Virtual RealityVR-WAHSNCT06817057
Virtual Reality in Wide-Awake Hand Surgery
A study testing Virtual Reality headset + headphones in people with Virtual Reality and Upper Extremity Problem, run by Barts & The London NHS Trust.
Trial summary
The vast majority of hand surgery performed at the Royal London Hospital is carried out with patients wide-awake. This is either using local or regional (brachial block) anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Upper Extremity Problem
- What is being tested?
- Virtual Reality headset + headphones
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written, informed consent provided prior to the occurrence of any study procedures;
- Aged 18 years or above;
- Undergoing a planned day-case operation involving the upper limb for any indication, under either local or regional anaesthesia.
Who cannot join
- Suffer from claustrophobia, seizures or vertigo;
- Have an active infection or open wound on the face;
- Require droplet or airborne infection precautions;
- Have eyesight or hearing problems that would impair the audio-visual experience of using VR (e.g. if the patient plans to wear hearing aids or eyeglasses during the operation);
- Have a pacemaker or any other implanted medical device;
- Are allergic to any materials on the VR headset or headphones (e.g. the VR headset facial interface foam).
About this study
Official title: The Effect of Virtual Reality on the Patient Experience During Wide-Awake Hand Surgery: A Randomised Controlled Trial
The vast majority of hand surgery performed at the Royal London Hospital is carried out with patients wide-awake. This is either using local or regional (brachial block) anaesthesia. A high proportion of patients find the process stressful and intimidating, which can lead to intraoperative anxiety and increased requirements for anaesthetic dosages. Most of the hand surgery lists are primarily performed by trainees under consultant supervision: conscious, aware, and anxious patients can hinder the degree of training that can take place intra-operatively. Trainees requesting for assistance can further contribute to patient anxiety levels. Virtual Reality (VR) is a relatively new technology that allows total immersion in audio-visual entertainment. Early research work has demonstrated a positive effect of VR at reducing patient anxiety and analgesia requirements during invasive procedures. The investigators hope to conduct a research study whereby adult patients undergoing wide-awake hand surgery under the care of the Department of Plastic Surgery at the Royal London Hospital are given a VR headset (the Oculus Quest 2) and headphones to wear during their operation. The investigators aim to compare their levels of perceived pain, discomfort, anxiety, relaxation and satisfaction with the intraoperative experience to patients who undergo the same operation without VR, i.e. under the conditions of standard care. The investigators will also look at the patients' additional anaesthetic requirements during the operation and physiological markers of anxiety, like heart rate and blood pressure. The operating surgeon will be given the opportunity to answer questions regarding their levels of comfort performing the operation, communicating with their assistant surgeon and calling for help if required. The investigators believe the use of VR will have a positive effect on the patient experience and will improve training opportunities for junior surgeons.
- Conditions
- Virtual Reality, Upper Extremity Problem
- Being tested
- Virtual Reality headset + headphones
- Keywords
- Virtual Reality, VR, Wide-Awake Hand Surgery, WAHS, Upper Extremity, Upper Limb, Local Anaesthesia, Regional Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality headset + headphonesDevice
Also called Oculus Quest 2 Virtual Reality Headset + Beats Ep Wired On-Ear Headphones
The intervention involves patient use of a Virtual Reality headset (the Oculus Quest 2) and headphones (Beats Ep Wired On-Ear) during their wide-awake hand operation.
| Study group | Role | What they receive |
|---|---|---|
| WITH Virtual Reality headset + headphones | Experimental | Participants in the VR arm will undergo wide-awake hand surgery while using an Oculus Quest 2 Virtual Reality headset and Beats Ep Wired On-Ear headphones for the duration of the operation, as an adjunct to standard local or regional anaesthesia. Receives: Device: Virtual Reality headset + headphones |
| WITHOUT Virtual Reality headset + headphones | No intervention | Participants in the non-VR arm will undergo wide-awake hand surgery under the conditions of routine intraoperative care, that is under local or regional anaesthesia without any adjuncts, such as the Virtual Reality headset, headphones, or any other form of distraction or relaxation strategy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Pain Score
This will be measured by asking participants to rate their level of intraoperative pain along a 100-mm long visual analogue scale (0 - 100).
Measured: Intraoperative score measured in the immediate postoperative period (<1 day)
Patient-reported Discomfort Score
This will be measured by asking participants to rate their level of intraoperative discomfort along a 100-mm long visual analogue scale.
Measured: Intraoperative score measured in the immediate postoperative period (<1 day)
Patient-reported Anxiety Score
This will be measured by asking participants to rate their level of intraoperative anxiety along a 100-mm long visual analogue scale.
Measured: Intraoperative score measured in the immediate postoperative period (<1 day)
Patient-reported Relaxation Score
This will be measured by asking participants to rate their level of intraoperative relaxation along a 100-mm long visual analogue scale.
Measured: Intraoperative score measured in the immediate postoperative period (<1 day)
Patient-reported Satisfaction Score
This will be measured by asking participants to rate their level of overall satisfaction with their intraoperative experience along a 100-mm long visual analogue scale.
Measured: Intraoperative score measured in the immediate postoperative period (<1 day)
Secondary outcomes (7)
Intraoperative Heart Rate
Mid-procedure heart rate measured in beats per minute
Measured: Intraoperative (<1 day)
Intraoperative Blood Pressure
Mid-procedure systolic and diastolic blood pressure measured in millimetres of mercury
Measured: Intraoperative (<1 day)
Additional Intraoperative Anaesthetic Doses
The type, dose and concentration of any additional doses of local anaesthesia given to the patient intraoperatively
Measured: Intraoperative (<1 day)
Additional Intraoperative Sedative Doses
The type, dose and concentration of any (additional) doses of sedative medication given to the patient intraoperatively
Measured: Intraoperative (<1 day)
Surgeon-reported Level of Comfort Performing the Operation
This will be measured by asking the operating surgeon to rate their level of comfort performing the operation along a 100-mm long visual analogue scale.
Measured: Intraoperative score measured in the immediate postoperative period (<1 day)
Surgeon-reported Level of Comfort Communicating with Assistant Surgeon
This will be measured by asking the operating surgeon to rate their level of comfort communicating with their assistant surgeon along a 100-mm long visual analogue scale.
Measured: Intraoperative score measured in the immediate postoperative period (<1 day)
Surgeon-reported Level of Comfort Calling for Help
This will be measured by asking the operating surgeon to rate their level of comfort calling for help from a more senior surgeon along a 100-mm long visual analogue scale.
Measured: Intraoperative score measured in the immediate postoperative period (<1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study startDec 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: Researchers left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817057
- Sponsor's protocol ID
- 292555
- Acronym
- VR-WAHS
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable personal patient data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on the Patient Experience During Wide-Awake Hand Surgery: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06817057
- Acronym / sponsor ID
- VR-WAHS / 292555
- Conditions
- Virtual Reality, Upper Extremity Problem
- Keywords
- Virtual Reality, VR, Wide-Awake Hand Surgery, WAHS, Upper Extremity, Upper Limb, Local Anaesthesia, Regional Anaesthesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Researchers left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 10 Feb 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.
The vast majority of hand surgery performed at the Royal London Hospital is carried out with patients wide-awake. This is either using local or regional (brachial block) anaesthesia. A high proportion of patients find the process stressful and intimidating, which can lead to intraoperative anxiety and increased requirements for anaesthetic dosages. Most of the hand surgery lists are primarily performed by trainees under consultant supervision: conscious, aware, and anxious patients can hinder the degree of training that can take place intra-operatively. Trainees requesting for assistance can further contribute to patient anxiety levels. Virtual Reality (VR) is a relatively new technology that allows total immersion in audio-visual entertainment. Early research work has demonstrated a positive effect of VR at reducing patient anxiety and analgesia requirements during invasive procedures. The investigators hope to conduct a research study whereby adult patients undergoing wide-awake hand surgery under the care of the Department of Plastic Surgery at the Royal London Hospital are given a VR headset (the Oculus Quest 2) and headphones to wear during their operation. The investigators aim to compare their levels of perceived pain, discomfort, anxiety, relaxation and satisfaction with the intraoperative experience to patients who undergo the same operation without VR, i.e. under the conditions of standard care. The investigators will also look at the patients' additional anaesthetic requirements during the operation and physiological markers of anxiety, like heart rate and blood pressure. The operating surgeon will be given the opportunity to answer questions regarding their levels of comfort performing the operation, communicating with their assistant surgeon and calling for help if required. The investigators believe the use of VR will have a positive effect on the patient experience and will improve training opportunities for junior surgeons.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WITH Virtual Reality headset + headphones | Experimental | Device: Virtual Reality headset + headphonesParticipants in the VR arm will undergo wide-awake hand surgery while using an Oculus Quest 2 Virtual Reality headset and Beats Ep Wired On-Ear headphones for the duration of the operation, as an adjunct to standard local or regional anaesthesia. |
| WITHOUT Virtual Reality headset + headphones | No intervention | –Participants in the non-VR arm will undergo wide-awake hand surgery under the conditions of routine intraoperative care, that is under local or regional anaesthesia without any adjuncts, such as the Virtual Reality headset, headphones, or any other form of distraction or relaxation strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written, informed consent provided prior to the occurrence of any study procedures;
- Aged 18 years or above;
- Undergoing a planned day-case operation involving the upper limb for any indication, under either local or regional anaesthesia.
Key exclusion criteria (6 listed)
- Suffer from claustrophobia, seizures or vertigo;
- Have an active infection or open wound on the face;
- Require droplet or airborne infection precautions;
- Have eyesight or hearing problems that would impair the audio-visual experience of using VR (e.g. if the patient plans to wear hearing aids or eyeglasses during the operation);
- Have a pacemaker or any other implanted medical device;
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 headset + headphonesAlso: Oculus Quest 2 Virtual Reality Headset + Beats Ep Wired On-Ear HeadphonesThe intervention involves patient use of a Virtual Reality headset (the Oculus Quest 2) and headphones (Beats Ep Wired On-Ear) during their wide-awake hand operation. | Device | WITH Virtual Reality headset + headphones |
Primary outcome
Patient-reported Pain Score
Time frame: Intraoperative score measured in the immediate postoperative period (<1 day)
This will be measured by asking participants to rate their level of intraoperative pain along a 100-mm long visual analogue scale (0 - 100).
Patient-reported Discomfort Score
Time frame: Intraoperative score measured in the immediate postoperative period (<1 day)
This will be measured by asking participants to rate their level of intraoperative discomfort along a 100-mm long visual analogue scale.
Patient-reported Anxiety Score
Time frame: Intraoperative score measured in the immediate postoperative period (<1 day)
This will be measured by asking participants to rate their level of intraoperative anxiety along a 100-mm long visual analogue scale.
Patient-reported Relaxation Score
Time frame: Intraoperative score measured in the immediate postoperative period (<1 day)
This will be measured by asking participants to rate their level of intraoperative relaxation along a 100-mm long visual analogue scale.
Patient-reported Satisfaction Score
Time frame: Intraoperative score measured in the immediate postoperative period (<1 day)
This will be measured by asking participants to rate their level of overall satisfaction with their intraoperative experience along a 100-mm long visual analogue scale.
7 secondary outcomes
Intraoperative Heart Rate
Time frame: Intraoperative (<1 day)
Intraoperative Blood Pressure
Time frame: Intraoperative (<1 day)
Additional Intraoperative Anaesthetic Doses
Time frame: Intraoperative (<1 day)
Additional Intraoperative Sedative Doses
Time frame: Intraoperative (<1 day)
Surgeon-reported Level of Comfort Performing the Operation
Time frame: Intraoperative score measured in the immediate postoperative period (<1 day)
Surgeon-reported Level of Comfort Communicating with Assistant Surgeon
Time frame: Intraoperative score measured in the immediate postoperative period (<1 day)
Surgeon-reported Level of Comfort Calling for Help
Time frame: Intraoperative score measured in the immediate postoperative period (<1 day)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No. No identifiable personal patient data will be shared with other researchers.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality headset + headphones in people with Virtual Reality and Upper Extremity Problem, run by Barts & The London NHS Trust.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Pain Score (time frame: Intraoperative score measured in the immediate postoperative period (<1 day)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025.