Clinical trial NCT06817057: Virtual Reality in Wide-Awake Hand Surgery
Official title: The Effect of Virtual Reality on the Patient Experience During Wide-Awake Hand Surgery: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Virtual Reality
Upper Extremity Problem
Keywords: Virtual Reality
VR
Wide-Awake Hand Surgery
WAHS
Upper Extremity
Upper Limb
Local Anaesthesia
Regional Anaesthesia
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Patient-reported Pain Score
timeFrame: Intraoperative score measured in the immediate postoperative period (<1 day)
measure: Patient-reported Discomfort Score
timeFrame: Intraoperative score measured in the immediate postoperative period (<1 day)
measure: Patient-reported Anxiety Score
timeFrame: Intraoperative score measured in the immediate postoperative period (<1 day)
measure: Patient-reported Relaxation Score
timeFrame: Intraoperative score measured in the immediate postoperative period (<1 day)
measure: Patient-reported Satisfaction Score
timeFrame: Intraoperative score measured in the immediate postoperative period (<1 day)
Secondary outcomes:
measure: Intraoperative Heart Rate
timeFrame: Intraoperative (<1 day)
measure: Intraoperative Blood Pressure
timeFrame: Intraoperative (<1 day)
measure: Additional Intraoperative Anaesthetic Doses
timeFrame: Intraoperative (<1 day)
measure: Additional Intraoperative Sedative Doses
timeFrame: Intraoperative (<1 day)
measure: Surgeon-reported Level of Comfort Performing the Operation
timeFrame: Intraoperative score measured in the immediate postoperative period (<1 day)
measure: Surgeon-reported Level of Comfort Communicating with Assistant Surgeon
timeFrame: Intraoperative score measured in the immediate postoperative period (<1 day)
measure: Surgeon-reported Level of Comfort Calling for Help
timeFrame: Intraoperative score measured in the immediate postoperative period (<1 day)
Other outcomes:
Locations:
Study officials:
References: