Virtual Reality in Wide-Awake Hand Surgery

NCT06817057 | Withdrawn

• 1 other identifier: 292555
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Virtual Reality; Upper Extremity Problem

Keywords

Virtual Reality; VR; Wide-Awake Hand Surgery; WAHS; Upper Extremity; Upper Limb; Local Anaesthesia; Regional Anaesthesia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Intraoperative Heart Rate

  Intraoperative (<1 day)

• Intraoperative Blood Pressure

  Intraoperative (<1 day)

• Additional Intraoperative Anaesthetic Doses

  Intraoperative (<1 day)

• Additional Intraoperative Sedative Doses

  Intraoperative (<1 day)

• Surgeon-reported Level of Comfort Performing the Operation

  Intraoperative score measured in the immediate postoperative period (<1 day)

Study Arms (2)

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.

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.

Interventions

Virtual Reality headset + headphones DEVICE

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.

Also known as: Oculus Quest 2 Virtual Reality Headset + Beats Ep Wired On-Ear Headphones

WITH Virtual Reality headset + headphones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share