Virtual Reality in Wide-Awake Hand Surgery

Not Applicable

Withdrawn

• Conditions: Virtual Reality; Upper Extremity Problem

• Registration Number: NCT06817057
• Lead Sponsor: Barts & The London NHS Trust

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12
• Primary Completion: 2021-03
• Study Completion: 2021-04
• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient-reported Discomfort Score	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	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	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 Pain Score	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 Satisfaction Score	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.

Secondary Outcome Measures

Name	Time	Method
Intraoperative Heart Rate	Intraoperative (<1 day)	Mid-procedure heart rate measured in beats per minute
Intraoperative Blood Pressure	Intraoperative (<1 day)	Mid-procedure systolic and diastolic blood pressure measured in millimetres of mercury
Additional Intraoperative Anaesthetic Doses	Intraoperative (<1 day)	The type, dose and concentration of any additional doses of local anaesthesia given to the patient intraoperatively
Surgeon-reported Level of Comfort Performing the Operation	Intraoperative score measured in the immediate postoperative period (<1 day)	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.
Additional Intraoperative Sedative Doses	Intraoperative (<1 day)	The type, dose and concentration of any (additional) doses of sedative medication given to the patient intraoperatively
Surgeon-reported Level of Comfort Communicating with Assistant Surgeon	Intraoperative score measured in the immediate postoperative period (<1 day)	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.
Surgeon-reported Level of Comfort Calling for Help	Intraoperative score measured in the immediate postoperative period (<1 day)	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.