Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia

Study Overview
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Brief Summary
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By means of an investigator-initiated, monocentric, single-blinded, prospective, randomized controlled superiority trial, the effect of virtual reality (VR) therapy on patients undergoing ambulatory hand surgery under ultrasound-guided regional nerve block will be investigated. It is hypothesized that the usage of VR during the placement of the nerve block in ambulatory hand surgery patients provides a significant decrease in pain score during anesthesia compared to without VR glasses. Additionally, an objective stress related parameter (HRV), anxiety, VR experience (immersion and presence), adverse effects and patient satisfaction are evaluated before anesthesia, during anesthesia and surgery or after surgery through validated questionnaires or measurements.

Detailed Description
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Ultrasound-guided regional anesthesia (RA) is the golden standard in ambulatory superficial hand surgery due to its safety and reliability. Frequently used RA techniques are ultrasound-guided distal peripheral nerve block of the n. medianus and n. ulnaris is and ultrasound-guided axillary nerve block of the n. medianus, n. ulnaris, n. radialis, and n. musculocutaneous. The needling is frequently accompanied by stress, fear or anxiety and it has been proven in studies that psychological factors can affect the sensation of pain. At this moment systemic opioids and/or sedatives used, however, these partially neutralize the benefits of locoregional techniques. Virtual reality (VR) is a non-pharmacologic and non-invasive simulation in which the user can interact within a 3D-computer-generated environment using special glasses with a screen and a headset. VR offers the ability to distract patients from reality and can therefore relieve a pain sensation from harmful stimuli. An important aspect of pain reduction in VR is presence and immersion. The physical/sensory stimulus offered by the artificial environment is referred to as immersion. Presence can be defined as one's sense of being in an artificial environment. The VR glasses of the firm Oncomfort called Sedakit™ have been proven to be safe and effective in previous clinical trials. A VR program namely 'Aqua', has been provided and designed for relaxation and distraction from anxiety or pain of patients. Current literature is lacking objective parameters of stress within an operative, anesthesiologic framework. One of these objective stress-related parameters of is heart rate variability (HRV). HRV is the fluctuation of the length between consecutive heart beats and refers to the heart's ability to react to a wide range of physiological and environmental stimuli such as stress. HRV can be measured by the Empatica E4 wristband. The proposed study, performed at the Jessa hospital, will assess the effect of VR glasses on pain levels of hand surgery patients during placement of the nerve block and surgery by comparing a group with VR glasses to without VR glasses. It is hypothesized that the usage of VR during the placement of the nerve block in ambulatory hand surgery patients provides a significant decrease in pain score during anesthesia compared to without VR glasses. Additionally, an objective stress related parameter (HRV), anxiety, VR experience (immersion and presence), adverse effects and patient satisfaction are evaluated before anesthesia, during anesthesia and surgery or after surgery through validated questionnaires or measurements.

Official Title
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Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia: A Randomized Controlled Superiority Trial.

Conditions
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Hand Injuries, Anesthesia, Local, Surgery

Intervention / Treatment
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* Device: The Sedakit Oncomfort VR glasses (30-minutes Aqua program)
* Procedure: Ultrasound-guided regional nerve block and hand surgery without VR glasses
* Procedure: Ultrasound-guided regional nerve block and hand surgery with VR glasses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years and <65 years ASA (American Society of Anesthesiology) classification: 1 - 3 Patient scheduled for ambulatory hand surgery using ultrasound-guided axillary block regional anesthesia or ultrasound-guided peripheral nerve block. Exclusion Criteria: Bilateral surgery BMI ≥ 40 kg/m² Motion sickness Patient that take medication that affects heart rhythm (beta-blockade) Infection in the area for peripheral nerve block injections. Existing neurological conditions. Chronic pain symptoms Opioid use within the past 3 months Allergy to local anesthetics Inability to experience the VR glasses experience (Vision disorders) Inability to understand study design or mental impairment Patients with autonomic nervous system dysfunction Pregnancy Heart transplant patients, patients with diabetic neuropathy, patients with myocardial infarction (or having passed through it) and/or tetraplegic patients Fear of being under water Sea sickness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-guided regional nerve block and hand surgery without VR glasses<br>Patients will not receive the VR glasses during the ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery. | Procedure: Ultrasound-guided regional nerve block and hand surgery without VR glasses<br>* During placement of ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery, patients are NOT subjected to a 30-minutes VR program (Oncomfort SA, Wavre, Belgium) 'Aqua' via a head-mounted display and headphone.<br>|
| Experimental: Ultrasound-guided regional nerve block and hand surgery with VR glasses<br>Patients will receive the VR glasses during the ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery. | Device: The Sedakit Oncomfort VR glasses (30-minutes Aqua program)<br>* During placement of ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery, patients are subjected to a 30-minutes VR program (Oncomfort SA, Wavre, Belgium) 'Aqua' via a head-mounted display and headphone. The patients watch a VR underwater view of the ocean while listening to speeches to induce relaxation and meditation.<br>Procedure: Ultrasound-guided regional nerve block and hand surgery with VR glasses<br>* Ultrasound-guided regional nerve block and hand surgery with VR glasses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain due to the placement of the ultrasound-guided regional anesthesia block: Numeric Rating Scale (NRS) | Pain caused by performing the anesthesia technique (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable) | Procedure (At the end of performing the ultrasound-guided regional anesthesia block) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain due to the surgery: Numeric Rating Scale (NRS) | Pain caused by performing the hand surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable) | Intraoperative (At the end of surgery) | 
| Stress: Heart rate variability (HRV) | Heart rate variability (HRV), is the fluctuation of the length between consecutive heart beats in milliseconds and is regulated by the autonomic nerve system. It determines the balance between the parasympathetic 'rest and digest' and sympathetic 'flight or fight' nerve systems. The sympathetic branch decreases HRV during stressful situations, while the parasympathetic branch increases HRV at rest. This natural interplay between the two systems allows the heart to quickly respond to different stimuli, including stress. HRV (being RMSSD and HF-HRV), is measured during placement of an ultrasound-guided regional anesthesia block and surgery through the Empatica E4 wristband (Photoplethysmography). | Before performing the ultrasound-guided regional anesthesia block for 5 minutes in rest (baseline), procedure (during performing the ultrasound-guided regional anesthesia block ) and minute 0 - 5 during the surgical procedure. | 
| Anxiety due to placement of the ultrasound-guided regional anesthesia block: Numeric Rating Scale (NRS) | Anxiety caused by performing the anesthesia technique (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable) | Procedure (At the end of performing the ultrasound-guided regional anesthesia block) | 
| Anxiety due to the surgery: Numeric Rating Scale (NRS): Numeric Rating Scale (NRS) | Anxiety caused by performing the hand surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable) | Intraoperative (At the end of surgery) | 
| Pre-surgical anxiety (Surgical Fear Questionnaire) | Pre-surgical anxiety for the anesthesia and surgery (measured with the Surgical Fear Questionnaire) | Arrival at the 1 day clinic | 
| VR experience: Immersion and presence (Igroup questionnaire) | An important aspect of pain reduction in VR is presence and immersion. The physical/sensory stimulus offered by the artificial environment is referred to as immersion. Presence can be defined as one's sense of being in an artificial environment. | Intraoperative (At the end of surgery) | 
| Adverse effects (Simulation Sickness Questionnaire and Virtual Reality Symptom Questionnaire) | Adverse effects (dizziness, headache, motion sickness, postoperative nausea and vomiting, fatigue, claustrophobia) are evaluated by the virtual reality symptom questionnaire (VRSQ) and Simulator sickness questionnaire (SSQ). | Intraoperative (At the end of surgery) | 
| Opiod use peroperatively | Rescue medication in case of block failure. | Intraoperative (At the end of surgery) | 
| Patient satisfaction (7-point Likert scale) | Patient satisfaction measured with the Patient Satisfaction Questionnaire and a 7-point Likert scale for measuring satisfaction rates with anesthesia, surgery and VR experience. | Intraoperative (At the end of surgery) | 
| Needling time | The time from injection of the needle to the removal of the needle. | Procedure (During performing the ultrasound-guided regional anesthesia block) | 
| Surgical time | The time from incision to surgical completion | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality glasses, Heart rate variability