 Oct 16.
- National Early Warning Score (NEWS)Link provided by the sponsor.
- Pearson Education Ltd. Wechsler Memory Scale - Fourth UK Edition (WMS-IV UK).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Johnston principal investigator
Belfast Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Total Knee Arthroplasty, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Gallagher (02895043746, nicola.gallagher@belfasttrust.hscni.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using VR during total knee arthroplasty with spinal anaesthesia (time frame: Postoperative Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06962046, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.