Virtual Reality in Wide-Awake Hand Surgery (VR-WAHS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Virtual Reality; Upper Extremity Problem
• Intervention / Treatment: Device: Virtual Reality headset + headphones

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written, informed consent provided prior to the occurrence of any study procedures;
2. Aged 18 years or above;
3. Undergoing a planned day-case operation involving the upper limb for any indication, under either local or regional anaesthesia.

Exclusion Criteria:

1. Suffer from claustrophobia, seizures or vertigo;
2. Have an active infection or open wound on the face;
3. Require droplet or airborne infection precautions;
4. 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);
5. Have a pacemaker or any other implanted medical device;
6. Are allergic to any materials on the VR headset or headphones (e.g. the VR headset facial interface foam).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WITH Virtual Reality headset + headphones; 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.	Device: Virtual Reality headset + 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.; Other Names: Oculus Quest 2 Virtual Reality Headset + Beats Ep Wired On-Ear Headphones
No Intervention: WITHOUT Virtual Reality headset + headphones; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	Intraoperative score measured in the immediate postoperative period (<1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Heart Rate	Mid-procedure heart rate measured in beats per minute	Intraoperative (<1 day)
Intraoperative Blood Pressure	Mid-procedure systolic and diastolic blood pressure measured in millimetres of mercury	Intraoperative (<1 day)
Additional Intraoperative Anaesthetic Doses	The type, dose and concentration of any additional doses of local anaesthesia given to the patient intraoperatively	Intraoperative (<1 day)
Additional Intraoperative Sedative Doses	The type, dose and concentration of any (additional) doses of sedative medication given to the patient intraoperatively	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.	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.	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.	Intraoperative score measured in the immediate postoperative period (<1 day)

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2020
• Primary Completion (Estimated): March 1, 2021
• Study Completion (Estimated): April 1, 2021

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Virtual Reality; Upper Extremity; Regional Anaesthesia; Upper Limb; VR; Local Anaesthesia; Wide-Awake Hand Surgery; WAHS
• Other Study ID Numbers: 292555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No identifiable personal patient data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No